Prior to Conception: the role of an acupuncture protocol in enhancing women’s reproductive functioning
by
Suzanne Cochrane BSW, DTCM, BAS
A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy, Centre for Complementary Medicine Research, School of Science and Health, University of Western Sydney
16th July 2012
Statement of authentication
I declare that this thesis does not incorporate without acknowledgement any material previously submitted for a diploma or degree in any university, and that to the best of my knowledge it is original and does not contain any materials previously published or written by another person except where due reference is made in the text.
Suzanne Cochrane
July 2012
Preface
This thesis is a work in progress; it is a static time point (perhaps a way-station) in my journey to understand health and disease, and the contribution Chinese medicine has made and can make to the relief of human suffering. To practise Chinese medicine is such a privilege: to have a sense of thousands of careful, caring, thoughtful and insightful physicians throughout Asia (and beyond), over many centuries building a knowledge base that guides my actions in the immediacy of this patient at this time, is overwhelming. Their knowledge is felt in my body – how I stand, how I look at this person requiring my help, how I hold an acupuncture needle, how I touch another, how I write a herb prescription. On a good day, Sun Simiao, Zhang Zhongjing, Li Shizhen, Chris Madden, John MacDonald, Drs Guo and Hu from Hangzhou, Jane Lyttleton, Huang Yinkang, Ding Huiqin, Zhao Shihua (and many more) are all present, and all with opinions!
I may have remained in clinic plying my chosen trade had not personal losses launched me on an unknown trajectory. We can be undone by each other.
It is not as if an “I” exists independently over here and then simply loses a “you” over there, especially if the attachment to “you” is part of what composes who “I” am. If I lose you, under these conditions, then I not only mourn the loss, but I become inscrutable to myself. Who “am” I, without you?...At another level, perhaps what I have lost “in” you, that for which I have no ready vocabulary, is a relationality that is composed neither exclusively of myself nor you, but is to be conceived as the tie by which those terms are differentiated and related (Judith Butler quoted in (Dumm 2008:143)).
As Dumm goes on to say, grief sets in motion the idea of our dispossession from ourselves (2008:144). An exploration was begun and part of the expedition became a desire to understand the lack of congruence between what I understood as a Chinese medical reality and the reality held up as inviolate by scientific medicine. And, of course, great loneliness is inevitable in such a search – by definition. And yet the loss of relationality and the absence of a „ready vocabulary‟ at a personal level are also echoed in the disjunct between the performative knowledge of Chinese medicine and the empirical dictates of biomedical science. There is so little common language, there are so few shared spaces, and apparently so few open hearted and minded people willing to explore this territory. There are two outstanding guides that I have found.
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One is Professor Francois Jullien, a philosopher standing at the boundaries of Chinese and „Western‟ thought. He identifies the foundations of Chinese thinking as being deliberately indeterminate, careful not to construct and define –the tao, buried, is perceived as the hazy bottom of a deep body of water we gaze into from above (Jullien 2009:29). Existence is an emergence from an undifferentiated fount.
If the Chinese painter paints not some particular view but an entire landscape simultaneously emerging-submerging, appearing-disappearing, he does so to shake the beholder free from the cramped enclosure of an ego-subject constituting an autonomous fate for itself vis-à-vis the consistency of objects (Jullien 2009:28).
He insists that this „Chinese‟ view is not a different state of reality but at the „far edge of the sensible‟ – on a continuum of possible visibility. This means that we cannot „inquire after it all the way‟ and that seeing, hearing and touching, escaping the specification of the different sense organs, become indistinguishable (Jullien 2009:31). I take this to mean that those who follow the standard methods of science will fail to fully comprehend the vibrational vitality of qi and the relational dynamism of yin-yang because they cannot look out of the corner of the eye. An understanding of foundational Chinese medical (and philosophical) concepts requires „non-looking‟ – the way that can be known is not the way!
Breath-energy deploying in the great primordial void rises and falls, and moves unceasingly: such is the mainspring of empty and full, motion and rest, the starting point of yin and yang, of hard and malleable. Floating and rising: such is the limpidity of yang; lowering and descending: such is the disorder of yin. Through incitement and communication, gathering and dispersal, wind and rain, hail and snow are formed: both the flow of the multitude of existents and the union and fusion of mountains and streams. Down to the dregs of wine and the ash of the hearth, there is nothing of that which is not a lesson. - Zhang Zai (one of the first thinkers of the Song dynasty) quoted and translated in (Jullien 2009:135).
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The second guide to understanding these marginal „wild‟ lands with glimpses of other ways of seeing is the scientist Professor Karen Barad (Barad 2003; Barad 2007; Barad 2008). It is she who has brought me to an appreciation of diffractive methods – a method that focuses on the relationality rather than the objects. Diffractive methodologies place the „knower‟ or observer inside what is being sought to be known. Diffraction challenges the notions of objectivity and subjectivity and suggests that the patterns/configurations/intra-actions that differing ideas or relationships or bodies or objects make on and between each other is more informative than representation from an „external‟ independent observer. Representing the object or body as a fixed thing denies the fluidity of matter and how matter interacts and is understood.
When set free from my (old) life, I found myself standing between Chinese medicine and science, wanting to honour both through this research project. This is why translating across difference is the main concern of this thesis. Reproductive health was a topic of both urgency and interest for the women I worked with in clinic. It is also the area of Chinese medicine practice most „integrated‟ – that is, where there are overlaps between Chinese and biomedical practice and they are most in dialogue. This thesis is a search for methodologies – how do we practise research so that we can work out: 1. Whether Chinese medicine has an intervention (or many) that will assist women with trouble conceiving? 2. If we can pin down or define Chinese medicine enough, how do we research it? How do we research it in a way that retains the “Chinese medicine-ness” of its sensibility and practice? 3. If we can research in such a way as to honour Chinese medicine, how do we report it so that it will have meaning for biomedicine? Which part of biomedicine do we speak to? 4. What research tools are considered credible or valid for such an endeavour? Were the tools used in this study useful and to whom?
Barad, K. (2003). "Posthumanist performativity: Toward an understanding of how matter comes to matter." Signs: Journal of Women in Culture and Society 28(3): 801-831. Barad, K. (2007). Meeting the universe halfway: Quantum physics and the entanglement of matter and meaning. Durham, Duke University Press. Barad, K. (2008). Living in a posthumanist material world: lessons from Schrodinger's cat. Bits of life: Feminism at the intersections of media, bioscience and technology. A. Smelik and N. Lykke. Seattle, University of Washington Press. Dumm, T. (2008). Loneliness as a Way of Life. Cambridge & London, Cambridge University Press. Jullien, F. (2009). The Great Image Has No Form, On the Nonobject through Painting. Chicago & London, The University of Chicago Press.
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Acknowledgements Although a thesis dissertation is inevitably a solitary endeavour, it is also a collective project that requires an army of helpers to bring to fruition. My primary supervisor has been Associate Professor Caroline Smith, a very experienced acupuncture researcher. It is difficult to acknowledge clearly how important her guidance and support have been. Firstly, she gave me the „gig‟! Secondly, she has been actively and thoughtfully engaged with this research task. I know I have been a challenge to her and I have valued her ability to have me focus on the task at hand – again and again – and also to allow me to explore non-quantitative methodologies. If there is value in what I have produced she deserves a significant share of the credit. Dr Alphia Possamai-Inesedy has to be the gentlest yet most rigorous supervisor and qualitative researcher created. Her immediate acceptance of the request to join my supervisory panel speaks to her openness to work across the science-social science divide. I owe much to her preparedness to think outside her own „square‟. The rest of my supervisory panel comprised Professor Alan Bensoussan and Jane Lyttleton. Alan, although too busy to be very hands-on, created the space that allowed my research to happen – literally, by creating the Centre for Complementary Medicine Research and by facilitating a grant from the National Institute of Complementary Medicine that became the scholarship for my doctoral studies. And Alan has been at the forefront of bringing Chinese medicine and biomedicine to dialogue. Jane Lyttleton is my mentor. Without Jane my Chinese medicine life would have been diminished. She rescued me, as a beginning student from a disintegrating teaching institution. And on several occasions since, she has intervened to such good effect in my life. Jane does not need to do more than be herself for me to be in awe – she is the model of a Chinese medicine practitioner in the West without equal.
There are many people whom I want to acknowledge for their support of me and this project in these last few years (in no particular order and for many reasons): Anne Traynor, Vanessa Traynor, David Traynor, Rory O‟Brien, Mary Dimech, Annie Parkinson, Sue Bowrey, Annie Pfingst, Lynne Keevers, Lynne Dooley, Barbara Bloch, Alissar Gazal, Lyndal Sullivan, Ruth Ley, Sharon Callaghan, Kylie Willis, Luo Haiou, Zhu Xiaoshu, Kerry Carmody, Trudy Zipf, Volker Scheid, Cinzia Scorzon, Suzanne Grant, Stef Penkala, Rebecca Olsen, Dr Paul Fahey, Jan Jamieson and the Splendids. And I wish to acknowledge wholeheartedly the importance and generosity of the 56 women who volunteered to participate in this study. Without them and their open engagement none of this would have been possible.
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For very specific assistance I would like to thank Dr Ben Colagiuri (the expert communicator who is doomed to be the stats person – for me at least!), Micki MacDonald and Ros Priest (for their endless helpfulness and know-how) and Sandra Sewell (for her ongoing support and for her tireless patience copy editing this thesis). Heather Crawford was a great help as a research assistant and participating acupuncturist. I am very grateful for her data entry expertise. Tony Chianese and Helio Acupuncture Supplies provided the acupuncture needles for the clinical trial and are perennially supportive of acupuncture research and practice. Lastly I want to acknowledge my canine support, Sadie, my loved and loving companion through so much. And, of course, ABC Classic FM radio station for (nearly) everything they broadcast, and the Madura tea company for their sustenance.
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Prior to Conception: the role of an acupuncture protocol in enhancing women’s reproductive functioning
by Suzanne Cochrane BSW, DTCM, BAS
A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy, Centre for Complementary Medicine Research, School of Science and Health, University of Western Sydney January 2013
[1]
Statement of authentication I declare that this thesis does not incorporate without acknowledgement any material previously submitted for a diploma or degree in any university, and that to the best of my knowledge it is original and does not contain any materials previously published or written by another person except where due reference is made in the text. Suzanne Cochrane July 2012
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Contents List of Tables ...... 7 List of Figures and Illustrations ...... 8 Abbreviations ...... 9 Abstract ...... 10 Chapter 1: Setting the Context...... 12 Introduction ...... 12
The research opportunity ...... 12
Epidemiology of infertility and subfertility ...... 13 Causes and risk factors ...... 13 Determinants of fertility and infertility ...... 14 Main Categories of Infertility ...... 16
Ovulatory disorders ...... 16 Tubal problems ...... 17 Endometriosis ...... 18 Premature ovarian failure ...... 18 Unexplained infertility ...... 19 The impact on fertility of lifestyle, diet and exercise ...... 19
Conventional treatment and management options ...... 21
Primary Care ...... 21 Periconception Care ...... 24 Reproductive management of PCOS ...... 26 Reproductive management of Endometriosis ...... 26 Reproductive management of ovarian failure ...... 27 Reproductive management of tubal blockages ...... 27 Assisted Reproduction ...... 27 Experience of Infertility ...... 28
CAM use for fertility ...... 34
Overview of thesis ...... 35
Chapter 2 An overview of the role of Chinese medicine and the management of fertility ...... 37 Introduction ...... 37
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Chinese medical understanding of fertility ...... 37
Literature search strategy ...... 41
Acupuncture mechanisms of action ...... 41 Acupuncture for female reproductive disorders ...... 48 Menstrual regulation………………………………………………………………………….. 47
Ovulation…………………………………………………………………………………… 49
Menstrual pain…………………………………………………………………………………50
Premenstrual syndrome……………………………………………………………………… 51
Infertility………………………………………………………………………………………51
(a) Acupuncture and ART……………………………………………………………51
(b) Acupuncture and natural fertility…………………………………………………..56
Acupuncture research methods ...... 57 Complex intervention………………………………………………………………………….58
Comparative effectiveness……………………………………………………………………..60
Comparison interventions……………………………………………………………………. 61
Placebo………………………………………………………………………………………..61
Acupuncture dose……………………………………………………………………………..62
Expectation……………………………………………………………………………………62
Evidence and outcomes………………………………………………………………………..62
Qualitative perspectives………………………………………………………………………..63
Discussion…………………………………………………….………………………………64
Conclusion ...... 68
Chapter 3 Methodological overview & Theoretical frames ...... 69 Methodological choices ...... 69
Rationale for mixed methods ...... 71
Which methods mixed ...... 71
Quantitative methodology ...... 75
Pragmatic trials ...... 75 Qualitative methodology ...... 78
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Grounded theory ...... 80 Feminist Analysis & Research Methods ...... 81 Strengths & limitations of mixed methods ...... 85
Chapter 4: Developing a fertility acupuncture protocol ...... 88 Methodology...... 88
Acupuncture research protocols ...... 88 Phase 1 ...... 90 Phase 2 ...... 91 Results ...... 97
In-depth interviews [Phase 1] ...... 97 Results from online forum [Phase 2] ...... 101 Discussion ...... 108
Conclusions ...... 111
Chapter 5: Fertility acupuncture to improve health during preconception: a pragmatic randomised controlled trial ...... 112 Methodology...... 112
Study aim ...... 112 Research Plan and Methods ...... 113 Data Collection ...... 121 Results ...... 126
Recruitment ...... 126 Feasibility ...... 127 Participant flow ...... 130 Characteristics of women at trial entry ...... 132 Quality of life ...... 137 Trial outcomes ...... 139
Primary study endpoints ...... 139 Self-knowledge about fetrility and ovulation………………………………………………….137
Regularity of menstrual cycle…………………………………………………………………137
Reduced menstrual symptoms………………………………………………………………..138
Secondary study endpoints ...... 142 Time from study entry to conception………………………………………………………...140
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Biochemical pregnancy……………………………………………………………………….140
Quality of life changes………………………………………………………………………..141
Lifestyle changes……………………………………………………………………………..141
Outcomes relating to feasibility ...... 145 Reasons for study non-participation………………………………………………………….143
Participant compliance……………………………………………………………………….144
Study participant acupuncture attendance…………………………………………………….145
Patient acceptability and experience of study intervention……………………………………145
Acupuncturist compliance with treatment protocol…………………………………………..146
Adverse event outcomes……………………………………………………………………..146
TCM Diagnosis ...... 151 Discussion ...... 152
Trial outcomes ...... 153 Fertility awareness……………………………………………………………………………151
Measures of menstrual change……………………………………………………………..…152
Time to conception…………………………………………………………………………..154
BBT charting…………………………………………………………………………………154
MYMOP……………………………………………………………………………………...155
BMI…………………………………………………………………………………………..156
Lifestyle modification………………………………………………………………………...156
Experience of acupuncture…………………………………………………………………...157
Trial participants……………………………………………………………………………...158
Recruitment………………………………………………………………………..…………159
Randomisation………………………………………………………………………………..161
Expectancy…………………………………………………………………………………...161
Methodology…………………………………………………………………………………162
Future Research Directions ...... 166
Conclusion ...... 167
Chapter 6 Experiences of acupuncture...... 168
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In-depth Interviews ...... 168
Extended interview Results ...... 169 1. Embodied physical and responsive nature of acupuncture…………………………………172
a) Acupuncture, physicality and touching…………………………………………….172
b) Holism and cyclicity………………………………………………………………173
c) Embodiment……………………………………………………………………...174
d) Physical changes (Symptom relief)…………………………………………….…..177
2. The therapeutic relationship is uniquely constructed in acupuncture……………………….178
a) Therapeutic relationship…………………………………………………………...179
b) Imagination……………………………………………………………………….180
c) Trust………………………………………………………………………………181
d) Narratives…………………………………………………………………………182
3. Transformation after acupuncture is multi-faceted and complex…………………………...185
a) Transformation……………………………………………………………………185
b) Emotional change………………………………………………………………...187
c) Relaxation…………………………………………………………………………188
d) Self-identity……………………………………………………………………….189
e) Responsibility……………………………………………………………………...189
f) Reconceptualisation……………………………………………………………….190
Discussion ...... 194
Conclusion ...... 195
Chapter 7: Threads in the weave ...... 197 The meeting of biomedical and Chinese medical methods (and of quantitative and qualitative methods) ...... 198
Main findings from this exercise ...... 201
Findings about research questions ...... 200
Findings about the research methods ...... 201
Implications for theory ...... 204
Implications for policy and practice ...... 205
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Acupuncture Practice and Research ...... 206
Limitations ...... 207
Implications for further research ...... 208
Conclusion ...... 209
Literature cited ...... 211
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List of Tables
Table 1.1 Biomedical assessments of conditions that impact on female fertility………………..22 Table 2.1: Possible TCM diagnoses for female infertility with source text…………………..….37 Table 3.1 Key differences between trials with explanatory and pragmatic attitudes………..…..74
Table 4.1: Questions for Forum Discussion……………………………………...……………98
Table 4.2: Focus Group Participants………………...………………………………………..100
Table 4.3: Survey : Components of fertility acupuncture protocol for clinical practice……….102
Table 5.1: Recruitment information source nominated by participant at 1st contact………….124 Table 5.2: Age & fertility characteristics of women at trial entry to allocated treatment group.130
Table 5.3: Demographic & lifestyle characteristics of women at trial entry to allocated treatment group…………………….………………………………………………..132
Table 5.4 : Menstrual characteristics of women at trial entry ……….……………………….134
Table 5.5: Symptoms nominated on MYMOP questionnaires either as Symptom 1
or Symptom 2. …………………………………………………………..….………..134
Table 5.6.1 : Primary study endpoints by treatment group(A)…………..…………………….137
Table 5.6.2 : Primary study endpoints by treatment group(B)……………………...…………138
Table 5.6.3 : Primary study endpoints by treatment group(C)….……………………………..139
Table 5.7 : Secondary study endpoints by treatment group………..………………………….141
Table 5.8: Participant expectations of study………………………………………………….146
Table 5.9: What aspects of acupuncture care were important to you?...... 148 Table 5.10: TCM Diagnoses made at Recruitment Interview…………………………………149
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List of Figures and Illustrations
Figure 2.1: Flow chart of search strategies used of electronic data bases……………………….40
Figure 3.1 Mixed methodology sequential, phased quantitative and qualitative research process…………………………………………………………………………...….....72
Figure 4.1: Responses to ‗Fertility acupuncture should be a specialist endeavour requiring‘.….104
Figure 4.2: Responses to ‗Guiding diagnostic principles‘…………………………………..….104
Figure 4.3: Responses to ‗Differential diagnoses should include‘……..………………………105
Figure 5.1: Guidelines for choosing acupuncture points for treatments for trial acupuncturists……………………………………………………………………….116
Figure 5.2: Information source as indicator of participant meeting inclusion criteria ….…….125 Figure 5.3: Spread of 1st contact dates by information source…………………………...……126
Figure 5.4 Fertility acupuncture clinical trial flowchart of participants……………………….128
Figures 5.5 & 6 showing MYMOP profile ratings for acupuncture intervention (A) & lifestyle- only intervention (B) preintervention (left) and postintervention (right)……………………..142
Figure 6.1 Representation of relationships between themes that emerged from interviews…...170
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Abbreviations
AIVFSC Acupuncture IVF Support Clinic ART Assisted reproductive technologies BMI Body mass index CAM Complementary and alternative medicine CompleMED UWS Centre for Complementary Medicine Research CPR Clinical pregnancy rate EA Electroacupuncture fMRI Functional magnetic resonance imaging HSG hysterosalpingogram IVF In vitro fertilisation LBR Live birth rate MMR Mixed methods research MYMOP Measure Your Medical Outcomes Profile NICE National Institute for Health and Clinical Excellence NICM National Institute of Complementary Medicine NICMAN National Institute of Complementary Medicine Acupuncture Network NIH US National Institute of Health PID Pelvic Inflammatory Disease POF Premature ovarian failure PMS Premenstrual syndrome RCT Randomised controlled trial SBR Scientifically based research SR Systematic review STI Sexually transmitted infection STD Sexually transmitted disease UWS University of Western Sydney WM Western medicine
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Abstract
Background: Fertility has become a major presenting condition in both biomedical and Traditional Chinese Medicine (TCM) clinics. Estimates of the number of couples encountering fertility problems vary from one in six to one in ten. The biomedical response to female fertility problems is generally agreed to be invasive, stressful and expensive. Chinese medicine has also been treating female fertility problems using a range of methods throughout its history. Acupuncture is increasingly used as an adjunct to assisted reproductive technologies and more widely in the complementary health care system. This study sought to explore the potential contribution of an acupuncture protocol to enhancing female fertility. The following three stage research questions were posed: 1. What are the parametres of contemporary acupuncture practice in relation to female fertility and can a consensus be achieved among specialist practitioners on what constitutes an adequate acupuncture intervention to enhance women‘s reproductive functioning? 2. Does an acupuncture protocol administered prior to conception assist with female fertility outcomes? 3. Can the experience of women using acupuncture to promote their health in the period prior to conception shed light on our understandings of this intervention and future research directions? The research process used a mixed methodology through developing a protocol from the experiences of specialist practitioners, applying that protocol within a clinical trial to explore the use of acupuncture in the lead up to conception, and exploring the experiences of the women who received the acupuncture intervention.
Methods: The acupuncture protocol was developed by consensus from an online focus group of internationally-sourced acupuncturists specialising in fertility. The clinical trial was a pragmatic design: 56 women were randomised to two groups – one receiving a lifestyle-only intervention and the other acupuncture-plus-lifestyle – with the manualised acupuncture intervention responsive to participants‘ presentation at the time of treatment. Half of the acupuncture recipients were interviewed in depth after the intervention. A mixed methods research methodology offered a richer data set with which to examine the outcomes for the trial population and the individual experiences of an acupuncture intervention.
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Results: The acupuncture protocol developed by consensus was applied in the clinical trial without any difficulties reported by the participating acupuncturists. The results of the trial for the acupuncture recipients included significant changes in fertility awareness (adj.p=.011), quality of life scores (adj.p=.042), and personal agency measures (adj.p=.047). For these women there were also positive menstrual changes and halved times to conception. Participant reports reinforced the importance of wellbeing for women with fertility problems and the contribution acupuncture treatments make to a sense of personal transformation. The interviews also gave detailed explanations of trends in the trial data, for example, the trend toward increased menstrual regularity specifically meant several anovulatory women with polycystic ovary syndrome menstruated naturally. The data from the interviews brought new perspectives that elaborated or challenged the quantitative data. The participants in describing their responses to the acupuncture intervention related a complex story of change and transformation.
Conclusions: Mixed methodology research emerged as a useful approach to understanding a complex intervention such as acupuncture. This study points to acupuncture as a safe and beneficial preparation for conception. It also provides additional guidance to practice in that it tested a particular acupuncture protocol that treated according to time in the menstrual cycle, TCM and biomedical diagnosis, and presenting symptoms. The study results also confirm the importance of understanding acupuncture as an intervention that assists women to transform themselves. This thesis faces the challenge of interpreting a Chinese medical approach to the common and profound medical and personal dilemma of failed fertility to a biomedical science reader through the perspectives of the women who undertook the intervention. It concludes that knowledge is produced from diverse sources and diverse methodologies are required to understand how change occurs.
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Chapter 1: Setting the Context
Introduction This chapter provides an overview of the context of the research project. Fertility problems confront many couples in different yet shared ways and solutions are neither reliably accessible nor successful. Epidemiology, aetiology, standard management, lifestyle interventions, experience of infertility and the use of complementary and alternative therapies to treat fertility problems are the topics addressed here.
The research opportunity Chapters 1 and 2 provide the background and literature review that justify the research endeavour reported here. These chapters include an overview of current standard care of fertility problems, how these are experienced by consumer/patients and an assessment of current research approaches to exploring the role of acupuncture in this arena. What will emerge is a research gap that this study goes on to explore. A brief overview here will facilitate the reader‘s understanding of the research questions addressed in this study. The review of existing biomedical care of women suffering as a result of difficulty conceiving shows that they are not always being well-served by current interventions. The stressful nature of ART may aggravate the outcome or at least impair personal wellbeing at a time when a couple is trying to conceive and then build a family environment for a new baby.
The place of CAM in fertility care is evident from consumer use. Chinese medicine in particular has a long history of enhancing fertility of both men and women. The research question for this study is whether Chinese medicine, and acupuncture in particular, has an intervention that will enhance female fertility and assist women prior to conception. The contribution of Chinese medicine to female fertility is explored further in the next chapter.
The drivers of this pilot research project have been built out of this context and are framed in the following research questions which have evolved through three stages: 1. What are the parametres of contemporary acupuncture practice in relation to female fertility and can a consensus be achieved among specialist practitioners on what constitutes an adequate acupuncture intervention to enhance women‘s reproductive functioning?
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2. Does an acupuncture protocol administered prior to conception assist with female fertility outcomes? 3. Can the experience of women using acupuncture to promote their health in the period prior to conception shed light on our understandings of this intervention and future research directions?
Epidemiology of infertility and subfertility Infertility is a reproductive health disorder recognised by the World Health Organization that affects one in 10 couples in the world today and about one in 6 Australian couples [are] currently struggling with impaired fertility (Alfred and Ried 2011:718). Subfertility is usually defined as the involuntary failure to conceive or achieve a clinical pregnancy after 12 or more months of regular unprotected sexual intercourse. Infertility can also be subclassified as primary or secondary, depending on whether the woman has been pregnant before, irrespective of the outcome of that pregnancy (Zegers-Hochschild, Schwarze et al. 2008:578; Zegers-Hochschild, Adamson et al. 2009). Around 10–15% of couples have difficulty conceiving at some point in their reproductive lives and seek specialist fertility treatment (Evers 2002). In fact, the impact of reduced fertility is wide with the US National Survey of Fertility Barriers data set revealing that 51.8% of women aged 25 to 45 reported an episode of infertility at some point in their lives (Greil, McQuillan et al. 2011). Infertility is a confronting and difficult development for most women and their partners and can disrupt life plans and relationships. This may then impact on general health and well-being. For many couples, the inability to bear children is a tragedy. The conflux of personal, interpersonal, social, and religious expectations brings a sense of failure, loss, and exclusion to those who are infertile (Rutstein and Shah 2004:i49). Seeking resolution to sub/infertility will take women down paths that are often expensive, perhaps untested, can aggravate ill-health and only may deliver the long desired outcome of a live baby.
Causes and risk factors The major causes of subfertility are sperm factors (30%), ovulation disorder (25%) and fallopian tube damage (20%). About 15% of couples will have more than one cause for their subfertility (Cahill and Wardle 2002). For most couples history and examination will not indicate a cause and investigations will be required. Australian and New Zealand IVF data indicates that
of the 69,364 initiated autologous and recipient cycles [in 2009], 20.7% reported male infertility factors as the only cause of infertility; 34.6% reported only female infertility factor(s); 12.0% reported combined male–female factors; 27.6% reported unexplained infertility; and 5.1% were not stated. Male infertility
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factors (alone and combined with female infertility factor) were reported for 32.6% of cycles (Wang, Macaldowie et al. 2011:11-12). The component of female factors (34.6%) is represented by tubal disease only (5.5%), endometriosis only (5.2%), other female factor only (19.6%) and combined female factor (4.2%). Unexplained infertility presented with a high incidence of 27.6%. The authors report that there may not necessarily be consistent diagnoses across fertility centres. These data do not reflect the causes of infertility in the actual proportion of the general population, only those who receive assisted reproductive technology (ART) treatment cycles.
A different proportion of types of female factors emerged from a non-ART centre based survey of North American women reported in Zegers-Hochschild, Schwarze and Alam (2008). This report found ovulatory disorders accounted for 17.6%, tubal diseases for 23.1% and endometriosis 6.6%. In the Walcheron study in the Netherlands (of a distinct geographic population but argued by Zegers-Hochschild, Schwarze and Alam as demographically and socioeconomically representative of an industrialized Western society) the authors: followed a cohort of 726 couples during 2 to 10 years without interventions. Almost 10% (9.9%) of them presented with fertility complaints at least once during the cohort follow-up. Thirty percent were due to male factors, 25.9% had ovulation defects, 13% were tubal factors, and again there was a high incidence (30%) of unexplained infertility (Zegers-Hochschild, Schwarze et al. 2008:580).
Two major factors that influence prognosis and the likely response to the range of treatments available are the age of the female partner and the duration of infertility. In general, there is a decrease in fertility with age. Studies show a decrease in monthly fecundity beyond age 30 with a more significant decline after age 35. The causes of this age-related decrease in conception have to do with chromosomal abnormalities, spontaneous abortions, aging of oocytes and luteal phase defects that are characteristic findings among older women (Sela, Lehavi et al. 2011). Secondary infertility increases sharply with age, from about 5% at ages 20–24 to about 62% at ages 45–49 (Rutstein and Shah 2004). In terms of the duration of infertility, women who have not conceived after 2–3 years have a poorer prognosis without intervention.
Determinants of fertility and infertility As well as specific causes of subfertility and infertility in individual women, there are broader social determinants that influence fertility and infertility. There are different patterns of fertility and infertility according to in which country one is resident and to social status. Marriage and
[16] pregnancy take place at an earlier age in many countries other than the industrialised countries which results in women getting pregnant at the height of their fecundity. Because health services are less accessible and less sophisticated, early onset of secondary fertility problems that result from sexually transmitted infections (STI) or pregnancy and birth complications are more prevalent (Zegers-Hochschild, Adamson et al. 2009). Countries with the highest overall fertility are also those with the highest prevalence of infertility. Countries in northern Africa, southern Asia, and Latin America all report high incidence of secondary infertility, ranging from 15% to greater than 25% (Rutstein and Shah 2004).This also applies to the situation of the poorest in wealthy countries who constitute a ‗fourth world‘ and often live in similar conditions to women in so-called ‗third world‘ countries and experience a similar disease burden.
In OECD countries the factor that influences fertility most is postponement of childbearing (d‘Addio and d‘Ercole 2005). Structurally, this trend is influenced by: (i) higher education and employment of women, and changes in patterns of family formation; and (ii) shifting values of younger women towards a less traditional role of women within family and society. Women with paid jobs, with higher education and income, and who are not married have lower births than other women (d‘Addio and d‘Ercole 2005:4). Although childbearing is often cast as a private choice, public policy does influence fertility rates, and this same study identified through cross-country analysis that total fertility rates are higher in OECD countries with wider childcare availability, lower direct costs of children, higher part-time work availability and longer leaves.
Social trends in developed countries are seen to underlie the tendency toward fewer women having fewer births. It is often characterised in social commentary as women choosing a career over childrearing. The factors helping to initiate parenthood are more diverse (e.g., demographic, relational, social) than those causing delays in starting a family (career/socioeconomic)... However there is a lack of studies examining other predictors of reproductive decision making and behaviour, i.e. psychological and biological factors (Kalebic, Harrison et al. 2010:i49). There is little research about how men decide about becoming parents. These gaps in knowledge emphasise the need for prospective cross-cultural research with men and women that cover psychological, social and biological drivers. Hakim (2011) identifies social and economic changes as polarising women into three groups: work-centred or careerist, home or family-
[17] centred and adaptive women seeking a balance between employment and family work. She argues that We need data on women‘s personal preferences as regards employment and fertility, as well as data on their partner‘s preferences. This is not the same as collecting data on societal norms regarding fertility, sex-roles, and women‘s employment. These societal norms differ between countries, but display relatively little variation within countries, whereas personal preferences vary a great deal (Hakim 2011: 4).
In an international decision-making study in relation to fertility (Bunting, Tsibulsky et al. 2010), it was found that for help-seeking behaviour when a fertility problem emerges, both men and women had positive attitudes towards medical treatment. Their concerns and worries, however, especially fear of treatment and their lack of knowledge about the availability of free treatment, are genuine barriers to seeking medical treatment. There were no pervasive gender effects for attitudes towards treatment. For example, while both men and women agreed that fertility treatment is expensive and can cause emotional problems, women’s agreement was higher compared to men‘s. Country variations in fertility help-seeking is mainly about which information source and treatment is utilised rather than about attitudes to it (Bunting, Tsibulsky et al. 2010:i50).
Main Categories of Infertility There are a number of conditions that contribute to a diagnosis of infertility.
Ovulatory disorders Polycystic Ovary Syndrome (PCOS) accounts for more than 70% of anovulatory infertility and is thought to have a strong genetic component. This syndrome is a common complex condition in women and is evident through, and presents with, psychological, reproductive and metabolic features. As Teede, Deeks et al (2010) indicate, it is a chronic disease with manifestations across the lifespan and represents a major health and economic burden. Both hyperandrogenism and insulin resistance contribute to the pathophysiology of PCOS. Insulin resistance occurs in the majority of women with PCOS, especially those who are overweight, and these women have a high risk of metabolic syndrome, prediabetes and type 2 diabetes mellitus. Worsened quality of life, anxiety and depression in young women with PCOS is related to body mass index (BMI). Increased concerns about fertility, femininity and sexuality (significantly greater than those without PCOS) are expressed by young women with PCOS and this affects their quality of life negatively. Risk perception is appropriately high in PCOS, yet perceived risks of future metabolic complications are less common than those related to weight gain and infertility (Moran, Gibson-Helm et al. 2010:29).
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These authors argue that there is a direct relationship between perceived risk (of metabolic syndrome, cardiovascular disease, diabetes) and the capacity of women with PCOS to engage in necessary lifestyle changes which will positively impact on their condition.
Another anovulatory condition is hypothalamic pituitary failure (hypothalamic amenorrhoea or hypogonadotrophic hypogonadism). This group of disorders is characterised by low gonadotrophins, normal prolactin and low oestrogen, and it accounts for about 10% of ovulatory disorders. This type of disorder can be precipitated by weight loss, stress, narcotic drug use and extreme exercise. Failed ovarian follicular development results in hypo-oestrogenic amenorrhoea in this group of disorders [see ‗premature ovarian failure‘ below].
Tubal problems Tubal patency can be impaired by obstruction or blockage of the fallopian tubes by inflammation following pelvic infections, such as chlamydia or the presence of adhesions. Pelvic inflammatory disease (PID) is the most common cause of tubal disease, representing more than 50% of cases, and may affect the fallopian tube at multiple sites (Pandian, Akande et al. 2008). PID can be silent and the tubal blockage may only be identified when a tubal patency test is done to diagnose fertility problems. For example, in a sample of women attending an IVF clinic, swabs for chlamydia antibodies indicated that previous infections caused by these microorganisms may have resulted in permanent damage and occlusion of the fallopian tubes, although a significant number could not recall a PID (Svenstrup, Fedder et al. 2008).
As discussed above there are variations in estimates of the incidence of tubal disease in different studies (5.5% in the Wang et al sample, 23.1% in the North American study, 13.0% in the Walcheron study). Other literature confirms this inconsistency; for example, tubal disease of the fallopian tubes is responsible for 25% to 35% of female infertility (Pandian, Akande et al. 2008) and fallopian tube abnormalities account for up to 40% of female subfertility (Lim, Hasafa et al. 2011). Where tubal patency is affected by infection, it can be assumed that higher incidence will occur where there is a low adherence to safe sex practices and where early treatment of infection does not occur. In poorly industrialized countries … secondary infertility is very high due to pelvic infections associated with STDs. Pelvic infections due to Neisseria gonorrhea and Chlamydia trachomatis, acquired through sex or after abortions and deliveries, remain a major public health challenge.Their prevalence has constantly increased in the last 20 years (Zegers-Hochschild, Schwarze et al. 2008:582). As diagnosis relies on sophisticated equipment and invasive abdominal surgery, accurate diagnosis will only occur in countries that can support such a health care service.
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Endometriosis The incidence of endometriosis affects 10% of women in the general population and as many as 48% women suffering from subfertility (Borase, Hillman-Cooper et al. 2011). Ectopic endometrial tissue grows within the abdomen and there the endometrial cells respond to hormonal cycling without the capacity to discharge in the same fashion as uterine endometrial stroma cells. This results in cyst development, inflammation and scarring at the site of the deposit. Forty percent of cases are deposited in and around an ovary and/or the fallopian tube (Marchment 2007:122). It is more common in younger women and diagnosed following severe dysmenorrhoea or dyspareunia. It has become clear that a link exists between endometriosis and infertility (Prentice 2001). Of women with external endometriosis, 30-40% suffer infertility; however, endometriosis is a contributing rather than an absolute factor (Marchment 2007:123). In some cases, the scarring may completely block the passage of the egg to the uterus, but even women with milder forms of endometriosis can suffer from impaired fertility. Although a cause has not been established definitively, it is thought the presence of endometriosis in the abdominal cavity triggers an inflammatory response that changes the environment for reproductive function and impacts on sperm health.
As endometriosis can only be diagnosed by laparoscopy, the incidence and prevalence is not accurately known although it has been diagnosed in a significant proportion of teenagers. It is estimated to be present in from 5 to 15% of women (Farquhar 2007).
Premature ovarian failure Premature ovarian failure (POF) is characterised by amenorrhea, elevated follicle-stimulating hormone (FSH), and age under 40 years or hypergonadotrophic hypo-oestrogenic oligo- or amenorrhoea before the age of 40. This condition affects around 10% of women seeking treatment for secondary amenorrhoea (van Kasteren and Schoemaker 1999), has diverse aetiology, often cannot be accurately diagnosed, and is therefore given a diagnosis of idiopathic POF. The known causes include: (a) Genetic aberrations, which could involve the X chromosome or autosomes. …(b) Autoimmune ovarian damage, as suggested by the observed association of POF with other autoimmune disorders. Anti-ovarian antibodies are reported in POF by several studies…. (c) Iatrogenic following surgical, radiotherapeutic or chemotherapeutic interventions as in malignancies. (d)
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Environmental factors like viral infections and toxins for whom no clear mechanism is known (Goswami and Conway 2005:391).
The fertility implications are uncertain, with women with POF having a 5–10% chance of conceiving sometime after diagnosis without any evidence of high miscarriage rates. Age is not the only predictor of ovarian reserve, or the pool of follicles in the ovary. Previous pelvic surgeries, smoking habits, and genetic factors can also affect ovarian reserve. When matched by age, women with decreased ovarian reserve have a lower fertility rate when attempting pregnancy, lower pregnancy rate per cycle when undergoing low-complexity ART, and lower oocyte yield when undergoing high-complexity ART (Zegers-Hochschild, Schwarze et al. 2008:581). Assessment of ovarian reserve is imprecise and perhaps of little therapeutic value.
Unexplained infertility A significant proportion of fully investigated couples (around 20-30%) are unable to have a definitive diagnosis of their failure to conceive as there is no obvious cause. Data suggest that 40-50% of these couples will spontaneously conceive in the subsequent 12 months (O'Connor and Kovacs 2003:461) without intervention. It is not always possible to establish a direct relation between what can be considered an abnormal test and the cause of infertility. In fact, a study done in normal fertile couples reports that at least one infertility factor was present in two-thirds of cases (Zegers-Hochschild, Schwarze et al. 2008:583). Imprecise and uncertain knowledge of fertility leads to difficulty in diagnosis that then leads into the often unrewarded difficult task of treatment.
The impact on fertility of lifestyle, diet and exercise Much research on the relationship of a woman‘s diet and lifestyle on her fertility has focused on her being overweight, and many studies concentrate on obesity, anovulation and infertility (e.g.Clark, Thornley et al. 1998). The association between obesity and infertility in women has long been recognized. Epidemiological studies have demonstrated that in the fertile period of their life obese women frequently present with menstrual cycle alterations, chronic or intermittent anovulation and signs of androgen excess…. the presence of the abdominal phenotype of obesity represents an independent risk factor associated with a decreasing chance of conception in healthy adult women without evidence of PCOS or other hyperandrogenic states (Pasquali 2006:364).
There is evidence that obesity can also impair the outcome of assisted reproductive technologies (ART).
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The lower probability of a healthy liveborn described in obese women seems to be the result of a combination of lower implantation and pregnancy rates, higher preclinical and clinical miscarriage rate, and increased complication during pregnancy for both mother and fetus . Studies performed in infertile women undergoing ART indicate that the ovary plays a leading but not exclusive role in the fertility prognosis of these patients. The endocrine and metabolic environment may in fact affect oocyte quality and, therefore, embryo development, implantation and pregnancy outcome. The endometrium also seems to play a subtle role in the more negative reproductive outcome of obese women, according to the recent studies based on the ovum donation model (Pasquali 2006:366). A retrospective study by Wang et al indicated that, compared with the reference group women with a BMI in the normal range (BMI 18.5 to 24.9 kg/m2), underweight women had a similar risk of spontaneous abortion, whereas there was progressive increase of risk in overweight, obese, and very obese groups (p <0.05, p < 0.01, and p < 0.001, respectively) (Wang 2002). Tsagareli and colleagues (Tsarageli, Noakes et al. 2006) report that every third woman attending an IVF clinic in Australia is overweight, although they do not necessarily directly attribute her infertility to this excess weight.
Undertaking an evidence-based review of the impact of lifestyle factors on reproductive performance, Homan et al examined studies between 1988 and 2005. They found conclusive evidence that age, smoking and weight were adversely associated with impaired fertility. They further proposed: It is reasonable to assume that the general health benefits associated with moderate levels of exercise and the consumption of a well-balanced diet would also apply to fertility. These lifestyle approaches should therefore be recommended to couples attempting pregnancy. Further research is needed to clarify the effect that exercise may play on reproductive performance (Homan, Davies et al. 2007). Although the authors found inconclusive evidence to implicate other lifestyle factors, such as psychological stress, alcohol and caffeine, they considered it ‗biologically plausible‘ that these factors may affect reproductive performance. Nakamura and colleagues (2008) describe a hierarchy of biological mediators involved in a stress trigger to reproductive failure (with particular attention to early pregnancy loss). They report that epidemiological evidence presents positive correlations between various pregnancy failure outcomes with pre-conception negative life events and elevated daily urinary cortisol (Nakamura 2008:47). A Cochrane systematic review focused only on obesity in subfertile women (Oyesanya, van Wely et al. 2009) is currently underway and posits that: Normal body mass and composition favour fertility; as indicated by the achievement, maintenance, progression or normality of human conception. This may be related to the fact that extremes of body mass index (BMI) can affect reproductive and neuro-endocrinology; metabolism, folliculogenesis, oocyte quality,
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endometrial receptivity; and increase the risks of miscarriage and other problems in early and late pregnancy (Oyesanya, van Wely et al. 2009).
Most authors consider dietary intervention for overweight and underweight infertile women an important contribution. Also helpful are other lifestyle factors such as stress reduction, reduced caffeine and alcohol consumption, smoking cessation and improved food quality and fluid intake, although the evidence of fertility-specific outcomes are not yet conclusive.
Conventional treatment and management options
Primary Care General practitioners are frequently the first clinicians consulted about difficulty conceiving. Because 84% of couples fall pregnant within the first year (NICE 2004) of unprotected sexual activity, many are advised to keep trying unless specific difficulties are apparent or there is a history of prior problems conceiving. People who have not conceived after 1 year of regular unprotected sexual intercourse are generally offered further clinical investigation, including semen analysis and/or assessment of ovulation. The older the woman the more likely the physician will recommend immediate testing for reproductive abnormalities. As well as the increased risk of genetic difficulties with chromosomal disorders which may increase the likelihood of miscarriage, the older patient has had more time to develop pelvic adhesions secondary to untreated pelvic infection or occult endometriosis…. increased risk for ovulatory dysfunction and associated luteal phase abnormalities, [and] coital frequency often decreases with age (Whitman-Elia and Baxley 2001). Prompt evaluation of both partners is recommended in clinical guidelines.
Initial advice to couples - suggested as useful by a range of clinical guidelines (Whitman-Elia and Baxley 2001; NICE 2004; Balen and Rutherford 2007) - includes advice on the frequency and timing of sexual intercourse, advice to limit consumption of alcohol, cessation of smoking and reduction of caffeinated drinks (although the evidence for the latter is various). A discussion of body weight is recommended, and women with a BMI above 29 advised to reduce weight, particularly if they are anovulatory; if they are below BMI of 19, then they are advised to increase weight. Care is also recommended around exposure to occupational chemicals and practices such as long working hours that are indicated to reduce fertility. Investigation of the use of prescription, over-the-counter and recreational drugs is required to identify substances (such as nonsteroidal anti-inflammatories, NSAIDS) that have a known impact on fertility.
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Specific investigations to determine the possible causes of fertility problems are undertaken by either the general practitioner or, following referral, by a gynaecologist or fertility specialist. The following chart summarises likely investigations.
Table 1.1 Biomedical assessments of conditions that impact on female fertility Assessments Assessing ovulation .a blood test to measure serum progesterone in the midluteal phase of their cycle (day 21 of a 28-day cycle or later in cycle for those with long cycle) to confirm ovulation and repeated weekly thereafter until the next menstrual cycle starts.
.use of basal body temperature charts to confirm ovulation may be recommended (although it does not reliably predict ovulation).
.a blood test to measure serum gonadotrophins (follicle-stimulating hormone and luteinising hormone).
.a blood test to measure prolactin in women who have an ovulatory disorder, galactorrhoea or a pituitary tumour.
.tests of ovarian reserve (which currently have limited sensitivity and specificity in predicting fertility. However, women who have high levels of gonadotrophins should be informed that they are likely to have reduced fertility.)
.assessment of thyroid function (which should be confined to women with symptoms of thyroid disease). .an endometrial biopsy to evaluate the luteal phase as part of the investigation of fertility problems (because there is no evidence that medical treatment of luteal phase defect improves pregnancy rates). Screening for Chlamydia .before undergoing uterine instrumentation women should be offered screening for trachomatis Chlamydia trachomatis using an appropriately sensitive technique.
Assessing tubal damage . hysterosalpingography (HSG) or hysterosalpingo-contrast-ultrasonography to screen for tubal occlusion (because this is a reliable test for ruling out tubal occlusion, and it is less invasive and makes more efficient use of resources than laparoscopy).
.women who are thought to have comorbidities should be offered laparoscopy and dye so that tubal and other pelvic pathology can be assessed at the same time.
Assessing uterine .a hysteroscopy indicates uterine abnormalities abnormalities
Ovulation induction
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Antioestrogens .those with ovulation disorders (hypothalamic pituitary dysfunction) such as polycystic ovary syndrome should be offered treatment with clomifene citrate (or tamoxifen) as the first line of treatment for up to 12 months because it is likely to induce ovulation.
Metformin .anovulatory women with polycystic ovary syndrome who have not responded to clomifene citrate and who have a body mass index of more than 25 should be offered metformin combined with clomifene citrate because this increases ovulation and pregnancy rates.
Ovarian drilling .women with polycystic ovary syndrome who have not responded to clomifene citrate should be offered laparoscopic ovarian drilling because it is as effective as gonadotrophin treatment Gonadotrophin use in .those who do not ovulate with clomifene citrate (or tamoxifen) can be offered treatment ovulation induction therapy with gonadotrophins. for ovulatory disorders Pulsatile gonadotrophin- .women with ovulation disorders (hypothalamic pituitary failure, characterised by releasing hormone hypothalamic amenorrhoea or hypogonadotrophic hypogonadism) should be offered pulsatile administration of gonadotrophin-releasing hormone or gonadotrophins with luteinising hormone activity because these are effective in inducing ovulation.
Dopamine agonists .women with ovulatory disorders due to hyperprolactinaemia should be offered treatment with dopamine agonists such as bromocriptine Monitoring ovulation .ovarian ultrasound monitoring to measure follicular size and number should be an induction during integral part of patient management during gonadotrophin therapy to reduce the risk of gonadotrophin therapy multiple pregnancy and ovarian hyperstimulation
Tubal and uterine surgery Tubal microsurgery and .for women with mild tubal disease, tubal surgery may be more effective than no laparoscopic tubal surgery treatment
Tubal catheterisation or .for women with proximal tubal obstruction, selective salpingography plus tubal cannulation catheterisation, or hysteroscopic tubal cannulation may improve the chance of pregnancy.
Uterine surgery .women with intrauterine adhesions should be offered hysteroscopic adhesiolysis because this is likely to restore menstruation and improve the chances of pregnancy.
Medical and surgical management of endometriosis
Surgical ablation .women with minimal or mild endometriosis who undergo laparoscopy should be offered surgical ablation or resection of endometriosis plus laparoscopic adhesiolysis; women with ovarian endometriomas should be offered laparoscopic cystectomy; women with moderate or severe endometriosis should be offered surgical treatment
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Intrauterine insemination .couples with mild male factor fertility problems, unexplained fertility problems or minimal to mild endometriosis should be offered up to six cycles of intrauterine insemination because this increases the chance of pregnancy.
Table based on information taken from National Institute for Health and Clinical Excellence (NICE 2004).
These medical investigations and treatments, with the exception of intrauterine insemination rely on the continuation of sexual intercourse to achieve a pregnancy. The developments in the last several decades of assisted reproductive technologies (ART) have replaced this need with in vitro fertilisation (IVF) with some success. ART in particular has assisted couples with male factors and those women with tubal obstructions. For many reproductive conditions a complex intervention is required to achieve a successful outcome. For women with PCOS, for example, using a reproductive strategy which, in conjunction with specialist medical management, includes a lifestyle intervention has better results.
Periconception Care A review of literature follows in order to explore the use of lifestyle interventions, such as diet and exercise, in care prior to conception. Beyond interventions that correct specific reproductive conditions (detailed below), standard periconceptual care advice is limited. Maintaining good health, reducing stress and regular sexual intercourse is generally advised.
Healthy lifestyle behaviours are recognised to improve a healthy pregnancy and birth outcomes (Gardiner, Nelson et al. 2008) and have become embedded in prenatal care guidance (NICE 2010; Lum, Sundaram et al. 2011). A systematic review (Anderson, Norman et al. 2010) of the effect of preconception lifestyle advice on fertility outcomes found no randomised controlled trials (RCTs) that had assessed this issue. Body mass and constitutions that fall within the normal curve favour fertility, as indicated by the achievement of conception, the maintenance of pregnancy, and a successful live birth. This may be related to the fact that extremes of BMI can affect reproductive and neuro-endocrinology, metabolism, folliculogenesis, oocyte quality, endometrial receptivity, and can increase the risks of miscarriage and other problems in early and late pregnancy. There are specific links between obesity and fertility. Specialists working in the field of reproductive medicine are frequently confronted with overweight and obese subfertile women. It is assumed that their pregnancy chances are reduced, and that they might benefit from weight reduction (Mutsaerts, Groen et al. 2010). Obesity affects the body‘s capacity to make and
[26] use sex hormones; the resulting abnormalities can directly affect folliculogenesis and implantation. Increased adipose stores lead to hyperinsulinaemia and insulin resistance contributing to conditions such as PCOS. Obesity can also directly affect the functioning of the hypothalamic-pituitary-ovarian axis and it impacts on the ovary, uterus and the endometrium. Through altered leptin expression (in adipose tissue), obesity can affect the hypothalamic- pituitary-ovarian axis, gonads, placenta and the foetus (Oyesanya, van Wely et al. 2009). A recent study of 3,029 consecutive ovulatory infertile women has confirmed that for every BMI unit above the UK National Institute for Health and Clinical Excellence (NICE) threshold of 29kg/m2, the probability of pregnancy was reduced by 5% (van der Steeg, Steures et al. 2008).
There is some evidence emerging from longitudinal studies that diet does matter in relation to fertility. Polotsky and Houston (2009:42) argue that medical advice can reasonably suggest that anovulatory patients eat less animal protein, cut down on transunsaturated fats, and take multivitamins. They recommend caution as the studies these recommendations are based on are observational (Chavarro, Rich-Edwards et al. 2007; Chavarro, Rich-Edwards et al. 2007; Chavarro, Rich- Edwards et al. 2008). They argue that randomised clinical trials of purported fertility-promoting dietary alterations are needed before a more definite assessment can be made. As reported by Campagne (2006), there is ample evidence that lower stress levels mean better female and male natural fertility, though there is as yet no conclusive experimental evidence that lower stress levels result in better fertility treatment outcomes.
In a pilot study (Homan and Norman 2009) of couple‘s perception of lifestyle effects on fertility, most couples thought smoking and being over or underweight would adversely affect the chance of conceiving and a healthy pregnancy. Couples also perceived that taking recreational drugs and psychological stress would adversely affect the chance of conception, but were not as convinced about the effects of other lifestyle factors such as alcohol and caffeine consumption. Although most were taking some type of over the counter supplement, only half of the females were taking folic acid. The majority of participants wanted to make changes to their lifestyle, and common barriers included insufficient time, difficulties in finding an enjoyable exercise and lack of motivation.
Although no single pattern of adjustment to infertility appears common, a recent systematic review has identified several psychosocial factors that might make particular infertile individuals more vulnerable to stress. It is often a complex combination of factors which makes stress more difficult to manage. Gourounti, Anagnostopoulos et al (2010) state that it is important to keep in
[27] mind that the risk posed by some factors may be mitigated by the presence of buffers. Through a review of studies describing the impact of certain personality and cognitive appraisals, coping strategies and social support on infertility related stress, they identified enhanced personal control, a marital relationship with high satisfaction and good communication, and enriched social support networks as important buffers to the risk of stress. An insight into such risk and protective factors would facilitate the identification of women at risk experiencing high infertility related stress prior to treatment and identify who requires greater support (Gourounti, Anagnostopoulos et al. 2010).
Reproductive management of PCOS Researchers in this field advocate management of PCOS with a focus on support, education, addressing psychological factors and strongly emphasising healthy lifestyle, with targeted medical therapy as required. Treatment for the large majority is lifestyle focused and an aggressive lifestyle-based multidisciplinary approach is optimal in most cases to manage the features of PCOS and prevent long-term complications (Teede, Deeks et al. 2010:1). A systematic review of exercise interventions for PCOS (Harrison, Lombard et al. 2011) found the most consistent improvements included improved ovulation, reduced insulin resistance (9–30%) and weight loss (4.5–10%). Improvements were not dependant on the type of exercise, frequency or length of exercise sessions. Although the reviewers were wary of rating this evidence as conclusive, they found that exercise-specific interventions in PCOS are limited and the studies vary considerably in design, intensity and outcome measures. They called for larger, optimally designed studies both to gain insights into the mechanisms of exercise action and to evaluate the public health impact of exercise on PCOS.
Reproductive management of Endometriosis An assessment of medical management of endometriosis concludes: Medical treatment will not enhance fertility. Laparoscopic surgery has benefits for infertility with a sustained effect over 36 months. In vitro fertilisation does not have a good outcome for women with endometriosis (O'Connor and Kovacs 2003:483). The poor fertility outcomes of medical treatment are accounted for by the main use of anti- oestrogenic hormones to suppress the growth of endometriosis which also have androgenic effects that impair fertility. This text identifies complementary and alternative medicine (CAM) as being helpful for endometriosis but notes the lack of appropriate studies. There is a recent report of trial participants responding better to active intervention with Chinese herbal medicine
[28] compared to placebo (Flower, Lewith et al. 2011) and a case report of the successful use of acupuncture (Duggan 2008).
Reproductive management of ovarian failure In a systematic review of the various therapeutic interventions thought to restore ovarian function in premature ovarian failure (POF) (van Kasteren and Schoemaker 1999), the authors concluded that interventions were equally ineffective and unlikely to be an improvement on ‗expectant management‘ combined with ovarian monitoring which enhances the coincidence of timed intercourse. Only IVF and embryo transfer using donor oocytes has demonstrated high success rates and is considered to be the fertility treatment of choice in patients with POF (van Kasteren 2001). The likelihood of recovery of ovulation is not possible to predict. Regression of autoimmune disorders or management of endocrine dysfunction where applicable may restore ovulation (Goswami and Conway 2005).
Reproductive management of tubal blockages Where there is complete occlusion evident on hysterosalpingogram (HSG) then outcomes of treatment on the fallopian tubes are not good. HSG has a sensitivity of 65% and specificity of 83% for diagnosis of tubal patency… however, accuracy in detecting peritubal disease is poor (Zegers-Hochschild, Schwarze et al. 2008:582). Referral to ART is generally advised. Microsurgery and laparoscopic surgery have been the treatments of choice for tubal diseases and adhesions, with success rates in the range of 20–40% according to the extent of tubal damage and the surgeon‘s experience (Zegers-Hochschild, Schwarze et al. 2008:583). A systematic review of tubal surgery (Pandian, Akande et al. 2008) could find no suitable RCTs to include in the review and found that: Estimated livebirth rates after surgery range from 9% for women with severe tubal disease to 69% for those with mild disease, however, its effectiveness has not been rigorously evaluated in comparison with other treatments such as in vitro fertilisation (IVF) and expectant management (no treatment) (Pandian, Akande et al. 2008). The risks of surgery and increased risk of ectopic pregnancy following surgery are noted by the authors. Surgery is the main alternative to IVF when tubal factors are the primary cause of infertility.
Assisted Reproduction Over the last decade the annual increase of ART services has been 5-10% in developed countries. With live birth rates per initiated cycle of 20-40% worldwide, ART is now widely accepted as
[29] clinically effective in the treatment of many forms of subfertility. In Chambers et al (2009) study of the cost-effectiveness of ART, it was found that Australia had the highest utilisation rate of ART in the developed world – 1,574 cycles per million population. The authors surmised that Australia is one of the few countries where services approximate demand. Australia was shown to have the highest level of public subsidy with 71% reduction in cost of a standard cycle as a percentage of disposable income. Total expenditure on ART treatment represented 0.25% of total health care expenditure. Again, this is the highest level in the developed world (Chambers, Sullivan et al. 2009).
In comparison with the USA where, in 2005, more than 134 000 ART procedures were performed and more than 52 000 infants were live-born as a result of these procedures, representing 0 .1% of all US births. This proportion is expected to continue to rise… (Reefhuis, Honein et al. 2009). In Australia 3.2% of women giving birth in 2008 received some assistance from ART to conceive. In Australia in 2009 there were 65,180 ART treatment cycles, a 13.9% increase on 2008 and a 48.0% increase on 2005. Women used their own oocytes/embryos in more than 95% of treatments. It is estimated that more than 35,000 women undertook autologous ART treatment in Australia and New Zealand in 2009 (Wang, Macaldowie et al. 2011). The average age of these women having autologous treatment was 35.8 years with 1 in 4 aged over 40 years. The average age of women undergoing ART treatment using donor oocytes/embryos was 40.8 years. Most ART interventions are both personally costly, undermine emotional and physical health, and are expensive from the perspective of the public health purse. Of the 70,541 treatment cycles [in Australia and New Zealand], 22.6% resulted in a clinical pregnancy, and 17.2% resulted in a live delivery (the birth of at least one liveborn baby). There were 12,127 live deliveries resulting in 13,114 liveborn babies including 9,732 singletons at term of normal birthweight (Wang, Macaldowie et al. 2011). These figures elide the reality that there were 82.8% of couples who, having undergone an ART cycle in 2009, found themselves without the desired outcome of a take home baby.
Experience of Infertility Women‘s experiences of difficulty conceiving and subsequent infertility or childlessness are not necessarily similar across cultures and over time. It is, however, recognised that a strong desire for a child that is not easily attained has a profound influence on women and their partners.
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Infertility challenges the person‘s feelings about gender roles, self-worth, self-esteem, and self- perception of the body (Zegers-Hochschild, Schwarze et al. 2008). The level of distress experienced by women with fertility problems is reported as high. Most studies of infertility- related distress have been undertaken with women recruited from fertility clinics. The US National Survey of Fertility Barriers, however, aimed to distinguish between those who received treatment and those who did not receive infertility treatment at two time periods three years apart. The survey conducted telephone interviews with a probability-based sample of 4787 U.S women aged 25 to 45 during the years 2004-2007 (Wave 1) with follow-up interviews with all women who could be reached three years after the initial interview (Wave 2).The results showed that at the first time period: Infertile women who did not receive treatment and who had no live birth reported lower distress levels than women who received treatment at Wave 1 only, regardless of whether their infertility episode was followed by a live birth. At Wave 2, women who received no treatment have significantly lower fertility-specific distress than women who were treated at Wave 1 or at Waves 1 and 2, regardless of whether there was a subsequent live birth (Greil, McQuillan et al. 2011). The study also found that fertility-specific distress did not increase over time among infertile women who did not receive treatment. The increased infertility-specific distress was significantly higher for women who received treatment at Wave 2 that was not followed by a live birth than for women who received no treatment or for women who received treatment at Wave 1 only. These patterns suggest that infertility treatment is associated with levels of distress over and above those associated with the state of being infertile in and of itself. The study results do not distinguish what type of treatment women received, nor whether seeking treatment indicated a greater ambition to become a parent and therefore a more urgent distress when not successful. In the US fewer than 50 percent of women with fertility problems seek treatment (from biomedical clinics)(Greil, McQuillan et al. 2011). Whether these findings can be generalised to Australia where fertility services are more accessible and affordable remains unknown.
The infertility treatment experience has been described as a situation that engulfs patients and dominates their daily routine (Redshaw, Hockley et al. 2007). Women report feeling that they have little control over treatment and that they are not being treated like people. The highly technical approach of ART and the complex biomedical language is experienced as intimidating (Wingert, Harvey et al. 2005).
Dropout rates from medical infertility treatments have been estimated to be between 48–62% even in countries that cover the financial cost of services.
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In studies investigating decisions to terminate medical treatment, psychological factors have been among the most salient…For instance, Hammarberg et al.(2001) reported that, for women who had not become pregnant, principal reasons for discontinuation included having ―had enough‖ (66%), emotional costs (64%), not being able to cope with treatments (42%), and physical demands (39%) (Sexton, Byrd et al. 2010:348). These data were supported by a survey of women who failed to return to IVF for a third cycle when the previous cycles were not successful (Domar, Smith et al. 2010). Thirty-nine percent of these women nominated stress (expressed as ‗psychological burden‘) as the primary factor for discontinuation. Intervention programs, which are based on relaxation responses, cognitive restructuring, emotional self-care, and group support, have been found to be efficacious in the treatment of the emotional aspects of infertility, and have also resulted in increased conception rates (Domar and Dreher 1996; Domar, Clapp et al. 2000). These results have encouraged ART facilities to include such interventions within their course of treatment for example (Lemmens, Vervaeke et al. 2004; Campagne 2006).
A meta-analysis (Boivin, Griffiths et al. 2011) indicates a lack of association between pre- treatment emotional distress and pregnancy outcome in women undergoing a cycle of treatment with an assisted reproductive technology. These findings, however, could be influenced by the early withdrawal from treatment of the most stressed, and, that the data was collected from first ART cycle users. Consequently, the authors‘ conclusions, contrary to popular belief, may be premature in guiding fertility doctors to advise couples that their distress levels will not impact on the outcome. Sexton, Byrd et al (2010:348) report that there is some evidence that psychological interventions improve the likelihood of conception for infertile couples, and argue that: Continued research is needed to more definitively understand whether mental health interventions enhance rates of pregnancy, for which types of infertility-related impairments (e.g., ovulation dysregulation, structural impairment, and sperm quality) these are most helpful in assisting, and whether these benefits are noted in the absence of medical fertility treatments.
The perpetuation of emotional disability into the future appears to vary. In a systematic review of studies of women‘s experience of IVF (Verhaak, Smeenk et al. 2007), it was concluded that the negative emotions generated by IVF cycles were only alleviated by a successful outcome. Many women took their experiences into the future as poor emotional adjustment. However, one research study (Sundby 1999) has shown that some eight to ten years after the most
[32] intensive phase of confronting infertility, the emotional and psychological well-being of infertile women was no different from that of a sample of the general population. There are some exceptions: infertile women and men who have underlying emotional problems may be more vulnerable than others; for them, the crisis caused by infertility may become a chronic problem (Sundby 1999:18). Improving the experience of people using IVF and other fertility treatments may ameliorate ongoing distress and perhaps improve treatment outcomes.
Looking at reproductive functioning more broadly, outside the context of ART, there has only been one epidemiologic study examining psychological distress. This study asked respondents to complete questionnaires until pregnant or through six cycles of follow-up observation. The probability of conception in cycles with the highest distress scores was lower compared to those with lower distress scores. The study concluded that stress levels reduce fecundity (Hjollund, Jensen et al. 1999). Generally, the outcomes of the advice given to individuals experiencing infertility stress to relax to promote fertility has anecdotal support but little quantitative evidence. One study identified a negative correlation between α-amylase and fecundity (Buck Louis, Lum et al. 2011). The researchers concluded that stress significantly reduced the probability of conception each day during the fertile window. This biological evidence suggests an immune– endocrine disequilibrium in response to stress.
A phenomenological exploration of infertility following failed treatment reports women‘s experience of childlessness as multiple and continuing losses. McCarthy (2008) recounts women confronting a search for meaning that they were compelled to address in order to move forward in their lives. They shared stories of their efforts to resolve the pain and found it paradoxical to find hope for the future in the midst of their experience of loss. Planning a life that was substantially different to the one assumed to be theirs presented challenges and was most difficult in the transition from hopeful engagement with treatment to acceptance of their failure to conceive. Women treated for infertility described an existential crisis that necessitated a life review and a redefinition of themselves while coming to understand their own life story. Honoring the nature of the losses and challenges associated with involuntary childlessness and the ramifications for the future is critical to grasping the influence of infertility on women‘s lives (McCarthy 2008:324). Improving outcomes of fertility treatment and/or lessening the stressful experience of treatments may make a significant contribution to the lives of many.
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CAM use for fertility Studies of the contribution of complementary and alternative medicines (CAM) indicate that these non-standard care options may provide an avenue for couples to both enhance fertility and reduce stress. Choosing often unorthodox medical care such as CAM may increase a sense of agency in women and couples who experience subfertility as a lack of control.
Surveys indicate that the use of complementary and alternative medicines (CAM), such as acupuncture, herbal medicines, vitamins, massage and other therapies, has steadily increased in Australia from 50% in 1993 to 69% in 2006; forty-four percent (44%) of Australians consulted a CAM practitioner in 2006, which is a 20% increase since 1993, almost the same as the annual number of visits to medical practitioners. In Australia, expenditure on CAM in 2005 was $AUD4.13 billion, with $AUD85 million spent on visits to naturopaths and herbalists (excluding the costs of medicines) in 2004 (Rayner, Willis et al. 2011). Also in 2005, 9.2% of Australian adults reported acupuncture use in the previous 12 months, and made an average of 8.8 visits to an acupuncturist, totalling an estimated 10.2 million visits during that time (Xue, Zhang et al. 2007; Xue, Zhang et al. 2008; Sibbritt, Adams et al. 2011). CAM users are more likely to be women who are well-educated, employed with higher-than average incomes, and with private health insurance. CAM use by Australian women includes consultations with practitioners (38%) and self-medication with over-the-counter (OTC) CAM supplements (66%) or non-prescription medications (50%).
A substantial minority of infertile couples utilise CAM treatments. There are indications that infertile patients in general make a greater use of CAM for their infertility than the general population (Coulson and Jenkins 2005). CAM was chosen most commonly by wealthier couples, those not achieving a pregnancy, and those with a baseline belief in the effectiveness of CAM treatments (Smith, Eisenberg et al. 2010). While there has been a documented rise in the use of CAM generally, the extent of this use by women and couples seeking fertility outcomes is not well researched. Among the studies reporting on CAM use to enhance fertility, the proportion of women or couples using CAM to enhance fertility or treat infertility varied considerably from 12% to 91% (Rayner, McLachlan et al. 2009). A review of research on CAM use for fertility found the most common CAM used in fertility enhancement were herbal medicines, acupuncture and nutritional advice, including the use of supplements (Rayner, Willis et al. 2011:2). It should be noted that these researchers did not specifically search the literature for Chinese herbal medicines, only ‗Western herbal medicine‘ and ‗traditional medicines‘.
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The contribution of CAM to fertility outcomes is uncertain. CAM therapies are diverse and unevenly practised and researched. The fact that CAM is chosen by many does not explain why, in a society with subsidised reproductive health care, people would expend their time and money on CAM. Further research that addresses this issue has been called for (Stankiewicz, Smith et al. 2007). The reasons why women and couples seek out CAM have been surveyed. A British study found that there were several factors that influenced the choice of CAM: a belief in the value of treating the ‗whole‘ person; a positive opinion or experience of CAM; a belief that CAM offered a more effective treatment than biomedicine; the experience or belief that mainstream biomedicine was ineffective; and belief that CAM treatments allow more direct participation in one‘s care (Vincent and Furnham 1996). Interviews with infertile couples (van Balen, Verdurmen et al. 1997) reinforced these perspectives, with three main reasons to pursue CAM identified: the belief that it would increase the chances of having a child, standard fertility treatments had failed, and/or the couple wished to avoid engaging in the standard fertility treatments.
Cultural preferences are also major factors influencing the type of CAM use and the pattern of use. Concerns that infertile couples are vulnerable and are potentially able to be exploited by CAM practitioners is evident in some reports, for example (Coulson and Jenkins 2005), while many reports acknowledge that quality of life and sense of wellbeing outcomes are often better delivered by CAM compared to biomedical standard care. This is a strong theme in the interviews of women using acupuncture with IVF (de Lacey, Smith et al. 2009). A study (Stankiewicz, Smith et al. 2007) conducted in Adelaide, reported that 60% of subjects had used some form of CAM prior to attending a fertility clinic and that the use of CAM declined when resurveyed six months later. By contrast, whilst the use of other CAM modalities declined over time, the use of acupuncture by women having ART increased. Stress is acknowledged as a major factor affecting women and couples with fertility problems. Preliminary research indicates that acupuncture has a role in building resilience during IVF (Magarelli, Cohen et al. 2006; de Lacey, Smith et al. 2009).
Overview of thesis Chapter One has outlined the context of this study. A range of fertility problems affect women and their partners and require expensive and complex biomedical treatments to correct. The causes of these fertility problems are not fully known, but delayed attempts to conceive until later years (post 35 years old) has a major role. The range of standard primary and specialist care
[35] available to women has been discussed with a detailed examination of lifestyle modification approaches to enhance fertility. This chapter also includes an exploration of women‘s experiences of infertility and their experiences of fertility treatments.
Chapter Two examines the Chinese medicine understanding of fertility and fertility problems, particularly focusing on the use of acupuncture. The physiology of acupuncture‘s impact on female reproductive function, contemporary research and issues in acupuncture research are explored.
Chapter Three provides an overview of the methodological decisions taken to design and implement this research project. It examines the implications of a mixed quantitative/qualitative approach to CAM research.
Chapter Four describes the development of a fertility acupuncture protocol (FAP), including the methodology used, the results of the process and a discussion of both the process and outcomes.
Chapter Five describes the fertility acupuncture clinical trial (FACT) which implemented the protocol developed through FAP. The chapter includes the methodology used, the results of the process and a discussion of both the process and outcomes.
Chapter Six reports the interviews of selected trial participants about their experience of acupuncture and how this perspective extends understandings gleaned from the clinical trial.
In conclusion, Chapter Seven distils what has been learnt about using an acupuncture intervention for female fertility and about undertaking research in this field.
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Chapter 2 An overview of the role of Chinese medicine and the management of fertility
Introduction CAM use for fertility is extensive and a significant proportion of consultations and treatments occur with practitioners of Traditional Chinese Medicine (TCM) – predominantly acupuncturists and Chinese herbalists. A survey of British acupuncturists found that the treatment of fertility- related problems was common in practice and for some practitioners had become a specialty. Acknowledging that the research results from using acupuncture in conjunction with IVF had greatly influenced the demand for acupuncture and the type of acupuncture protocols used, the authors state that traditional approaches may provide more sustained and wide-ranging benefits to a greater range of patients. Further research is required... (Bovey, Lorenc et al. 2010). Another British survey found treatment for infertility by independent acupuncturists increased fivefold in 10 years (Hopton, Curnoe et al. 2012:489). In the USA practitioners have established a certifying body, American Board of Oriental Reproductive Medicine (ABORM), for specialists using acupuncture and Chinese herbal medicine for reproductive purposes. These developments of a specifically fertility focussed TCM practice are also evident in Australia.
This chapter will review TCM perspectives on fertility and, because this review focussed primarily on the use of acupuncture for female fertility, it addresses the current understandings of the physiology of acupuncture‘s impact on female reproductive function, contemporary research on acupuncture for fertility and a discussion of the issues in current acupuncture research.
Chinese medical understanding of fertility From an origin of conceiving the male and female body as androgynous (Furth 1999), Chinese medicine texts gradually differentiated treatments for women and, by the Song dynasty (960- 1279 AD), a gynaecological specialty had developed in both text and practice. Because of the foundation concepts of yin/yang fertility was not considered an exclusively female province. The creation of the fetus was seen as an act performed by two equal partners, with yin and yang intermingling and stimulating each other (Wilms 2011:29); Wilms goes on to quote Sun Si-Miao (652) who stated that yin and yang blend in harmony, the two qi respond to each other, and yang bestows and yin transforms. As well as recognising reproduction as a joint project it was also Sun Si-Miao who famously said that the disorders of women are ten times more difficult to cure than those of males. Male causes of infertility were largely diagnosed as insufficient qi. For Chinese medicine, the female body, its health,
[37] sickness and treatment was deeply influenced by the idea that blood, as its energetic basis, flows around the body, is discharged through menstruation, feeds the unborn child and transforms into breast milk (Valussi 2008:52). Intervention to assist health, and therefore a healthy reproductive life, must nourish and regulate blood and dispel any pathogens that interfere with or congest its free circulation. From the Song dynasty on, ‗blood is the root of women‘ is the aphorism that guides gynaecological treatment (Wilms 2011:42), and Chen Zi-Ming advises whenever treating disease, one first needs to discuss what [a particular case] is ruled by. In men, regulate their qi; in women, regulate their blood…Thus in women, blood is the foundation. When qi and blood flow freely, their spirit is naturally clear (Chen 1237; Wilms 2011:42).
This idea of the primacy of blood for women‘s health has not faded and is still part of contemporary TCM gynaecology, although with a more nuanced and differentiated understanding. By late imperial China Doctors recognized three broad categories of illness that directly impaired a woman‘s ability to conceive: menstrual irregularity, ‗girdle discharges‘ (daixia, namely, pathological vaginal flows), and internal accumulations (Wu 2010:105). The Chong (thoroughfare) and the Ren (controller) vessels are said to originate in the uterus and, when they open to circulation and flourish (at 14 years old), menstruation comes on schedule and the woman has the capacity to conceive. An inability to conceive is caused by injury to the Chong and Ren vessels, abnormal vaginal discharges (that can indicate infections), and menses that ‗leak or gush‘. By the seventeenth century, Chen Shi-Duo had identified six male and ten female causes of infertility (quoted in (Wu 2010:115)), the latter reflecting the more complicated female role in conception and gestation.
Weakening of the key foundations of reproduction in Chinese medical theory – the kidney, blood and uterus – can be attributed to inherited genetic defects; it can also be accounted for by overwork, too little rest or injury from too much menstrual bleeding; emotional disorders such as anxiety, worry or depression; improper diet such as an excess of food or alcohol or too much chilled food. Contemporary TCM practitioners such as Song (2009) also argue that medicines and other medical interventions can seriously damage a woman‘s reproductive capacity, such as long-term use of the contraceptive pill or other hormonal contraception, and damage the lining of the uterus through (perhaps unnecessary) treatments like dilation and curettage.
Contemporary TCM gynaecology texts differentiate a range of patterns, with the proviso, of course, that each woman has a unique presentation of patterns and that the diagnostic pattern and formula or prescription modifications are made appropriate to each menstrual phase. Pattern of disease identification and treatment based on that pattern (bian zheng lun zhi) is the dominant approach to TCM and especially is the guiding framework for Chinese herbalists.
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Acupuncturists use this framework exclusively less often. Acupuncture treatment can also be guided by the concept of channel or meridian disorder and the five phase theory. A senior professor of acupuncture (Wang Ju-Yi) reminds practitioners (of whatever specialty) that there are three pillars that are the foundation of Chinese medicine practice: yin-yang and five phase theory, organ theory and channel theory.
Only during the second half of the 20th century did the understanding of channel theory truly begin to decline. This was largely a function of the practice of placing acupuncture theory strictly within the organ (zang fu) framework that characterizes modern Chinese herbal medicine (Wang and Robertson 2008:9).
This is evident within the TCM literature on fertility. A frequently used acupuncture practice for fertility enhancement and menstrual regulation, activating the Chong and Ren channels, is rarely mentioned in contemporary literature as a guiding diagnosis. Rather than being recognised as a channel diagnosis, it is presented as a way of implementing a zang fu (organ) diagnosis.
The table below [2.1] gives a breakdown of which patterns of imbalance are considered to contribute to infertility in a woman. The data were taken from major TCM authors published in English and one recent systematic review (Ried and Stuart 2011) that also included several of these publications.
Table 2.1: Possible TCM diagnoses for female infertility with source text
Kidney jing deficiency (Lyttleton 2004; Ried and Stuart 2011)
Kidney qi deficiency (Flaws 2001; Song 2009)
Kidney yang deficiency (Xia, Guo et al. 1987; Maciocia 1998; Flaws 2001; Lyttleton 2004; Marchment 2007; Liang 2010; Ried and Stuart 2011)
Kidney yin deficiency (Xia, Guo et al. 1987; Maciocia 1998; Flaws 2001; Lyttleton 2004; Marchment 2007; Liang 2010; Ried and Stuart 2011)
Blood stasis (Xia, Guo et al. 1987; Maciocia 1998; Lyttleton 2004; Marchment 2007; Song 2009; Liang 2010; Ried and Stuart 2011)
Blood deficiency (Maciocia 1998; Song 2009; Liang 2010; Ried and Stuart 2011)
Liver qi stagnation/constraint (Xia, Guo et al. 1987; Maciocia 1998; Flaws 2001; Lyttleton 2004; Marchment 2007; Song 2009; Liang 2010; Ried and Stuart 2011)
Heart qi stagnation (Lyttleton 2004)
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Spleen yang deficiency (Flaws 2001)
Spleen qi deficiency (Ried and Stuart 2011)
Heat (Maciocia 1998; Liang 2010; Ried and Stuart 2011)
Liver or Heart Fire (Ried and Stuart 2011)
Damp/Phlegm (Xia, Guo et al. 1987; Maciocia 1998; Flaws 2001; Lyttleton 2004; Marchment 2007; Song 2009; Liang 2010; Ried and Stuart 2011)
Damp Heat (Ried and Stuart 2011)
Cold in uterus (Maciocia 1998; Ried and Stuart 2011)
Each of these patterns presents as a different configuration of signs and symptoms, especially in relation to the menses. For example, Kidney yin deficiency could manifest as bright red bleeding, blood stasis as clotty and dark blood, blood deficiency as scanty short bleeds, and qi stagnation would be indicated by a menses flow that stops and starts.
Female fertility is intimately related to menstrual health. From a Chinese medical perspective cyclical disorders (yue jing bing) are both indicative of and causal in subfertility. The TCM approach to infertility treatment integrates the menstrual cycle as a simple, non-invasive, sensitive, motivational, diagnostic tool to understanding a woman‘s fertility status (Ried and Stuart 2011:11). Unlike ART, which seek to override menstrual cycle difficulties by artificially controlling a woman‘s cycle through pharmaceutical and surgical interventions, TCM considers delayed ovulation, excessive or scanty menstrual flow, dysmenorrhoea, premenstrual symptoms, short or long menstrual cycles as diagnostic signs and a means of intervention to enhance fertility. The idea of varying or staging treatment according to developments in the menstrual cycle has a long history in Chinese medicine and has contemporary expression in the work of Nanjing gynaecologist Dr Xia Gui- cheng (Xia 1998) who advocated the use of the basal body temperature (BBT) in identifying the wax and wane of yin, yang, qi and blood throughout the cycle. Chinese herbal medicine prescriptions dominate TCM gynaecological literature and practice in gynaecology (fu ke) departments in TCM hospitals. There are positive indicators that Chinese herbal medicine significantly enhances fertility. One meta-analysis which included a wide range of studies and case reports estimated that Chinese herbal medicine to be more effective in the treatment of
[40] female fertility achieving on average a 60% pregnancy rate over 4 months compared with 30% achieved with standard Western medical drug treatment, or IVF over 12 months (Ried and Stuart 2011:11). These findings need to be further researched by means of more rigorous methodologies.
Acupuncture historically receives less attention as an intervention for women‘s health and the acupuncture department of a TCM hospital usually has a generalist practice rather than specialising in gynaecology. The gynaecology department is staffed by herbalists and much of the research undertaken in China has been limited to herbal interventions. Interest in the usefulness of acupuncture in reproductive medicine has come from a range of sources, including from acupuncture mechanism experimental studies, for example: The volt-ampere characteristics of acupoints vary with the menstrual process, which is of the acupoint specificity. The resistances on the acupoints increase with the menstrual process, and such results may be due to the blood loss during menstruation. The volt-ampere characteristics can be used as a quantitative index to study on the change of Qi and blood (Wei, Zhang et al. 2006). This could be evidence in support of modifying acupuncture protocols to match the phase of the menstrual cycle.
Literature search strategy This review included searches of data bases – PubMed, CINAHL, Biomed Central, Cochrane Library and Google Scholar - and hand searches of texts and journals. Electronic search strategies were developed to identify English language reports (abstracts or full text) of studies of:
(1) Acupuncture mechanism of action, employing the key words of ‗acupuncture‘, ‗mechanism‘, ‗mechanisms of action‘, ‗physiology‘ (2) The use of acupuncture in relation to women‘s reproductive health, including key words ‗acupuncture‘, ‗reproduct*‘,‘*fertil*‘, ‗ovula*‘, ‗menstru*‘. (3) Acupuncture research methodology. The searches included all accessible articles until end of March 2012 with key word combinations.
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Figure 2.1: Flow chart of search strategies used with electronic data bases.
Studies examining:
(1) Acupuncture (2) Acupuncture (3) Acupuncture
mechanism of intervention for research methods action female reproductive n=123 n=75 health [Pubmed n=4136 n = 186 BMC CAM n=153 Sciencedirect n= 10,285]
Records identified through
database searches:
n=75 (after duplicates removed) n=176 (after duplicates removed)
searching PubMed, Cochrane Library, BiomedCentral, Google Scholar and CINHAL with subject heading and text word combinations
(2) 176 potentially relevant studies were screened
abstracts of all potentially relevant studies were reviewed to identify potentially relevant outcome measures. 59 (31.4%) reported clinical trials 35 (18.6%) were reviews 31 (16.5%) reported experimental studies 30 (16%) were commentary 11 (5.9%) were case reports 10 (5.8%) were deleted as duplicates or concerning acupressure 7 (3.7%) reports focused on acupuncture research
methodology 3 (1.6%) were reports of qualitative research. 56 reports were of the use of acupuncture in ART/IVF. This represented 31.6% of the relevant reports (that is, after exclusions were made). Nearly 43% of the reviews were ART/IVF related.
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Acupuncture mechanisms of action Leading acupuncture researchers have identified what they call ‗provocative paradoxes‘ in acupuncture research (Langevin, Wayne et al. 2011). One is that many studies in animal and human experimental models have reported clear physiological effects and (in animal models) therapeutically relevant outcomes, such as anaesthesia, that vary as a function of needling parameters, and yet the extent to which these parameters influence therapeutic outcomes in clinical trials is not yet clear. The mechanisms of action of acupuncture are becoming increasingly patent. How this is applied to a woman‘s fertility is less apparent but can be theorised from basic research.
This section will examine demonstrated mechanisms of action, and the following section will examine how this is likely to be an explanation of how acupuncture impacts on female reproduction. In a review of acupuncture studies, Moffet (2006) identified those studies that gave a physiological rationale for why acupuncture was hypothesised to work in the nominated study. Of the 79 clinical studies prior to 2005 identified, he noted that 33% provided no physiologic rationale. He noted that the dominant explanation posited in the remaining studies (62%) were neurochemical mechanisms, and argued that proposing a rationale can help investigators to develop and test a causal hypothesis, choose an appropriate control and rule out placebo effects (Moffet 2006:5- 6). Experimental research, some of which is outlined below, contributes to an understanding of how acupuncture affects physiology and, therefore, to better acupuncture clinical research design.
The transmission of messages from the stimulation of an acupuncture needle has been partly explained by Ingber (2008) who argues that cells sense mechanical forces and transduce these into intracellular structures (including genes). Langevin also (Langevin, Churchill et al. 2001; Langevin and Yandow 2002; Langevin, Bouffard et al. 2006; Langevin 2010) with her co- researchers has identified a fluidity or ‗visco-elastic behaviour‘ in connective tissue which supports the mechanism of mechanotransduction1. These findings suggest that loose connective tissue may actively and rapidly respond to changing tissue loads such as needle insertion and manipulation. A unique feature of acupuncture therefore is that, unlike stretching of whole skin, needle rotation specifically probes the loose subcutaneous tissue layer (Langevin, Bouffard et al. 2006:767), and thus
1 Mechanotransduction is responsible for a number of senses and physiological processes in the body, including proprioception, touch, balance, and hearing. The basic mechanism of mechanotransduction involves converting mechanical signals into electrical or chemical signals. In this process, a mechanically gated ion channel makes it possible for sound, pressure, or movement to cause a change in the excitability of specialized sensory cells and sensory neurons. (Wikipedia)
[43] activates the cellular mechanotransduction and, presumably, a cascade of bodily responses (including leading to regulation of gene expression and the subsequent production of related proteins (Fung 2009)). Langevin (2010) is careful to advise that this research does not yet explain the therapeutic impact of acupuncture. Additional recent research (Li, Liang et al. 2011) has identified an acoustic shear wave model acting on cytosolic calcium and beta-endorphins.
One set of reviewers (Yang, Li et al. 2011) conclude that:
The initial action of acupuncture appears to be mechanical and not neural or electrical. In any case, the mechanistic function provides a model to explain acupuncture… Separated from the central nervous system, we speculate that the mechanism introduces a separate channel of cellular communications with calcium waves playing the role of the second messenger. The mechanical wave, the acoustic shear wave and the calcium wave turn out to have come from the same source, and these different forms of waves appear ideally suited to describe what the ancient Chinese called ―qi‖ (Yang, Li et al. 2011:652).
A strong theme (and a more historically popular approach for researchers) in explaining the actions of acupuncture is based in neurophysiology. A review of the experimental literature (Cabioglu and Surucu 2009) identified local, regional, central nervous system, and general levels of reaction to acupuncture stimuli. Locally, the insertion of the acupuncture needle to the acupuncture point creates the first reaction. A greater regional reaction via activation of an area (dermatomes) through reflex arches has been identified. Acupuncture stimulates the viscero- cutaneous, cutaneo-visceral, and cutaneo-muscular reflexes. The stimulus generated influences the central nervous system and reaches the cortex in the spinal cord and brain stem, and activates the pain control system by stimulating the periaqueductal and periventricular neurons in the mesencephalon. Neurotransmitters such as endorphin, enkephalin and serotonin are activated and this general reaction affects many organs and systems. One overview reports:
Recent animal research provides clear evidence of the role of antinociceptive limbic, hypothalamic, and brainstem networks in acupuncture analgesia. Animal studies on inflammatory pain suggest that electroacupuncture (EA) activates the hypothalamus–pituitary–adrenal axis and neural circuits and is parameter dependent (Xu and Lao 2012).
This assessment is shared by other reviewers (Han 1997; Dhond, Kettner et al. 2007; Napadow, Ahn et al. 2008; Fung 2009). There are reported methodological problems (Beissner and Henke 2011) with the functional magnetic resonance imaging (fMRI) studies that have been seen as
[44] exciting evidence of acupuncture point specificity. These problems, however, are apparently not insurmountable.
Acupuncture has both physiological and psychological effects, and may provide an excellent alternative to medications for stress reduction in women undergoing infertility treatment. Feelings of relaxation were reported by as many as 86% of patients following acupuncture (List and Helkimo 1992; Ernst and White 2001; Birch, Hesselink et al. 2004; Ng, Wing et al. 2008)2. Acupuncture has been demonstrated to reduce anxiety and depression through the regulation of the autonomic nervous system by inhibiting sympathetic tone and stimulating vagal tone (Schillemans-Eliyahu 2011). The use of manual acupuncture, electroacupuncture and laser acupuncture have been identified as active on brain function on fMRI studies (Kong, Gollub et al. 2007; Napadow, Kettner et al. 2007; Quah-Smith, Sachdev et al. 2010; Liu, Zhou et al. 2011). A recent meta-analysis of studies of acupuncture assessed on fMRI concludes: Brain response to acupuncture stimuli encompasses a broad network of regions consistent with not just somatosensory, but also affective and cognitive processing. While published results were heterogeneous, from a descriptive perspective most studies suggest that acupuncture can modulate the brain activity within specific brain areas, and the evidence from meta-analysis confirmed part of these results (Huang, Pach et al. 2012:16). Changes in brain activity initiated by acupuncture have also been found to coincide with heart rate variability (Napadow, Dhond et al. 2005) indicating support for acupuncture as an influence on blood circulation. Liu, Zhou et al (2011) were able to show that acupuncture points identified as having a particular function (in this case vision-related) activated that aspect of the brain anatomy when measured on fMRI.
Reporting in an overview of the use of acupuncture in gynaecology, Stener-Victorin states that: recent basic and clinical research demonstrate that acupuncture regulates uterine and ovarian blood flow
2 This reference to acupuncture having a relaxation effect on patients was first reported as a ‗reported event‘ by 86% of 29 subjects in a trial reported by List, T. and M. Helkimo (1992). "Adverse events of acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders." Journal of Craniomandibular Practice 10: 318 –326. It was subsequently reported by Ernst, E. and A. R. White (2001). "Prospective studies of the safety of acupuncture: A systematic review." American Journal of Medicine 110(6): 481–485. This was a report of the effect as an adverse event. Again this statement was taken up by Birch, S. (2004). "Clinical research on acupuncture: Part 2. Controlled clinical trials, an overview of their methods." The Journal of Alternative and Complementary Medicine 10(3): 481–498. and Ng, E. H. Y., S. S. Wing, et al. (2008). "The role of acupuncture in the management of subfertility." Fertility & Sterility 90(1): 1-13. Both reviews reported relaxation as a physiological effect of acupuncture. The statement has become a ‗given‘ in the evidence base of acupuncture, based on the reported experience of 25 people receiving acupuncture for dental problems in the early 1990s.
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that the effect most likely is mediated as a reflex response via the ovarian sympathetic nerves, and that the response is controlled via supraspinal pathways (Napadow, Ahn et al. 2008). Since this encourages a thicker uterine wall, fertility is improved through embryo implantation being more successful. In a Stener-Victorin study, compared to the mean baseline pulsatility index (PI), the mean PI was significantly reduced both shortly after the eighth electroacupuncture (EA) treatment (P < 0.0001) and 10-14 days after the EA period (P < 0.0001) (Stener-Victorin 1996). Electroacupuncture (EA) applied to the abdomen and hindlimb (of laboratory animals) modulates the ovarian blood flow (OBF) response. …the OBF response to both abdominal and hindlimb EA stimulation was mediated as a reflex response via the ovarian sympathetic nerves, and the response was controlled via supraspinal pathways. Furthermore, the OBF response to segmental abdominal EA stimulation was frequency dependent and amplified in the estrous phase (Stener-Victorin, Fujisawa et al. 2006:84).
In another animal study of induced PCOS, ovarian function normalised in response to both exercise and EA (Manni, Lundeberg et al. 2005). A further study by the Stener-Victorin group found that low-frequency EA and exercise ameliorate insulin resistance in rats with PCOS. They hypothesise that the effect may involve regulation of adipose tissue metabolism and production because EA and exercise each partially restore divergent adipose-tissue gene expression associated with insulin resistance, obesity, and inflammation. In contrast to exercise, EA improves insulin sensitivity and modulates adipose-tissue gene expression without influencing adipose tissue mass and cellularity (Mannerås, Cajander et al. 2007; Mannerås, Jonsdottir et al. 2008; Napadow, Ahn et al. 2008).
A more recent animal study of endometrial damage (thin and impaired) induced by clomiphene citrate (which is estimated to cause the majority of implantation failures) found that it was not the endometrial thickness (P = .07) but the glandular area (P = .01) of endometrium [that]was significantly increased in the [acupuncture] group compared with the [control] group. [The authors suggest that acupuncture] may have [the]capacity to mainly stimulate the growth of gland rather than stoma, which cannot be observed by ultrasound in clinics (Fu, He et al. 2011:6). This study found that acupuncture significantly suppressed the high serum oestradiol induced by clomiphene citrate to better prepare for implantation and increased the glandular area and the expression of receptivity markers during the implantation period. The acupuncture protocol and technique used were consistent with standard TCM care. These conclusions were not supported by evidence from Smith, Coyle and Norman (2009), and the inconsistency perhaps can be
[46] explained by Fu et al.(2011) identifying an alternative mechanism by assessing endometrial thickness through dissection rather than ultrasound.
Further, acupuncture causes a significant increase in β-endorphin levels during treatment. A review of Japanese research supports this evidence that the analgesic effects of acupuncture have been well clarified by experimental studies and the participation of various endogenous opioids and their receptors has been widely accepted (Okada and Kawakita 2009:15), but they report that this seems to be an incomplete explanation of why, for example, acupuncture treats pain. It has been hypothesised that, because acupuncture impacts on β-endorphin levels and thus hypothalamic function (Petti, Bangrazi et al. 1998), which affect GnRH secretion and the menstrual cycle in turn, it is logical to hypothesize that acupuncture may positively influence ovulation and fertility (Duggan 2008). Zhu, Hamilton et al. (2011) report that, as acupuncture increases endogenous opioids and the neurotransmitters serotonin and dopamine, this would lead to analgesia, sedation and recovery of motor function and impact on, for example, menstrual pain. The review also reported that acupuncture may induce visceral and somatic signals that are transmitted to the central nervous system to induce an anti-inflammatory signal through both humoral and neural mechanisms (Zhu, Hamilton et al. 2011:3).
Research detailed by Al-Inany (2008) has postulated three potential mechanisms for acupuncture‘s effects on fertility. Firstly, acupuncture may mediate the release of neurotransmitters which may in turn stimulate secretion of gonadotrophin releasing hormone, thereby influencing the menstrual cycle, ovulation, and fertility (Ferin and Vande Wiele 1984). Secondly, acupuncture may stimulate blood flow to the uterus by inhibiting uterine central sympathetic nerve activity (Stener-Victorin 1996); and thirdly, acupuncture may stimulate the production of endogenous opioids, which may inhibit the central nervous system outflow and the biological stress response (Han, Chen et al. 1991). Animal studies indicate that intensive electroacupuncture can facilitate substantial change in PCOS, that is, systemic and local effects involving intracellular signalling pathways in muscle that may account for the improved insulin sensitivity (Johansson, Feng et al. 2010). Repeated low-frequency EA and physical exercise each improves hyperandrogenism and menstrual frequency in women with PCOS more effectively than no active intervention, with low-frequency EA being superior to physical exercise. These findings suggest that low-frequency EA may be used in the treatment of hyperandrogenism and oligo/amenorrhea in women with PCOS (Jedel, Labrie et al. 2011).
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As discussed in Chapter 1, stress is known to have a negative effect on reproduction and perhaps the menstrual cycle. As acupuncture, for example, aids in lowering stress hormones, which undermine fertility it is thought that this may be a major mechanism for acupuncture to influence reproductive function and accounts for fertility-boosting effects. One study examining the levels of ‗stress hormones‘ - serum cortisol (CORT) and serum prolactin (PRL) - during an IVF cycle demonstrated biochemical differences in serum levels of CORT and PRL in patients receiving [acupuncture] along with their IVF treatments (Magarelli, Cridennda et al. 2009:1873). This connection is demonstrated in further clinical studies (detailed below) of stress reduction using acupuncture impacting on reproductive health.
Acupuncture for female reproductive disorders A overview of systematic reviews (SR) of acupuncture in obstetrics and gynaecology (Ernst, Lee et al. 2011) concluded that the data available in SRs was contradictory and inconclusive. A SR which undertook an overview of studies of acupuncture treatments for reproductive/ gynaecological disorders found that menopause and dysmenorrhoea were the most frequently studied, and acupuncture treatments had shown positive indicators of effectiveness. Acupuncture to treat PMS, PCOS and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies (Smith and Carmady 2010). This systematic review included all studies prior to September 2009. The literature search undertaken here found 75 additional articles published since that time (including only those focused on reproductive conditions, that is, excluding menopause). Not all would have met the inclusion criteria for the review but all would have fallen within the search strategy.
Accumulated clinical experience indicates acupuncture regulates the menstrual cycle. TCM gynaecological textbooks all provide treatment approaches to a range of menstrual irregularities – the cycle is too short or too long or variable, the bleeding is too scant or too heavy, menses are accompanied by a range of other symptoms such as abdominal pain, headache, acne or mood changes. Those diagnosed with ‗idiopathic infertility or sterility‘ or having no known cause often have a ‗hidden disturbance of gamete interaction‘ (Kielwin, Sulistyo-Winarto et al. 2010) where ova are not maturing or not fertilisable or there is disturbed sperm function and they often have accompanying premenstrual syndrome and dysmenorrhoea. Such couples profit the most from the possibilities of TCM, for example in the areas of cycle optimization and timed intercourse (Kielwin, Sulistyo-Winarto et al. 2010:63). In a series of articles published in Nanjing in 1998-99,
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Professor Xia Gui-cheng (1998) identified the importance of menstrual regulation both to the resolution of both menstrual disorders and the promotion of fertility. His approach was subsequently adopted by Jane Lyttleton (2004) and broadcast through her teaching and publications throughout the English-speaking TCM community. There are no published clinical trials that test the premise of regulating the menstrual cycle in order to promote fertility. There is a tradition within Western herbalism called multiphasic prescribing for menstruating women that mirrors this approach (Yarnell and Abascal 2009). There are studies, however, which do examine the influence of acupuncture on different aspects of the menstrual experience (discussed further below). Chinese medical theory would posit that an improvement in a single component of menstruation will positively influence other components (and the whole). Promoting the full discharge of blood, for example, during the menses will positively feedback into egg formation and ovulation. Evidence to support this assertion is not available at this time.
Stener-Victorin and Wu (2010), in an overview of contemporary literature, found, as Smith and Carmady (2010) did, that the use of acupuncture to treat reproductive dysfunction has not been well investigated. They state: only a few clinical studies have been reported, most of which are flawed by poor design and a lack of valid outcome measures and diagnostic criteria, making the results difficult to interpret (Stener-Victorin and Wu 2010:46). The incidence of ‗poor quality‘ clinical studies perhaps speaks to the difficulty of achieving high quality clinical research that is acceptable both to acupuncturists and research scientists. The following is a review of clinical evidence for the effectiveness of reproductive/fertility related acupuncture interventions. This review is not systematic and includes studies that are methodologically flawed. They are included to supplement the narrative on trends and possibilities for future research and to reflect what practitioners consider within the ambit of their practice of acupuncture.
Menstrual regulation Menstrual irregularity may originate from a variety of conditions. Frequently in clinic, women have irregularity sourced from a diagnosis of PCOS. A recent literature review (Lim and Wong 2010) of reports of acupuncture use for PCOS found four studies although no randomised controlled trials (RCT). One study led by Stener-Victorin found that the ‗dose‘ of acupuncture influenced the size of the effect, and she concluded: Experimental observations in rat models of steroid- induced polycystic ovaries and clinical data from studies in women with PCOS suggest that acupuncture exert (sic) long-lasting beneficial effects on metabolic and endocrine systems and ovulation (Stener-Victorin, Jedel et al.
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2008:290). Indications are that repeated acupuncture can stimulate the return of ovulation without adverse side effects. An RCT since completed by Lim3 indicates acupuncture as efficacious for initiating ovulation in women with PCOS. Acupuncture and moxibustion have a good regulatory effect on the function of endocrine, sugar and lipid metabolism (Liu, Sun et al. 2004) so it can be hypothesized to be, therefore, useful to regulate the menstrual cycle. Although unable to discern a difference between the true and sham acupuncture protocols for …women with PCOS, … both groups had a similar improvement in their LH/FSH ratio (Pastore, Williams et al. 2011:3143) the findings support acupuncture as a possible non-pharmaceutical treatment for PCOS.
An exploration of the physiological effects on PCOS of major CAM treatments indicates they could reduce the severity of PCOS and its complications. Acupuncture has been shown to reduce hyperandrogenism and improve menstrual frequency in PCOS (Raja-Khan, Stener- Victorin et al. 2011).
An analysis of clinical trials (Li, Wei et al. 2007) of the effect of acupuncture-induced weight reduction on menstrual activity identified acupuncture treatment achieving the effects of weight reduction and menstrual improvement via regulating activities of leptin, thyroid gland system and hypothalamus-pituitary-adrenal cortex axis. The authors report clinical practice has demonstrated that acupuncture stimulation of some commonly-used acupoints for weight reduction also has a favourable regulation on menstrual activity in obese women.
Shi et al (Shi, Feng et al. 2009) undertook a clinical trial of patients with TCM-defined ‗kidney deficiency and phlegm stasis‘ type PCOS, comparing a herbal intervention with the same herbal intervention plus acupuncture. The results were a total effective rate of 93.8% in the combined acupuncture and Chinese herb group and 80.6% in the simple Chinese herb group, the former being significantly better than the latter (p<.05). The decrease of testosterone in the combined acupuncture and Chinese herb group was significantly superior to that in the simple Chinese herb Group (p<.01).
In a study contrasting real and sham acupuncture for PCOS, Pastore et al (2011) found the improvement in the LH to FSH ratio in both arms and the increase in menstrual frequency during the trial compared with pre-enrolment suggest that both interventions may have been beneficial (:3149). As well as
3 As yet unreported and stated in a personal communication from Dr Danforn Lim Sham acupuncture a control group which may include invasive needling or no invasive needling
[50] confirming the likelihood of sham acupuncture not being inert, the lack of an observational control and/or pre-enrolment ovulation data meant the improvement could not be accurately assessed.
Anovulatory disorders most frequently display with menstrual irregularity. Assisting ovulation can be a way of re-establishing a regular cycle.
Ovulation Acupuncture has been shown to assist ovulation.
Chronic anovulation is diagnosed in different types by menstrual disorder history, consecutive monophasic basal body temperature (BBT) for 3 months, serum hormone, and pelvic ultrasonography data. As a whole, the success rate[of acupuncture] is around 50 percent; in pubertal dysfunctional uterine bleeding, 87.7 percent; in pubertal oligomenorrhea, 60 percent; and in PCOS, 36.8 percent….This correlation suggests patients with sympathetic activity suppressed by acupuncture (a sign of fluent flow of Qi and blood in TCM) are likely to ovulate after acupuncture (Yu 1997).
Yu further comments that acupuncture is especially effective when infertility is caused by a hypothalamic disorder (Yu 1998). If patients are screened to include those most likely to respond (for example, those with adequate oestrogen levels), the success rate can be as high as 80% in achieving ovulation. Ovulation delay or failure is a common occurrence in women with PCOS and can be an aspect of other subfertility conditions.
Some investigations have already demonstrated that acupuncture has positive effects on anovulatory subfertility. Studies include the clinical application of ovulation induction (Mo 1990; Mo, Li et al. 1993) and the use of electroacupuncture for women with PCOS over several months to initiate menstrual cycles (Stener-Victorin, Waldenstr¨om et al. 2000). Women in this latter study were carefully monitored for hormonal changes, skin temperature, basal temperature, body mass index (BMI) and waist-to-hip ratio (WHR) allowing the researchers to hypothesise mechanisms of action of the acupuncture. The participants who responded best were almost consistently characterized by comparatively low BMI, WHR, basal insulin and testosterone serum concentrations, but high serum testosterone/ sex hormone binding globulin (SHBG) concentration. Consequently, they were less androgenic and had a less pronounced metabolic disturbance. The authors theorised that a higher dose of acupuncture for either a longer time or more frequently may have produced better results in the non-responders.
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Menstrual pain Dysmenorrhoea is an important indicator of disturbed menstrual flow. Two recent SRs examine the evidence for acupuncture in alleviating menstrual pain (Zhu, Hamilton et al. 2011; Smith, Zhu et al. 2012). One review by Zhu and colleagues of menstrual pain originating from endometriosis could find only one RCT that met inclusion criteria and could make no real assessment of the value of acupuncture based on this one study. The other SR conducted by Smith and colleagues addressed studies of dysmenorrhoea more generally and included 10 trials. Although concluding that data was insufficient to confidently evaluate acupuncture as a treatment for dysmenorrhoea, because of methodological problems in the trials, most reported positive outcomes for acupuncture.
Some of the research not covered in the SRs is discussed below.
One experimental blinded crossover study explored the impact of ‗real‘ and ‗sham‘ acupuncture on heart rate variability as an indicator of the autonomic nervous system in women with primary dysmenorrhoea. They found that both real and sham acupuncture affected heart rate variability but in different ways. The researchers concluded manual acupuncture at bilateral acupoints of LI4 and SP6 may play a role in dysmenorrhea treatment with autonomic nervous system involvement (Kim, Cho et al. 2011). One clinical trial of two different acupuncture interventions for dysmenorrhoea during the menses for three cycles showed significant decrease in the severity and frequency of pain. It also indicated no significant difference in outcome between the two interventions, supporting the idea that there may be more than one successful prescription (Li, Bu et al. 2011). Another pair of studies suggests that needling at Sanyinjiao SP6 can immediately improve uterine arterial blood flow of patients with primary dysmenorrhea, relieving the pain (Kashefi, Ziyadlou et al. 2010; Yu, Ma et al. 2010 ). Further study of the timing of acupuncture for dysmenorrhoea (Bu 2011) found no significant difference between applying it premenstrually or during the menses, but there was significant positive difference for a third group who received none. In another study (Bu, Du et al. 2011) the importance of timing was further refined to distinguish between those receiving ‗preconditioning‘ acupuncture (PA), and those receiving immediate acupuncture(IA), and both groups compared with a non-treated third arm. Into the second and third month outcomes for the PA group outstripped IA and they both showed significant improvement compared to the control. Despite encouraging indications, another systematic review concluded: Because of low methodologic quality and small sample size, there is no convincing evidence
[52] for acupuncture in the treatment of primary dysmenorrhoea (Yang, Liu et al. 2008). A later review found more methodologically sound trials and concluded: The review found promising evidence in the form of RCTs for the use of acupuncture in the treatment of primary dysmenorrhoea compared with pharmacological treatment or herbal medicine. …The evidence for the effectiveness of acupuncture for the treatment of primary dysmenorrhoea is not convincing compared with sham acupuncture (Cho and Hwang 2010). And a third the following year found: Acupuncture may reduce period pain, however there is a need for further well-designed randomised controlled trials (Smith, Zhu et al. 2011).
Premenstrual syndrome
Premenstrual syndrome (PMS) arises because of imbalances that are triggered in the lead up to a period. A systematic review of acupuncture interventions found: Although the included trials showed that acupuncture may be beneficial to patients with PMS, there is insufficient evidence to support this conclusion due to methodological flaws in the studies (Cho and Kim 2010:110). In one systematic review (Kim, Park et al. 2011) of acupuncture use for PMS the pooled results demonstrated that acupuncture is superior to all controls (eight trials, pooled RR 1.55, 95% CI 1.33–1.80, P < 0.00001). The meta-analysis comparing the effects of acupuncture with different doses of progestin and/or anxiolytics supported the use of acupuncture (four trials, RR 1.49, 95% CI 1.27–1.74, P < 0.00001). In addition, acupuncture significantly improved symptoms when compared with sham acupuncture (two trials, RR 5.99, 95% CI 2.84–12.66, P < 0.00001). No evidence of harm resulting from acupuncture emerged.
Infertility Acupuncture has been a treatment for infertility and menstrual disorders throughout the history of Chinese medicine (Liu, Gu et al. 2005). Differing approaches are evident in the literature (Dean 2004) and achieving a common consistent TCM diagnosis and treatment is difficult (Birkeflet, Laake et al. 2011).
(a) Acupuncture and ART A major research effort in the last decade has indicated that acupuncture assists IVF. The literature search identified 15 reports that identified themselves as a review of studies of acupuncture intervention as an adjunct to IVF/ART. The most recent systematic review (Zheng, Huang et al. 2012) includes 10 more studies not included in earlier SRs, and concludes that
[53] acupuncture improves CPR4 and LBR5 among women undergoing IVF based on the results of the studies that do not include the Streitberger6 control, and that the Streitberger control may not be an inactive control (:610). The meta-analysis results showed that the pooled CPR from all of the acupuncture groups was significantly higher than that from all of the control groups (P=.04). The difference was more obvious when the studies that used the Streitberger control were not considered (P=.007) suggesting that the Streitberger control needs reevaluation. The reviewers further recommend that more positive effects from acupuncture in IVF can be expected if an appropriate control and more individualized acupuncture programs are used.
Six systematic reviews (including five meta-analyses) have shown that acupuncture on the day of embryo transfer has improved pregnancy rates in IVF (Kang, Jeong et al. 2011). None of the reviews call for a rejection of this intervention and all, in fact, call for more exploration of its value to enhance IVF cycles. Although the intervention is assessed as being relatively painless and causing few side effects, another review (El-Toukhy, Sunkara et al. 2008) implies that the cost, invasiveness and potential for harm of acupuncture means that it should not be recommended to women receiving IVF treatment. Given that the studies reported very few adverse events and that the cost of acupuncture compared to additional IVF cycles is substantially less, it can only be surmised that these systematic review authors were in some way biased against the intervention to make such a conclusion. Manheimer and colleagues, for example, conclude that the effects are significant and clinically relevant but ‗still somewhat preliminary‘ (Manheimer, Zhang et al. 2008). Another meta-analysis shows that acupuncture around the time of embryo transfer (ET) achieves a higher live birth rate of 35% compared to 22% without active acupuncture (Cheong, Ng et al. 2008).
More recent clinical trials since the Cheong systematic review throw this conclusion into doubt. The published studies include Domar (Domar, Meshay et al. 2009), Moy (Moy, Milad et al. 2011), So (So, Ng et al. 2009) and Andersen (Andersen, Løssl et al. 2010) and, if the results of these 1311 patients were added to those of the meta-analysis, it is unlikely that there is conclusive evidence of a major effect of acupuncture accompanying embryo transfer (Drake 2011). There are many confounding aspects of these studies that need to be examined such as the effects of
4 CPR= clinical pregnancy rate 5 LBR= live birth rate 6 Streitberger is a type of sham needle.
[54] the use of placebo or sham acupuncture, the practice of using minimally trained acupuncturists, and outcome measures that do not include live births. Drawing on experience-based practice and three decades of research, Shi, Ma et al (2011) question the value of the Moy et al. study on several grounds, including the failure to document the proficiency of the acupuncturists, inattention to the multiple causes of infertility displaying uniquely in each participant and the lack of an appropriate ‗dose‘ of acupuncture. While identifying flaws in trial design of the included studies (and suggesting these are general difficulties encountered in evaluating the efficacy of acupuncture in subfertility), another less rigorous systematic review concluded that the pregnancy rate of IVF treatment is significantly increased when acupuncture is administered on the day of ET (Ng, Wing et al. 2008). Another review (Huang and Chen 2008), while not a systematic appraisal, offers a discussion of how Chinese medicine and particularly acupuncture is helpful to infertility. The SRs found sufficient homogeneity between studies to be able to include them in a review.
The research studies make clear that, despite the consistency across studies, there was also much diversity. The actual acupuncture treatment protocols used varied across studies. The training of the person administering the acupuncture was not always in acupuncture. Another factor in the studies was the timing and therefore the location of the treatment appears to have impacted on outcome. Off-site acupuncture treatments, for example, - as reported by Craig, Criniti et al. (2007) - failed to show any benefit for the women treated. (This was not the case, however, in Johnson‘s audit of cases of women treated off-site (2006).) In addition, women receiving intracytoplasmic sperm injection (ICSI) and acupuncture along with agents for ovarian stimulation produced more follicles than when not receiving acupuncture (Emmons and Patton 2000).
Measures of outcome vary between acupuncture trials. This appears to be a result of the availability of data from the IVF clinics where the trials have occurred. There is no national or international consensus on data collection and outcome measures in ART clinics. Of course, unlike many other disorders treated with acupuncture, infertility has a clear and unequivocal outcome measure – a take-home live baby (or not). Biochemical, clinical and ongoing pregnancy rates are defined differently in IVF clinics and in these acupuncture trials. They are an important
[55] measure because ART does not yet have reliable techniques to continue a pregnancy and avoid miscarriage: the emphasis is on achieving conception rather than a baby.
The role of placebo and sham controls varied within these ET studies. Using placebo needles on sham acupuncture points was the method Smith adopted (Smith, Coyle et al. 2006), finding no statistically significant difference in the increase in the pregnancy rate between acupuncture and sham acupuncture. There were, however, indications that the control was active as women in the control reported an increase in relaxation. In the study by So and colleagues (So, Ng et al. 2008) non-invasive placebo acupuncture on true acupuncture points was chosen as the best control, and they found that changes in endometrial and subendometrial vascularity responded to both real and placebo acupuncture. Further, serum cortisol concentration and anxiety levels were reduced in both acupuncture and placebo acupuncture groups, indicating how potentially active placebo acupuncture can be. Dieterle (Dieterle, Ying et al. 2006) did not discount the possible adverse influence of placebo acupuncture on the pregnancy rate. The placebo needles could be effective in controlling for some of specific and non specific effects of acupuncture, and because acupuncture is a complex intervention the size of some effects may be small, and many of the studies are under-powered. The use of sham acupuncture has created controversy, as reported for example, in the discussion by Domar (Domar 2006) of Paulus‘ unreported second trial which used sham acupuncture and showed unremarkable differences in pregnancy between real and sham acupuncture. Birch proposes that placebo or sham acupuncture cannot be inert (Birch 2006) and therefore should not be used to assess ‗verum‘ acupuncture.
There are also indicators that there is potential for harm from ill-applied or mistimed real or sham acupuncture; for example, the Westergaard study (Westergaard, Mao et al. 2006) found that a group receiving two sessions of acupuncture had a higher miscarriage rate compared to one- session and control. Some acupuncture points used in this study are contraindicated in pregnancy. It is possible that by adding an additional acupuncture treatment 2 days after ET any gains offered by the Paulus (Paulus, Zhang et al. 2002) protocol were lost. Although Dieterle et al. (2006)used similar timing and point selection their protocol included a point classically used to prevent miscarriage. It is possible that the poor results from the Craig study were also related to the acupuncture point selection and timing.
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Some of these ET studies used untrained acupuncturists (such as nurses trained particularly for the study, for example, in Westergaard et al. (2006) and Andersen et al. (2010)), and in many studies the qualifications and training of acupuncturist/s are not stated. The study by So et al.(2008) used an acupuncturist with 2 years experience. Within most styles of acupuncture practice, the achievement of deqi is considered essential to effective treatment. This deqi sensation is one felt by both the patient and acupuncturist and it is both difficult to blind for and usually the subject of discussion between acupuncturist and patient. While it could be argued that this exchange is crucial to the success of acupuncture, it is difficult to design research that excludes this aspect and it is quite possible untrained or inexperienced acupuncturists would not recognise the sensation at all or not recognise it as significant.
The issue of whether the acupuncture protocols used in these studies reflect good clinical practice is important. If acupuncture is to be included as an adjunct therapy for IVF or other infertility patients, then the study results need to be able to be replicated in practice and adopted by acupuncturists outside IVF clinics. The results of the research studies provide significant support but not statistically significant results for acupuncture on the day of ET. Beyond this evidence, the dosage or number of acupuncture treatments were very low in these trials. TCM diagnoses were mostly not employed to guide treatment (although Smith (2006) used it to guide the first treatment and So (2008) recorded the diagnosis for comparative purposes) which potentially creates a fixed protocol bias and reduces the likelihood that the treatment will be appropriate and effective for individual subjects (Rosenthal and Anderson 2007).
Despite some recent evidence that CAM use may have a negative impact on ART outcomes (Boivin and Schmidt 2009), the evidence for acupuncture use during IVF shows the reverse – acupuncture may increase pregnancy rates.
Findings and conclusions between systematic reviews differ on the effect of acupuncture and live birth rates, due to variation in their inclusion criteria, the inclusion of new trials in subsequent meta-analyses, and variations in the quality of the acupuncture intervention which may have contributed to clinical heterogeneity (de Lacey, Smith et al. 2009).
The research focus of acupuncture has been with improving the outcomes of fertility treatments, most notably in IVF cycles, especially at the point of embryo transfer. It has been hypothesised on the basis of a small study that acupuncture has a beneficial effect at the time of embryo transfer because it is a time of great stress for women which may cause uterine vasoconstriction
[57] and acupuncture can significantly modify these stress levels (Balk, Catov et al. 2010). In support of this view Domar (2009) found reduced anxiety and increased relaxation and optimism although So found no differences in anxiety (So, Ng et al. 2008) levels between the women receiving acupuncture or placebo.
(b) Acupuncture and natural fertility Outside the context of IVF clinics there has been research that supports the role of acupuncture in promoting fertility. As reviewed earlier findings on the physiological mechanisms of acupuncture offer some guidance in understanding the possible contribution that acupuncture makes to female fertility Other research reports of Chinese medicine‘s supportive contribution to fertility are largely case reports.
Clinical case reports support the value of acupuncture in the lead up to conception, although no clinical trial has been reported to date either supporting or contradicting this case-based evidence (Emmons S and P. 2000; Liang 2003; Lyttleton 2004; Johnson 2006). Acupuncture has a long history in the treatment of fertility problems, and there is apparently much consistency in the actual points chosen (Liu, Gu et al. 2005). Chinese medicine texts and case history books, for example, frequently cite the use of acupuncture to induce ovulation. A study by Chen Qiong using acupuncture in women with endometriosis-induced infertility, reported in a recent publication on infertility (Chen and Li 2008), indicated significant effectiveness. In the same publication there is a report of a study undertaken by Ding Hui-jun (2008)(Ding 1998) into tubal infertility effectively treated by acupuncture.
Summary of research
Further clinical trials are required to establish how the experimental results discussed above unfold in a clinical context. Theoretically, from a Chinese medicine perspective, an acupuncture approach should prove effective whether the women being treated are enrolled in an IVF program or not. Acupuncture, even a standardised acupuncture protocol such as the Paulus (Paulus, Zhang et al. 2002) protocol before and after an IVF biomedical procedure, represents a complex intervention. A Chinese medical understanding (as opposed to a physiological or biomedical one) of an adequate acupuncture intervention would require at least differentiation
[58] of patterns of symptoms, individualisation of treatments, perhaps an assessment of qi circulation, and/or more extended treatment times, in addition to attention to the timing of a surgical procedure. Standardisation might reduce the effect of acupuncture in individual patients (Huang, Huang et al. 2011). Little research is available that applies a more traditionally acceptable acupuncture protocol to facilitate fertility.
Both the experimental and clinical research studies have yielded interesting but inconclusive findings. The effects of acupuncture are apparently multimodal using physiological, endocrine and neurological pathways to precipitate changes in the body, including to women‘s reproductive functioning. Similarly, clinical trials offer promising evidence of reproductive outcomes initiated by a variety of acupuncture interventions. Clinical research into acupuncture efficacy has been heavily criticised for methodological flaws and bias. Most systematic reviews find a large proportion of studies that fail to meet inclusion criteria on the basis of their methodology. The next section of this Chapter addresses issues of research methodology.
Acupuncture research methods Searching electronic databases using the search term ‗acupuncture research methods‘ precipitates a cascade of possibilities. A recent review of acupuncture research in the Science Citation Index found 6,004 publications with 13 document types indexed in the SCI Expanded, which include 3,975 articles. The article, as the most popular document type, comprises 66% of the total production and was followed distantly by reviews (508; 8.5%), letters (458; 7.6%), meeting abstracts (457; 7.6%), editorial materials (286; 4.8%), proceedings papers (213; 3.5%), and the remainder having less significance (Han and Ho 2011:681). There was a substantial jump in publications following 1997, and many of these were produced in the USA. Much discussion of acupuncture research methodology happens within the context of clinical trials and acupuncture mechanisms research, and is too copious to review. The selected 123 articles are general and discuss either an overview of acupuncture research or specific aspects of methodology, such as placebo or suitable controls for acupuncture. The following discussion attempts to distil the key contemporary views on methodology and is then followed by a critical analysis and reflection on how it might influence the research questions addressed in this study.
Complex intervention In the earlier years of 1970s almost all clinical articles on acupuncture were open trials, since acupuncture treatment required close interaction between the acupuncturist and the patient in order to obtain the
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maximal sensation of deqi (a complex feeling under the needle) for best therapeutic effect. In this case the placebo effect is hardly avoidable. Starting from the late seventieth, clinical trials were requested to set a control group to blind the patient (single blind) at least, if not the acupuncturist (double blind). The randomized controlled clinical trial (RCT) started to emerge at 1992 (Han and Ho 2011:684).
Within a decade and a half, acupuncture researchers began to question the value of the standard RCT for acupuncture. Researchers seem to have reached a consensus that acupuncture as a healthcare intervention needs to be understood as ‗complex‘ (Plsek and Greenhalgh 2001; Paterson and Britten 2004; Joos, Schneider et al. 2006; Walach, Falkenberg et al. 2006; MacPherson and Schroer 2007; MacPherson, Nahin et al. 2008). Doing research and accepting ‗complexity‘ means abandoning the idea of unraveling the active ingredient (or even conceiving of acupuncture as having an active ingredient) or the ‗specific effect‘. The acupuncture intervention is a package that includes the consultation and its accompanying pulse taking, palpation, symptom discussion and so on – not just the insertion of needles. And, even if read as only the application of needles, this is in itself a complex engagement of practitioner and patient with their separate intentions and anticipations, sensations of the needle from either end, deqi and explanations of what is occurring. Every therapeutic engagement is loaded with complex meanings and events, as the discussion of placebo and nocebo identifies (see discussion below).
An argument has been put forward that effective clinical evaluation of acupuncture should use a different model to that developed to assess the safety and efficacy of pharmaceutical drugs. Lewith and his colleague Machin suggested that it was not possible to investigate techniques such as acupuncture as an ‗alternative pharmaceutical‘ (Lewith 2008). Key acupuncture researchers (Lewith 2008; MacPherson 2008) have proposed an alternative ‗whole-system‘ model based on that put forward by Fonnebo et al (2007) which reverses the process of phased testing of new drugs, giving greater priority to all aspects of the treatment approach not just the perceived ‗active ingredient‘. In discussing whether the RCT is a valid research design for acupuncture Paterson and Dieppe (2005) concluded that the randomized placebo controlled trials have questionable value for non-pharmaceutical interventions and can lead to false negatives in the case of complex interventions. They did, however, advocate the use of, for example, pragmatic RCTs where the effectiveness of intervention is tested without identifying the specific active ingredient.
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The methodology used in research of CAM has been used to explain a gap between what is perceived as possible in clinical settings compared to what has been evident in research trials. This gap has been explained as at least partly the result of complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited (Fonnebo, Grimsgaard et al. 2007). They too argue that more research is required to establish effectiveness prior to exploring efficacy through more RCTs.
Boon, MacPherson and colleagues (2007:284), critiquing 4 approaches to evaluating complex healthcare interventions, conclude that there is a growing international understanding of the need for a new conceptual framework for assessing complex healthcare systems. Multiple methods and integrated programs of research undertaken by interdisciplinary teams appear to be necessary.
This call for acupuncture to be researched as a complex intervention has attracted direct opposition or challenge from one quarter (Ernst and Canter 2005; Ernst 2006; Ernst and Lee 2008) but few other active critics. Ernst argues that the whole point about doing a clinical trial is to answer a research question about causal inference (Ernst and Canter 2005:203), and thus finds any other purposes of research meaningless. Despite this near consensus, authoritative opinions of the value of acupuncture as a medical intervention are made based on what is regarded as the pinnacle of evidence – the systematic review and meta-analysis which most often exclude studies that do not measure efficacy.
Comparative effectiveness The need to assess acupuncture as a complex intervention has led to the identification of ‗effectiveness‘ as a primary measure of acupuncture rather than ‗efficacy‘ (Witt, MacPherson et al. 2012). The focus then is to research how acupuncture performs in a clinical setting (that is maximizing the external validity of a study) rather than seeking to identify causal effects through an explanatory study (where internal validity is maximised).
In non-pharmacological medical interventions, the pragmatic randomised controlled trial is seen as more useful than tightly controlled standardised RCTs. The importance of developing an evidence-base for acupuncture and Chinese medical practices is not in question. Indeed, one commentator argues that in the encounter between ‗evidence-based medicine‘ and acupuncture,
[61] evidence-based medicine requires more critical scrutiny than vice versa (Schulman 2005). It is necessary that researchers develop tools that measure actual practice and inform acupuncturists and their patients. If results are to be generalised beyond the research setting and evidence garnered to support particular interventions in medical settings then these findings need to be recognisable as ‗real‘ acupuncture.
The differences and value of pragmatic and explanatory trials is discussed at greater length in Chapter 3.
Comparison interventions Another major topic of discussion about acupuncture research methods is in relation to the comparator. The question has become: what is equivalent to acupuncture that isn‘t acupuncture (but could be perhaps perceived as acupuncture in a blinded trial)? Birch (2004) recommends that any sham acupuncture needs to be tested in pilot studies prior to any trial to assess the relative effectiveness of the sham, and to assist in determining if indeed it is an appropriate sham treatment. He states that all of the sham interventions tested so far are thought to activate physiologic nonplacebo nonspecific effects and some activate specific effects (Birch 2004:489). Researchers have argued that the reason why it is difficult to find a truly inactive control for acupuncture is because the actual mechanisms of acupuncture are still unknown (White, Wayne et al. 2007:106). A further argument is that using conventional care as a comparison to a novel treatment such as acupuncture can be choosing a form of care that has consistently failed that cohort of patients over time (for example, conventional medical care for difficult to cure conditions such as low back pain or migraine) (O'Connell, Wand et al. 2009). Criticism (Ernst and Lee 2008) has also been levelled at the 'A + B versus B' model adopted particularly in pragmatic trials because of the impact this approach has on expectancy. One solution proposed is: that future trials compare several different treatments head to head to try to avoid recruiting only a sample of individuals who may, for whatever reason, be particularly in favor of one specific treatment approach. Another option would be to consider using a cohort multiple-randomized trial design in which patients seeking care as usual form a new, large cohort that is followed up regularly over time. Within this cohort, there is the capacity for multiple RCTs over time (Foster 2010:190). The possibility that acupuncture has no contribution beyond placebo has been raised (O'Connell, Wand et al. 2009), and the fact that acupuncture researchers have not conceded this fact is seen as interpretive bias(Ernst and Lee 2008).
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Placebo Another hot topic is the discussion on how important is the role played by placebo (psychological) effect as compared to the physiological effect induced by acupuncture (Han and Ho 2011:684). There is a large literature on the variations in the magnitude of effect according to different forms of placebo (O'Connell, Wand et al. 2009:396). There is also a body of work mainly led by Ted Kaptchuk (Kaptchuk, Stason et al. 2006; Kaptchuk, Kelley et al. 2008; Kaptchuk 2009; Kaptchuk, Shaw et al. 2009) that identifies the complex interplay of ritual and performance that impact on acupuncture outcomes. This issue is discussed further in Chapter 6 in the context of the reported experiences of acupuncture by trial participants.
Acupuncture dose There are calls for more attention to the dose of acupuncture provided (White, Cummings et al. 2008) although there are few studies comparing different doses of acupuncture. A study of variations in acupuncture technique by Harris et al (2005) reported in (White, Wayne et al. 2007) found that the frequency of treatment provided more pain relief for those suffering with fibromyalgia, with few differences emerging from the application of different techniques and needle stimulation. Both Stener-Victorin (Stener-Victorin 1996) and Cridennda (Cridennda, Magarelli et al. 2006) have indicated that the number of acupuncture treatments may be critical to outcomes in female reproductive health.
Expectation Assessed prior to study commencement, expectations of acupuncture are generally very positive, and there is some evidence that patients with higher expectations for acupuncture are more likely to have favourable outcomes (Linde, Streng et al. 2007; Foster 2010:190). This effect, however, has not been extensively researched. A systematic review of expectancy in acupuncture studies (Colagiuri and Smith 2012) found they were unable to conduct a meta-analysis to estimate and test the effect size for the relationship between expectancy and acupuncture outcomes due to the high heterogeneity in methodology and incomplete reporting in some studies (2012:10). The authors‘ general conclusion was that there was an apparent significant relationship between patient expectation and acupuncture outcomes. Means of measuring this relationship would be a useful addition to future research.
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Evidence and outcomes The issue of what constitutes evidence in Chinese medicine and what are suitable outcome measures for acupuncture research have been frequently raised by practitioners in relation to research studies. Acupuncturists operate with two different conceptions of evidence, one biomedical, and one experience-based. The first conception resembles the understanding of evidence found in conventional medicine, while the second is based either on personal experience or on the history of acupuncture. Although most of the interviewees embraced both conceptions, they differed in how much epistemological weight they gave to the different types of evidence (Hansen 2011:6). Trina Ward (2012) has identified what she calls six different ‗enactments‘ or styles of practice of Chinese medicine. These differing enactments have implications for research – both in the way acupuncture is conceived and delivered in a trial setting and in the manner in which results are interpreted once reported. Ward characterises contradictory information as being ‗usual‘ in Chinese medicine and states that the ‗both/and‘ approach to knowledge is more likely than the ‗either/or‘ approach to knowledge exemplified by biomedicine. As the current challenge to CAM by advocates of evidential science-based medicine exemplifies, the possibility of contradictory ‗truths‘ has no place in that world view. There are, in fact, few forums that allow a dialogue to occur on these issues.
Research generally requires measurable outcomes or endpoints. Problems have been identified with this approach: 'Outcomes' are often conceptualised as disease-focused endpoints of a linear cause and effect intervention, which are ideally measured in terms of a single objective primary outcome at a fixed time-point. Context effects, which include aspects of the process of the intervention and the wider context of peoples' lives, are viewed as separate entities which are best removed from the evaluation process by means of a randomised controlled trial design. Our analysis indicates that whilst this concept of outcome may be appropriate for measuring the shortterm efficacy of pharmaceutical interventions, it is inappropriate for most complex interventions (Paterson, Baarts et al. 2009:9). Of course, in the field of CAM the choice of endpoints needs to be limited to what can be easily and objectively measured. The measurements used in an acupuncture clinic, such as changes in the pulse and tongue presentation and abdominal palpation, are rarely measured in clinical trials. Most measures adopted and recommended by experienced researchers are sourced from biomedicine. This issue is discussed at length by Verhoef, Vanderheyden et al (2006). The concern that valuable information is excluded by standard outcome measures has led to the adoption of qualitative research methods in acupuncture research.
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Qualitative perspectives Standard or conventional quantitative research methods have been criticised as offering only partial understanding of the value of acupuncture. This has emerged from several sources; Claire Cassidy and Charlotte Paterson in (MacPherson, Nahin et al. 2008) and others (Nester 1999; MacPherson, Mercer et al. 2003; Paterson 2004; Paterson 2006; McManus, Kaptchuk et al. 2007; Paterson 2009; Yeung 2009; Hansen 2011). In this study, the review of acupuncture research located only 1.6% of studies that were primarily qualitative in method. A more complete discussion of this issue is offered in Chapter 3.
Discussion Across the whole spectrum of acupuncture disciplines there is a continuing trend towards the separation of acupuncture from its roots in TCM (Kingston 2011:47). This trend has made acupuncture easier to research and more portable as a technique in other fields of practice such as physiotherapy. If ‗dry needling‘ a ‗trigger point‘ is more acceptable terminology for biomedicine, and people receiving this treatment experience relief, then perhaps there is some benefit to be gained from distancing acupuncture from its Asian roots and theoretical origins to give it broader application. Yet it could also be argued that this is acupuncture ‗dumbed down‘ to its lowest efficacy or most basic mechanical action. It is useful to know that the point Pericardium 6 (neiguan) is helpful and safe to use for nausea and vomiting during pregnancy or during chemotherapy, but its application in the many clinical trials bears no relationship to how that point is or could be used in traditional clinical practice. Is it inevitable that science at its best in RCTs has to be Chinese medicine at its worst or most diluted?
Of course, it is not a simple matter of ‗science‘ proving or disproving the efficacy of acupuncture. There is no level playing field and ‗players‘ in the arena have become fervent contestants, using (and perhaps distorting) the tools of science to serve interests that are not always apparent. Witness the activity of Professor Edzard Ernst in his apparent endeavours to demonstrate that acupuncture is both more harmful and less effective than is claimed (Bovey 2011:18) and Ernst‘s (Ernst and Lee 2008) own defence of his position that often acupuncture researchers choose research methods that offer only ‗false positives‘.
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Examining knowledge in the professions (biomedicine) and those currently professionalising (CAM practitioners), Hirschkorn (2006) challenges the view (Kelner, Wellman et al. 2004) that conflict about whose knowledge is ‗scientific‘ and non-scientific is essentially (or not just) a competition for power and market share. She instead points to how health providers define their competencies and make knowledge claims that are more complex than and not reducible to depictions of ‗science‘. She identifies a difference between indeterminate knowledge (acquired through experience, ascription or initiation) and technicality (knowledge which can be codified, broken down into constituent tasks, that is, rationalised and delegated). The ratio of these different knowledges offers professions ease or difficulty in transferring and transmitting knowledge internally and externally.
Across broad categories of CAM practitioners, increasing professionalisation has been positively correlated with increased scientisation of the practice – including the use of scientific rhetoric in publicly presenting the knowledge form, as well as a corresponding shift of the content of knowledge and practice. An additional pattern of professionalisation that has been noted is an increase in specialisation, … the limiting of the scope of both knowledge and practice (Hirschkorn 2006:549).
There is no dispute that TCM is becoming more ‗scientised‘ with an emphasis on robust biomedical content and evidence-based practice. The discussion in the literature turns on whether this is progress that will advantage practitioners (and therefore increase the therapeutic gain for their patients) or a retrograde development that will hinder their efficacy.
Reflecting on the task of teaching research methods to acupuncture students, Seem stated: Pragmatically, even when taught the skills necessary to access, read and critically assess acupuncture research, students perceive little incentive to do so as a majority of the research being conducted is perceived by the average practitioner as wholly irrelevant to the actual treatment of patients, and dubious with respect to methodology (Seem, Cassidy et al. 2004:149). Many researchers have chosen to explore the contribution acupuncture can make to improving specific conditions and diseases. Richard Nahin7 has evaluated the 1997 US-based National Institute of Health (NIH) Acupuncture Consensus Conference on Acupuncture Research as initiating new classes of acupuncture research. Although not in the ‗big NIH 13‘, fertility acupuncture has captured public attention. Research into improving the outcomes of fertility
7 cited in a report of a conference held to mark the 10th anniversary of the original conference MacPherson, H., Nahin, Richard, Paterson, Charlotte, Cassidy, Claire, Lewith, George T., Hammerschlag, Richard (2008). "Developments in acupuncture research: big-picture perspectives from the leading edge." The Journal of Althernative and Complementary Medicine 14(7): 883-887.
[66] treatments, most notably in IVF cycles, especially at the point of embryo transfer, has also attracted the interest of assisted reproduction researchers and clinicians. Both the public interest from infertile women and positive research outcomes have flowed into acupuncture clinics and changed acupuncture practice. This burgeoning research has been perhaps driven by the urgent attempts to maximise assisted reproductive technologies (ART) and so to respond to the sheer desperation and consumer demands of the sub-fertile. The positive feedback from ART patients who have used acupuncture and other complementary medicines, accompanied by shifts in health care practice, must be contributing factors to the willingness of ART clinics to participate in this research.
Most ‗acupuncture-in-fertility‘ researchers have shown a faithful commitment to the methodologies of the ‗conventional medical model of assessing efficacy‘ (White, Linde et al. 2008), that is, randomized controlled trials, with their ‗reductionist paradigm‘. Since the ground- breaking work of Paulus and colleagues (Paulus 2002) there has been a broadening shift in thinking about acupuncture research precipitated at least in part by practising acupuncturists‘ discomfort with research designed to provide empirical evidence of the efficacy of their work, and in part by those medical researchers who have pointed to the complexity of many medical interventions which are not well served by a ‗simple‘ pharmaceutical model of a clinical trial (Plsek and Greenhalgh 2001; Craig, Dieppe et al. 2008; Shiell, Hawe et al. 2008).
If the randomized controlled trials (RCT) undertaken in IVF cycles to measure the degree acupuncture enhances embryo transfer success are examined in detail, some of the weaknesses of acupuncture research become apparent. In a complex medical intervention such as acupuncture, the primary difficulty is isolating the ‗working‘ element in the intervention. Is it the actual needle puncturing the skin? Is it the successful manipulation of the needle to achieve deqi? The combination of points used? The timing? The interaction of acupuncturist and patient? The setting in which this interaction takes place? Or, as is more likely, all of the above and more? Chinese medical theory encompasses this complexity. Biomedical theory and research practice has fewer tools to include and account for so many ‗unknowns‘. In one randomised sham- controlled acupuncture trial, for example, the researchers concluded that the acupuncture given in the trial differed from ‗real life‘ acupuncture and that these differences affected the needling and the contextual factors significantly and inevitably (Paterson, Zheng et al. 2008). Similarly, a
[67] study examining patient experiences of differences in psychosocial context between a RCT acupuncture intervention and usual acupuncture practice settings found possible under-reporting of benefit by patients in trials. The authors recommend: New trial designs that ensure participants‘ experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects (Barlow, Scott et al. 2011:79).
As well as acupuncture researchers developing a more sophisticated understanding and use of research methods, what is also required is for those research methods to better accommodate acupuncture. Complementary and alternative medicine (CAM) provides not just a wider range of therapeutic tools which require evaluation it presents other ways to think about disease and therapeutics, and consequently new ideas about research should be developed (Fonnebo, Grimsgaard et al. 2007).
There has been increased focus in recent years both on defining an adequate dose of acupuncture and on evaluating the quality of acupuncture research (see for example (Smith, Zaslawski et al. 2011)). There are many aspects of acupuncture research methods that require further assessment and methodological issues which raise concern (White 2011). A detailed discussion of developing acupuncture research protocols follows in Chapter 4 and a discussion of the value of pragmatic trials to acupuncture research in relation to methodology is included in Chapter 3.
Conclusion We have preliminary data indicating acupuncture may improve coping for women experiencing delays falling pregnant. There are, however, no studies that specifically address the question of whether an acupuncture intervention has a role in facilitating conception in those having trouble conceiving. There is experimental data that acupuncture can influence female reproductive functioning, although the actual mechanisms involved are not yet clarified. Acupuncture research methods are becoming more sensitive to the complexity of acupuncture as an intervention. The evaluation of acupuncture research still expects a consistency with designs and outcome measures that privilege efficacy over effectiveness. Further research is needed. The following chapter discusses the research methodology used in this study and developed to further this exploration.
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Chapter 3 Methodological overview & Theoretical frames
―…what – apart from the exercise of power – is the sense in examining something that in order to fit into specific research paradigms has been distorted to such an extent that it is no longer really what it is claimed to be?‖ – Volker Scheid8
This chapter describes the interacting engagement of theory and practice in designing and implementing this research project. The methods used to generate knowledge, or what health science likes to call ‗evidence‘, need to be explicit and transparent. This chapter examines why the choice of methods was made. It also examines the implications of a mixed quantitative/qualitative approach to CAM research generally.
The research questions that drive the shape and process of this study are threefold: the first addressed – can an acupuncture intervention or protocol be developed that is designed specifically to enhance female fertility and does this have acceptance amongst acupuncturists who specialise in fertility? Or can it be developed directly from current practice? The next and second phase of the study is designed to test this protocol for clinical effectiveness: does it make a difference to women‘s fertility outcomes? Is it a suitable intervention for a clinical trial? The third phase of the study is built on an in-depth exploration of the experience of acupuncture – what is the experience of receiving this acupuncture protocol? To address these questions required a range of decisions about methods. This chapter outlines the choices and directions adopted.
Methodological choices Choosing a methodology is neither simple nor straightforward. The textbooks clearly indicate that the research question or problem must dictate the method used. There may be other reasons, however, why research methods are included. Funding for this research came with the requirement to undertake a randomised controlled trial of an acupuncture intervention in the field of women‘s health. From the outset, quantitative methodologies were recognised as more valued in this research context. The funding brief also included the requirement to examine the
8 Scheid, V. and H. MacPherson, Eds. (2012). Integrating East Asian medicine into contemporary healthcare. Edinburgh, Churchill Livingstone. P.24
[69] dimensions of quality acupuncture research. As is clear from this defining of the research task it is not only research questions that set the boundaries for a research project. Sociologist Ann Oakley (1999) articulates the complexity of research design choices, identifying them as not necessarily rational and greatly influenced by the researcher‘s underlying philosophy:
[The] interplay between epistemological position and methodological decision is enormously affected by social context. We pay attention to what other[s]… are doing, to fashions in both methodology and topic – the things it is considered proper … to study; we are affected by research funding and publishing opportunities, by the material resources available to support our work, by intraprofessional rivalries and difference, and by politics – both in its commonly understood sense and as applied to power relations between academics and those who take part in research... And this is only some of what goes on. In short, it is a very complicated business (1999:247).
This researcher was moving from the clinic to the ‗bench‘. The complexity of making choices that were not primarily driven by the immediate well-being of the patient but by the possibility of long-term knowledge production was a great challenge. The decision to use a pragmatic trial design rather than an intervention with blinded sham control, for example, was guided by the nature of the treatment population as well as the feasibility of sham control to address this research question. In a fMRI study of laser acupuncture, researchers concluded: Our finding that laser stimulation of a non-acupoint produced some brain activation suggest that there is unlikely to be a completely neutral control non-acupoint, and this should prompt a re-examination of the use of sham points (in needle acupuncture studies) as control hence minimizing the true statistical effects of any acupoints (Quah-Smith, Sachdev et al. 2010). In addition, women who have been struggling to conceive are unlikely to risk ‗wasting precious time‘ on a sham intervention. An active non-acupuncture intervention was chosen as the control to address this concern. This came as a great relief to this researcher who doubted that she would have been able to comply with the requirements of sham acupuncture. Similarly, the decision to consult experienced practitioners rather than use theoretical Chinese medical first principles to design a suitable protocol for the trial was greatly influenced by the reality of extensive biomedical use (by means of assisted reproductive technologies) by women seeking to overcome fertility problems. The degree to which this biomedical perspective needed to be accounted for in the protocol required testing with those working in the field. A consensus achieved by collaborative efforts was far more compatible with the researcher‘s value base than an expert decree guiding practice.
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The history of contention between the relative value of ‗quantitative‘ and ‗qualitative‘ research methods appears to still be embedded within biomedical and, therefore, CAM research. Finding methodological means to make a productive use of both is still a work in progress.
The challenges in the path of this progress include ideological resistance among academics, the traditional culture of academia, which is opposed to collaborative and cumulative work, lack of methodological skills among [researchers], nonstandardisation of bibliographic databases, and a reluctance to accept the existence of problems in the way much …research is carried out and reported (Oakley 2004 B:12).
The practice of Chinese medicine, as other CAMs, has many dimensions which cannot be measured (and especially not measured without distortion) and can better be explored using qualitative methods. As detailed in Chapter 2 [section on Acupuncture Research], recognition of acupuncture as a complex intervention has increased interest in qualitative methods and this is flowing through into published research. For this research project a mixed methods approach has been adopted, with the aim of generating diverse data.
Rationale for mixed methods The proposition that the therapeutic engagement, and even matter itself, is complex and that understanding it requires more than the application of standard scientific methods has come at a time when the boundaries between ‗knowledges‘ are being challenged. It is Bruno Latour who drew our attention to the intellectual division of labour that separates the social-political, natural- scientific and the textual-conceptual representations of ‗reality‘. With specific reference to anthropology, this division plays out through what Latour calls the ―Two Great Divides‖: that between culture and nature, society and science, and that between the modern, western Us who supposedly maintain such a distinction and Them who do not (Zhan 2001:459-60). We note, of course, that this division has roots in geography, and the dualism evident in the Western philosophical tradition plays out differently in the ‗East‘ where the fundamental characteristic of Chinese philosophical thought holds what Wu terms the simultaneity of unity and duality, and indeed simultaneity of unity and multiplicity (Wu 2010:231). This difference has implications for the broader discussion in this thesis but here, in the context of ‗research methods‘, the focus will remain ‗Western‘.
In 1989 Nicolis and Prigogine (quoted in(Bennett 2010)) distinguished between linear and nonlinear systems: the former where a cause can be seen to add an individual or multiple effect; the nonlinear where adding a small cause triggers dramatic effects that cannot be measured against the amplitude of the cause. Applying this in an example of what she calls the ‗nonlinear
[71] assemblages of food‘, Bennett identifies how ‗effects‘ resonate with and against their ‗causes‘ such that the impact cannot be grasped without measures that assess heterogeneity: The agency of the added element(s) is only ‗slowly brought to light as the assemblage stabilizes itself through the mutual accommodation of its heterogeneous components‘ (Bennett 2010:42). The reality that matter is lively - whether biota or nonbiota – means that outcomes are unforeseen and ‗governed by an emergent rather than a linear or deterministic causality‘. The task for researchers examining complex and nonlinear phenomena and processes is choosing methodologies that can identify and describe ‗the emergent‘.
Healthcare research has become ‗a veritable battlefield‘, partly at least because of different sets of knowledge or paradigms that construct different research practices. In practice, rather than quantitative and qualitative research existing as two concepts in the same milieu, to answer different questions in the most pertinent way, a battle for hierarchical dominance exists (Muncey 2009:14), and this plays out as quantitative methods (RCT as ‗gold standard‘) occupying a dominant and hierarchical position in relation to qualitative methods.
Mixed methods research, that is, the combination of at least one qualitative and at least one quantitative component in a single research project or program, has become increasingly popular in the social, behavioural, and related sciences in recent years. And although some argue that the division between quantitative and qualitative methods is an artificial one and will become obsolete, they are still conceived and practised as if fundamentally different, and therefore the notion of ‗mixed methods‘ remains a necessary construct (Bergman 2008). Mixed methods are widely used in the social sciences - in nursing research, educational research, language and linguistics, public health, and organisational and management studies. Qualitative research …[has become] increasingly prominent, particularly in nursing research; not least because it is able to illuminate behaviour, perceptions and interactions in the complex world of health care (Muncey 2009:15-16).
Nevertheless, an essential question to address is ‗why use mixed methods?‘ As early as 1989 Greene, Caracelli and Graham (presented in Hesse-Biber (2010)) put forward several specific factors for researchers to consider when contemplating using mixed methods. To better exemplify the method, a brief outline of how each of these characteristics can be applied to this mixed method study is given.
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First, and the most commonly cited, is ‗triangulation‘ where the results of different research methods applied to the same research problem are used to enhance, reinforce or inform the credibility of the research findings making them acceptable to both quantitative and qualitative evaluators. An example in this study would be ascertaining that the important issues identified by the fertility acupuncturists interviewed in-depth were also rated as important through the Delphi process. Another example would be whether assessing women participants‘ assessment of their experience of acupuncture is supported by data on their actual attendance at acupuncture consultations.
The second reason is ‗complementarity‘, where the researcher considers that the research question would benefit from both a numerical and narrative explanation, expanding comprehension of the data generated from the research. In this research study, the story of one woman‘s discovery of her body‘s sexual and reproductive functions powerfully reinforces the data of the acupuncture cohort‘s increase in fertility awareness from the intervention.
A third reason is that mixed methods approaches can also be ‗developmental‘ when the results of one method inform the execution of another method. For example, the preferences of the focus group of fertility acupuncturists informed the design of the acupuncture protocol for the clinical trial.
A further reason for choosing mixed methods is ‗initiation‘, where questions or contradictions emerge that require clarification, thus initiating further research. It is common to hear researchers describe the function of qualitative research as a means to identify issues that then can be extracted and rigorously examined using quantitative means. This is qualitative results as an exploratory ideas mill for quantitative research. (Or, feasibly, vice versa.) An example from this research process could be the importance attributed to acupuncture by its recipients as an ‗embodied practice‘. An ensuing quantitative task that could be initiated would be the development of a measure of ‗embodiment‘ to be used in future research.
Which methods mixed On the basis of Teddle and Tashikkoris‘ (2006) typology of mixed methods research, this pilot study would be classified as having a sequential, multistranded quasi-mixed methods design. The ‗quasi‘ indicates that minimal data conversion from qualitative to quantitative (or vice versa) has occurred in the analytic and inferential stages of the project. The following diagram represents
[73] this process, where the oval shapes indicate qualitative method and the rectangles quantitative method.
Figure 3.1 Mixed methodology - sequential, phased quantitative and qualitative research process
Design of an acupuncture intervention
RCT for women with difficulty Conceptualisation conceiving prior to conception stage
What acupuncture intervention?
Phase 1: Framing acupuncture practice in
fertility [3 interviews] Experiential stage
Phase 2: Focus group with Delphi consensus
Protocol
Randomised controlled acupuncture intervention
What was the participants‘ experience of acupuncture?
Inferential stage Discussion of outcomes In-depth interviews + questionnaires of
experience of acupuncture Conclusions & future research Meta-inference directions
Diagram of sequential, phased quantitative and qualitative research process
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Quantitative methodology The central research question of this study was to determine the effectiveness of an acupuncture protocol in a specific population group, and not to define an ‗active ingredient‘ and exclude all other variables. Therefore this study adopted a pragmatic approach despite the reality that this goes against the orthodoxy of ‗scientific‘ research practice. Walach et al (2006) argue that the representation of research evidence as hierarchical (from the lowly case study to the heights of blinded, placebo-controlled RCTs) is only valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and drugs. They advocate a circular model because only a multiplicity of methods, which are used in a complementary fashion will eventually give a realistic estimate of the effectiveness and safety of an intervention. Every research method has strengths and weaknesses which cannot be resolved within that method itself...triangulating a result achieved with one method by replicating it with other methods may provide a more powerful and comprehensive approach (Walach, Falkenberg et al. 2006:5). Several of the authors of this paper argued subsequently (Fonnebo, Grimsgaard et al. 2007) that a different research strategy was required for CAM that reversed the phases of a drug trial so that CAM interventions were first assessed in clinical trials and the biological mechanisms identified later in the research process. The pragmatic trial is a means of furthering this different research strategy.
Pragmatic trials Schwartz and Lellouch (1967) coined the terms ‗pragmatic‘ to describe trials designed to help choose between options for care, and ‗explanatory‘ to describe trials designed to test causal research hypotheses—for example, an intervention that causes a particular biological change. The scientist Charles Peirce argued that the importance of an idea or action lies in whether it makes a difference in everyday life, that is, its pragmatic value needs to be evaluated. Ideas or actions that correspond to attractive explanations (e.g., metaphysical theories), but make no difference to outcomes, are problematic (referenced in Maclure (2009)). Similarly it could be argued that ideas and practices such as those of Chinese medicine that do not easily fit within biomedical scientific theory should only be dismissed if they are shown to have no pragmatic value. The difficulty is finding evaluative methods that are not embedded within the hegemonic ‗science‘ theory.
Most contemporary researchers recognise that the differences between explanatory and pragmatic trials should be seen as a continuum rather than as a clear dichotomy. Although Table
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5.1 below characterises the two research methodologies as distinct, this dualistic approach effectively highlights possible differences. Similarly, Thorpe et al (2009) have developed a two- dimensional model that allows trial designs to be recognised as occurring along a continuum, and originally Schwartz and Lellouch identified the distinction as one of attitude in the design of trial methodology.
Table 3.1 | Key differences between trials with explanatory and pragmatic attitudes, adapted from a table presented at the 2008 Society for Clinical Trials meeting by Marion Campbell, University of Aberdeen (Zwarenstein, Treweek et al. 2008)
Explanatory Pragmatic
Question Efficacy—can the intervention Effectiveness—does the intervention work? work when used in normal practice? Setting Well resourced, ―ideal‖ setting Normal practice Participants Highly selected. Poorly adherent Little or no selection beyond the participants and those with clinical indication of interest conditions which might dilute the effect are often excluded Intervention Strictly enforced and adherence is Applied flexibly as it would be in monitored closely normal practice Outcomes Often short term surrogates or Directly relevant to participants, process measures funders, communities, and healthcare practitioners Relevance to practice Indirect—little effort made to match Direct—trial is designed to meet design of trial to decision making needs of those making decisions needs of those in usual setting in about treatment options in setting in which intervention will be which intervention will be implemented implemented
Some commentators argue that pragmatic trials are useful not just for complex interventions such as CAM but also in drug therapy. For instance, in psychiatry, the benefits of therapeutic interventions established in randomised trials have been difficult to replicate in practice settings. The way in which therapeutic interventions play out in a real world setting is a significant measure of their effectiveness. This is because pragmatic trials are conducted on a range of patients to which the treatment might be applied, and these patients may demonstrate variable compliance, have a number of co-morbid conditions, and use other medications. To a great extent, compliance with the intervention is one of the most important outcomes of pragmatic trials. Unlike explanatory trials where compliance with the intervention must be ensured in order to know that the intervention can work, in pragmatic trials compliance with the intervention is measured as an outcome (Godwin, Ruhland et al. 2003:5).
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One of the dangers of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalisability or external validity.
There are concerns about the value of this methodology and critics of pragmatic trials identify a number of issues. The pros and cons of trial design have been pressed into the service of an ideological debate about whether CAM ‗belongs‘ in ‗scientific medicine‘ and therefore in health care provision. Critics of CAM pragmatic trials, including a major critic of acupuncture trials, in editorial comment stated: The results they produce are frequently next to meaningless. Essentially this is because their outcomes, positive or negative, can be interpreted in more than one way. In some medical areas, for example complementary medicine, pragmatic trials tend to be conducted by practitioners or others with a strong interest in promoting their therapy. In such instances, the weak design and scope for ‗‗spin‘‘ in interpreting results render pragmatic trials highly susceptible to bias. Under such circumstances pragmatic trials can resemble propaganda tools more than science (Ernst and Canter 2005:203). These critics do not address the difficulty of assessing efficacy or effectiveness of acupuncture as it is practised, rather than in a controlled laboratory setting. Nor do they acknowledge the difficulty of gaining funding for research where there is little benefit to corporate interests. The advantage of CAM practitioners conducting the research is that the intervention will more accurately approximate daily clinical practice.
Some other issues about clinical trials are raised by Relton, Torgerson et al (2010) who refer to the problem of patient incentive and expectation when they are randomly allocated to ‗standard care‘ readily available outside the trial. They argue that the only incentive for the patient other than the offer of a new or different intervention is altruism. Attrition bias or disappointment bias needs to be reported as an outcome. In a later paper (Ernst and Lee 2008) specifically examining the trials using acupuncture to control pain, the authors conclude that the studies report ‗false positives‘. Characterising the design as ‗A + B versus B‘, that is, the intervention as acupuncture plus usual care versus a control of usual care, these authors identify the studies as incapable of generating negative results: even in the absence of any specific therapeutic effect, the results of such studies would be positive due to nonspecific effects such as a placebo-effect, the additional care given to patients, the therapist-patient relationship or social desirability. A further contributor could be the disappointment experienced by patients of the control groups when not receiving the experimental treatments they may have hoped for (Ernst and Lee 2008:215).
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It is important to acknowledge that finding a way for science to embrace different evidence is an ongoing project.
The risk of bias which results from inadequate blinding and the absence of placebo interventions requires attention to measures that can be taken to minimise bias in the outcome assessment of pragmatic trials and to evaluate the influence of potential sources of bias on the results of a trial (Van der Windt, Koes et al. 2000). Finding and using objective clinical outcome measures will lessen the reliance on self- reported outcomes.
Looking at the disadvantages of pragmatic trials, MacPherson (2009) argues that a pragmatic clinical trial will not delineate a ‗specific‘ effect, nor improve practice, and specifically will not convince the ‗sceptics‘. The advantages, MacPherson reports, are equally clear: a pragmatic trial focuses on a real world context; it does not impact on the way practitioners practice; it is open to cost-effectiveness analysis; and it assists in making choices and policy. When evaluated in explanatory RCTs, CAM, as whole medical systems, have treatments fragmented or have interventions follow a Western diagnostic approach and Witt (2009) argues that pragmatic clinical trials are not only better measures of CAM effectiveness but also allow traditional diagnoses. A further argument for pragmatic rather than explanatory trials for acupuncture is made by Paterson, Taylor et al: Hypotheses directed at the effect of the needling component of acupuncture consultations require sham- acupuncture controls which, while appropriate for formulaic needling for single well-defined conditions, have been shown to be problematic when dealing with multiple or complex conditions, because they interfere with the participative patient–therapist interaction on which the individualised treatment plan is developed (2011:e296) . Although contested, especially by ‗CAM sceptics‘, the pragmatic trial design better suits the hypothesis of this study and best encompasses the acupuncture protocol defined by fertility acupuncture specialists.
Qualitative methodology Throughout this study, qualitative inquiry has been woven through the substantive and expected quantitative measures. As a pilot study there were no tested templates to guide this research and qualitative approaches were included to generate ‗from the ground up‘ the salient issues within and the boundaries to this project. This approach is guided by the understanding that knowledges are situated and practised; that is, they are not easily accessible to rational ‗scientific method‘. The voices of those who practise Chinese medicine and those who are living with
[78] fertility problems and using Chinese medicine therapies strengthen and enrich the knowledge of the complex interaction which occurs between practitioner and patient. These voices are marginalised by quantitative methods used alone. Qualitative health care research can produce rich stories of lived bodies in which health care is situated as a part of daily life. Identifying the ‗tragic aspects of living-in-tension‘ of patients and the ‗intervening-for-the-best‘ of health care practitioners requires disordered rather than smooth story lines:
They should be told by a variety of narrators whose voices may be drawn together or clash. For this is where patients come in again: aware, not just self-aware, but equally able to tell stories about medicine and the effects of its interventions. The overall aim of a multi-voiced form of investigative story telling need not necessarily be to come to a conclusion. Its strength might very well be in the way it opens questions up (Mol and Law 2004:102).
The qualitative research component of this project aims to foreground these voices and stories. The knowledges, identities, and communities of traditional Chinese medicine…are constituted through shifting, overlapping processes and networks that render the boundaries between traditional Chinese medicine, science and biomedicine anything but fixed and self-evident (Zhan 2001: 475). Qualitative methods applied with theoretical, methodological, procedural and interpretative rigour ensure that researchers can avoid accusations of overgeneralisations and the development of unsubstantiated conclusions (Liamputtong and Ezzy 1999). Presenting a case for the use of qualitative methods in CAM research, Paterson (2009) argues that rigorous analysis of the patients‘ perspectives can inform our understanding of specific and non-specific components of CAM practice and their associated effects. She further argues that knowledge of the ‗process‘ components can guide service provision and research design and knowledge of the ‗outcome‘ components, plus ongoing qualitative research, can guide choice of outcome measures. When researching CAM practices that offer holistic care – that is, the person is understood and treated as a whole person - it is important to gather a suite of research methods that most reflect and acknowledge this holism.
Without a range of analytic frameworks, the complexity of CAM will never be adequately evaluated. At a minimum, the deployment of qualitative methods can identify interesting locations for future quantitative research. Witt (2011) cautions against research that involves separating a complex intervention into different aspects and drawing conclusions on only one part of a complex intervention. The application of only quantitative methods in this study would have yielded data
[79] with a less relevance to the practice of acupuncture with fertility problems and less rich information for exploration in future research.
The qualitative research component of this project aims to bring the voices and stories of practitioners and patients to the foreground. Two methodologies suited to this task are grounded theory and feminist analysis.
Grounded theory Incorporating a qualitative component in what is essentially a quantitatively driven research process requires the adoption of an approach where quantitative and qualitative mutually complement and inform each other. Grounded theory, although clearly a qualitative method, endeavours to integrate the strengths inherent in quantitative methods with qualitative approaches. It was originally conceived as ‗scientific method‘, with its originators committed to a scientific realist methodology (Haig 1995). Grounded theory is one of the more frequently deployed research methodologies in qualitative health research; for example, it is advocated as a method of knowledge discovery for nursing (Wuest 1995). As Glaser comments, grounded theory has gone global, seriously global [in] the discipline of nursing (Glaser 1999).
Grounded theory is a systematic, inductive and comparative method of conducting inquiry for the purpose of constructing theory. Its origins were built upon the importance of careful observation of the social world, and the grounded theory process emphasises that concepts, categories and themes are identified and developed while the research is being conducted. Some say there are as many grounded theories as there are grounded theorists, and such diversity is perhaps suited to the fields in which work is undertaken. This author has used specifically the grounded theory explained by Kathy Charmaz (Charmaz 2003; Charmaz 2006; Bryant and Charmaz 2007) who offers a theoretical approach and techniques suited to an enquiry about what acupuncturists do and about how acupuncture is received by infertile women. To better address the differences and complexities of social life articulated through more contemporary analyses, Charmaz is regenerating and updating grounded theory. She advocates a journey back to the pragmatist heritage of grounded theory and to build on these antecedents while invoking twenty-first century constructivist sensibilities (Charmaz 2006:184). With a methodology based in the pragmatist emphasis on language, meaning and action, an additional constructivist approach attempts to make everyone‘s vantage points and their implications explicit – those of the researcher, the informants and other actors or perspectives in the setting/social process.
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For this research purpose, the formative notion in grounded theory is central: to allow any conceptualising of women‘s infertility and acupuncture to arise from those women‘s experiences themselves - not from the researcher‘s mind (although this will be an important filter and contributor); not from assessment instruments with their implicit assumptions and biases; and not from existing biomedical or Chinese medical theoretical frameworks (although again these provide useful windows into the complexity of human existence and health).
Data analysis methods that use predetermined code types (Bradley, Curry et al. 2007) were considered too prescriptive of code outcomes. This study is exploratory and required a more open method to analyse data. The aspects of grounded theory that make it a suitable approach for this qualitative component are:
1. Data collection is undertaken through intensive interviewing and textual analysis with an ethnographic focus on the process or what is being done/has been done, rather than the setting itself; 2. Coding methods encourage an analytic direction in the early stages of the research but remain open to the range and diversity of data; 3. Recording tools/memos are concept based and can be revisited as part of a reflective process; 4. Theoretical sampling techniques which allow the researcher to follow ideas and revisit relevant data to develop emerging theory, that is, move back and forward between data and category; 5. The notion of ‗saturation‘ recognises when sufficient data has been collected and further immersion is unnecessary; 6. The Chinese medicine tradition of moving between empirical and experiential data in order to build theory is reinforced: in the same way, Chinese medicine theorising is seen as a practice; 7. The research method can equally be applied to acupuncturists and their patients – the experience of ‗doing‘ acupuncture and being ‗done to‘ are woven strands within this research.
The process of coding leading to identification of themes, rather than categories, is considered stronger evidence in the arena of qualitative methodology (Green, Willis et al. 2007).
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By incorporating reflexivity- the critical reflective process that moves between action and reflection and back - the researcher can attend to the effects of interactions between researchers and participants in interview and participant observation contexts. Descriptions of the effects of interactions on interview data and attention to relationships between interviewers and interviewees are necessary for attending to the rigor of grounded theory findings. Therefore, it is argued that reflexivity and relationality, which are defined as attending to the effects of researcher- participant interactions on the construction of data and to power and trust relationships between researchers and participants, should be incorporated into grounded theory (Hall and Callery 2001:257). These authors argue that the incorporation of reflexivity and relationality brings rigour, especially when combined with existing attention to theoretical sensitivity within grounded theory. In this research, researcher-participant interactions were both utilised and examined. In the first phase the engagement of the researcher with acupuncture colleagues and peers gave important access to a shared culture with its own specialist language. In the final stage, when trial participants were interviewed about their experience of acupuncture, relationality was again considered and led to the exclusion from further interview of those women for whom the researcher had provided the acupuncture intervention: the inevitable over-familiarity of acupuncturist and patient was seen9 as a potential distortion of the data to be collected.
Grounded theorists while seeking to generalise their data display profound individualism in their work; bringing the individual voice to the centre of an understanding in any situation is both admirable and useful as well as potentially limiting. A strong theme of individual justice and reverence for the sanctity of each person emerges from and underpins grounded theorists‘ work, particularly in the field of illness and health care. The process of generalising from individual data is different from that undertaken by quantitative research and can err on the side of particularising the individual voice. This needs to be tempered by an understanding of the purpose of undertaking this (and most health care) research – to look at the effectiveness of an intervention in a population of people, not one by one. Robinson (1990) and Mol & Law (2004), although quite different from each other, give researchers tools to discern patterns within their data. Robinson‘s ‗taxonomy of accounts of changing health status‘ and analysis of the patterned narratives of illness are useful techniques to take the analysis beyond individual experience toward that of a population. He refers to the ambivalence with which personal accounts of illness are received in the research world and in his sample of accounts of the experience of
9 The primary supervisor experienced in this discipline, considers the level of knowledge gained through the therapeutic relationship inappropriate to bring to this research. Although ‗objectivity‘ is not considered important, or necessarily valued, in grounded theory or other qualitative methods many in the health sciences demand evidence of an ‗outside‘ stance by the researcher.
[82] multiple sclerosis, differentiates accounts, for example, into whether they report a heroic or tragic narrative of their life course. Similarly Mol and Law‘s focus on what is done to and by different people in a health care setting around a specific defined illness, such as atherosclerosis, extends the individual experience by inviting the reader to stand both in and outside the experience of the people described.
The results of this research draw on the expressive and informative individual voices of the research participants - both the acupuncturists and the women with fertility problems. Listening to a number of voices is helpful in identifying common and conflictual experiences and shared and diverse themes. This information can then be read against other accounts, especially of people receiving acupuncture and of women experiencing difficulty conceiving. Within a pilot study these voices assist in assessing the value of the research in a more complex way than through a solely quantitative method.
Feminist Analysis & Research Methods A feminist analysis has a meaningful contribution to make to contemporary health care research. The life experience of many women, especially in Western countries, has improved significantly since the burgeoning of a feminist critique and struggle in the 1970s. Although gender equity and sensitivity is still considered a concern10, health care is increasingly delivered by women to women, and greater sensitivity to women‘s concerns informs health care research. This research project focuses on women‘s reproductive health and thus places women‘s experience of fertility, their exposure to reproductive technologies and their experience of acupuncture at the centre of the project. A feminist analysis has been adopted in an attempt to document women‘s lives…illuminate gender-based stereotypes and biases, and unearth women‘s subjugated knowledge (Brooks and Hesse-Biber 2007). This analysis is not a complete rejection of ‗objective research‘, more an attempt to bring women‘s lives and experiences into the empirical discourse of the inevitably positivist paradigm of a randomised controlled trial.
Feminist emphasis on ‗embodied knowledge‘ (for example in (Diprose 1994; Haraway 2004) is critical to any research in Chinese medicine, particularly acupuncture. From the beginning, feminists challenged the artificial separation of reason (mind) and emotion (body)…(Fonow and Cook 2005), as do Chinese medicine theories, although often conceiving the dualism differently – emotions (mind)
10 An example is ‗Achieving Gender and Cultural Competence by Australia‘s Medical Workforce‘ a project collaboration of health, academic and cultural organisations to enable the medical workforce to be equipped with clinical skills to care for all women in Australia. Another example is the call from the ACT Women‘s Centre for Health Care (2009) for ‗gender sensitive‘ health care delivery.
[83] and physicality (body). This is an interesting distinction: some feminists have been keen to see women‘s subjective experience (which had been systematically excluded from ‗objective‘ representations of reality) included as legitimate knowledge, whereas Chinese medical theorists historically have not separated thoughts, emotions and the spirit from the body and have legitimised patients‘ expressions of feelings as part of the medical exchange. Nevertheless, contemporary feminist theory has added new ways to think about the body, which includes a shift from body as object to the body in relation to the material realm (Mol 2002); the body becomes multiple when it receives the attention of a multitude of practices. This last is an important point when one contrasts the biomedical reading of the infertile body with that of the Chinese medical practitioner.
Another major contribution of feminists to research is to insist that the researcher is not objective, neutral or absent from the research process and that the perspective and contribution of the observer and their interaction with the object of observation needs to be examined. To be useful, this reflexivity needs to be rigorous rather than token. The researcher brings particular conceptual frameworks to the research task and it is through self-critique that these frameworks and perspectives can become part of the inquiry. [‗Strong‘ reflexivity] requires the researcher to be cognizant and critically reflective about the different ways her positionality can serve as both a hindrance and a resource toward achieving knowledge throughout the research process (Brooks and Hesse-Biber 2007:9). In this instance, the writer/researcher/interviewer is an acupuncturist with many years experience working with women on fertility issues. This, of course, could be a strength in the project because it gives privileged access to situated knowledge, such as: an understanding of what acupuncture is; and the unique language of acupuncture; existing networks with colleagues to facilitate the research process; familiarity with the acupuncture clinical engagement favouring a potentially more layered analysis; and knowledge of the multiple challenges infertile and subfertile women confront. As well, these very attributes could be a hindrance because many years of experience can generate explicit and implicit perspectives on the likely outcomes of the acupuncture intervention and on what constitutes an adequate acupuncture protocol; overly presumptive conclusions about what a woman‘s experience of both acupuncture and fertility could be/should be; investment in acupuncture being recognised as a useful adjunct to promote fertility outcomes. 11 The fact that the researcher has no history of infertility or other fertility concerns may distort her perception of the complex situations of the women participants. In
11 Baarts, C. (2009). "Stuck in the middle: research ethics caught between science and politics." Qualitative Research 9(4): 423– 439. argues the opposite: as a researcher with no background in CAM practice (and a deep scepticism of CAM) she identifies the strength of ‗objectivity‘ as essential to CAM research.
[84] this project, the researcher has been alert to her own assumptions and perspectives that are likely to both expand and limit her engaged objectivity. The level of self-disclosure considered ethical in some qualitative research, viz.(Bishop and Shepherd 2011), would be judged negatively by many health science readers. The researcher shares the perspective of Karen Barad (Barad 2007:86) when she discusses reflexivity as potentially a reflecting mirror rather than a means to further knowledge. An extensive discussion of the personal reflections of the researcher as interviewer is not included in this thesis.
A central concern in feminist research is to further the interests of the most disadvantaged women. Prior to the conduct of this clinical trial, some observers predicted that the participants would be privileged women: privileged in the sense that they would have the resources to attend predominantly private IVF clinics; articulate enough (and in the English language) to organize themselves to participate in the trial; located in a major urban city with a wide range of diverse services; for the most part with the benefit of the attention of a highly trained gynaecologist; probable electronic access to wide ranging opinions on the best approaches to maximizing fertility; and supported by partners, friends and family. In the event, the women who did participate were in fact quite diverse, as reported in Chapters 5 and 6. Due to funding constraints, the research did not include women who speak a language other than English, or women who live in remote rural communities, or in countries struggling to provide basic health services, or women unable to transport themselves around a major city. It can be argued that infertility knows no bounds and turns economic and social privilege to dust, and there is no evidence that infertility is more prevalent in any particular social class (Schmidt, Christensen et al. 2005). It is probable, however, that seeking out solutions to infertility requires a level of privilege unavailable to many working class women.
Strengths & limitations of mixed methods The clinical evaluation of traditional techniques is too important to ignore, but no one has come to grips with it, and so far it appears to be intractable….It is hard enough to measure the curative power of a broad range of therapies, understood from a purely technical point of view. One must also ask whether their power was in fact purely technical. If it is equally necessary to consider the social and ritual circumstances in which each therapeutic encounter took place, how does one weigh their role? (Sivin 1998:752) Over a decade later, the measures developed to evaluate the clinical effectiveness of acupuncture and its mechanisms of action are still works in progress – and perhaps intractable? Questions of epistemology (the nature of reality) and ontology (what can be known) are inevitably part of this
[85] discussion. Effective research requires the researcher to be constantly aware of their epistemological position. Mixed methods offer the researcher a chance to critically assess both the ‗realist tale‘ and the ‗nonrealist tale‘. A mixed methods approach at least opens up possibilities of exploring the cultural and ritual dimensions of the therapeutic encounter through including the experiential with the quantifiable. The strength of mixed methods designs is to balance flexibility of qualitative exploration with the fixed characteristics of theoretical grounding and hypothesis-testing inherent to many quantitative approaches. Mixed methods designs systematically and purposefully combine fixed and flexible design components (Kroll and Neri 2009:37).
Reviewing the history of debates around mixed methods research (MMR) Denzin (2010) identifies how some themes are being reworked and recontested for the third time. He reports that scientifically based researchers (SBR) and random-control experimental design advocates such as Oakley (2004 A) are calling for research designs that use qualitative methods. By the end of the 1990s, however, SBR emerged as a force, poised to erase the majority of the gains previously won in qualitative researchers… [despite critical challenges that] SBR had no monopoly over the word evidence. Indeed [argument had concluded that] their model of evidence is inadequate for critical, qualitative, health care research (Denzin 2010:423). Mixed methods research (MMR) has not solved the circular argument about which ‗evidence‘ (quant or qual) holds (or should hold) precedence in relation to health research. The possibilities of ‗triangulation‘ are still not confirmed given the failure to find ‗logical connectors‘ between varied evidences (Miller and Fredericks 2010).
Applying MMR as a tool for social change or for improvement at least of the situation of research participants is a requirement of many MM researchers (Muncey 2009; Hesse-Biber 2010; Mertens 2011). A constraint in the MMR model applied in this study is its failure to provide a flexible circular design that could encourage participants to make use of interim findings throughout the research study. The linear progression and time limitations of postgraduate study necessitate a less flexible research design. Because extensive qualitative data was mainly gathered from those receiving the acupuncture intervention, synthesis and integration of the different data was not thoroughly achievable across all participants. The data, however, can at least be analysed and read in the same context.
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A question worth examining when attempting a diversifying and integrating approach is: Is it integrat[ing] or silencing the diverse voices?‖ (Tashakkori 2009:290). The concluding chapter of this thesis will examine the ‗fit‘ of the mixed research methods used, particularly how appropriate they were to the research question and the research population.
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Chapter 4: Developing a fertility acupuncture protocol
To effectively explore the impact of acupuncture on the fertility outcomes of women in a pragmatic trial it was necessary to use an acupuncture protocol that the TCM profession believes helps facilitate pregnancy or one that history or science deems credible. The research purpose here was to explore the parameters of contemporary acupuncture practice in relation to female fertility and to see whether a consensus could be achieved among practitioners on what constitutes an adequate acupuncture intervention to enhance women‘s reproductive functioning. This chapter outlines this process of establishing a protocol that could then be utilised for the clinical trial. It also explores the unintended consequences of seeking greater standardisation of TCM practice.
Methodology As the search of the literature and previous research (see Chapter 2) did not offer a clear protocol for the use of acupuncture in the peri-conceptual period for women, the initial qualitative strategy was to consult with experienced practitioners who worked in the field of female fertility. Adopting a grounded theory approach allowed the parameters of the trial protocol to emerge from the field of practice. The methods used (detailed below) moved from exploratory in-depth interviews to generate discussion material for an online focus group who were then asked to seek a consensus on key components of a protocol.
Acupuncture research protocols Acupuncture practice, almost by definition, resists standardisation. There is great diversity in practice even amongst those trained within the same schools. White, Cummings et al. (2008) understand this as an outcome of acupuncture developing over several thousand years in different centres in China, Japan, Korea and other parts of the world, resulting in many different styles of practice. In the West, at least, there is much contest and debate about what is ‗true‘ acupuncture: A treatment protocol (i.e. precise description of the procedures and the schedule for a course of treatment) that is one practitioner‘s favourite may be dismissed by another… there is a dearth of data upon which to base decisions about optimal acupuncture protocols… (White, Cummings et al. 2008:112). Acupuncture researchers strive to utilise valid and reliable methods that can inform the work of clinical practitioners. Accordingly, researchers need to arrive at an acupuncture intervention that accommodates the research aims as well as an intervention that is endorsed as ‗good‘ acupuncture (at least in the eyes of a majority of clinicians, for example, TCM-trained practitioners). ‗Good‘ interventions may be identified as ones that are widely practised in clinics
[88] and/or true to, or representing, the theoretical origins of the medicine. Reports of previous acupuncture research indicate there has been a range of methods to fashion an intervention. The Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist (MacPherson, White et al. 2002) asks only that researchers report the rationale for treatment derived from expert literature sources. The utility of this item in the checklist has been supported in a survey of authors (Prady and MacPherson 2007) although not universally adopted and still there are reports of studies where the rationale is stated as ‗commonly used points‘, for example, Yeh (2009). If the rationales for treatment interventions in a trial lack transparency there is no means of assessing validity.
Some interventions are individualised according to theoretical constructs such as constitutional acupuncture, ‗same-name channel‘ or ‗mirror X‘; others are chosen by palpation of channels, acupuncture points or painful points. Another method is to select empirical treatments based on presenting symptoms, such as Spleen 10 xuehai for period pain or Large Intestine 4 hegu for headache. One study, for example, chose local tender points and … distant acupuncture points according to the ‗near and far‘ technique, depending on the condition being treated (Giles and Müller 1999) and in another acupuncture was performed according to the rules of traditional Chinese medicine, including diagnostic palpation to identify sensitive spots (Irnich, Behrens et al. 2001). More recently there have been attempts to discern ‗usual practice‘ by seeking a consensus of practitioners: for example in Germany, study interventions were developed by consensus of acupuncture experts and societies (Linde, Streng et al. 2005; Melchart, Streng et al. 2005; Brinkhaus, Witt et al. 2006).
The early acupuncture studies, for example, in the 1990s and early 2000s, were more usually selected from texts and teachers, for example: the categories and points for treatment are in common use in China and were confirmed by consultation with a midwife who uses these treatments regularly (Knight, Mudge et al. 2001). Or they were guided by a senior acupuncturist: acupoints and sham points were chosen by a study acupuncturist with 15 years of experience in treating [the nominated condition] and were approved by 3 other senior acupuncturists (Assefi, Sherman et al. 2005). Where there is no rigorous research to identify a protocol, the practice has been to accept the guidance of an experienced practitioner or use a protocol found in a standard or classic text. This results in a protocol, such as the ‗successful‘ one developed by the Paulus team (Paulus, Zhang et al. 2002), which, however imperfect or driven by accepted TCM theoretical concepts, becomes reified. When a sufficient body of evidence has accrued from enough research, it becomes possible to identify patterns of point use and methods of applying acupuncture that consistently generate significant change. In a systematic review of RCTs (including 33 of 386 possible trials) of acupuncture treatments for
[89] peripheral facial paralysis, for example, the authors considered there was sufficient evidence to be able to recommend a standard acupuncture protocol (Zheng, Li et al. 2009).
Another way of arriving at a suitable treatment design is through studies of the physiological mechanisms of acupuncture and the results of animal studies. Based on animal studies using Baihui acupoint (Du20) Liu et al (Liu, Hsieh et al. 2009), for example, hypothesised that using scalp acupoints would improve balance in stroke-affected patients. They concluded that acupuncture stimulation may induce an immediate effect which improves balance function in stroke patients.
In contrast to the idea of a single standard prescription for all, there has been the counter perspective of acupuncture point prescriptions individualised to each patient and chosen at the discretion of the acupuncturist (Vickers, Rees et al. 2004). One research group planning a clinical trial of acupuncture for back pain conducted a survey of practitioners‘ treatment records; they asked several practitioners to examine a single case of back pain and to detail how they would treat the patient. As they found little agreement in their assessments and treatment strategies, researchers, in the trial itself, asked practitioners to do largely what they wanted rather than use a standardised approach. The authors comment that this disagreement between clinicians on the diagnosis and treatment of back pain is probably universal in all kinds of medicine, complementary and orthodox (White, Cummings et al. 2008). The possible universality or inevitability of diversity in diagnosis and treatment of some conditions does not gainsay the conundrum that MacPherson and Schroer (2007) identify, that is, a trade off between a tightly and a loosely defined complex intervention.
To address this ‗trade-off‘ more sophisticated and complex means of fashioning an intervention are being developed. Sinclair-Lian and colleagues (2006), for example, outline a method that starts with a biomedically defined condition (in their case, post-traumatic stress disorder), uses TCM literature and clinical experts to develop a diagnostic structure meaningful to TCM which is then applied to individuals with the condition. This method also formalizes a procedure to develop and individualize an acupuncture treatment plan that accurately reflects standard clinical practice yet can be used in a clinical trial (Sinclair-Lian, Hollifield et al. 2006). This approach resulted in a core point prescription that addressed all the main patterns and issues. A modular approach then added 3 additional acupuncture points to treat secondary or constitutional patterns evident in the subject being treated. This approach balances the standard point prescription with a flexible response from the treating acupuncturist. In a similar attempt to address complexity, Schnyer et al (2008) aimed to develop an ecologically valid and viable multimodal treatment intervention applying ‗Japanese
[90] acupuncture‘. They employed ‗manualisation‘, a method which standardises treatment by providing the acupuncturist with a method or algorithm that can be adapted to each patient. The authors reported manualisation as facilitating practitioner compliance with a replicable treatment protocol. They also reported that translating acupuncture clinical skills into the research setting requires careful training and supervision of the participating clinicians, and should not be underestimated (Schnyer, Iuliano et al. 2008:521).
The shift in research to account for acupuncture as a complex intervention has demanded more of the protocols used in clinical trials. To honour the recognition that acupuncture is more than needling, the research intention for this project was to seek a wider view, one which could only be provided by those in practice.
Protocol development Little research has been undertaken into the course of treatment leading up to conception that can be judged ‗adequate‘ for treatment and research purposes. More specificity is required so research approaches can be standardised and approximate clinical practice. Two questions here - what is an adequate acupuncture protocol and how can such a protocol be developed - are addressed by this research. Research into the use of acupuncture to promote fertility is an international endeavour and finding a consensus between acknowledged experts who are experienced acupuncturists requires a global strategy.
Research Purpose:
1. To develop a consensus about what is adequate acupuncture treatment to promote female fertility in the peri-conception period. 2. To examine what acupuncturists do and what are considered aspects and components of acupuncture treatment of fertility problems.
Ethics approval was granted by the University of Western Sydney Human Research Ethics Committee in 2009 (approval number H6661) and the study was undertaken at the University‘s Centre for Complementary Medicine Research between March and September 2009. The study consisted of two phases. In Phase 1 the intention was to explore the current practices of a selected few fertility acupuncturists to identify their approaches to treating women as a preparation for conception. Phase 2 used issues identified from Phase 1 and set these before an online focus group of fertility acupuncturists to see if there was a consensus about an acupuncture protocol to guide acupuncturists and this research study.
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Phase 1
Methods for collecting data The first phase included semi-structured interviews with key participants which were undertaken to provide the initial input into the discussion forum. The semi-structured interview guide was based on two main themes. These practitioners were asked about their practice and what factors they considered important when working with women with fertility problems. The interviews followed a similar script [Appendix 1] and all central themes were covered in each. The interviews were conducted by the author (who comes from a background with similar training and clinical experience), two in person and one by audio-visual conferencing. Interviews were digitally recorded and professionally transcribed. Each interview lasted approximately one hour.
Participants The three in-depth interviews were conducted with Australian-based practitioners to explore how they worked with women with fertility problems. All three practitioners had greater than 20 years experience as acupuncturists, much of that time working predominantly with women with gynaecological problems. The three interviewees were selected because of their experience, their history of thoughtful reflection on their own work (apparent via publications, teaching and past discussions with the author) and their accessibility to the interviewer as colleagues. Personal familiarity with the respondents allowed greater depth of discussion because the interviews built on themes known to be of common interest12. This familiarity could be considered a controversial issue by those attached to the idea of objectivity in research interviews. Ezzy explores this issue at some length and concludes: Emotional distancing makes it harder to hear the voices and experiences of research subjects. It turns research participants into passive objects and knowledge into conquest. Knowledge experienced as communion requires mutual recognition, which acknowledges the interdependence of the researcher and the researched (Ezzy 2010:169). This issue of the perceived ‗bias‘ of qualitative methods is examined again in Chapter 7.
Analysis A thematic analysis of each interview provided the basis for questions posed to the recruited fertility acupuncture specialists. Among the issues discussed were the following: the interviewees‘ views of what acupuncture does; their approaches to treating women with fertility problems and
12 Within the context of a small practitioner group specialising in this way in Australia, being known to each other was inevitable. Even internationally, mutual knowledge or common links would have been unavoidable.
[92] how that differs from treating other conditions; the course of treatment; the role of lifestyle advice and modification; the therapeutic relationship established as well as approaches to diagnosis and treatment. At the conclusion of the third interview, it became clear that there was sufficient material to guide the larger forum discussion. Grounded theory (Dey 1999; Charmaz 2003; Denzin and Lincoln 2003; Charmaz 2006; Corbin and Strauss 2008) was used as a guiding approach to generate data and to codify and theorise from the data from participants in the field. The outcomes of the analysis will be explored later in this chapter.
Phase 2 The research aim of the second phase was to develop a consensus among acupuncture fertility specialists on what is adequate acupuncture treatment to promote female fertility in the peri- conception period and to examine what acupuncturists ‗do‘ in a consultation - their actions and their exchanges with their patients.
Rationale for interviews and focus group The rationale for interviewing each participant individually was to generate sufficient data on which to base the acupuncture protocol. A synthesis could be made and where views and opinions were contradictory, the researcher could make a choice based on explicit or implicit criteria. Such a process would exclude the potential benefits arising from a group discussion, such as, emergent new data from the interaction between participants. The professional discourse about an acupuncture protocol is, in itself, of value. Examining the social process of reaching an agreement (or attempting to do so) contributes to a greater understanding of how Chinese medicine functions in its social setting.
Focus groups offer a middle path between in-depth interviews and participant observation. As well as offering an opportunity to broadcast and elicit information, a focus group provides an opportunity for new topics to arise from the interaction within the group. Semi-structured questioning can guide the discussion and lead to more explication or refinement of the issues discussed. For the purpose of this research the focus group was used to: draw upon the experiences of experts in a given field in order to pull together thoughts and ideas from individuals that have a high level of knowledge in the field. In this way, a great deal of information and knowledge can surface within the discussion among these experts. (Rezabek 2000:9). This approach suited the research task of building a consensus among experts. Interactions, supporting and contrary points of view can all be brought to the fore and added into the
[93] discussion Electronic or online focus groups allow this function to be played out across time and space. By facilitating discussion between people who live and work at great distances from each other the Internet has offered a new vehicle for such research. Because these exchanges can be asynchronous it reduces the need for each participant to commit a particular time to the endeavour. The participants read other‘s comments and are able to contribute their own comments at any convenient time.
Rezabek (2000) identifies a number of advantages to an internet-based focus group: it reduces the cost of communication; it has a broad geographic scope; it facilitates access for the hard-to- reach who may not be available in normal working hours or across time zones; it is both convenient and comfortable for participants (assuming a reasonable level of electronic experience and functioning technology). Whether it offers a more time efficient option than face-to-face groups is debatable. For the participants it is obviously quicker to log in to a discussion when they have time available; for the researcher, leaving the discussion window open for all to contribute may make for a lengthier process than a one-off meeting.
The major concern about an online focus group is the question of how the methodology might distort communication and privilege some participants over others. The absence of non-verbal communication cues can lead to misunderstandings that would not be evident in a face-to-face discussion or be much more easily or quickly resolved. Silence or absence of contribution is ambiguous and harder to read online. In his research into online discussion, Rezabek found that some participants were fearful of technology, which had an effect on how they joined the group and what they said within it. He reports: The drawbacks to using an asynchronous focus group technique include lack of timeliness from beginning to the end of the process, sporadic participation and loss of participation at times by certain members of the group, and variable interaction among the participants (Rezabek 2000:62). Obviously, other technologies such as videoconferencing are a richer medium although for the participants in this research group logistically almost impossible.
Research comparing online and face-to face groups (Schneider, Kerwin et al. 2002) on the same task has found that online participants tended to contribute shorter comments and were more likely to say just a few words of agreement. This outcome was unlikely to impair the quality of the discussion in this focus group. The purpose is not to draw out the participants‘ feelings but their ideas. The online format suited a more equitable contribution which benefitted this research purpose.
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The role of the facilitator or moderator is central to the progress of the group. Jenny Kitzinger (1994) argues that maximizing interaction is a key role for the facilitator and that this will in turn maximise the outcomes of the group process. She reported (Kitzinger 1994) that by encouraging interaction between research participants as much as possible, and assisted by group dynamics, the co-participants acted as co-researchers taking the research into new and often unexpected directions and engaging in interactions which were both complementary and argumentative. It is these contradictory interactions that clearly accentuate the differences between people‘s views and can lead to useful new material and patterns of information. Identifying ‗consensus‘ as the primary group task may have been too prescriptive in this research process; however, the aim of an agreement on a fertility acupuncture protocol was primary and participants were recruited to participate in that endeavour.
Methods of collecting data A short-term online discussion forum was established with selected experts in fertility acupuncture and fertility acupuncture research to act as a focus group. The primary criterion for recruitment was that practitioners who had authored publications on the use of Chinese medicine to treat female fertility/infertility. Other secondary guiding criteria were to achieve a desirable international geographic spread of recruits and representation of the diversity within acupuncture practice styles or paradigms.
The work of the focus group was conducted asynchronously by email and through an electronic Nexus website (Confluence Wiki) that was set up through the cooperation of the University of Western Sydney. Participants were first asked to consider a series of data collected from the extended interviews [Table 4.1], respond with their thoughts, feelings, experiences and suggestions, and then react to the responses given by other participants. An ensuing discussion resulted in a rich environment of thought and idea formation. The investigator facilitated and moderated discussion, attempting to maximise contributions, clarify detail and identify points of consensus and difference. Participants‘ responses to the questions were collated and a questionnaire in the form of statements was developed based on these responses [Appendix 2]. By means of using a modified Delphi process the questionnaire was distributed to participants asking them to rank the statements according to relevance to fertility acupuncture. The conventional Delphi is defined as a method that aims at a consensus on a particular topic among a group of experts (Gnatzy, Warth et al. 2011) and was developed as a means of forecasting. Although much criticised, it is commonly used as a method of structuring communication between a group of people who can provide valuable contributions in order to resolve a complex problem (Landeta
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2006:468). Usually it is a repetitive process with the questionnaire undergoing several iterations before a final conclusion. It was modified in this study to only applying the questionnaire until a consensus was apparent. A consensus was considered achieved when there was little diversity of opinion expressed by participants in their responses to the questionnaire. The design of the questionnaire included the response options of: ‗Highly relevant‘, ‗Relevant‘, ‗Mildly relevant‘, ‗Not relevant‘ and ‗No Comment‘. Surveymonkey, a web-based survey program, was used to distribute and evaluate the statements.
Participants Recruitment was via mail (electronic and postal) to fertility acupuncture specialists. Snowball sampling extended the network to maximise relevant participation. The second round of recruitment included acupuncturists who were recommended by those within the first recruitment round. There was no target number of participants set prior to recruitment and the ten recruited were considered sufficient to proceed.
Data Analysis Data generated by the online discussion and the extended interviews were coded, emerging concepts noted and any new theoretical perspectives documented for dissemination. The distillation of issues from the interviews for inclusion in the focus group, and also the summary of statements from the focus group for the Delphi questionnaire, was developed and confirmed in collaboration with research supervisor, Caroline Smith. The primary researcher read the transcripts of interviews and extracted themes to form questions that shed light on the practice of acupuncture with women with fertility problems. In conjunction with the supervising researcher these themes were formed into questions for the focus group. Similarly, the focus group responses were read by both researchers, themes coded and, following discussion, formulated into statements suitable for a Delphi questionnaire. The themes were not fully developed into theoretical frameworks. They were limited to statements more suited to the consensus exploring process of the Delphi. Grounded theory was used as a guiding approach, in both the extended interviews (Phase 1) and in the forum responses (Phase 2) to finalise the content of the final survey, to generate data, and to codify and theorise from the data generated by interviews, written responses and discussion.
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Results
In-depth interviews [Phase 1] The in-depth interviews with the three experienced practitioners provided important insights into the practice of Chinese medicine in the contemporary West, and were designed to specifically explore the current practices of a selected few fertility acupuncturists to identify their approaches to treating women as a preparation for conception. Issues that arose included the importance of the therapeutic relationship formed with a client, the position of Chinese medicine in relation to the mainstream health care system, the challenge of working with women in anguish about their poor or delayed fertility, and the difficulties of self-care when working closely with clients. The literature refers to significant evidence that, in any health encounter, the therapeutic relationship is a major influence on health outcomes (Neumann, Edelha¨user et al. 2010; Rakel, Barrett et al. 2011), although there are few references to the experiences of practitioners of acupuncture in building and sustaining such a relationship. There is one study that suggests the Chinese medicine therapeutic alliance is stronger than that for psychologists (Miller and Greenwood 2011). Also the literature refers to the quality of a ‗listening physician‘ fostering more accurate diagnosis, having a healing and therapeutic effect and strengthening the ongoing therapeutic relationship (Jagosh , Boudreau et al. 2011). The particular ‗listening stance‘ of the acupuncturist is not explored anywhere outside Chinese medicine literature. One study assessing acupuncture patients‘ experience of acupuncture concluded that patients‘ perception of practitioner empathy was associated with patient enablement at initial consultation and predicted changes in health outcome at 8 weeks (Price, Mercer et al. 2006:244). The interviews with the three practitioners in this study underlined the importance of these factors while offering more specific acupuncture- related perspectives. One example is the location of Chinese medicine at the margins of fertility health care provision and rarely the first and primary provider which often means Chinese medicine becomes the ‗last resort‘ when other modalities have failed. Another perspective of the practitioners interviewed, was the centrality of Chinese medical theory and diagnostic frameworks as a guide to effective treatment. Despite being marginalised as a result of their theoretical frameworks, and however compelling the biomedical data, these practitioners were advocates of the value of Chinese medicine in this field. In fact, it became apparent that biomedical data and perspectives were folded into the Chinese medical process – informing but not guiding.
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The three acupuncturists‘ responses provided insight into the complexity represented within the therapeutic exchange of acupuncture when applied to women with fertility problems. One respondent reported:
It‘s a different journey when you are working with someone who is trying to fall pregnant…you know, it‘s a very different emotional journey.
Another:
They‘ve probably got a little bit more invested in what I can do or not do, than someone who‘s coming for a different sort of disorder.
The third stated:
It‘s not just their body, it‘s their huge trust that they place in you. And especially when you‘ve got that added thing of, you know, you‘re [their] last resort.
These responses pointed to the importance of relationship, as in any medical encounter, and led to the inclusion of the following question in the forum: ‗How important is the therapeutic relationship in fertility acupuncture? Is this more important than when treating other disorders?‘
The most apparently challenging question was: What do you do when you do acupuncture? This question spoke directly to the issue of standardisation in acupuncture research. All three respondents hesitated. One answered:
What do you mean, what do I do?...sometimes I‘m really clear about what I‘m doing. Sometimes I‘m not. So do you mean, am I tuning into how that person feels or am I gathering myself?... The thing that I think of most of all, and that bothers me as well, is I just feel very responsible. I feel that this person trusts me.
Another responded:
Do you want to come back to that one? That‘s a really big one and, yeah, I don‘t think there‘s an easy answer to that.
The third saw herself as facilitating another‘s access to energetic balance and harmony. This question was therefore retained in its entirety in the forum discussion.
Respondents identified the particular situation of women engaged on a fertility journey:
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SC: For you facilitation of their healing journey needs to be an empowering one?
Yep, absolutely…I think that‘s important particularly with assisted fertility, where so much control is taken away from them. And they get so immersed – for many women they lose control over their bodies, but also their life gets very narrowly focused, without seeing the bigger picture of where they‘re going.
Respondents also raised the importance of being a knowledge expert and sharing this information was also raised:
You know, there‘s a more mundane view of it, too. You know, my relationship with them is about making sure they‘re thoroughly informed, know all their options, know what I can and can‘t do, know what other doctors can and can‘t do, and I see myself as a primary care person in that sense... So if I guess if I‘m holding anything, I‘m holding their big picture, in terms of what they can expect, what they can‘t expect, what‘s possible, what‘s not possible, maybe a time frame, although I‘m not always honest about that one. Rather than me … and in some sense I‘m there to hold them energetically and emotionally too, but if that‘s a big need, I refer them somewhere else as well, because that‘s not my expertise.
None of the respondents viewed their work as practitioners as a casual task or technical fix. There was certainly a component of, in some way, walking a fine line between acupuncture as an esoteric practice and as a very practical way of working with people. Questions from the researcher that asked about either the concrete practice or esoteric aspect, that is, firmly on either side of this line, generally elicited responses that refused to be located on just that side. Although this conceptual tension within acupuncture practice was not taken directly into the focus group, it emerged there as well and will be further discussed later and in the concluding Chapter 7.
The most consistent response to requests for details of treatment approaches from the initial three interviewees was, ―It depends…‖ :
It depends on them and how they are as well. You know, they‘re not all like this but that heightened sensitivity. It depends where they‘re up to in the whole fertility thing, depends whether they‘ve been trying for a long time, whether they‘ve been to a whole lot of other people, whether they‘re doing IVF. I‘m really careful …I‘m really aware of the language I use before I even stick pins in them. And then it depends on how fragile they are, just like everybody. But I think maybe it is heightened with some particular women.
This respondent emphasised, as did her colleagues, the importance of individualisation over standardisation. Although these acupuncturists reported varying their whole approach as well as
[99] treatment – depending on how the woman was on the day, on what other support she had, on how informed she was about her own body and fertility and so on – general guidelines did emerge. These practitioners considered both Chinese medical pattern differentiation and a biomedical understanding of factors such as hormonal climate to be essential frameworks for successful work with ‗Western‘ women.
SC: So a TCM diagnosis is central to your practice?
Yes…it‘s central, it‘s central but I also always want to know if the tubes are patent...I also always want to know if the sperm are functional. And so, and I have to tick those boxes before I even start treatment because if either of those come up as being a problem, then maybe there‘s a whole different route and it might not be with TCM… I always go through all those boxes first and then we do the Chinese medicine analysis… And then my treatment‘s based on Chinese medicine analysis but my view of the possibility of an outcome might be coloured by the biomedical diagnosis, and whether we do TCM or not.
This response was echoed in the focus group although an emphasis on the Chinese medical perspective was considered most critical.
Sensitivity to the perceived or expressed needs of the woman patient was a theme in each interview. The particular vulnerability of women dealing with the prospect of infertility – as emerged from the literature examined in Chapter 1 - dominated the interviews. This further reinforced the respondents‘ emphasis on individualised responses to patients.
It probably depends on what their expectations are in seeking my support as a practitioner. I guess a foundation of my therapeutic approach would be to try and maximise their reproductive potential. But also very mindful of their emotional journey. And for me, I would give probably equal emphasis to both... – it would be very rare for someone not to present during a consultation the kind of emotional distress that they‘ve been through.
There was a sub-theme that suggested that practitioners had some difficulty balancing their own needs with the needs of their clientele. Each reported different methods to negotiate this conflict. As this issue was more related to personal practice it was not included as a theme in the subsequent focus group forum. It would, however, be another fertile area for further investigation.
The three respondents also emphasised attention to the treatment environment – imparting a sense of safety to patients was primary.
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I think creating a nurturing environment is important. I‘m not sure that is specific to reproductive work. It‘s about creating that environment irrespective of what – I‘m not sure I would do anything different in a physical context. I mean my room space is important to me as a nurturing environment. But because I‘m working with fertility or pregnancy, obviously what I‘ve done is probably a reflection of that energetic....[Elements of environment?] It‘s about intimacy, a small space to create intimacy. It‘s about having – yeah it is about colour. Colour‘s really important. For me it‘s about having warm colours. I like art, so quite often I have some art which is reflective imagery. Or I might have … those inspirational messages. I‘ve got a couple of those that I have around, which is about empowering messages.
This issue then was taken forward to the focus group.
To summarise, respondents‘ commentaries on their practices with women with fertility problems were relatively consistent. It emerged that acupuncture practice is complex and that working with women on reproductive issues required an extra more specialist level of expertise beyond that of general practice. Aspects of practice emerged that could usefully offer parameters for a treatment protocol. In this way, issues were flagged for inclusion in the broader forum.
The extended interviews with key informants generated a range of topics which were collated into the 14 questions posed to the forum participants [Table 4.1].
Table 4.1: Questions for Forum Discussion 1. The definition of acupuncture What constitutes 'acupuncture'? What do you do when you do acupuncture?
2. Acupuncture treatment and menstrual cycle What do you each think is essential in an acupuncture treatment of a woman designed to promote conception?
Is the stage of her menstrual cycle the key indicator of which treatment principle, point selection and needling technique you use?
How precise is it necessary to be? For example, is a Day 8 treatment very different from a Day 10 treatment?
3. TCM/OM diagnosis How important is the differential diagnosis to acupuncture point choice?
4. Timing of acupuncture Does timing matter? in relation to the menstrual cycle? season? time of day? What timing is important if women are intending to undertake ART? or acupuncture between ART cycles?
5. Number of acupuncture treatments How many treatments are necessary to be adequate (for maximising fertility)? Would you expect to give acupuncture weekly? more than weekly? monthly?
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6. Needling technique In reporting on acupuncture research it is important to specify details such as needling depth, needle direction, insertion mode, retention time, manipulation, order of insertion, unilateral or bilateral. Are there particular techniques which you would deem essential in acupuncture for fertility management?
7. Relationship with patient How important is the therapeutic relationship in fertility acupuncture? Is this more important than when treating other disorders?
8. Lifestyle components How important is lifestyle change? Do you give specific diet and exercise recommendations to fertility patients? Does this advice vary with differential diagnosis or is it standard? What is it?
9. Collaboration with other therapies Do you work collaboratively with other modalities? E.g. Herbalism, homeopathy, counselling, nutrition. Does this non-acupuncture health care make a major contribution to the treatment package?
10. Importance of biomedicine How important is a biomedical diagnosis to your choice of acupuncture treatment? Do you require a full biomedical work-up (blood tests, ultrasounds, laparoscopy) prior to treatment?
11. Referral on At what point do you advise a patient to stop treatment? refer on to ART or adoption services? what are the indicators that you use to seek other treatment options?
12. Treatment environment Have you created a special environment in which to treat women with fertility problems? What are the components of that place?
13. Personal agency How important is your personal style or how you are on the day/at the point of treatment?
14. Specific Acupuncture Points Are there particular acupuncture points that are essential to fertility treatment?
______
The strength of Chinese medicine, and acupuncture in particular, as a transformative medicine requiring a direct and present engagement of practitioner and patient was evident in the interviews yet may not be obvious in the forum questions extracted from them. The absence of set, clearly defined protocols to guide practice is frustrating for beginners or researchers, but it reflects the fluidity and interactivity of ‗good‘ practice where a conversation between the body and the practitioner through the needle (Emad 2004) is both immediate and changing. Acupuncture researchers (Birch 2003; Lewith, White et al. 2006; White, Linde et al. 2008) have attempted to
[102] identify what are specific effects of acupuncture and distinguish these from the non-specific effects such as the therapeutic relationship. The degree to which the effects – specific and non- specific – are measurable by standard quantitative research methods alone is questionable. Without interviews such as those conducted in this phase, aspects of the practice itself that are meaningful to practitioners risk going unnoticed. Also unnoticed would be the areas of disagreement and failed consensus which could form the basis of fruitful investigation.
Results from online forum [Phase 2] In all, 23 acupuncturists were approached to participate; 19 replied and 10 accepted the invitation to participate, signed consent forms and completed the process. Those who declined were unable to participate due to pressure of work, personal circumstances or little expertise in acupuncture. As summarised in Table 4.2, two of the ten participants were male, nine of the ten had received orthodox TCM training and one was acupuncture only. At least five participants had extensive biomedical training, mostly undertaken prior to their involvement in Chinese medicine. All respondents reported specialising in or primarily undertaking fertility treatments.
Table 4.2: Focus Group Participants Participant Residence Years of Experience Gender Mode Postgraduate study
1 UK 18 Male TCM Yes
2 UK 17 Female TCM/ Yes
‗eclectic‘
3 USA 15 Female TCM/WM Research
4 USA 14 Female TCM/ Yes
fertility retreats
5 (team) USA 62(26+27+8) Female TCM/WM Yes
6 USA 10 Male TCM Yes
7 USA 20 Female TCM Yes
8 USA 7 Female TCM Yes
9 Australia 20 Female Acupuncture Yes
10 Australia 30 Female TCM Yes
The themes that emerged from Phase 1 were presented as questions [Table 4.1] in the online focus group where participants in their own time posted responses. Their responses are
[103] summarised here. Answers on the forum to the question of what acupuncture ‗is‘ and ‗does‘ spoke to the complexity of acupuncture as an intervention:
I use acupuncture to bring the body back towards normal functioning and to optimise each menstrual phase. It depends how deviated from normal functioning the body has become as to how successful acupuncture alone will be.
Another:
The obvious is placing needles at specific points throughout the body. However, ―acupuncture‖ is so much more than that.
And
As the Nei Jing13 says, ‗above all, in needling, we must be rooted in spirit‘. Having a relationship with what the patient is presently going through is crucial to having a feel for the appropriate direction the acupuncture treatment takes. … when we are connected to the patient, our points are guided by a deeper understanding, and takes us to the actual points that are appropriate in that moment.
All respondents indicated that the tradition of Chinese medicine was central to their practice, despite the dominance of biomedical perspectives in contemporary Western approaches to female fertility.
An example of disagreement was in relation to the treatment environment. One member reported giving great attention to detail in her treatment room and sent photos of her clinic room. Another reported he did not attend at all to such details and just required a serviceable space in which to work. The demand that the clinic room be both a workspace for the acupuncturist and a therapeutic environment for the client may conflict. Both of these focus group respondents had strong and different views on the importance and meaning of the treatment working environment.
Delphi questionnaire results There was, however, a high degree of agreement evident in most of the written responses to the questions in the Fertility Acupuncture Protocol (FAP) website and email was replicated in the final survey [Table 4.3] where each statement was ranked for its relevance to a fertility acupuncture protocol. Most participants rated most statements as ‗relevant‘ or ‗highly relevant‘.
13 The Huangdi Neijing ‗The Inner Canon or Classic‘ of unknown authorship is the oldest medical text extant in China.
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There were no consistent differences of opinion, and where ‗no relevance‘ was chosen it was only ever by a single respondent (and never the same respondent). For example, only a single respondent considered there was no relevance to assessing the spirit in differential diagnosis; or a single respondent excluding coffee from dietary prohibition; or that biomedical information should inform diagnosis. There were only two occasions where ‗no comment‘ was chosen, indicating that participants made a commitment of their views in most instances. There was 100% response rate from participants. As a greater than 80% consensus was reached, a second Delphi round was not necessary.
No No Mildly Relevant Highly Table 4.3: Survey : Components of fertility acupuncture comment relevance relevant relevant protocol for clinical practise 1. Acupuncture should be considered a complex 1 0 1 1 7 intervention encompassing more than the technique of needling; it encompasses the therapeutic relationship and the range of Chinese medicine modalities such as diet and lifestyle advice. 2. Fertility acupuncture should be a specialist endeavour requiring: a. knowledge of reproductive 0 0 0 3 7 endocrinology/physiology b. knowledge of TCM gynaecology 0 0 0 1 9 c. knowledge of ART procedures 0 0 1 1 8 d. personal capacity to professionally engage with women‘s fertility journey 0 0 0 3 7 3. Treatment should be based on a diagnosis of pattern 0 0 1 2 6 differentiation. 4. Treatment should be based on time in the menstrual 0 0 2 6 2 cycle- responding to at least 4 phases of the cycle. 5. Treatment should include a response to the patient‘s 0 0 1 4 5 spirit or presenting emotional state. 6. Biomedical information should inform decisions 0 1 0 6 3 about diagnosis and treatment. 7. Consideration of acupuncture treatment should be 0 1 2 3 4 precisely timed and acupoints selected for specific patient groups, eg. timing for reluctant ovulators, or embryo transfer or ovarian stimulation during IVF. 8. Differential diagnosis should include the following patterns: a. Kidney yang/ yin deficiency/vacuity 0 0 0 3 7 b. Liver blood deficiency/vacuity 0 0 0 4 6 c. Heart yin &/or blood deficiency/vacuity 0 0 1 4 5 d. Spleen qi deficiency 0 0 0 4 6 e. Liver qi stagnation 0 0 0 3 7 f. Blood stasis 0 0 0 3 7 g. Phlegm/damp accumulation 0 0 0 4 6 h. Assessment of the spirit 0 1 0 2 7 9. Weekly acupuncture treatments should be a 0 0 0 6 4 minimum when using an acupuncture-only intervention. 10. Three months of acupuncture treatment should be 0 0 4 5 1 an adequate intervention peri-conceptually. 11. Acupuncture techniques: a. 20 minutes should be a minimum for needle retention; 0 0 1 8 1
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b. Deqi should be a felt response to needling; 0 1 3 4 2 c. Needle manipulation for tonification (bufa) or reduction (xiefa) should be applied; 0 0 6 3 1 d. Actual technique should be dependent on patient presentation 0 0 0 6 4 e. Electroacupuncture for ovarian stimulation or to move qi & blood as appropriate 0 1 3 4 2 12. The practitioner-patient relationship should be 0 0 1 5 4 developed as a central part of the acupuncture intervention. 13. Lifestyle & dietary changes based on differential 0 0 1 4 5 diagnosis should be a component of an acupuncture intervention. 14. Lifestyle recommendations should include:
a. stop smoking 0 0 0 2 8 b. no recreational drugs/substance abuse 0 0 0 2 8 c. moderate alcohol 0 0 1 1 8 d. no coffee 0 1 2 6 1 e. appropriate exercise for constitution (not 0 1 0 5 4 vigorous) f. relaxation & rest 0 0 1 2 7 g. emotional support 0 0 0 6 4
h. improved nutrition 0 0 0 6 3 i. nutritional supplements 0 1 0 7 1 j. stress management 0 0 0 5 5
15. Collaboration with other modalities of care (eg. 0 0 1 4 5 counselling, herbalism) should be undertaken when appropriate or when sought by patient 16. Explicit referral on or termination of treatment 0 0 3 6 1 should be considered when inadequate response is encountered within 6 months, although this will vary with patient 17. Treatment environment should recognise patient need for:
a. Safety 0 0 0 6 4 b. Quiet 0 0 1 8 1
c. Restful & calming 0 0 1 5 4 d. Confidential 0 0 0 4 6 e. professional 0 0 0 4 6 18. The practitioner should be: a. Attentive 0 0 0 4 6 b. Caring & supportive 0 0 0 3 7 c. Engaged/patient-focused 0 0 0 3 7 d. Professional relationship between practitioner and patient based on trust 0 0 0 3 7 19. Acupoints that should be considered include: a. Extraordinary meridians/channels 0 0 0 5 5 b. Abdominal points in follicular phase 0 0 0 4 6 c. Back shu points in luteal phase 0 1 1 6 2 d. Shen/spirit calming points like Yintang, chest kidney channel points 0 0 0 6 4 e. Lumbo-sacral points &/or abdominal points like zigong for stimulating ovulation 0 0 0 5 5
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Because respondents needed to nominate a value on a scale there were more gradations in ‗relevance‘ in the survey than was clear in the respondents‘ comments in the forum. In question 2 (Figure 4.1), for example, 9 out of 10 respondents considered knowledge of TCM gynaecology highly relevant to a fertility acupuncturist whereas knowledge of ART procedures were graded a lesser measure of ‗relevant‘.
Figure 4.1: Responses to 'Fertility acupuncture should be a specialist endeavour requiring':
100% 90% 80% 70% Highly relevant 60% 50% Relevant 40% 30% Mildly relevant 20% 10%
0%
endocrinology/
Personal capacity to
Knowledge Knowledge of TCM
Knowledge Knowledge of ART
Knowledge Knowledge of
reproductive
women's fertility
physiology
professionally
gynaecology
engage with
procedures
journey
Comparing the answers to questions 3 to 6 presented in Figure 4.2 as to the basis of treatment, ‗differential diagnosis‘ (that is, ‗pattern‘) outstripped other factors as ‗highly relevant‘ although all factors were considered relevant (except for one respondent who excluded ‗biomedical information‘). When looked at proportionally in the diagram, however, variations do appear in emphasis or weighting.
Figure 4.2: Responses to 'Guiding diagnostic principles':
100% 90% 80% Highly relevant 70% 60% Relevant 50% 40% Mildly relevant 30%
Percentage of Percentageof responses 20% Not relevant 10% 0% No comment Pattern Cycle Spirit Biomedical Precisely Primary diagnostic frames diagnosis timed
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Figure 4.3: Responses to 'Differential diagnoses should include':
100% 80% Highly relevant 60% Relevant 40% 20% Mildly relevant
0%
Phlegm/damp Phlegm/damp
Spleen deficiency qi
Liver blooddeficiency
Kidney Kidney yin/yang
Assessment spirit of
Liver stagnation qi
Heart Heart yin &/or blood Blood stasis
accumulation
deficiency
deficiency
Within differential diagnosis (Figure 4.3) there is high consistency in defining the ‗relevant‘ categories or patterns which can contribute to female fertility problems.
Discussion The process of developing the fertility protocol raised issues about the practice of acupuncture, many worth pursuing in future research. The role of the practitioner and the ideas and intentions of the practitioner which influence the outcome of treatment are discussed in the historical literature on acupuncture technique, and are challenging concepts for researchers. The value of qualitative methods is that they allow such exploration to be included, adding depth and meaning to an analysis of applied acupuncture.
The Delphi technique becomes useful only when there is a likelihood of agreement or at least not strongly opposing disagreement. If the cohort being surveyed could be divided into equal groups with clear and opposing views, these would cancel each other out, making the process null. There have been significant methodological weaknesses identified in the Delphi method, including the issue of who is ‗expert‘ and whether consensus is a way to approach ‗truth‘. Landeta (2006:469) also identifies the limitation of the interaction involved in written and controlled feedback … the ease inherent in the methodology of interested manipulation by the person running the study, the difficulty of checking the method‘s accuracy and reliability …In the situation of shared and overlapping views, as evident in this cohort, the Delphi survey allowed participants‘ views to be differentiated more carefully, and relative values attributed to factors that were agreed to be important. In this setting where the quest was not for ‗truth‘ but an indication of what was considered adequate or good practice the method was helpful in refining the focus group discussion into priorities and attributing values to a range of options. The opportunity for the facilitator to manipulate results was countered by involving a second researcher and by making the process open and explicit.
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The fact that the input that framed the focus group discussion was derived from the in-depth interviews with experienced practitioners also countered the likelihood of personal biases of the facilitator distorting the content of the discussion. The fact that this framing content came ‗from the field‘ and was reflected back ‗to the field‘ may have enhanced the possibility of consensus.
Agreed adequate acupuncture protocol guidelines for female infertility, which could then be applied in the clinical trial, was the outcome of this process. In addition greater understanding of what constitutes an ‗acupuncture treatment‘ and how acupuncturists work has emerged from the extensive interviews and the subsequent discussion forum.
The in-depth interviews with the three acupuncturists in Phase one evinced deeply felt duty of care, a respect for the tradition to which they belonged and a preparedness to embrace the insights of biomedicine in the reproductive arena. These qualities were also apparent in the forum discussion. All respondents appeared to approach the task asked of them with careful reflection, given the difficulty of applying an ‗ancient‘ medicine to the highly technical and incommensurable field of reproductive health.
Most Chinese medical clinical practices employ therapeutic strategies and techniques in addition to acupuncture interventions. Most fertility acupuncturists use at least Chinese herbal medicine as an adjunct to enhance their treatment strategies. Unfortunately, this study did not have the capacity to include these adjunctive therapies. A broader examination of the range of Chinese medicine approaches to fertility is warranted.
The strengths of the methodology were that, at minimal expense, leading specialists were gathered to exchange views with their peers. The use of a grounded theory approach allowed the parameters and substance of discussion to emerge from the field – the experience of people steeped in an understanding of Chinese medicine and its clinical application to female fertility in a modern context.
One of the limitations of this research was what was understood as the ‗expertise‘ that guided recruitment of participants. It is an assumption that publications and professional visibility represent the highest level of expertise. Other recruitment methods may have derived a different group of people for the study. Those practitioners who had no website presence or for whom an email address was not publicly accessible were approached by mail or fax. None of those approached in this way responded to the invitation. In part at least, this may have been due to
[109] an online consultative process being inaccessible and/or dependent on technological expertise they may not have possessed.
There are a number of concerns arising from the sampling in this study. One is that none of the participants were from East Asia – China, Japan, Korea – the classical homeland and engine room of acupuncture. Another is that the sample was predominantly American and all were from the English-speaking West – 6 of the 10 acupuncturists work in the USA, 2 in Great Britain and 2 in Australia. This can be explained in several ways: English-speaking or translated journals were used to locate published authors; both the recruitment and discussion was in English; perhaps a fertility specialty in acupuncture is only a phenomenon in these countries; a sampling technique that followed networks inevitably located those who were known to the core respondents. One participant, Jane Lyttleton, has written a seminal text on the use of Chinese medicine for infertility (Lyttleton 2004) which is widely read and used as an educational text. It is possible that the consensus achieved in this study is an artefact of how knowledge, such as this text, is transmitted within the professional network.
A number of important issues emerged from the study process which have implications for practice:
acupuncture should be considered ‗a complex intervention encompassing more than the technique of needling; it encompasses the therapeutic relationship and the range of Chinese medicine modalities such as diet and lifestyle advice‘; working effectively with infertility has become a specialist endeavour beyond the knowledge and skill set of frontline acupuncture practitioners; inclusion and emphasis on the spirit or emotional state of women influences fertility (this is consistent with the Chinese medical concept of the bao mai which links the heart and the uterus); and the relationship between practitioner and patient is another tool in the therapeutic alliance.
Future research would be helpful to explore some of the issues raised by this research. Is this view of practice shared by Asian and non-English speaking European practitioners? Are the principles expressed here translated into the reality of daily practice? How different is fertility acupuncture from the practice surrounding other conditions like internal medicine or musculoskeletal health? Is this protocol workable in all acupuncture contexts such as medical acupuncture practices? Could this protocol be integrated into ART practice? and so on. Each
[110] practice principle that emerged from this process could be separately tested as to its relevance to treatment outcomes. This type of research may be appropriate but it should be approached carefully because one of the central themes of this research is that the ‗wholeness‘ of the package offered patients matters a great deal. Overemphasising and testing, say, the wall colour in a treatment room when the key issues are safety and comfort would appear to have less productive research outcomes. Research that tests the validity of the protocol itself against protocols arrived at by other means (such as pure TCM theory or the view of a single expert) would usefully test the methodology used here.
Conclusions While the consensus among acupuncture practitioners in the field of female fertility did not reach a precise agreement on which acupuncture points and techniques to use on all women seeking to conceive, they did agree on guiding principles. The trial protocol used in the clinical trial [Appendix 3] did ‗manualise‘ these principles into a decision tree for the trial acupuncturists. The development of ‗best practice‘ guidelines has implications for clinical practice and this ‗consensus-between-experts‘ method of achieving such guidelines is a transparent way to develop protocols that are appropriate for both acupuncture research and clinical practice.
Chapter 5 describes the application of the protocol in a pragmatic clinical trial with women who were having difficulty conceiving.
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Chapter 5: Fertility acupuncture to improve health during preconception: a pragmatic randomised controlled trial
Against a background of extensive accumulated clinical experience, Chinese medical practices, such as acupuncture, are now being assessed for their effectiveness as a contributor to contemporary health care. The absence of previous research on applying acupuncture in the period of peri-conception for women who are having difficulty conceiving was identified in Chapter 2 as a research gap. Following the discussion of appropriate research methods for acupuncture practice (Chapter 2) and the consensus views of acupuncture fertility specialists (Chapter 4), this chapter reports on the methodology used in a pragmatic clinical trial which was designed and implemented, and the results of the trial. It includes a discussion of the value of this trial as a pilot study. The qualitative analysis of the trial participants‘ experiences of receiving the acupuncture intervention is discussed in Chapter 6.
Methodology
Study aim The overall aim of the study was to examine the role of acupuncture to promote women‘s health in the period of peri-conception.
The study objectives were:
1) to assess the feasibility criteria for conducting this trial, including, compliance with intervention, recruitment procedures, potential recruitment rates, the acceptability and adequacy of these, and to acquire data to inform a fully powered trial. 2) to conduct a pilot study to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles and increased fertility awareness. 3) to assess the experience of women using acupuncture to promote their health in the period prior to conception.
The primary hypothesis of the study was that women with sub/infertility who received a course of acupuncture compared with an active control would: 1. increase their awareness of their fertility; and 2. achieve normalisation of their menstrual cycle.
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The secondary hypotheses were that women with sub/infertility receiving a course of acupuncture compared with an active control of lifestyle modification would demonstrate: reduced time from study entry to conception; increased clinical pregnancy rates; improved quality of life changes; and increased lifestyle change.
Other questions explored by the feasibility study included:
1. What was an estimate of the treatment effect? 2. How many acupuncture treatments were needed to obtain this effect? 3. How many women needed to be approached to obtain the sample size? 4. What were the reasons for women not agreeing to participate in the study? 5. Was the treatment acceptable to study participants?
Research Plan and Methods
Study Design
The pilot study was a pragmatic parallel arm randomised controlled trial of manualised acupuncture, plus lifestyle modification, compared to active control of a lifestyle intervention.
As discussed in Chapter 2 acupuncture is described as a complex non-pharmaceutical intervention and findings from Chapter 4 described the treatment framework for acupuncture to promote women‘s health prior to conception as a complex intervention. A more detailed discussion of the rationale for the methodology adopted here is included in Chapter 3. The pragmatic trial design better suits the hypothesis of this study and best encompasses the acupuncture protocol defined by fertility acupuncture specialists.
Pilot study This study is a pilot study as no previous studies of similar design or intent are evident. As a pilot trial, all methodological issues were considered as important as for a full trial, such as trial registration, randomization, hypothesis testing, statistical analysis and reporting according to the CONSORT/STRICTA guidelines. The UK Medical Research Council guidelines, for example, explicitly suggest that preliminary studies, including pilots, be used prior to any major trial which seeks to evaluate complex interventions. Other authors (Shanyinde, Pickering et al. 2011) who have reviewed the reporting of pilot and feasibility studies recognise that non-pharmaceutical
[113] pilot trials are useful ways to explore methodological and efficacy issues prior to investment in a fully powered trial.
Eligibility criteria The aim was to recruit women with a diagnosis of subfertility or infertility (IVF & non- IVF/natural fertility patients) actively trying to conceive. Entry criteria: 1. women of reproductive age (18-44 years old); 2. women who had been actively trying to conceive (unprotected sex) without success (including miscarriage) for at least 12 months; 3. women who had a gynaecological diagnosis of the causes of their infertility; 4. women not planning to use acupuncture during the trial intervention; 5. women able to attend at least 7 of 9 treatment sessions; and 6. women prepared to give informed written consent. Gynaecological assessments and diagnoses were provided verbally by participants based on previous examinations prior to the study, and were not re-assessed. Exclusion criteria: 1. non-patent fallopian tubes; 2. absence of uterus; 3. primary anovulation; or 4. partner sperm defect (and not enrolled in IVF to use intracytoplasmic sperm injection (ICSI) to counter defect).
Ethics Ethics approval for this study was obtained from the Human Research Ethics Committee of University of Western Sydney: Fertility acupuncture clinical trial in late 2009 [approval no. H7588]. The trial was registered with the Australian and New Zealand Clinical Trial Registry as ACTRN12610000631000.
Recruitment It was anticipated participants would be recruited from existing contact lists within the research centre. Further recruitment sources were via media and social network advertising, such as local paper and Facebook and other internet sites. Also posters and pamphlets were distributed, within Bankstown and Campbelltown campuses of UWS and to other likely referral sources such as medical centres, chemists and community centres. Women who made early contact also suggested further avenues for recruitment, their main suggestion being to access the forums on
[114] fertility-specific websites. These interactive forums offer women mutual support in the context of providing fertility-related information and advertising. Several Web forums agreed to include a statement about the trial and a request for women to contact the researcher for further information. A letter requesting referrals to the study was forwarded to women‘s health centres, medical centres, TCM clinics and fertility centres in the target area of Western Sydney.
Randomisation & blinding The randomisation sequence was computer generated by a researcher independent of the study based at the Centre for Complementary Medicine Research. The random allocation was sealed in opaque numbered envelopes held in sequential order and accessed by the acupuncturist in sequential order. Randomisation was to acupuncture plus lifestyle or lifestyle alone. Participants were randomly allocated to the two different interventions to control for selection bias. As this was a pragmatic design there was no blinding of patient or acupuncturist. Data entry and analysis was undertaken blind to group allocation.
Study Group Control: life style intervention Lifestyle support is the most common first stage intervention offered in general care and is an appropriate base from which to assess fertility changes from an acupuncture intervention. Clinical experience with women seeking to conceive suggests that they are unlikely to defer changes or interventions that they consider could be of benefit to conception. Although lifestyle advice is a standard component of Chinese medicine care (Evans, Paterson et al. 2011) a specifically targeted lifestyle intervention provides a viable active comparator to an acupuncture intervention.
For effective comparison with an acupuncture intervention this study used an active control. Women with fertility problems were also facing the inevitable age-related fertility cessation deadline. Offering an active control intervention which is evidence-based at least facilitates rather than diverts the advancement of their desire for a pregnancy. It is unlikely women would accept participation if the control role offered them nothing. For this reason, the adoption of a lifestyle modification intervention was chosen.
Study group: Acupuncture intervention The acupuncture intervention offered in addition to the lifestyle intervention was based on the treatment protocol developed through the online focus group outlined in Chapter 4. As such it was more complex and less standardised than would be expected in most acupuncture trial protocols. The focus group emphasised the importance of providing a treatment personalised and responsive to a woman‘s menstrual timing and presenting symptoms. The protocol
[115] therefore required the treating acupuncturists to modify their prescription according to guidelines based on diagnosis and presentation at each consultation.
Trial entry During initial telephone and/or email contact, inclusion criteria were clarified, and the women who appeared to meet inclusion criteria were given appointments to meet with the researcher. These interviews occurred at several locations, but primarily at UWS Campbelltown campus, or alternatively at UWS Bankstown campus and at the Acupuncture IVF Support Centre in Maroubra. A small number of interviews were undertaken in public places close to women‘s homes or workplaces. At each interview the potential participant was given the trial Information Sheet [Appendix 4] to read and discuss. When questions were clarified, the researcher proceeded to explain the randomisation procedure and to ask whether she wanted to participate and agreed to be randomised. If the interviewee agreed to both of these then she was asked to complete and sign the Participant Consent Form [Appendix 5]. Following randomisation, the participant was asked to complete the following forms:
1. Trial Entry Form [Appendix 6] which included contact information, confirmation of meeting inclusion criteria, details of fertility history, medical history and BMI, and demographic details. A calibrated scale was used to measure participant‘s weight; 2. Measures of Primary Outcomes Form [Appendix 7] which included details of menstrual history, lifestyle and diet, assessment of stress and fertility awareness. 3. For those randomised into the acupuncture intervention the Diagnostic Assessment Form [Appendix 8] was completed and the researcher undertook a TCM diagnosis of the participant and chose a treatment strategy for the participating research acupuncturist. 4. Each participant was asked to complete the Measure Your Medical Outcome Profile (MYMOP) Preintervention Form [Appendix 9] and return it to the researcher before concluding the interview.
Baseline descriptive data The following baseline data was collected from all participants at the initial entry interview:
Age (years) Fertility history Duration of infertility Reasons for infertility
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Biomedical fertility diagnosis BMI Previous use of acupuncture Current use of CAM Demographic details – employment status, education status, racial origin, marital status Menstrual characteristics – including age at menarche, period length, menstrual cycle length and regularity, nature of menstrual flow and pain. Lifestyle factors - incidence of smoking, alcohol consumption, caffeine consumption, exercise, diet and fluid intake.
Treatment Schedule Following randomisation, the intervention was administered over three months and completion of baseline data forms all women received the active control based on diet and exercise administered over three months.
Study: Group Control: life style intervention The diet was based on the CSIRO Total Wellbeing Diet14 (Noakes and Clifton 2005), and is based on research supporting evidence of an effect that the diet optimises fertility treatment outcomes (Homan, Davies et al. 2007; Derbyshire and Bokhari 2011). All participants were also asked to develop an exercise program within the guidelines offered by Noakes and Clifton, that they were able to incorporate within their daily schedule. Those participants with a heavily weighted active exercise regime were asked to include softer exercise routines like meditation, yoga, Tai Chi or walking, and to reduce the amount of heavy exercise during their menses and ovulation. Those with little active exercise were encouraged to increase this, especially outside the times of menstruation and ovulation. Those who smoked cigarettes and/or drank alcohol or caffeine regularly were encouraged to understand the fertility implications of these practices and to develop a plan to reduce or remove them from their daily lives. Attention was drawn to the fertility implications of the BBT charts [Appendix 10] and to the research on lifestyle behaviours
14 The CSIRO Total Wellbeing Diet has been tested both in research and in the marketplace. It offers an explanation of a recommended diet and exercise regimen, detailed recipes and a long-term maintenance plan. This research project lacked the resources for individualised assessment and program design. The CSIRO diet is considered nutritionally balanced. In its presentation the diet is accessible, sufficiently applicable to a range of women and has a health, rather than just weight-loss, focus.
[117] implications for fertility [Appendix 11], and to research that indicated that conception was more likely if intercourse occurred prior to rather than after ovulation [Appendix 12].
For women in the lifestyle intervention, the course of intervention was for the equivalent period of time that the other participants received acupuncture. Each participant was contacted by phone or email at least fortnightly or an attempt was made to have such contact. The phone call (or occasionally email when requested by the participant) was designed for the researchers to complete Fortnightly Contact Form [Appendix 13] which recorded compliance with diet, exercise and BBT charting as well as general well-being. The researcher attempted to remain interested and engaged with developments in the participant‘s life, particularly in relation to fertility.
Study group : acupuncture All participants randomly allocated to the acupuncture intervention received a Chinese medicine assessment. This was undertaken by the lead researcher who allocated each participant a TCM diagnosis and treatment strategy.
The following possible diagnoses were used as a guide: Kidney jing xu, Kidney yang xu, Kidney yin xu, Blood stasis, Blood xu, Liver qi stagnation, Heart qi stagnation, Heart yin xu, Spleen qi xu, Heat, Damp/Phlegm, Shen disorder, Extraordinary meridian presentation, and other and were taken from the ‗Diagnostic Assessment Form‘ [Appendix 8].
The allocated diagnosis were forwarded to the treating acupuncturist. Acupuncture was administered using a manualised treatment protocol (Cochrane, Smith et al. 2011), predominantly within a TCM paradigm (although opportunities to vary the approach to include meridian-style acupuncture were available)[discussed in Chapter 4 and available in Appendix 7].
Treatment schedule All participants randomly allocated to the acupuncture intervention were given a Chinese medicine assessment including a history of signs and symptoms, tongue and pulse diagnosis and occasionally abdominal diagnosis. [See Appendix 8 Diagnostic Assessment Form for options charts for tongue and pulse diagnosis.]
Treatment was administered over three months with weekly acupuncture (minimum 7 of 9 treatments), acupuncture treatment was tailored and based on their TCM diagnosis, the phase of their menstrual cycle, an assessment of their spirit or emotional state, and biomedical condition.
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Additional acupuncture points could be added according to particular signs and symptoms. The following Diagram 5.1 was issued to participating acupuncturists.
Figure 5.1: Guidelines for choosing acupuncture points for treatments for trial acupuncturists
A TCM diagnosis will be provided following subject‘s intake interview with Sue Cochrane. Do not change this diagnosis without consultation with Sue first.
1st choose points suited to the time of the menstrual cycle
Eg. Zigong for ovulation time or
Sp10 during period
2nd choose points suited to the TCM diagnosis
Eg. Ren 4 + Ki 3 for Kidney yin xu
3rd choose points suited to the biomedical diagnosis
Eg. Sp 6 for PCOS
4th choose points on presenting symptoms
Eg. GB 20 for occipital headache
As the diagram indicates acupuncturists were required to identify on the day of treatment which day in her menstrual cycle the participant was, in relation to the four distinct phases of: during menstruation, post-menses and prior to ovulation, ovulation and post-ovulation prior to menses. The main treatment principle needed to address this phase and could then be varied according to the TCM diagnosis. Additionally, acupuncture points could then be added, as appropriate, to reflect the woman‘s biomedical diagnosis and presenting symptoms.
Acupuncture points were needled bilaterally on body channels except for unilateral needling on channels that bisect along the midline (Ren & Du channels). Needle insertion was at a location and to tissue depth as defined by recognised acupuncture text (Deadman, Al-Khafaji et al. 1998),
[119] and the needling sensation known as ‗Deqi15‘ was sought on each point, needles were retained for 20-30 minutes each session. Needles used on all treatments were Vinco brand sterile acupuncture needles in guide tubes (sizes 0.22 X 25mm, 0.25 X 40mm and 0.25 X 75mm) donated by Helio Supply Company, Sydney. Additional TCM modalities were included in the treatment and individualised; these included heat applied as appropriate by Teding Diancibo Pu (TDP) Infrared Heat Lamp or smokeless moxibustion. Moxibustion heat was applied by holding a moxa stick above the area to be warmed continuously until the patient reported a sensation of warmth being retained in the area. This process took between 5 and 10 minutes per area selected for warming. Each session, details of participant signs and symptoms and treatment given were recorded. This included pulse and tongue presentation, changes to BBT, compliance with exercise and diet and acupuncture points needled.
When the women were issued with the CSIRO Total Wellbeing book the diet and lifestyle advice was tailored to be appropriate to their TCM diagnosis. For example, in relation to exercise most women were advised to increase their physical exercise routines although some were heavy exercisers and were advised to reduce their exercise or incorporate gentler less physically demanding routines especially at the time of their ovulation or during their menstrual period. Those with a TCM diagnosis that included Dampness, for example, were especially encouraged to attend to ‗damp-producing‘ foods that were unsuitable in the recommended diet. In relation to both diet and exercise, treating acupuncturists were free to offer guidance that was appropriate to the participants‘ TCM diagnosis.
The acupuncturists included the lead researcher who is TCM trained with 23 years clinical experience; a research assistant/acupuncturist also TCM trained with 3 years experience; and acupuncturists employed by The Acupuncture IVF Support Clinic (AIVFSC) in the Sydney City and Maroubra clinics. Each of these latter acupuncturists were TCM trained and had undergone further training with Jane Lyttleton in supporting women undergoing IVF treatment as part of their employment at the Clinic. The research assistant was casually employed within the research project to assist with providing acupuncture treatments for the trial and also to assist with data entry. All acupuncturists were members of the Australian Acupuncture and Chinese Medicine Association (AACMA) or Australian Traditional Medicine Society (ATMS) with more than 2 years of post-graduate clinical experience. Detailed discussion and orientation to the treatment
15 Among the sensations typically associated with deqi, aching, soreness and pressure were most common, followed by tingling, numbness, dull pain, heaviness, warmth, fullness and coolness. Sharp pain of brief duration that occurred in occasional subjects was regarded as inadvertent noxious stimulation. Hui, K. K. S., E. E. Nixon, et al. (2007). "Characterization of the "deqi" response in acupuncture." BMC Complementary and Alternative Medicine 7(33).
[120] protocol was given to the research assistant/acupuncturist and to the supervising acupuncturist at AIVFSC. Who, in turn, managed communication between the AIVFSC participating acupuncturists and the researcher.
The allocation of acupuncturist to participant was determined by firstly, the most convenience for the participant, for example, proximity to work or home. Those referred to the AIVFSC had their allocation to treating acupuncturist managed by the clinic manager, but this was largely determined by participant availability during particular acupuncturists‘ shifts during each week. The ideal was to provide consistency to support the acupuncturist-patient continuity. On several occasions a trial participant was seen by more than one acupuncturist during the course of the treatment. All participating acupuncturists were given the lead researcher‘s contact details and asked to call if there was any confusion or doubt about appropriate implementation of the treatment protocol. Regular email or phone contact encouraged discussion of any concerns to be raised. In the case of the Acupuncture IVF Support Clinic, the clinic manager was the primary communication channel between the acupuncturists and the researcher.
Protocol for withdrawing a participant or stopping treatment All subjects were free to withdraw from the study at any stage. When participants in either group reported pregnancy, their treatment intervention was terminated. They were asked to confirm pregnancy by blood test.
Data Collection Demographic, menstrual, fertility awareness, lifestyle (including BMI) and MYMOP measures were collected at baseline at the initial interview; adherence to study guidelines in relation to BBT, diet and exercise were assessed fortnightly; menstrual details were assessed monthly and all measures – fertility, menstrual, BMI, MYMOP and experience of the intervention - were measured at 3 months, that is, post-intervention in the final interview. Further measures of fertility, further treatment and lifestyle change adherence were taken at 12 month telephone follow-up.
Outcome measures
Primary study endpoints The effects of the intervention were assessed by: a) self-knowledge about fertility and ovulation, knowledge of fertile period at 3 months; b) regularity of menstrual cycle at 3 months;
[121] c) reduced menstrual symptoms, including pain and clotting and improved menstrual blood quantity at 3 months.
Secondary study endpoints The effects of the intervention were also assessed by: a) time from study entry to conception; b) biochemical pregnancy demonstrated by blood test at six weeks; c) quality of life changes as measured by MYMOP at three months; d) lifestyle change demonstrated by BMI at three months.
Other outcomes relating to feasibility included:
a) rate of recruitment and identification of successful recruitment strategies; b) reasons for study non participation; c) participant compliance with measurement tools - BBT, fortnightly menstrual record, and exit interview – assessed at conclusion of trial; d) study participant acupuncture attendance; e) patient acceptability and experience of the study intervention; f) acupuncturist compliance with treatment protocol – assessed from patient records at conclusion of trial and report of participating acupuncturists‘ experience of protocol; g) an estimate of the treatment effect and number of acupuncture treatments needed to obtain this effect.
Data collection tools 1. Increased awareness of fertility was measured by comparing self-knowledge about fertility and ovulation at intake and exit, and a self-report question of whether their knowledge of when they were fertile had improved and in which way. 2. Menstrual normalisation was documented by basal body temperature (BBT) chart and monthly record measured at end of 1st, 2nd and 3rd month of treatment. 3. Incidence of pregnancy was measured by self-report and report of HcG blood test. 4. Time from study entry to conception was assessed from the date of recruitment to the report of first missed period that resulted in pregnancy. 5. Measure Your Medical Outcome Profile (MYMOP) data was collected at the first (entry) and last (exit) interviews [Appendices 9 & 14]. 6. Lifestyle change was primarily assessed from BMI calculated from weight measured at the first (entry) and last (exit) interviews and self-report of changed behaviour.
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7. Acceptability of intervention was reported at exit interview and in ‗Experience of Acupuncture‘ questionnaire [Appendix 15]. 8. 12 month Follow Up Collection Form was modified from that used at the exit interview [Appendix 16]. Contact was attempted three times and then abandoned if unsuccessful.
Menstrual regularity No comprehensive instrument exists to assess aspects of the menstrual cycle from a TCM perspective, nor is there a standard validated biomedical menstrual assessment tool. Haywood, Slade and colleagues (2002:223) in a review of measures report that menstrual cycle research have used two basic approaches: menstrual cycle symptoms have been measured by a variety of instruments including both retrospective (rating the severity of symptoms over a typical cycle from memory) and prospective/concurrent reports (daily checklists of symptoms). Many of the measures reviewed focus on ‗menstrual distress‘ or experience or attitudes to menstruation rather than description of menstrual events. This latter aspect – the physical presentation of the menstrual cycle – has greater meaning for TCM diagnosis. The questionnaire used in this study was developed by the researcher based on clinical experience and was designed to facilitate TCM diagnosis as well as record changes.
In relation to menstrual cyclicity, many women with a history of infertility have become attentive students of their bodily changes and opportunities for conception and the failure to conceive. Charting the menstrual cycle can assist in locating fertility problems and indicating improvements following intervention. Whether menstruation is early or late or variable, the nature of the menstrual blood (heavy /light flow, bright/dull colour, presence of clots, size of clots, thickness of blood), degree of pain, mood changes, and changes in vaginal discharge can all be used as key indicators of change in fertility status. Participants were asked to self-report on their menstrual cycle during fortnightly telephone contact to ‗Monthly record of menstrual changes‘ form [Appendix 17] or during their acupuncture consultation to ‗Diagnostic assessment‘ form [Appendix 8] which was then transferred to ‗Monthly record of menstrual changes‘ [Appendix 18]. This information was checked against that recorded on their BBT charts where available.
BBT Participants were asked to record their temperature at the same time daily prior to rising from bed, that is, to measure their basal body temperature at its lowest (close to having been asleep and before activity). They were asked to record the temperature on the BBT chart [Appendix 10]
[123] and record the date, day of cycle and changes to their vaginal discharge. Incidence of sexual intercourse was also recorded on the chart, and other information such as changes in mood or other symptoms. A new chart was commenced at the beginning of the menses, recorded as Day 1.
Quality of life Measure Your own Medical Outcomes Profile (MYMOP) was developed by Charlotte Paterson and has undergone extensive testing and validation as a research tool (Paterson 1996);(Verhoef, Vanderheyden et al. 2006). The tool is patient-centred, as it asks participants to choose the measures they will assess and then to rate perceived change at given time intervals. It is well- suited to this research as it encourages those receiving intervention to identify their own priorities for personal outcome measures rather than having them prescribed by the researcher.
Lifestyle changes BMI was measured using the same calibrated weighing machine and height measure. Also included was a qualitative self-report of compliance with the lifestyle measures at 12 weeks.
Fertility awareness Questions concerning the participants‘ awareness of fertility included their knowledge about when they ovulated, examining cervical mucus, charting BBT. This information was collected to assess change in their awareness of fertility issues, particularly in relation to their own body function and health. The exit questionnaire asked participants to rate their change in fertility awareness.
Time to conception A simple measure of number of weeks was taken of the time from study entry to conception.
Experience of intervention The Experience of Acupuncture questionnaire [Appendix 15] was designed specifically for this study. Unlike other questionnaires administered to acupuncture patients (Cassidy 1998a; Gould and MacPherson 2001; Kim, Park et al. 2008) which were designed to establish who was using acupuncture, what represented an outcome or specific sensations they experienced, this questionnaire was a brief measure of : their assessment of whether the acupuncture they received contributed to their fertility and/or health and wellbeing; their expectations; their experience of the non-specific effects of acupuncture; any side effects; and opportunity to give a general comment.
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Handling of adverse events An adverse event is defined as one that endangers an existing pregnancy, future fertility or the health and well-being of participants. All adverse events (serious and non-serious) were reported to the primary researcher. They were recorded firstly on the treatment record, a copy lodged in a separate adverse event record and analysed and reported.
Sample size of pilot study To assess the improvement in menstrual regularity we expected a moderate effect from acupuncture. Given the lack of research in this area it was difficult to estimate the effect of acupuncture compared to control on changes in lifestyle, and pregnancy. Previous research into acupuncture‘s action in regulating menstrual characteristics suggested a moderate effect size. We expected to detect an absolute improvement in menstrual regularity of 40% from baseline between groups, from 40% in the control group to 80% in the intervention group at the end of the intervention (p<0.05, 80% power). A trial of 56 women was required, 28 women per group, with 80% power at the 5% significance level.
Databases Databases were designed in SPSS for each set of data represented by each recording form. Each variable was coded according to the possible options for that question designed into the questionnaire or where the questions were open-ended according to the range of answers received. Data were entered by a research assistant blinded to group allocation and participant identity. To ensure data was consistent and accurate it was checked and cleaned prior to analysis. This was done by checking for out-of-range numbers, running trial analyses to assess likely outcomes and outliers, identifying nonsensical answers through cross-tabulations and ensuring all missing data was coded as ‗missing‘. Where errors were identified a manual check of the participant record forms was undertaken and corrections made in the database. Where data was missing from the database and not evident from the written record no estimation was made. It was classified as ‗missing‘ data.
Data analysis Quantitative data analysis was undertaken using software program IBM SPSS 2016. Databases were combined to allow analyses to cross separate data and blinded to participant ID number and therefore group allocation. Data analysis was undertaken by the author with the assistance of Dr Ben Colagiuri and with guidance from Assoc Prof Caroline Smith. Descriptive analyses including mean, standard deviation and frequency were undertaken describing the baseline
16 IBM SPSS Statistics Version 20
[125] characteristics of participants. For parametric data the assumption of normal distribution was assessed by a normal plot. Using mean t-test, correlation test and chi-square tests randomisation was examined for any imbalances and then the analysis adjusted.
An ‗intention to treat‘ analysis was performed. Pre and post-intervention comparisons were made of data generated by the outcomes, that is, pregnancy, changes in fertility awareness, changes in menstrual cycle, quality of life, and changes in BMI. These were analysed between groups by means of analysis of variance and measures of effect size using relative risks and 95% confidence interval. P<0.05 has been considered statistically significant. An adjusted analysis or covariance was undertaken to assess unexplained or error variance using the variables that were unequal between the two groups, namely, age, duration of fertility problems and diagnosis of PCOS. For categorical variables a chi-square measure was used and a binary logistic regression undertaken. For continuous variables ANOVA and ANCOVA were used to analyse covariants.
Results The results of the pilot study are presented below in the following order: the recruitment process, randomisation by examining baseline characteristics in each group, the outcomes against nominated study endpoints, quality of life results as measured by MYMOP, indicators of the acceptability of the intervention, results of the ‗Experience of Acupuncture‘ questionnaire, report of adverse events and an outline of the TCM diagnoses given recipients of the acupuncture intervention.
Recruitment The recruitment strategy used in the pilot study was successful in promoting the study to potential participants. Posters and pamphlets were distributed around campuses of UWS and medical centres, chemists and community centres. The UWS media unit assisted by writing and placing advertisements in community newspapers in Western Sydney and the Eastern suburbs of Sydney. A press release was also issued targeting print media, and appeared on the UWS Website for a period while the media release was current. A notice was also published on the website of the Acupuncture IVF Support Centre which was participating by providing acupuncture to some trial participants. An advertisement limited to 25 words was placed on the Facebook pages of women of reproductive age who nominated themselves as being partnered and living within the Sydney region. The advertisement contained a clickable link (to a specifically designed Surveymonkey site) that required the interested reader to answer questions designed to establish their eligibility to participate in the trial and give them information. They
[126] were then asked to give their name, telephone number and/or email address to be further contacted.
The study received a total of 160 enquiries which were generated over a 12 month period. Recruitment occurred over a 12 month period within the anticipated time frame to achieve the study sample size.
Data on source of enquiries are available for 149 enquirers who made contact regarding the study and is presented in Table 5.2. The major source of enquiries was from a series of advertisements on the social networking site Facebook. The targeted ad tailored to specific Facebook members (female, partnered, adult, within Sydney metropolitan area) attracted the highest number of responses to the electronic survey link and the women were therefore able to be contacted to confirm they met inclusion criteria and were available for recruitment.
Table 5.1: Recruitment information source nominated by participant at 1st contact Source of referral Frequency Percent
Facebook 65 43.6 Media release (newspapers) 28 18.8 Complemed list 18 12.1 UWS website 14 9.4 Newspaper ad 8 5.4 Other 6 4.0 Fertility websites 3 2.0 Missing 7 4.7 Total 149 100.0
Feasibility As Figure 5.3 shows close to 60% of these Facebook responses met the inclusion criteria and although this was a lower proportion than other sources such as newspaper articles, UWS website and the research centre contact list, the total numbers meant that it was the most successful source of study recruits.
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Figure 5.2: Information source as indicator of participant meeting inclusion criteria
A strategy which yielded no results was letters to clinicians, including fertility specialists working within Western Sydney, both biomedical and Chinese medical practitioners. Pamphlets and posters distributed in public places and at the venues of service delivery (that is, UWS campuses) were also minimally effective. The pre-existing list within CompleMED from women who had nominated interest or participated in previous research was the starting point for recruitment and served to disseminate the trial‘s commencement within social networks. The second phase of recruitment was via a UWS media release targeting both local community newspapers in Western Sydney and general media. It was only picked up by one broadly distributed newspaper (The Telegraph) and several local broadsheets and, as Figure 5.4 indicates, the time spread of contacts from the media release is very short.
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Figure 5.3: Spread of 1st contact dates by information source
The presence of the media release on the UWS website generated nearly as many responses as the newspaper coverage. Paid newspaper advertising was both expensive and minimally effective generating only 6 new contacts. As indicated in Table 5.2 the most dramatic and immediate response was to a targeted Facebook advertisement. This also required payment which was variable according to ‗clicks‘ made on the ad. Those who clicked the Facebook ad were then asked to click a link to a Surveymonkey survey (designed to assess the inclusion/ exclusion criteria), complete the survey and give their telephone and email contact details. As the online survey established inclusion criteria through the process of completing it, it should have excluded inappropriate contacts. As evident from Figure 5.3 many respondents did not meet inclusion criteria. Several lived outside Sydney which theoretically should not have been possible for them to receive the Facebook ad which included a geographic boundary limit. This was generally quickly established by an email or phone call and did not progress to interview and therefore was not hugely wasteful of researcher‘s time.
There were 104 inquiries which were excluded from further interview on the basis of initial telephone or email contact. The reasons for exclusion related specifically to not meeting the
[129] inclusion criteria, for example, they lived outside the study area or a study centre was not accessible to them, their period of infertility were less than 12 months, male partner infertility was a factor or had not been excluded as a factor, or complete tubal obstruction was the cause of their difficulty conceiving. Of those who met inclusion criteria 29 declined to participate for a variety of reasons: because the prospect of receiving acupuncture was not welcome; the prospect of being randomised (that is, not receiving acupuncture) was not accepted; several already were receiving acupuncture and/or Chinese herbs for their condition and they were not prepared to terminate this treatment; several expressed ambivalence at focusing on fertility so intently (for example, keeping BBT charts were seen as onerous and undermining their peace of mind); and several women did not wish to be so ‗monitored‘ by strangers. There was a smaller group of 18 women who did not proceed for other reasons such as planning to move or have a long holiday during the study period or they failed to recontact the researcher.
To summarise, the rate of recruitment was slow and dispersed over the year in response to the recruitment techniques used at that time. This did mean that it was manageable for a single researcher and recruitment did not overwhelm the capacity of the trial acupuncturists to deliver the intervention. The study did identify successful recruitment strategies for this population of women and also identified reasons why women were likely to lead to study non-participation.
Participant flow Women were randomised into two groups: 28 into acupuncture and lifestyle intervention and 28 into lifestyle modification only. The flowchart [Figure 5.5] represents how these 56 women progressed through the study and the points at which data were collected. Seventy-seven percent of study participants completed the intervention and the exit interview at 3 months: 82% of the acupuncture participants and 71% of the lifestyle only participants. Fifty-nine percent of participants provided some BBT data: 67% of the acupuncture participants and 50% of the lifestyle only participants. Seventy-five percent of participants provided data on menstrual changes: 89% of the acupuncture participants and 61% of the lifestyle only participants.
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Figure 5.4 Fertility acupuncture clinical trial flowchart of participants
Assessed for eligibility (n=160)
Excluded (n=104) Declined to participate (n=29) Other reasons (n=18)
Randomised = 56
Allocated to acupuncture Allocated to lifestyle only intervention (n=28) intervention (n= 28) Withdrew Withdrew due to because of Received allocated intervention Received allocated intervention pregnancy prior random (n= 27) (n=25) to intervention allocation Did not receive allocated Did not receive allocated (n=1) (n=3) intervention (n=1) intervention (n=3) Drop out n=5
Drop out n=4
Fortnightly Fortnightly record record 0 =2 0 =6
1 = 26 1 =22
2. =26 2 =18 3 =24 3 =14
4 =23 4 =12
5 =16 5 =10
6 =9 6 =7 7 =2 7 =8
Menstrual Menstrual change change 17 25
BBT 14 BBT 19 Exit Exit data 1 = 0 data 1 =5 20 23 2 =5 2 =10 3 =7 3 =6 4 =2 4 =3 [131]
Characteristics of women at trial entry The data were not assessed for normal distribution due to the small size of the sample. It was considered that violations of normality usually do not affect parametric tests significantly, many of the variables assessed were unlikely to be parametric and transforming to another distribution could make interpretation of any data analysis difficult. In small samples, it is both less likely that the distribution will be normal even if being drawn from a normal population because there is more sampling error and there will be less power to detect deviation from normality.
The women who were having trouble conceiving and who volunteered for this trial were diverse and broadly representative of women of reproductive age [Table 5.2]. The average age was 33.54 years (SD 5.1). Eleven women (19.6%) were aged 30 years or below and 5 (8.9%) 40 years or above.
The mean number of previous pregnancies were 1.5 (SD 1.7) with the average number of successful live births 0.34 (SD 0.6). Many women came to the study having experienced at least one miscarriage. The average duration of their fertility problems was 4.85 (SD 4.1) years.
Twenty-six (46.4%) women had fertility problems solely sourced in female factors, for 24 (42.9%) women their fertility difficulties were unexplained and the balance of six women had combined female-male factors that were being addressed through techniques such as ICSI. Twenty-one women (37.5%) were diagnosed as having PCOS prior to the commencement of the study and five (8.9%) with endometriosis. Nine women were currently enrolled in IVF and a further nine reported having tried IVF in the past, 21 had taken clomiphene citrate to stimulate ovulation and 25 women (44.6%) of the study sample had used no other biomedical treatment prior to the study.
The mean BMI of the study population is 30.12 (SD 8.6). This measure being over 30 means the BMI of the average participant would be classified as ‗obese‘.
Twenty-five women (44.6% of the total group) reported previous use of acupuncture and 27 (48.2%) reported current use of some CAM treatment, such as vitamins, chiropractic or massage. Twenty-four women (42.9%) reported that they had been diagnosed with a major medical condition (such as diabetes and cancer) and 14 (25%) were currently taking prescribed medication.
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Table 5.2: Age & fertility characteristics of women at trial entry to allocated treatment group
Acupuncture Lifestyle-only intervention P value intervention n=28 n=28 Age (years) 33.14 (5.4) 33.93 (5.0) 0.572 Fertility history Gravida = 0 n(%) 11 (39.3) 7 (25) 0.252 Parity = 1 or >1 n(%) 8 (28.6) 7 (32.1) 0.771
Duration of infertility mean (SD) 3.9 (3.4) 5.8 (4.6) 0.080* Reasons for infertility Female factor n(%) 15 (53.6) 11 (39.3) Unexplained 10 (35.7) 13 (26.4) Unknown, combined + male factor 3 (10.7) 4 (14.3) Biomedical fertility diagnosis
PCOS n(%) 12 (42.9) 9 (32.1) 0.408 Unknown n(%) 10 (35.7) 14 (50) Other n(%) 6 (21.4) 5 (17.9) BMI Combined -mean(SD) 30.0 (9.8) 30.3(7.4) 0.893 Underweight 1 (3.6) 0 Normal (18.5-<25) 9 (32.1) 7 (25) Overweight (25-<30) 7 (25) 11 (39.3) Obese (>30) 11 (39.3) 10 (35.7) Previous use of acupuncture 13 (46.4) 12 (42.9) 0.788 n(%) Current use of CAM n(%) 13 (46.4) 14 (50) 0.789 * indicates possible significance, eg. p<0.05 The socio-demographic characteristics of study participants are described in Table 5.3. Thirty- three woman (58.9%) were of English-speaking background and the remaining 23 (41.1%) identified themselves as from non-English speaking backgrounds. The racial background included 35 (62.5%) Caucasian, six Asian, three Arabic, three Pacific Islanders, three mixed origin and five others.
The employment status of the trial participants included 32 (57.1%) working full-time, 12 (21.4%) working part-time, six (10.7%) performing home duties, three working casually, two unemployed, one student.
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Educational status included 29 women (51.8%) who completed high school or TAFE, and six (10.7%) did not complete high school. Of those completing tertiary studies 25 (44.6%) completed university studies and 21 (37.5%) completed TAFE qualifications.
In terms of lifestyle behaviours nine women (16.1%) smoked daily although most of these had a low to moderate cigarette consumption (only four women smoked more than 10 cigarettes a day). Twenty women (35.7%) reported that they consumed alcohol with only two (3.6%) consuming more that 2 glasses per day. Thirty-two women (57.1%) consumed caffeine in some form on a daily basis with nine women (16.1%) drinking three or more cups daily. None of the participants reported recreational drug use of any kind.
Regular exercise was part of most women‘s lives: 19 (33.9%) reported vigorous exercise and 26 (46.4%) moderate exercise. Forty-five women (80.4%) stated they used walking as regular exercise with only four (7.2%) walking slowly or strolling. Most (28/50%) assessed their walking speed as normal and 24 (42.9%) as fairly quick or fast.
When eating habits and food consumption were assessed and 45 (80.4%) reported eating 3 meals a day regularly. Thirty-eight (67.9%) regarded their diet as balanced and 29 (51.8%) estimated their food intake as similar to the food pyramid shown to them. Forty-six women (82.1%) reported their fluid intake as regular and 20 women (35.7%) had five or less cups of fluid a day.
Stress was regarded as significant for 41 women (73.2%) who rated their stress levels from moderate to severe. The factors that were most frequently reported as contributing to stress were their fertility status (53/94.6%), work (42/75%), money (32/57.1%), their health (31/55.4%) and their relationship (10/17.9%).
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Table 5.3: Demographic & lifestyle characteristics of women at trial entry to allocated treatment group
Acupuncture Lifestyle-only intervention P value intervention n=28 n=28 Demographic details Employment n(%) Working fulltime 17 (60.7) 16 (57.1) 0.528 Working parttime 8 (28.6) 6 (21.4) Unemployed/home duties 2 (7.1) 6 (17.9)
Education status n(%) School incomplete 0 2 (7.1) School/TAFE completion 16 (57.1) 13 (46.4) 0.309 Tertiary completion 12 (42.9) 13 (46.4)
Racial origin n(%) Caucasian 16 (57.1) 19 (67.9) 0.408
English-speaking 15 18 0.415 background (ESB) NESB 13 10 0.275
Marital status n(%) Married 25 (89.3) 22 (78.6) De facto 3 (10.7) 6 (21.4) Age at menarche (mean(SD)) 12.61/ 1.3 10.54/ 1.9 0.906 Lifestyle factors n(%) Incidence of smoking 4 (14.3) 5 (17.9) 0.716
Incidence of alcohol consumption 9 (32.1) 11 (39.3) 0.577
Incidence of caffeine consumption 17 (60.7) 15 (53.6) 0.589
Incidence of exercise Vigorous 9 (32.1) 10 (35.7) 0.778 Moderate 15 (53.6) 11 (39.3) 0.284 Walking 25 (89.3) 20 (71.4) 0.093 Usual walking speed 0.831
Diet Three meals/day 24 (85.7) 21 (75) 0.313 Balanced diet 21 (75) 17 (60.7) 0.252 Food intake similar to food pyramid 15 ( 53.6) 14 (51.9) 0.898 Regular fluid intake 25 (89.3) 21 (75) 0.249
The menstrual characteristics of the study population [Table 5.4] indicated an average age at menarche of 12.63 (SD 1.6), length of period 4.85 days (SD 1.9), length of cycle 31.42 days (SD 10.1) and regular cycle reported by 40 women (71.4%), 10 (17.9%) irregular tending to late, four (7.1%) with a variable irregular cycle and two (3.6%) irregular tending to early. The nature of menstrual flow varied with 23 (41.1%) reporting a heavy period, 20 (35.7%) a moderate flow, nine (16.1%) a light flow and four (7.1%) an inconsistent or variable period. Menstrual clotting was also assessed by self-report and 19 (33.9%) reported no clots, 21 (37.5%) small clots, 15 (26.8%) large clots and 1 reported a variable incidence of clotting. The colour of menstrual
[135] blood was assessed as bright red by 24 women (42.9%), dark red by 19 (33.9%) and as varying throughout by 13 (23.2%).
Menstrual pain was reported by 43 (76.8%) with the average length of pain lasting 1.9 days. The intensity of menstrual pain was reported as mild by 6 (10.7%), less mild by 7 (12.5%), moderate by 11 (19.6%), close to severe by 11 (19.6%) and severe by eight (14.3%). The nature of the menstrual pain was reported as dull only by 20 (35.7%), sharp only by 15 (26.8%) fixed only by 5 (8.9%), and spreading only by 3 (5.4%). Eleven women reported more than one quality to their menstrual pain. Warmth provided the most frequent means to ameliorate menstrual pain (20/35.7%), 10 (17.9%) used pain medication, five (8.9%) found pain relief from rest, three (5.4%) found the pain relieved when they passed menstrual clots, exercise assisted two women (3.6%) and two found no relief by any means. Nineteen women reported using more than one approach to relieving their menstrual pain.
Incidence of sexual intercourse varied amongst the population with an average of 11.88 times (SD 11.5) per menstrual cycle.
The awareness of fertility through identifying ovulation was 28 (50%) indicating that they knew when they ovulated. Of these 13 (46.4%) recognised ovulation by their fertile mucus, seven (25%) by abdominal pain, seven (25%) based on other factors and two (7.2%) by monitoring temperature changes. Twenty-six women (46.4%) monitored their mucus discharge, nine (16.1%) their BBT and 13 (23.2%) recorded other changes to assist in identifying their fertile period.
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Table 5.4 : Menstrual characteristics of women at trial entry
Acupuncture Lifestyle-only intervention intervention n=28 n=28 P value Menstrual details (mean(SD)) Length of period 4.86(2.3) 4.85 ( 1.5) 0.984 Length of cycle 28 (18.3) 29.5 (18.4) 0.873 Regularity of cycle n(%) Regular cycle (Y/N) 20 (71.4) 20 (71.4) 1
Nature of menstrual flow n(%) Heavy 11 (39.3) 12 (42.9) 0.716 Moderate 9 (32.1) 11 (39.3) Light 5 (17.9) 4 (14.3) Inconsistent 3 (10.7) 1 (3.6) Incidence of menstrual clots n(%) None 10 (35.7) 9 (32.1) 0.556 Small 12 (42.9) 9 (32.1) Large 6 (21.4) 9 (32.1) Variable 0 1 (3.6) Incidence of menstrual pain n(%) 23 (82.1) 20 (71.4) 0.342 Length of menstrual pain 1.7 (1.6) 1.2 (1.0) 0.669 Intensity of menstrual pain 3 (1.3) 2 (1.4) 0.261
Awareness of ovulation 13 (46.4) 15 (53.6) 0.593 MYMOP profile preintervention (mean 4.38 (0.7) 4.17(0.8) 0.309 (SD))
Quality of life For the MYMOP2 questionnaire participants are asked prior to intervention to: ―Choose one or two symptoms (physical or mental) which bother you the most‖. Many of the participants found it difficult to nominate two symptoms and one activity which they expected and wanted to change in the course of the intervention. After discussion, which carefully did not include direct guidance but a range of options and examples, they all were able to think of symptoms that they nominated. There was remarkable consistency in the symptoms nominated. To illustrate this, the following table is a conflation of the grouped symptoms nominated as 1 or 2. Table 5.5: Symptoms nominated on MYMOP questionnaires either as Symptom 1 or Symptom 2.
Symptom Number of times Percentage of nominated total responses Tiredness 23 20.7 Weight 21 18.9 Stress 16 14.4 Emotional problems 13 11.7 Pregnancy failure 13 11.7 Menstrual problems 11 9.9 Fitness 6 5.4 Specific physical symptoms 7 6.3 Other 1 0.9 Total 111 99.9
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The symptoms nominated clearly fell within these categories and there was little variation in the language used to describe the symptom. For example, ‗weight‘, ‗weight loss‘, ‗shape/size‘, ‗excess weight‘, ‗less appetite for food‘, ‗reduced weight‘ all clearly indicated a concern for both body image and perhaps the impact that exceeding one‘s ideal weight is said to have on fertility. Surprising, given the purpose of the clinical trial, was the small percentage of these women who nominated infertility and pregnancy failure as their primary concern at that time. Perhaps because their fertility problems were, by definition, longer than 12 months duration, they had become background to the more immediate symptoms of tiredness and fatigue, weight gain, stress and emotional problems - although of those who completed the ‗Experience of acupuncture‘ questionnaire 49% report pregnancy/fertility related expectations from the trial. Perhaps the women did not perceive fertility as impacting on their wellbeing. It was poignant to read, ―I just want to feel good in my body without continuous pain – like I used to be‖ on a form which did not encourage lengthy contributions. Several women wrote ‗depression‘, ‗jealousy‘, ‗anger‘, ‗being emotionally vulnerable‘, ‗anxiety‘, testifying to the difficulty of their lives at that time.
The participants were also asked to: ―Choose one activity (physical, social or mental) that is important to you, and that your problem makes difficult or prevents you doing.‖ Of the respondents, 37.5% nominated getting more exercise or getting up and moving as their major desired activity. Nearly 11% nominated the opposite – being able to relax. Several women chose increasing their social activity as a priority and they mentioned in particular wanting to socialise with their friends who had children or being able to discuss their fertility difficulties. These findings speak to the difficulties women with fertility problems faced in accepting themselves both personally and in social settings – their unease with their ‗faulty‘ body extending into their lack of ease within their social milieu, especially when confronted by the apparently easy fertility of others.
As indicated in Tables 5.2 and 5.3, randomisation was successful without significant selection bias across age, reason for fertility, racial origin and current employment. Previous use of acupuncture, current use of CAM therapies, and BMI at recruitment were all equivalent across the two groups. There was an imbalance in randomisation for two variables: the duration of infertility and biomedical diagnosis – these were adjusted for in the analysis.
The menstrual characteristics of both groups (shown in Table 5.4) are similar with similar period and cycle length, menstrual flow and incidence of pain. The group receiving acupuncture had
[138] slightly lower awareness of their ovulation and slightly higher MYMOP profile score. Neither of these differences, however, was statistically significant.
Trial outcomes
Primary study endpoints
Self-knowledge about fertility and ovulation: [Table 5.6.1] There was a statistically significant increase in fertility awareness in the group of women who received acupuncture (86.4%,19) compared to 40% (n=8) of the lifestyle-only participants, (Relative Risk (RR) 2.38, 95% confidence interval (CI) 1.25,4.50), with an adjusted p value of 0.011.
Regularity of menstrual cycle: [Table 5.6.1] There was no significant change in menstrual regularity over time between the two groups, however, the participants receiving acupuncture trended toward retaining regularity over 3 cycles (of 71.4%) whereas the lifestyle-only group lost regularity (71.4% to 50%). The low numbers of responses of 3rd cycle data limits the value of interpreting this trend.
There were no statistically significant differences in the length of the follicular and ovulatory phases of the menstrual cycle over three months between groups. There was some change in the length of the follicular phase in the acupuncture group and not in the lifestyle group, reducing from 16.12 to 14.88 days over 3 cycles but this did not reach levels of statistical significance. The length of ovulation in the acupuncture group lengthened by 0.8 days compared to 0.5 days in the lifestyle group. Temperature change at ovulation trended upward by 0.5 degree in the acupuncture group whereas only by 0.03 in the lifestyle only group. The data for the length of the luteal phase was variable and it is difficult to assess any trends.
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Table 5.6.1 : Primary study endpoints by treatment group(A)
Acupuncture Lifestyle only P value Adjusted RR /CI intervention intervention analysis (CI 95%)
N=28 N=28
Increase in fertility awareness (%) 19 (86.4) 8 (40) 0.002* .011* 2.38(1.25,4.50) Regularity of cycle n (%) At entry (%) n=56 20 (71.4) 20 (71.4)
M1 n=43 16(61.5) 12(70.6) 0.543 0.823 0.87(0.57,1.34) M2 n=31 12(60) 5(45.5) 0.436 0.262 1.32(0.63,2.77) M3 n=15 5(71.4) 4(50) 0.398 0.252 1.43(0.65,3.30) BBT (mean(SD) Length of follicular phase M1 n=26 16.12(4.3) 14.11(3.4) 0.237 0.739 2.01(-1.4,5.42) M2 n= 23 15.00(3.1) 14.33(2.6) 0.598 0.690 0.67(-1.73,3.07) M3 n= 17 14.88(3.4) 14.00(4.2) 0.646 0.555 0.88(-3.09,4.85) Length of ovulation M1 n= 29 2.95(1.6) 3.33(1.3) 0.530 0.327 -0.38(-1.61,0.86) M2 n= 24 3.43(1.2) 3.60(1.8) 0.781 0.601 -0.17(-1.44,1.1) M3 n= 17 3.75(1.3) 3.89(1.6) 0.848 0.993 -0.14(-1.66,1.38) Temperature change at ovulation M1 n= 32 M2 n= 31 0.37(0.2) 0.41(0.2) 0.632 0.259 -0.04(-0.2,0.12) M3 n= 19 0.43(0.2) 0.38(0.2) 0.582 0.506 0.04(-0.11,0.2) 0.42(0.2) 0.44(0.2) 0.764 0.989 -0.02(-0.19,0.15) Length of luteal phase M1 n= 26 M2 n= 21 11.84(2.1) 14.67(4.4) 0.041 0.027 -2.73(-5.34,-0.12) M3 n= 15 14.46(6.7) 11.50(3.1) 0.258 0.388 2.96(-2.36,8.28) 11.86(3.2) 11.75(3.3) 0.950 0.928 0.11(-3.51,3.73)
Reduced menstrual symptoms: [Table 5.6.2 & 3] There were no statistically significant differences between groups in other menstrual characteristics including length of cycle [Table 5.6.2], presence of menstrual clots and menstrual pain [Table 5.6.3]. There was a trend towards reduction in the length of the menstrual cycle in both groups and this move toward normalisation indicates that lifestyle modification may have impacted on these factors. There was also a tendency to fewer menstrual clots (although this was a stronger trend among those receiving acupuncture) and less incidence of menstrual pain.
There were also trends apparent in the acupuncture intervention group: reduced incidence of menstrual pain (from 82.1% to 28.6% (53.3% improvement) over 3 cycles compared to 71.4% down to 50% (21.4% improvement) in the lifestyle-only group); intensity of menstrual pain (an intensity of 3(1.3) down to 1.5(1.0) over 3 cycles compared to an increase from 2 to 2.67 in the lifestyle group) and length of menstrual pain reduced by 1.13 days in the acupuncture group and by 0.57 days in the lifestyle-only group although none of these measures was statistically significant .
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Table 5.6.2 : Primary study endpoints by treatment group (B)
Acupuncture Lifestyle only P value Adjusted RR /CI intervention intervention analysis (CI 95%) N=28 N=28 Menstrual details (mean/SD) Length of period Mentry n=56 4.86(2.3) 4.85(1.5) 0.984 M1 n=36 5.39(2.5) 5.08(1.1) 0.671 0.383 0.31(-1.18,1.8) M2 n=30 5.11(2.0) 4.33(1.4) 0.255 0.631 0.78(-0.77,2.33) M3 n=18 5.11(1.3) 4.67(1.3) 0.478 0.452 0.44(-0.85,1.73) Mexit n=39 4.52(2.2) 4.72(2.2) 0.783 0.764 -0.2(-1.65,1.25)
Length of cycle Mentry n=56 34.64(18.3) 35.43(18.4) 0.873 M1 n=34 32.52(13.9) 31.00(6.2) 0.713 0.360 1.52(-6.8,9.84) M2 n=29 29.12(4.0) 29.25(8.9) 0.957 0.802 -0.13(-5.15,4.89) M3 n=16 29.43(2.6) 26.78(3.1) 0.091 0.996 2.65(-0.48,5.78) Mexit n=37 29.05(11.9) 30.65(6.4) 0.624 0.285 -1.6(-8.15,4.95)
Nature of menstrual flow (%) Chi-square Heavy Mentry Mentry n=56 11(39.3) 12(42.9) 0.716 0.92(0.49,1.72) M1 n= 41 11(44) 2(12.5) 3.52(0.89,13.85) M2 n= 29 11(55) 1(11.1) M1 0.077 4.95(0.75,32.76) M3 n= 14 2(28.6) 2(28.6) 1(0.19,5.25) Moderate M2 0.009* Mentry n=56 9(32.1) 11(39.3) 0.82(0.4,1.66) M1 n=41 10(40) 8(50) M3 0.819 0.8(0.4,1.59) M2 n=29 6(30) 3(33.3) 0.9(0.29,2.82) M3 n=14 3(42.9) 2(28.6) 1.5(0.35,6.4) Light Mentry n=56 5(17.9) 4(14.3) 1.25(0.37,4.17) M1 n=41 4(16) 6(37.5) 0.43(0.14,1.28) M2 n=29 1(5) 5(55.6) 0.09(0.01,0.66) M3 n=14 2(28.6) 3(42.9) 0.67(0.16,2.84) Inconsistent Mentry n=56 3(10.7) 1(3.6) 3(0.33,27.12) M1 n=41 0 0 M2 n=29 2(10) 0 M3 n=14 0 0
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Table 5.6.3 : Primary study endpoints by treatment group (C)
Acupuncture Lifestyle only P value Adjusted RR /CI intervention intervention analysis (CI 95%) N=28 N=28 Incidence of menstrual clots (%) Mentry 0.556 None Mentry n=56 10(35.7) 9(32.1) M1 0.221 1.11(0.53,2.31) M1 n= 39 11(45.8) 11(73.3) 0.63(0.37,1.06) M2 n= 28 9(47.4) 7(77.8) M2 0.287 0.61(0.34,1.1) M3 n= 13 6(85.7) 4(66.7) 2.14(0.95,4.85) Small M3 0.188 Mentry n= 56 12(42.9) 9(32.1) 1.33(0.67,2.65) M1 n= 39 8(33.3) 3(20) 1.67(0.52,5.31) M2 n=28 7(36.8) 1(11.1) 3.32(0.48,23.06) M3 n= 13 1(14.3) 0 Large Mentry n=56 6(21.4) 9(32.1) 0.67(0.27,1.62) M1 n= 39 5(20.8) 1(6.7) 3.13(0.4,24.22) M2 n=28 3(15.8) 1(11.1) 1.42(0.17,11.83) M3 n= 13 0 2(33.3) Variable Mentry n= 56 0 1(3.6) M1 n= 39 0 0 M2 n=28 0 0 M3 n=13 0 0 Incidence of menstrual pain Mentry n= 56 23(82.1) 20(71.4) 0.342 1.15(0.86,1.54) M1 n=40 17(68) 5(33.3) 0.033* 0.056 2.04(0.95,4.38) M2 n= 30 10(50) 3(30) 0.297 0.430 1.67(0.59,4.73) M3 n=13 2(28.6) 3(50) 0.529 0.67(0.17,2.67) Length of menstrual pain (days) (mean(SD) 1.7(1.6) 1.2 (1.0) 0.669 Mentry n=56 1.46(1.7) 0.63(1.4) 0.108 0.238 0.83(-0.2,1.86) M1 n=40 0.9(1.2) 0.47(1.1) 0.271 0.258 0.43(-0.36,1.22) M2 n= 36 0.57(0.5) 0.63(1.1) 0.906 0.587 -0.06(-1.02,0.9) M3 n= 15 Intensity of menstrual pain (mean (SD) Mentry n= 56 3(1.3) 2(1.4) 0.261 M1 n= 23 3(1.3) 2(1.4) 0.146 0.285 1(-0.37,2.37) M2 n=14 1.91(1.4) 2.67(1.5) 0.423 0.141 -0.76(-2.76,1.24) M3 n= 7 1.5(1.0) 2.67(1.5) 0.272 0.840 -1.17(-3.6,1.26) Secondary study endpoints
Time from study entry to conception: [Table 5.7] Seven women (adjusted p=0.992) achieved a pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group (p=0.422). For those who received acupuncture this is effectively half the time to conception.
Biochemical pregnancy: [Table 5.7] The number of pregnancies during the study intervention did not differ between groups. The follow up data does indicate a difference in the numbers of pregnancies in the 12 months since trial completion: 10 women in total in the acupuncture group became pregnant and 5 in the lifestyle only group, with the number of live births also varying to 80% in the acupuncture group
[142] and 60% in the lifestyle-only group (p= 0.176). Women in both groups received assistance from IVF and two women in the lifestyle-only group received acupuncture and Chinese medicine and fell pregnant after these treatments.
Quality of life changes: [Table 5.7] The MYMOP scores indicate an improvement in two self-nominated quality of life measures and a more significant change for the women receiving the acupuncture intervention compared with the control. In relation to changes in desired activity the acupuncture intervention participants recorded a change of 1.80(1.2) compared to the lifestyle only group of 0.94(1.2). This represented a statistically significant adjusted p value of 0.047. The MYMOP measure of changes in wellbeing also showed significant differences between the two groups: 0.95(1.4) in the acupuncture group and 0.05(1.4) in the lifestyle-only group. This represented a statistically significant adjusted p value of 0.042.
Lifestyle change demonstrated by BMI: [Table 5.7] There was no significant difference in BMI at conclusion of the intervention for women in the lifestyle-only group compared with the acupuncture group. Follow-up at 12 month established that 10.7% (53% of those in follow-up) of the acupuncture group had sustained changes in their lifestyle with an equivalent number of 7.1% (50% of those in follow-up) in the lifestyle-only group. Although some participants reported sustained diet and exercise routines number were not enough to record significance.
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Table 5.7: Secondary study endpoints by treatment group
M= numbers followed up Acupuncture Lifestyle only P value Adjusted intervention intervention analysis N=28 N=28 Pregnancy (%) Incidence n = 43 4 (16) 317(15) 0.927 0.992 Pregnancy status at 12 month follow up (%) 10 (35.7) 5 (17.9) 0.552 n=32 Live birth (%) n=32 8 (80) 3 (60) 0.176 0.183 Time from study entry to conception(weeks) 5.5 10.67 0.422 0.452 n=43 Quality of life changes (MYMOP) n=43 (mean(SD)) Changes in symptom 1 1.27(2.1) 1.55(1.5) 0.628 0.775 Changes in symptom 2 1.81(1.4) 1.40(1.1) 0.305 0.291 Changes in activity 1.80(1.2) 0.94(1.2) 0.033* 0.047* Changes in wellbeing 0.95(1.4) 0.05(1.4) 0.043* 0.042* Change in MYMOP profile score 1.47(1.1) 1.03(0.8) 0.156 0.165
Lifestyle change (BMI) At entry 30.0 (9.8) 30.3(7.4) 0.893 0.726 At exit 29.31(10.1) 28.39(5.6) 0.719 0.273
Change in BMI (mean(SD)) 0.0318(1.1) -0.75(1.3) 0.475 0.585 Sustained lifestyle change at 12 month 10(53) 6 (50) 0.886 n=31 (%) Acceptability of intervention n(%) Compliance with BBT records 24(85.7) 14(50) 0.538 Completion of exit interview 22(78.57) 20(71.43) 0.314 Record of menstrual changes 26(92.86) 16(57.14) 0.677
17 One of these pregnancies was achieved through IVF due to male factor problems for the couple. The participant advised the researcher after her pregnancy that she had used acupuncture prior to this conception – her first ever after years of IVF cycles.
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Quality of life (MYMOP)
Figures 5.5 & 6 showing MYMOP profile ratings for acupuncture intervention (A) & lifestyle-only intervention (B) preintervention (left) and postintervention (right).
Figures 5.5 and 5.6 contrast the MYMOP profile scores by group allocation. The plots display the amount of change in the acupuncture intervention group has been greater despite the mean scores being equivalent at the conclusion. Note that the higher the MYMOP profile rating the worse the situation is perceived to be.
Outcomes relating to feasibility
Reasons for study non-participation The reasons why eligible women refused recruitment and why recruited women did not fully adhere to the intervention are discussed above in the sections on ‗Recruitment‘ and ‗Participant flow‘. The opportunity to receive ‗free acupuncture‘ was an obvious motivation for participation in the study. The desire to assist research was not expressed as an incentive by participants, except by resignation when randomised to the lifestyle-only group. What became apparent was that an intervention of 12 weeks duration required a relatively stable population of participants. Several potential or actual participants reported moving house or city and it is assumed that at least some of the 21 (37.5% of the total) women lost to follow-up may also have undergone changes, as they were no longer accessible via their work and home contact details.
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Participant compliance with measurement tools Compliance with measurement tools is discussed above in ‗Participant flow‘. Compliance varied between acupuncture and lifestyle-only groups. The flowchart provides some valuable information in relation to the feasibility of the study design. Participant compliance with measurement tools becomes evident through the chart: a) Study participants who completed acupuncture attendance that is, complied with the intervention were 25 of the 27 who began, although 2 of these participants failed to complete the final exit interview. b) The participants receiving the lifestyle-only intervention were less compliant with on-going data collection although 80% of those who did not formally withdraw at randomisation completed the final exit interview. c) The fortnightly record of compliance with diet, exercise and BBT was also designed to keep the participants in touch with the researcher. As indicated by the flowchart for the participants who received acupuncture the fortnightly record (completed by their treating acupuncturist) successfully collected data until the acupuncture intervention was concluded, hence the drop off in numbers in later weeks. For the participants receiving lifestyle- only intervention, using the fortnightly phone call to collect data was less successful and there was loss of contact with the study. d) The monthly record of menstrual activity and change was also collected either at the acupuncture appointment or in the fortnightly phone call. The result shows a similar imbalance between groups: 25 women receiving acupuncture provided data about their menstruation, 17 women in the lifestyle only group provided such data. e) Record of menstrual regularity and other details provided by the BBT charting showed less compliance in both groups, 19 and 14 respectively. f) The collection of final trial exit data indicates higher compliance in the lifestyle-only group participants compared to their compliance with the other data collection methods. The data was primarily collected in a personal interview, the time of which was often set at the study entry interview. The loss of 2 acupuncture participants after completion of the intervention included one woman who travelled overseas for an extended period and could not be contacted and another who failed to respond to all methods of communication.
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Although the differences in compliance between groups were not statistically significant [Table 5.7] the actual proportions of participants completing their BBT charts (85.7% against 50%), recording their menstrual details (this required lifestyle-only participants accepting a phone call from the researcher)(92.9% against 57.1%) and attending a trial exit interview (78.6% against 71.4%) were substantially different between groups. This reduced further the number of participants being assessed and introduces potential biases from the measurements being underpowered.
Study participant acupuncture attendance Analysis of actual attendance for acupuncture shows that only 67% received the full course of 9 treatments with a mean of 7.62 and standard deviation of 2.5. Four trial participants randomised to receive acupuncture completed either part or all treatments and then failed to agree to an exit interview. Of the 28 women one was excluded because she fell pregnant prior to receiving any acupuncture; 3 withdrew after receiving less than the prescribed 9 acupuncture treatments (2 of these were lost to follow-up because they moved outside the area); 2 women completed their acupuncture (administered by acupuncturists other than the researcher) but would not respond to requests for an exit interview and they also became lost to follow-up. This represents 6 women (21%) either not completing the intervention or all the reporting requirements within the trial.
Patient acceptability and experience of the study intervention Two women randomised to the lifestyle-only intervention telephoned within a few days of recruitment to withdraw from the study. Additional women appear to have come to the same conclusion as they refused further contact with the researchers at subsequent attempts at follow- up. In all 8 women (28.6%) were lost to follow-up in the lifestyle-only group although some partial data from some of these women were able to included in the analysis.
Of the women who completed the acupuncture intervention none expressed dissatisfaction with the intervention despite some not complying with data collection measures. (See results from ‗Experience of Acupuncture‘ questionnaire below.)
Acupuncturist compliance with treatment protocol This outcome was assessed from patient records at conclusion of trial and reports of participating acupuncturists‘ experience of protocol. There were no reported problems with acupuncturists complying with the treatment protocol nor were difficulties apparent from the patient records. One acupuncturist rang the researcher to discuss and review the diagnosis. It was agreed to amend the original diagnosis of one participant.
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Estimate of the treatment effect and number of acupuncture treatments needed to obtain this effect The average number of days in treatment was 64.74 (SD24.1). In actuality only 4 (14.3%) women received treatment over 84 days or more (being equivalent to 3 menstrual cycles assuming an average length of menstrual cycle of 28 days).
Adverse event outcomes The participants receiving acupuncture intervention were asked whether they experienced any side effects from treatment and what these were. Eighteen women (nearly 82 percent) reported no side effects during the acupuncture intervention. Three women (13.6%) reported side effects which were nominated as: ‗slight bruising on some points‘, ‗headaches in the first three sessions which decreased in severity, felt very emotional (more than usual)‘, ‗awareness of old buried feelings‘, ‗a little pain, occasional bruising‘. One participant found it hard to judge whether there had been side effects to her treatment.
There were no reported adverse events from the lifestyle-only participants.
Although these reported side effects were not said to have major consequences the report that acupuncture assisted in accessing ‗buried feelings‘ is not unusual in accounts of acupuncture outcomes. This could potentially have major implications for the participant reporting this effect. There were no serious adverse events requiring the activation of the procedure to refer the participant for medical assessment and emergency treatment.
‘Experience of Acupuncture’ Questionnaire Results The written ‗Experience of acupuncture questionnaire‘ [Appendix 15] included both scaled and quantifiable responses to questions in addition to room for written comment. The questionnaire was given to the participants who had received the acupuncture intervention and was completed at the final (exit) interview in the presence of the researcher but without the researcher‘s participation. Although it was completed in the context of a general discussion about their perceptions of the study and acupuncture in general and their intentions to pursue further treatment they were able to complete it privately and without scrutiny.
The questionnaire offered an opportunity for participants receiving the acupuncture intervention to evaluate and comment on their experiences of the intervention. The predominant message was that they perceived their well-being to have improved through the study. Those who had
[148] tangible indications of bodily (especially menstrual) change felt positive about the intervention‘s impact on their fertility. The side effects of treatment were deemed minor.
The quantifiable responses were collated into SPSS Statistics version 20. The written comments were de-identified and collected into a common document.
Twenty-two (81.1%) out of twenty-seven women who received acupuncture completed the written questionnaire on their experience of acupuncture.
Participants were asked to identify their expectations in joining the study. This was presented as an open-ended question and the responses fell within a limited range which is detailed in Table 5.8 below.
Table 5.8: Participant expectations of study Frequency Percent Pregnancy 11 35.5 Better health(esp. menstrual) 6 19.4 Reduced stress 2 6.5 Balance/Wellbeing 2 6.5 ART support 1 3.2 No expectation/open mind 4 12.9 More knowledge about 4 12.9 body/fertility Missing 1 3.2 Total 31 100.1
The participants had high expectations of the trial. In the largest nominated expectation (35.5%) participants clearly aspired to achieve a pregnancy as a result of participation. They stated it was part of their mission to leave no stone unturned or possibility unexplored to assist their fertility objectives. No participant nominated being part of furthering research on fertility or acupuncture as an expectation although this had been an element of the recruitment interview. The researcher found that it was those participants randomised into the lifestyle-only intervention who expressed that at least they could be contributing to the research process. Nearly half of the sample nominated a second expectation and these have been incorporated into Table 5.8. In total, 50% of the 22 participants completing the questionnaire nominated ‗pregnancy‘ as an expectation.
In response to the question, ‗How much do you think acupuncture has helped your fertility?‘ the following answers were given: 13 (59.1%) stated ‗a great deal, 2 (9.1%) ‗only a little‘, a further 2 (9.1%) stated ‗not at all‘ and 5 (22.7%) concluded that they ‗don‘t know‘.
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Close to 68 percent of these participants considered that acupuncture had ‗helped their fertility‘ with the large majority assessing this to be significant assistance. From the written comments it becomes clear that those who had what they considered a tangible outcome were most positive about the acupuncture intervention‘s impact on their fertility. Those, for example, who had achieved a pregnancy, attained more regularity in their menses or seen a distinct change in other symptoms such as premenstrual tension or menstrual pain, assessed the acupuncture as helping ‗a great deal‘. Over one-fifth stated that they ‗didn‘t know‘, and it becomes clear from the comments that this could be read as ‗yet‘. These women were waiting for a more substantive form of ‗help‘. The two women who chose ‗not at all‘ were referring to their failure to achieve a pregnancy during the course of the study.
A more general question: ‗Do you think acupuncture has contributed to your health and wellbeing during the study?‘ elicited a clear positive response (95.5% reported ‗yes‘) with only one participant nominating ‗no‘. This woman withdrew from the study early with her scheduled acupuncture sessions incomplete. She had experienced great difficulty attending because of work commitments and travel constraints. She consulted her biomedical physician who advised her that she was not ovulating and that IVF was the only available option for her to pursue. She reported that her expectation of the study was ‗to get pregnant‘. She accepted her physician‘s advice and sought specialist biomedical assistance.
The comments associated with this question were extensive and most used the three lines of space to record their views. Many reported clearly physiological responses to treatment: ‗assisted greatly with premenstrual condition‘, ‗started to have my periods every month‘, ‗sleep well after sessions‘, ‗feel less tired‘, ‗better circulation, less back and neck ache‘, ‗no back pain‘, ‗more energy‘, ‗period volume is higher than before‘, ‗hardly any headaches‘. Other comments included more emotional reactions: ‗it gives me hope‘, ‗less emotional before my period‘, ‗that I was doing all that I possibly could‘, ‗it gave me a chance to relax‘, ‗I felt less stressed‘, ‗motivated and had energy‘, ‗morale – uplifting feeling – walked out upright‘, ‗lovely experience‘. Several reported gaining a different concept of their bodies or of fertility and acupuncture: ‗I don‘t understand it fully but it does work‘, ‗I felt more in control‘, ‗it made me eat healthy, exercise, stress little‘, ‗learned a lot about the condition‘.
They were also asked: ‗Acupuncture treatment involves needling of specific acupuncture points; in addition acupuncture may involve other aspects of care. In this study were any of the
[150] following important to you?‘ And four options were offered and respondents were not limited to just one or asked to rank their responses.
Table 5.9: What aspects of acupuncture care were important to you? Number who Percent nominated this aspect A positive relationship between yourself 20 90.9 and the practitioner Inviting and sharing of information 21 95.5 Being listened to 18 81.8 Helping you to make sense of your 19 86.4 condition
The majority of respondents reported most aspects of care in receiving the acupuncture intervention as important.
The participants were offered the space to make other comments of their own choice. Several women took the opportunity to thank the researchers and their acupuncturists for the positive experience that they had received. Others elaborated on their previous comments: ‗the feeling of being in control and feeling so much more relaxed and confident‘, ‗definitely felt the benefit of regular acupuncture‘, ‗I did find that participating has assisted in gaining knowledge of the preparations required before trying to get pregnant‘, ‗I am glad that I took this trial, it has improved my wellbeing‘, ‗I think acupuncture is good to help release stress and helpful in fertility‘, ‗at the beginning I didn‘t feel I had much hope of having kids but in the end I really felt that I had hope‘. A number of women stated their intention to seek out acupuncturists to continue their treatments and asked the research team for referrals.
The questionnaire expanded the data available beyond what would have been possible with a single quantitative methodology. Providing space for participants to write their own comments attracted valuable comments.
TCM Diagnosis A TCM diagnosis was undertaken to guide the treatment protocol. All were assessed by the principal researcher and no inter-rater assessment was undertaken. In TCM, diagnoses can overlap and also can have a causal relationship, for example, Liver qi stagnation can lead to Blood stasis or Kidney yang xu can cause or co-relate with Spleen qi xu, Damp/Phlegm and/or Blood stasis. Hence there are multiple diagnoses for each participant.
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Table 5.10 TCM Diagnoses made at Recruitment Interview
TCM Diagnosis No. incl. this dx % of dx % of total n=87 n=28
Kidney jing xu 2 2.3 7.1
Kidney yang xu 18 20.7 64.3
Kidney yin xu 8 9.2 28.6
Blood stasis 11 12.6 39.3
Blood xu 7 8.0 25.0
Liver qi stagnation 12 13.8 42.9
Heart qi stagnation 3 3.4 10.7
Heart yin xu 1 1.2 3.6
Spleen qi xu 7 8.1 25.0
Heat 4 4.6 14.3
Damp/Phlegm 10 11.5 35.7
Shen disorder 1 1.2 3.6
Extraordinary 0 0 0 meridian presentation
Other 3 3.4 10.7
Total 87 100.0
The fact that there were 28 diagnoses of a Kidney related condition is of little surprise. In TCM the Kidney function is equivalent to many aspects of reproductive function. Insufficient Kidney yang, the motive force of reproduction, is expected in women with fertility problems. Many received more than 1 diagnosis: 27 (96.4%) received at least 2 diagnoses, 20 (71.4%) more than 3, and 12 (42.9%) received 4 or more diagnoses.
Discussion The main findings were that this acupuncture intervention, compared to lifestyle–only, resulted in significant increases in fertility awareness and quality of life measures in relation to well-being, it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings show that a pragmatic trial with this population is feasible. It also provided evidence that the acupuncture intervention is
[152] acceptable and is not inert, and that acupuncture dose may have a significant influence on outcomes. It was also apparent that the lifestyle-only intervention was less acceptable to this population and as a comparator to acupuncture. The measurement tools to identify physiological changes, particularly menstrual change, require greater refinement to make adherence easier for the participant and to improve the researcher‘s capacity to analyse the data.
Trial outcomes
Fertility awareness The significantly improved fertility awareness outcome on the part of those who received acupuncture is interesting. All 56 women received the same information and the initial interview included detailed discussion of what constituted the fertile period, the evidence for timing of sexual intercourse, the significance of the changes in temperature and vaginal mucus which made BBT charting helpful, and the evidence for lifestyle modifications that may enhance fertility. Much of this information was reinforced within the contact telephone conversations or in acupuncture sessions. The impact of providing information alone having minimal effect on health behaviour is not a surprise to health educators and others working in the health care field (Di Blasi, Harkness et al. 2001; Gaston and Mitchell 2005; Hofrichter and Bhatia 2010). One study (Maly, Bourque et al. 1999) of those with chronic illness compared a group actively engaged with and contributing to their health record with their physician, compared to those receiving health education information sheets, found the former had a better health outcome. There has been a move away from patient education to the idea of health literacy (Advisor 2011) and much of the research on health-related information (where it excludes the presence of Internet as an information provider) is at least 10 years old. This shift in focus appears to reinforce the interest in the nature of the therapeutic relationship and its impact on health outcomes, that is, not what is said but how it is said and by whom has become the focus of research interest.
In this study protocol, at every acupuncture treatment the patient participant was asked about their menstrual cycle, at which day of their cycle they were, what were the accompanying symptoms and the treatment was varied according to the information given. This was a strongly embodied and engaged information exchange that alerted each woman to her menstrual health and the fertility implications of her current stage and state. As discussed in Chapter 6, many women found this exchange influential and some quite powerful in terms of their understanding of their bodies and reproductive functioning.
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The treatment effect showed significance for self-knowledge (fertility awareness), and quality of life changes such as wellbeing, but only trends in changes to more physiological based change such as menstrual characteristics.
Measures of menstrual change None of the measures of menstrual change was significantly different between groups. There are several possibilities why this was the case. One, of course, is that this acupuncture protocol did little to influence menstruation, but this is contradicted by the preliminary findings of reduced incidence of menstrual clotting, length of pain and intensity of pain, normalisation of the length of the menstrual cycle and the increased heaviness of menstrual flow18. These changes could have resulted from the lifestyle modification protocol although generally these trends were less apparent in the lifestyle-only group. A second possibility is that the acupuncture intervention was too short or too low a dose (one treatment per week). There was a high proportion of women with PCOS in the study and clinical experience indicates that the menstrual cycle is often irregular and treatment attempting to follow the usual movements of Yin and Yang or Chong and Ren vessel activity is not so easy (Lyttleton 2004:166). Lyttleton recommends a sequential approach to treatment which involves a treatment protocol that is staged over time and in response to changes in the patient‘s symptom picture. Jedel, Labrie et al (2011) found that both electroacupuncture and exercise had a significant effect on menstrual regularity after 16 weeks of treatment; and this research team has concluded that prolonged and high-dose acupuncture is most effective for PCOS (Stener-Victorin, Jedel et al. 2008; Raja-Khan, Stener-Victorin et al. 2011). Despite this, three women with PCOS in the acupuncture intervention reported the occurrence of a ‗natural‘ period, that is, one that was not precipitated by medication, and two others reported a ‗show‘ (light bleed) at the appropriate time in their cycle. They all stated this was their first natural menses since acquiring PCOS and attributed this event to the acupuncture treatments. On these grounds alone it appears that the acupuncture protocol was not inert in women with PCOS.
The effect of the acupuncture intervention on menstrual physiology, such as regularity, was smaller than moderate and the study was underpowered in relation to this issue. At the outset, 71% of women recruited (40) reported that their period was regular. This meant that a primary outcome measure of menstrual regularity was underpowered because there were a smaller number of women to work with as only 29% had irregular cycles.
18 The increased heaviness of menstrual flow could either be a sign of health or pathology. To change from a light scanty flow (indicating perhaps insufficient blood in TCM terms) to a heavier flow is a sign of a more robust blood picture. In someone who starts to bleed heavily because they are exhausted (qi deficient in TCM terms)it is a sign of perhaps failure of treatment. This measure needs to be refined or applied in a more individualised manner to be meaningful.
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The issue of the dose19 level within the acupuncture protocol being inadequate is worth examining. One systematic review of studies treating chronic pain with acupuncture found six or more acupuncture treatments were significantly associated with positive outcomes (P = 0.03) even after adjusting for study quality (Ezzo, Berman et al. 2000). In an examination of dose levels when using acupuncture as an adjunct to IVF the authors report that those who received an average of 8.4 treatments had better pregnancy outcomes than those who received less (Cridennda, Magarelli et al. 2006). In one of the Stener-Victorin studies the mean pulsatility index (PI), was significantly reduced shortly after the eighth electroacupuncture (EA) treatment (P < 0.0001) (Stener-Victorin 1996). Clinical experience attests to the need to treat at least three menstrual cycles in order to affect menstrual and reproductive change. The protocol in this study prescribed 9 treatments within 12 weeks, on the assumption that the participant would miss an appointment each month and that the whole treatment would extend over 3 months or 3 menstrual cycles. As reported in the results, analysis of actual attendance shows that only 67% received the full course of 9 treatments with a mean of 7.62 and standard deviation of 2.48. The average number of days in treatment was 64.74 (SD24.14). In actuality, only 4 (14.3%) women received treatment over 84 days or more (assuming an average length of menstrual cycle of 28 days). A course of treatment measured against the number of cycles may have been more appropriate than a fixed number of treatments or a fixed period of time.
The intervention protocol designed from the consensus of experts in this field held up to implementation with none of the participating acupuncturists reporting difficulty applying it. The major weakness appears to be the definition of dose in relation to the frequency and course of treatment. A more useful measure of course, rather than the number of treatments in a particular time frame, would be personalised to the menstrual cycle of the participant. Treatment throughout at least 3 menstrual cycles appears to be a necessary dose to achieve menstrual change.
This group of women had a surprisingly high incidence of menstrual regularity (71.4%), particularly given the number of women with PCOS. There were not sufficient numbers to separately analyse those women who reported an irregular cycle at the intake interview.
19 The concept of ‗dose‘ here refers only to the number of treatments. It is a far more complex factor than this, for example see White, A., M. Cummings, et al. (2008). "Defining an adequate dose of acupuncture using a neurophysiological approach - a narrative review of the literature." Acupunct Med 26: 111 - 120.
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Time to conception Although a small sample of women became pregnant during the intervention, those in the acupuncture group did so twice as quickly. Although, due to the small numbers involved this did not emerge as a statistically significant outcome (adjusted p value = 0.452) this finding supports the contribution of this acupuncture protocol to facilitating normal reproductive functioning that then allows a natural pregnancy to occur or for an ART intervention to be more successful. This finding is confirmed by the follow-up information that 7 women (in addition to those who fell pregnant during the intervention period) on concluding their acupuncture treatments fell pregnant within the next or subsequent cycle or sought assistance from ART and were quickly pregnant. At 12 month follow-up, the differences between groups were evident but not statistically significant (p value =0.552). Two of the women in the lifestyle-only intervention arranged to have acupuncture privately (after the study conclusion) and became pregnant after 3 months of treatment.
BBT charting Basal body temperature (BBT) has been refined by Chinese medical practitioners at the same time that it has lost favour in Western biomedicine. The BBT chart has become a tool that reveals to TCM specialists so much more information than it does to a Western specialist. For most specialists in the West, reliance on laboratory results far supersedes reliance on information gathered by the patient and the doctor purely by careful observation (Lyttleton 2004:48). BBT was chosen here as one of the measures of menstrual cyclicity because of its usefulness to the Chinese medical practitioner and its value in engaging the women who were participants in monitoring their bodily changes. It is, however, not entirely useless as a means to assist conception as an earlier study found after 3 different physicians examined 172 BBT charts to assess their accuracy as an index of ovulation: The average true positive rate was 90%, the false negative rate was only 2%. The remaining graphs (8%) were classified as non-interpretable, probably reflecting measurement problems. Retrospective assessment of 210 biphasic records showed the thermal nadir to occur within 1 day of the urinary luteinizing hormone (LH) surge in 75% of the cases, and in 90% when 2 days where considered. This confirms BBT as a relatively accurate guide for retrospective identification of the periovulatory period (Martinez, van Hooff et al. 1992:121).
The BBT charts were very helpful in providing information such as the degree of temperature rise at ovulation, length of follicular and luteal phases, and made it possible for this acupuncture protocol to be tested against precise indicators. The problem again was adherence and self-
[156] reporting of data. To start each day with a thermometer can become onerous and can serve as a constant reminder of the presence of fertility problems in one‘s life. There is a potential measurement bias here although in this case such a bias would occur across the two groups. Alternatively, BBT can be embraced as a welcome tool to enhance the chance of conception (discussed further in Chapter 6). For the researcher one issue has been the inconsistency of the BBT charts and the difficulty of collecting data from them. A number of examples of the charts collected in this study are attached as [Appendix 18]. Included is an example that is fully completed and the data is easy to collect. Also included are examples where data is scarce and incomplete. Perhaps varying acceptance of the BBT instrument resulted in variable precision in recording which made it difficult to retrieve data that was replicable across all participants.
MYMOP The MYMOP questionnaire results indicated what the ‗Experience of acupuncture‘ questionnaire confirmed – this course of acupuncture improves wellbeing. There is an extended discussion of this phenomenon in Chapter 6. In relation to nominated symptoms 1 and 2 (which predominantly concerned tiredness and weight control), both groups indicated an improvement which points to the lifestyle modification protocol as being effective for these symptoms. The improvement in the ‗activity‘ score by those receiving acupuncture confirms the literature‘s suggestion that consistently supported lifestyle change is more successful than change attempted alone or with minimal support. This is not to exclude the possibility that acupuncture treatment itself contributed to this change. There is significant evidence that acupuncture increases relaxation (an activity nominated by several women) and it is logical to associate increased feelings of wellbeing with the ability to motivate oneself to undertake a desired activity.
The nature of the nominated symptoms/activities in themselves is informative of the situation of this cohort of women and has been used to shed some light on their central concerns. It is these concerns and their meaning for these women that may inform future research and service delivery to other women experiencing fertility problems and looking for assistance in the lead up to conception. In addition, all participants who received the acupuncture intervention were asked to complete an ‗Experience of Acupuncture‘ questionnaire, and a number were asked to complete an interview designed to explore this experience further. Embedded within this research is another question of what is quality acupuncture and how can it be assessed within a research context? The questionnaire responses and interviews contribute to the discussion of quality assessment.
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BMI The only change in BMI occurred in the lifestyle-only group and was not statistically significant. Perhaps the women who were not receiving the acupuncture intervention applied themselves more rigorously because that was their only intervention although this seems unlikely when assessed against the MYMOP activity measure. As the literature indicates BMI is an insufficient measure of the value of lifestyle modification and more personalised assessments would have been useful here.
Lifestyle modification The value of the lifestyle-only intervention itself is difficult to assess.
Using lifestyle modification as an intervention with trials of women to improve their reproductive performance is not straightforward. The women randomised to lifestyle-only withdrew from the study at a higher rate than those in the acupuncture intervention arm. This imbalance in adherence was also evident in submitting of data at defined times. This may be a result of choosing a lifestyle modification comparator: in one trial (Tsarageli, Noakes et al. 2006), there was a 40% attrition rate and other trials have reported similar difficulty retaining participants. The loss to follow-up of approximately 28% of the lifestyle-only group is less than the attrition rate in these other trials.
The drop-out rate is perhaps best considered a reflection of resistance to modifying lifestyle behaviours in this group rather than a specific intolerance to the intervention selected (Lim, Noakes et al. 2007). This is an unusual assertion as clinical experience indicates that willingness to ‗do whatever it takes‘ (rather than resist change) is an important characteristic of this patient population. A systematic review of diet and exercise interventions for weight loss in the general population, combined with a phenomenological observational study (Perry, Hickson et al. 2011), found that key features of all successful programs, and not of the unsuccessful programs, included frequent weekly follow ups, compulsory supervised exercise and intense dietary counselling and exercise regimens. The participants interviewed in one dietician-led program valued regular appointments, realistic targets, recognising responsibility, positive attitude and support from others and the dietician. A key inhibiting factor was difficulty with exercise. The capacity of participants to sustain a weight management intervention outside the supervised program was questioned. A survey of women within a weight control clinic situated in a fertility facility found that insight into the psychosocial aspects of weight management was crucial for optimal management of individual weight targets (Potdar, Sihra et al. 2011).
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The CSIRO Wellbeing Diet was chosen for this study because it was evidence-based through tests in Australia. It included a 3 month recommended diet with exercise and was accessibly packaged. Several participants did, however, report difficulty with the diet: two were vegetarian and found the non-meat recommendations very inadequate, the food choices and preparation methods were not attractive to Asian-background participants and several participants reported that the recipes were too expensive for their budgets. Very few participants reported 100% adherence and two who did mentioned that they had in fact gained weight on the diet, although not dramatically.
There has been criticism of the CSIRO diet (Stanton and Crowe 2006; Russell 2009) with reference to possible adverse cardio-vascular consequences of such a high protein intake. However, after 12 month follow-up of a 3 month high protein versus high carbohydrate diet researchers reported a positive correlation between high protein and weight loss and changes in HDL cholesterol were greater in the high protein group (Clifton, Keogh et al. 2008:27). Generally, overall cardiovascular markers improved in both groups. Of interest is that after 12 months participants in the two groups who were requested to maintain their 3 month diet intervention had converged to have a similar dietary intake.
Experience of acupuncture The information gathered from the post-intervention questionnaire on participants‘ experiences of acupuncture indicated a positive response to the intervention and successfully identified aspects of the experience which emerged through the interviews with some of the cohort (reported in Chapter 6). The questionnaire itself was easy to administer, was easy to understand and respondents raised no concerns when completing it. The mix of multiple choice and open comment both gathered specific data and also allowed respondents the opportunity to comment freely.
These comments record a positive response to the acupuncture intervention which would be difficult to capture using quantitative methods alone, the latter require measurable outcomes and are usually framed to be precise rather than open-ended. A recent review (Barlow, Scott et al. 2011) of reports of participants‘ experiences of acupuncture indicates that those having ‗real‘ acupuncture (in a clinic) reported a more positive response than those in sham-controlled trials. The latter felt that they might be seen as foolish for having a positive response when they might have been receiving the placebo. This supports the choice of pragmatic trials to test effectiveness and the inclusion of qualitative measures to elicit more informative data.
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The study participants did not directly challenge the acceptability of the treatment. Adherence to the diet and lifestyle intervention was not comprehensive although no participants directly rejected it as inappropriate or as having adverse effects. Only one participant withdrew from the acupuncture intervention, reporting it as too difficult to meet the attendance requirements as she lived and worked at a distance from where the treatment was offered and she did not drive. No participants reported the acupuncture intervention as unacceptable.
Trial participants With regard to the representativeness of the trial population the major data available for comparison is from the data of women using ART services in 2009 (Wang, Macaldowie et al. 2011). The age distribution in this trial sample was different from those using ART services. The average age of women having autologous cycles increased from 35.3 years in 2005 to 35.8 years in 2009 (Wang, Macaldowie et al. 2011:42). The proportion of women under 30 years was not equivalent: 10.9% of the ART group and 19.6% of the study sample, and the number of women over 40 years also varied significantly - 23.8% of the ART users and 8.9% of the study sample. The proportion of the age group between 30 to 39 years was similar in both groups. Although the average age was roughly only two years apart the distribution of ages is younger in the study sample. The participants in a South Australian acupuncture in ART trial (Coyle and Smith 2005; Smith, Coyle et al. 2006) may be more comparable although more than 58% reported the reasons for infertility were male factors and tubal factors, both specifically excluded from this study. The average age in the South Australian (SA) trial was 35.7 (SD 4.8) compared to 33.54 years (SD 5.145) in this study. In a study of the psychosocial impact of acupuncture for women with fertility problems (Smith, Ussher et al. 2011) also undertaken in Western Sydney, the participants were slightly higher in age (34.6) while their average BMI at 23.65 was significantly lower than this cohort at 30. Despite being enrolled in IVF, these women reported only 12.5% fertility problems caused by male factor, 31.3% female factor (compared to 31.05% in this study), 35.9% unexplained (compared to 31.05% in this study) and 21.75 uninvestigated (compared to 12.5% in this study).
It is difficult to compare the study and ART populations on causes of infertility as major categories included by Wang and colleagues (2011) were deliberately excluded from the trial population; that is, male factor, tubal disease and combined male and female factors. In the ART population 27.6% causes for infertility were unexplained whereas 41% of the study population were in this position. This could be explained by the more rigorous diagnostic testing in ART to identify causes compared to this study was accepted the diagnosis brought to the
[160] study by the participant who had often not yet received a full ART diagnostic workup. Also the ART analysis and the SA trial collected specific data on the presence of endometriosis (5.2% in ART, 24.4% in the SA study, compared to 14.3% in the study) but not on PCOS which became apparent as a dominant diagnosis (37.5%) in the study group.
According to the Cancer Council of Victoria20 people with a BMI more than 30 kg/m2 means you're obese. The average BMI for Australian women is 26kg/m2 … which means the average Australian is overweight. This indicates that the study group had a higher BMI of 30.12 (SD 8.6) than the average Australian woman and higher than the women in the South Australian study 25.7 (SD5.3)(Coyle and Smith 2005). Details of expected age against BMI is not available although Adamson, Brown and colleagues (2007) found younger women (18-23 years) have a lower BMI than middle-aged women (45-50 years). However, when these young women are followed up over a 10 year period (bringing them into the age group equivalent to the study population) it is found that they are likely to gain weight at a greater rate than other age groups of women. The report of the longitudinal study on Australian women‘s health states that data demonstrates the relationship between overweight and obesity and poorer mental and physical health and higher health care costs (Adamson, Brown et al. 2007:14).
Comparing the study population with generalised census data for Western Sydney21 there are some differences apparent: 30.1% of Western Sydney population is of non-English speaking background (NESB) whereas the study population was 41.1% NESB. In Western Sydney 62.8% are in full-time work compared to 57.1% of the study participants. Compared to a population seeking fertility outcomes, for example in the SA study (Coyle and Smith 2005) 97.8% were Caucasian (and therefore it is assumed not of NESB) and 83.9% employed (assumed full-time).
Because there is no directly comparable population it is difficult to conclude that the study population is equivalent to the general female population seeking solutions to their fertility difficulties.
Recruitment Full recruitment within 12 months was the expected outcome and was achieved. Approximately three women were approached in order to recruit one. Women with difficulty conceiving are not accessible through one place or mechanism and this study shows that they are socio- economically diverse, and diverse in terms of age and ethnicity.
20 Accessed in February 2012 http://www.cancervic.org.au/preventing-cancer/weight/bmi 21 Derived from Western Sydney Region of Councils website at http://profile.id.com.au/Default.aspx?id=303&pg=103&gid=10&type=enum and based on 2006 census data from ABS.
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The reasons for women not agreeing to participate in the study varied. Most women who met the inclusion criteria agreed to participate. Of the total women contacted, 29 (18%) declined participation although they met the inclusion criteria. Several did so because there was not a participating acupuncturist close to their home or workplace, a small number reported that their male partners were unwilling to undertake a sperm analysis, and a further few considered the possibility of a diet and exercise program unwelcome. None was unwilling to accept acupuncture although this may have been a result of all the advertising material mentioning acupuncture and they self-selected, not finding the idea of acupuncture unacceptable.
Recruitment is acknowledged as one of the most difficult components of a clinical trial (Cambron 2001; Smith and Coyle 2006; Pastore and Dalal 2009). Poor recruitment may result in a variety of undesirable consequences, such as, Type II error, whereby researchers conclude no difference between groups which in fact differ (Stuardi, Cox et al. 2011:329). Successful recruitment strategies appear to vary and may do so according to geography, type of condition being researched, socio-economic status, ethnicity (and implicit within this is, language spoken) and country in which recruitment is occurring (Pastore and Dalal 2009). In Australia there are no methods of recruitment similar to that offered by the National Health Service (NHS) in the UK where participants can be accessed through data bases held in medical facilities. This recruitment method is, however, being explored in the US through searches of electronic medical records to identify candidates for recruitment (Stuardi, Cox et al. 2011). For CAM in particular, because of its lack of integration in the public health care system and its relatively marginalised status, recruitment for clinical trials is more complex. In this trial, finding the women to ‗make the pitch to‘ was most difficult.
Compared to the reports of other CAM trials (Hondras, Long et al. 2008; Cambron, Dexheimer et al. 2010) the recruitment process in this trial appears to have cost less in both time and money. Hondras et al (2008), reporting the recruitment process of 2 simultaneous clinical trials, found that after screening 3789 subjects over the telephone, 432 (11%) were enrolled at a cost in excess of US$156 000 for recruitment alone. For Cambron et al (2010) of the 1211 telephone calls taken, 60 responders (5.0%) were randomised into the study at a total direct cost for recruitment of US$40,740 or US$679 per randomised patient. These trials were both of chiropractic treatment on subjects with low back pain, a quite different population to women with difficulties conceiving. Yet chiropractic care has a high level of community acceptance compared to acupuncture. One important issue raised by these researchers was that: many self- identified participants are users of the CAM therapy; this is another important consideration and strategies for targeting nonusers should be developed early (Hondras, Long et al. 2008:992). This trial recruited 35%
[162] of those who made contact as potential participants for less than $2000 for the cost of advertisements in newspapers and on Facebook. Although at some stages the time taken appeared frustratingly long, full recruitment was achieved within 12 months of commencement.
This trial did not record at first contact whether the respondent was acupuncture naïve; however, of the recruited participants, 44.6% reported previous experience of acupuncture. When recruiting it is important to identify to potential participants which intervention is planned and perhaps unrealistic to expect those responding to recruitment strategies to offer to participate when they are innocent of the intervention, particularly those interventions that are ‗unconventional‘ therapies. It is more realistic to expect that people will put themselves forward for CAM trials if they have a chance to access CAM therapies ‗for free‘, as reported by Schneider, Vuckovic et al. (2003) to be a positive feature of CAM trials. Pastore and Dalal (2009) support this finding that ‗try for free‘ is a motivation for participation in CAM trials and they also report that asking potential recruits to stop a health routine they already use is an unpopular request. The decision in this pragmatic trial to include all other treatments (except acupuncture or Chinese herbal medicine) may have assisted both recruitment and retention of participants.
The question of whether recruitment strategies and actual sources of recruitment have unnecessarily distorted the recruited sample is difficult to ascertain. The women recruited were socio-economically diverse [see Table 5.3]. Their primary bias was a preparedness to try acupuncture for their difficulties conceiving. This fact may account for attrition and the difficulty encountered retaining participants in the lifestyle-only intervention. Interest in acupuncture was certainly a driver for recruitment and most recruits reported a positive attitude from themselves, their families and peers. In fact, many had been urged to contact the research centre by their peers. Another issue that is not addressed (and may be unmeasurable) is the degree to which the compliance of participants was due to their wanting not to cause problems for the student who needed the study results for her degree (Grypdonck 2006:1376).
Randomisation The randomisation technique in this study resulted in minimal selection bias and the imbalances in relation to mean age, duration of fertility and a biomedical diagnosis of PCOS were adjusted for in statistical analysis.
Expectancy Where randomisation failed to address inequality between the groups was in relation to the expectations participants brought to the study. Randomly allocating recruits to an acupuncture or
[163] lifestyle-only group proved ineffective in controlling for the expectation that acupuncture would be valuable in assisting fertility. Thus, receiving the ‗control‘ allocation dashed participants‘ hopes, sometimes quite visibly. One woman, for example, wept and said nothing was going well for her at that time in her life. The lifestyle-only intervention was not deemed equivalent by the women recruited. They welcomed the advice and resources given but felt let down by not receiving acupuncture. Although all were encouraged to continue their standard care they were asked not to seek out acupuncture treatment during their participation. The issue of expectancy has been examined quite recently in a meta-analysis of acupuncture trials (Colagiuri and Smith 2012) in relation to comparing verum and placebo acupuncture. It does appear that expectations of acupuncture as a beneficial treatment compared to lifestyle modification alone influenced participants to remain within the trial process. The extent that it influences outcomes is unclear. It does reinforce the pragmatic, that is, like actual clinical practice, nature of this trial where patients arrive at clinic with an expectation of benefit. Perhaps a third observational cohort arm of ‗treatment as usual‘ would have had important additional benefits as described in Relton, Torgerson et al. (2010:965). Or the introduction of a measure to assess the impact of expectation on the participant would have clarified this factor further.
Methodology As discussed in Chapter 1, women with fertility difficulties (similar to those recruited for this study) are seeking assistance from a range of CAM therapies and are frequent visitors to acupuncture clinics. The pragmatic design meant that the protocol delivered in the study most simulated contemporary acupuncture practice. As is found in clinical practice the manualised protocol approach allowed acupuncture treatments to be flexibly adjusted to the presenting situation of the participant at the time of treatment.
Aspects of this trial display both strengths and weaknesses for the same factor. A clear example is offered by the engagement of the acupuncturist practitioners as both advocates and deliverers of the intervention to participants. The strength of this approach is that it truly reflects the nature of acupuncture practice where practitioners actively use their enthusiasm for their medicine (based on their education, experience and available evidence) as a means to engage patient adherence and commitment to their own healing. It is rare to meet an acupuncturist who is not excited by the possibilities of their therapy and there is both discussion and evidence (McManus, Kaptchuk et al. 2007; Liu 2008; Paterson, Zheng et al. 2008; Hill 2009) that research that tries to modify this enthusiasm diminishes the outcome of the intervention. This researcher has no doubt that the acupuncturists who delivered the trial protocol were sufficiently conscious of the importance of providing ‗good‘ acupuncture to bring their full attention and commitment
[164] to the task in order for acupuncture to be assessed positively. It is critical to acknowledge that this is not a trial of ‗acupuncture‘ per se, but of an acupuncture protocol delivered in this manner. It could be argued that this is the study‘s major weakness – recruits who brought high expectations of acupuncture meshed with acupuncturists who expected high performance and outcomes from themselves and the trial participants. This is a buoyant mix of positivity absent from more ‗laboratory-compliant‘ clinical trials of acupuncture as an intervention, although it could be argued that even these studies contain an inevitable expectation bias because of the difficulty in blinding or masking acupuncture. Imaginably, hidden administration of acupuncture, if ethically possible, can by no means be associated with a therapeutic procedure (Liu 2008:186). This issue is discussed further in Chapter 6.
Although no differences were apparent in the ways in which participating acupuncturists approached the study, an appropriate response to the potential problem arising from the approaches of the different acupuncturists to the conduct of the intervention may have been to institute meetings with them. McManus, Kaptchuk et al (2007) concluded, after interviewing acupuncturists in a trial that used placebo needling, that training, careful monitoring and ongoing supervision of the acupuncturists was required to maintain high quality control. Another trial that used both sham and verum acupuncture, however, found that the acupuncturists interviewed had no difficulty complying with the standardised protocol used (Thompson, Jenkins et al. 2012). A research approach that monitors acupuncturists closely may be less necessary in a pragmatic trial such as this one. However, a mechanism such as reviewing the treatment records during the intervention may have been helpful rather than at the end of the trial.
The risk of bias – in fact, of a variety of biases – was high in this study. Attrition from the lifestyle-only comparator was higher than the acupuncture group, and data collected from this group less complete, resulting in the size of the two groups not being equivalent when outcomes were assessed.
Measures that rely on self-report tend also to be unreliable particularly when self-report relies on recall rather than documentation. An example of possible error that stems from this source is the disparity in the measures of menstrual details at entry interview (Mentry) and first period in the research process (M1) and, similarly, the report of menses at exit (Mexit) and last cycle within the research period (M3). These measures should be very similar, as they are roughly coterminous and no objective criteria were offered at different times to define flow, colour or
[165] other details. For example, 39.3% and 42.9% of women in each group reported a heavy menstrual flow at the initial interview (Mentry) and only 44% and 12.5% at M1. It is difficult to understand why such a high proportion of women in the lifestyle-only group had a change in their menstrual flow in what should have been a short time interlude. This may have been a random fluctuation or due to an unlikely explanation, such as only women with heavy periods withdrew from the study. Similar inconsistencies of data at these time periods also exist in relation to length of period and length of cycle.
Future Research Directions
Estimating the treatment effect in this study was difficult due to small numbers in the sample and the study being underpowered. Calculated against the measure that meant most to the participants – pregnancy – the power of the study was 3%. Analysing post study pregnancy rates the achieved power was 33% (calculated on the G*Power program). Several effects were evident in the study – specifically in awareness, wellbeing, capacity to undertake desired activity and time to conception. Changes in menstrual indicators were not significant, however, this may have resulted both from poor record keeping and reporting by participants and an inadequate dose of acupuncture that did not cover at least 3 menstrual cycles. This also may have been influenced by the high proportion of women with PCOS.
A more fully powered study is justified on the basis of results, including trends and indications, displayed by this underpowered feasibility study. On the measure of pregnancy a fully powered study would require a sample size of 189 (calculated on the dropout rate of 12.5% in this study added to 168 participants to achieve full power)(G*Power). The clear benefits to the women involved of increased awareness of their fertility, their improved sense of wellbeing and being able to engage in desired activities - may flow on to improved fertility outcomes. There are trends that indicate this may be the case: reduced time to conception, reduced incidence of menstrual clotting, reduced length of pain and intensity of pain, normalisation of the length of the menstrual cycle and the increased heaviness of menstrual flow in the acupuncture intervention participants.
The issue of dose in relation to the number of acupuncture treatments emerged as an important factor and an influence on the likely effect of the intervention. Nine weekly treatments are sufficient to influence, for instance, wellbeing, but perhaps are insufficient to change deep-seated physiological symptoms such as delayed ovulation or shortened luteal phase. Attention should
[166] also be given to the timing of treatments in relation to reproductive events – for example, in anovulatory women, timing a treatment to coincide with possible ovulation and, where there are few symptoms connected to the menses, avoiding treatment during the period.
Future research should build in an evaluation of both the recipients‘ expectations and subsequent experience of acupuncture and a similar evaluation of the participating acupuncturists‘ perspectives prior to and following the administration of the trial protocol. This approach to evaluating expectancy needs to be approached carefully as, the influence of asking patients to report their expectancies and both when and how expectancies should be assessed need to be addressed empirically in order to determine the most appropriate method of assessing expectancies (Colagiuri and Smith 2012:10).
The progress of ‗smartphone‘ technology has moved so quickly that now it would be possible to connect with study participants electronically, collect data daily and instantly plot it within a software program. There are over 20 different fertility monitoring systems for smart phones or other hand held devices, and researchers are building an online version that can be networked and accessible to physicians or researchers (Polyak, Ahamed et al. 2011). There are obvious limitations to this approach, as it requires all participants to be ‗connected‘ and at ease with this technology but its strengths would be in the ease of data collection.
A further study could examine the value of an acupuncture intervention such as this one as a preliminary preparation for ART. Although few participants were IVF patients those who were during the trial or immediately following the trial had improved outcomes. The value of attaching a research project to an ART clinic is that access to biomedical diagnostic and outcome measures is greater and follow-up can compare both fertility outcomes and also differences in the experience of the ART intervention itself.
The inclusion of biomarkers such as blood measures to assess stress levels and time of ovulation would have greatly enhanced the quantitative assessment of the intervention.
Conclusion The multiphasic fertility acupuncture protocol tested in this trial did positively influence the women who received it compared to the women who used lifestyle modification alone. It increased their fertility awareness and improved their wellbeing. Those who conceived they did so in half the time of their lifestyle-only peers.
The following Chapter 6 details the results of the interviews done with some of the women who received the acupuncture intervention and explores what we can learn from their experiences.
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Chapter 6 Experiences of acupuncture
The task of scholarship is ―investigating things and extending knowledge (gezhi)‖.
- Song dynasty philosopher Zhu Xi quoted by Benjamin Elman22
A mixed methods research methodology was adopted in this study to explore the ‗simultaneity of unity and multiplicity‘23 – trying to catch the simple causal action of inserting acupuncture needles into someone and the actual complexity of that therapeutic engagement and its outcomes. This chapter builds on findings that emerged from the clinical trial presented and discussed in Chapter 5. The report of the trial identified measurable outcomes that achieved statistical significance (or not) between the two treatment groups. The stories of the women who received the acupuncture intervention contribute another rich dimension to this research. A thematic analysis of their views has prompted theoretical explorations of the practice of acupuncture – what is happening in these therapeutic exchanges and how can these ‗doings‘ be understood beyond the Chinese medical frameworks that guide them?
In-depth Interviews Twenty-seven women received acupuncture within this study, 12 of them from acupuncturists other than the author. It was considered that the knowledge the researcher had of the 15 women she had previously treated would influence the direction and content of the interviews– and thus distort them - so those women were excluded from the follow-up in-depth interview24. Of the 12 eligible trial subjects who were asked to do an extended interview on their experience of receiving acupuncture, 1 declined as she was travelling overseas, 1 agreed to answer the questions in writing due to her busy schedule, and 10 undertook a recorded in-depth interview.
The questions in these interviews were semi-structured by a notional script although inevitably open-ended, as outlined in Appendix 19. The purpose of the questions was to elicit what these women experienced and understood about receiving acupuncture. The researcher‘s approach was to be a compassionate as well as inquiring presence for each participant as she shared her understanding and interpretation of the meaning of her experience. The locations of the
22 ―The formation of evidential scholarship and the return to antiquity in medicine reinforced each other.‖ Elman, B. (2005). On Their Own Terms: Science in China, 1550-1900 Harvard University Press. 23 Wu, Y.-L. (2010). Reproducing Women: Medicine, metaphor and childbirth in Late Imperial China. Berkeley, University of California Press. 24 This issue is a classic contradiction within a mixed methods approach. ‗Subjectivity‘ is considered a confounding factor in quantitative research and a strength in qualitative methods. The dominance of the ‗quant‘ perspective in this research process meant that the layered knowledge accumulated by the treating researcher was considered unacceptable. This is further discussed in the concluding chapter.
[168] interviews varied from the home of the participant, public places such as cafes, and interview rooms within the University of Western Sydney.
The recorded interviews were transcribed verbatim, and the transcriptions analysed according to sought themes and emergent themes and commonalities across interviewees. The questions asked by the researcher in the interviews followed anticipated sought themes, such as, the embodied experience of receiving acupuncture and the aspect of the therapeutic intervention which mattered most or least to the participant. Emerging themes were allowed for by open- ended questions and by following up any new issues raised in the interviews. The initial analysis grounded theory approach involved repeated readings of each transcript and the recording of initial observations and preliminary interpretations. The second stage involved the identification of sought and emerging themes for each participant. These themes were coded with key words or phrases that reflected the meaning of the individual‘s accounts, and then grouped across interviewees. An approach similar to that used by Cartwright and Torr (2005:228) was adopted to ensure that each transcript underwent the same analytic process, yielding a list of master themes and extracts. A second reader (Dr Alphia Possamai-Inesedy) read both the transcribed interviews and the draft thematic analysis, and then commented on additional themes she identified. This cross-checking added to the validity of the analysis.
Extended interview Results Conducting and then reading and re-reading the interviews allowed issues and themes to emerge from the data and move in and out of the foreground. The women are introduced below:
Pseudonym Demographics Personal
Annabelle (AW) Mixed ethnicity predominantly Trying to conceive for 2 years. Young married woman living Egyptian, 22 year old, works with husband, mother and grandmother. Her grandmother fulltime in retail industry died during the trial. Little tertiary education. Diagnosed with PCOS. Periodic use of unprescribed Clomid purchased on Internet. Long history of frequent migraines. Major concern is her weight.
Andrea (AM) Polynesian, 36 year old, fulltime Trying to conceive for 10 years. Unexplained infertility clerical worker although evidence of PCOS. Failure of 1st marriage because of infertility. Recent 2nd marriage. Raises adopted daughter. Travels long distances to work. Depression and poor self- esteem apparent on first meeting.
Elaine (EA) Anglo-Australian, 26 year old, Trying to conceive for 2 years, never pregnant and diagnosed with mild PCOS. Responsible position in NGO.
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works fulltime in charity Works hard. Expected that being socially responsible and ‗good‘ would be rewarded by life ‗going to plan‘. Dismayed by failure to conceive.
Felicity (FT) Anglo-Australian, 39 year old, Trying to conceive for 3 ½ years with 3 miscarriages. works fulltime in finance industry. Unexplained infertility. Has one child. Using IVF and has had 6 stimulated cycles. Raises a step-child having a difficult adolescence. Nominated stress as a major concern. She successfully conceived and sustained pregnancy within the intervention.
Julie (JW) Chinese, 34 year old, fulltime Trying to conceive for 4 years. Diagnosed with ‗extensive‘ accountant endometriosis. Has undertaken 3 IVF stimulated cycles and finds IVF medications have aggravated her stress and other symptoms. As a migrant has little family support.
Karin (KZ) Russian, 42 year old, fulltime Unexplained infertility, trying to conceive for 3 years. student Postgraduate research was in chaos causing extra stress. Started IVF which she experienced as very stressful toward completion of intervention.
Linda (LR) Anglo-Australian, 39 year old, Diagnosed with PCOS and endometriosis. Non-insulin fulltime manager dependent diabetic with strong chocolate habit. Trying to conceive for 10 years. Works very hard in responsible position. Emerging from a difficult separation with ex- husband and in new relationship. Mother suffering from serious illness. Nominates stress as a major concern
Mandy (MB) Asian, 38 year old, parttime Trying to conceive for 4 years. Diagnosed with ―high natural shiftworker in airline industry killer cells in cervix‖. Has had 1 miscarriage. Has high stress levels and has used counselling to improve emotional well- being in past. Husband resists changing lifestyle to maximise fertility eg. wearing tight underclothes and poor diet.
Nicki (NH) Polish-Australian, 35 year old, Trying to conceive for 2 years. Cause of infertility fulltime designer in advertising unknown. Mother of 8 year old. Father dying of disabling illness and requiring much support. Tiredness and stress nominated as major concerns for her.
Rhoda (RW) Lebanese-Australian, 33 year old, Trying to conceive for 4 years. Diagnosed with PCOS with Fulltime responsible management insulin resistance following 18 months taking a weight loss position. medication when her periods stopped and she gained weight 5 years ago.
Teresa (TB) Anglo-Australian, 41 year old, Trying to conceive 2nd child for 6 years (after 10 years trying fulltime home duties for 1st). Diagnosed with PCOS. History of cancer. One child diagnosed with Asperger‘s syndrome who requires much attention. Excess weight and depression are
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nominated concerns. Had severe back pain which improved with the acupuncture intervention.
These snapshots of the women interviewed at length show that they are diverse – in their ethnicity, their ages, their life circumstances, their biomedical diagnoses, even their experience of their fertility problems. Yet their responses to the acupuncture intervention were similar in theme and tone.
Is there a core category around which the thematic analysis can be grouped? For the interviewer the core question was, ‗What does acupuncture do to/for a woman seeking fertility?‘ This question has layers: What is her experience of ‗receiving‘ acupuncture? What does acupuncture change for this woman in terms of her fertility, her experience of herself and her body? How does she understand acupuncture when she, unlike the acupuncturist, has no explanatory theory? By practising acupuncture, what are we offering people and these women in particular?
In the literature, most discussions and explorations of the experience of acupuncture have a quite specific focus, for example, naming the precise physical sensation when needles are inserted, manipulated and retained (Kim, Park et al. 2008). Other research has focused on establishing the strength of blinding when sham acupuncture was used (Conboy, Quilty et al. 2008) and on the experience of placebo within a sham acupuncture trial (Kaptchuk, Shaw et al. 2009). Research similar to this study has focused on hearing the patient narratives about having acupuncture or their experiences after acupuncture (Rutberg and O¨ hrling 2009), on differing experiences of different practices of acupuncture and holism as a unifying concept (Paterson and Britten 2008), on the unanticipated or nonspecific effects of an acupuncture intervention (Hsu, BlueSpruce et al. 2010), and on identifying a range of health changes that are not picked up by commonly used outcome measures (Alraek and Malterud 2009). The most detailed discussion of patient experience (and it was of acupuncture placebo only) concluded that: Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo—e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment—provides an inadequate model to explain its salubrious benefits (Kaptchuk, Shaw et al. 2009:383). Kaptchuk and his colleagues (who had diverse training) found it difficult to find a ‗cut‘ or angle into these interviews of people‘s experiences that did not involve leaving an immense amount
[171] out. Representations and summaries inevitably edit and make partial a whole story. The same could be said of researchers‘ current capacity to understand people‘s experience of acupuncture.
As in any communication, the recorded interviews were layered and complex. There may have been other pathways to access the same information, such as recording actual therapeutic encounters, but it is generally agreed that …talking is an act that is socially effective [and] the interactive dimensions of social discourse – how a person presents and evaluates his/her own experience and how he/she is interpreted, understood and responded to… offers a practical and useful way for understanding local experience… (Zhang 2007). In terms of experiential data, there is no alternative to listening to the voices of the women with the experience. Writing the themes will be inevitably linear, compared with the richness of listening, so the reader needs to be aware of the interconnections between themes while reading in linear mode.
The themes that emerged from the interview data in this study are consistent with other research studies (reported above) of people‘s experience of acupuncture, but with an additional level of complexity resulting from the implications of living with fertility problems. The following themes were identified in the transcribed interviews: imagination, perceived effects, holism and cyclicity, relaxation, trust, symptom relief, therapeutic relationship, narratives, energy, transformation, sense of responsibility, emotional change, embodiment, being seen and touched, reconceptualisation, self-identity. Please note that these themes are randomly presented - listed here in no particular order although as detailed below linkages and groupings do emerge.
These topics that arose from the interviews could be viewed as sub-themes that exist in loose relationship to each other as expressed in the following diagram [Figure 6.1] The diagram draws links, sometimes causal, sometimes interactive, between the sub-themes that emerged from interview discussions.
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Therapeutic relationship
Narratives Trust
Perceived effects Imagination Being seen & touched
Holism & Physical changes cycliciity Relaxation
Emotional change Embodiment
Energy
Reconceptualisation
Sense of responsibility
Self-identity
Transformation
Figure 6.1 Representation of relationships between themes that emerged from interviews
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There is evidence of overriding themes that emerge from this complexity. Although not causal linkages these issues or sub-themes do speak to three consistent messages: There is a pattern that indicates that it is the embodied physical and responsive nature of acupuncture that engages the patient in a therapeutic process. Another theme is that the therapeutic alliance developed in acupuncture is unique. A third theme is that the transformative changes in response to acupuncture are multi-faceted and complex.
1. Embodied physical and responsive nature of acupuncture
It has been argued that alternative and complementary practices attract clientele because they promote ‗recognition of the authentic self‘ or subjectivity of the client (Sointu 2006) in contrast to the biomedical engagement. There is evidence from the interviews with these acupuncture clients that the physicality of the consultation took the encounter further – recognising both their ‗selfhood‘ and how this is worked out and presented in their bodies.
1 (a) Acupuncture, physicality & touching When asked to nominate the ‗active ingredient‘ in the treatment, the respondents were adamant that the acupuncture was an/the agent for change – not the kindness of the acupuncturist, nor the time lying reflectively relaxed, or any other component of care. The ‗Experience of Acupuncture‘ questionnaire reported in Chapter 5, confirmed that aspects of care such as, a positive relationship with the practitioner, sharing of information, being listened to and being helped to make sense of your condition were all important to participants. The interviews, however, highlighted the importance of the actual needles:
Facilitator: So in terms of the session itself, it was the actual needles that you think did the job?
Yes.
Facilitator: Not, chatting to [acupuncturist] or...
No, chatting to [her]- like she gave me like information about like what was going on in my body, especially when I got that first period where like I was happy but I didn't know what exactly was going on and all that. I didn't know if it was a fake period or a real period or - so, yes, she was really good.
Facilitator: Yes. But the experience of the needles was the main thing?
Yes, that was cool. (Annabelle)
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Feeling the presence of needles in the body, and sometimes how they caused sensations when in situ, appeared to facilitate a positive regard for their effect.
Then the needles, it's a nice sensation, someone touching and finding the points. It's a pleasant feeling, unless a few times, it did hurt. It wasn't so bad. But most of the time it was very relaxing. (Nicki)
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It's like you feel there's something which is passing through your body. I think I tried to explain it to [acupuncturist]. So I don't know if it got across. It was just like something was just washing through your body and that's what I said to her…. sometimes it's like a wave of something passing through your body and it's just - it was something that I never experience which was quite amazing to me…. I think the needles added something more. (Andrea)
These women, and it was replicated by other participant‘s interviewed support Emad‘s (2004) identifying that, through the needles and the needle sensation (deqi), the acupuncturist engages with the ‗personhood of the body‘. Using ethnographic analysis of actual acupuncture consultations, she surmises a shift in the patient‘s understanding of the process of acupuncture through practitioners‘ ‗reframing‘ discourse but it also relies on an emergent body-consciousness, a way of being and feeling the body, that the patient did not have prior to acupuncture treatment (Emad 2004:167). The physicality of acupuncture draws the body more immediately into the transformative process and affects a more than cognitive engagement in the patient.
1 (b) Holism & Cyclicity Trial subjects reported that they were positively aware of having treatment that was varied according to changes reported, or evident on pulse and tongue diagnosis in each session, and in relation to time in the menstrual cycle.
[This approach to acupuncture] felt more organised, so more in tune with my cycle. Things were explained to me so I was understanding why certain points were being used….some consistency with some of the treatment in terms of some of the points that we use, but also variation, depending on how I was feeling and just an opportunity to really talk about that. Because each day and each week is not the same. (Linda)
This view is a further emphasis of Emad‘s point above that a ‗re-framing‘ is occurring in acupuncture that prompts a whole body experience. In this study the acupuncture was ‗manualised‘. The acupuncturists were given direction to choose acupuncture points hierarchically (see Chapter 5). The first priority was to choose points that addressed the patient‘s
[175] time in the menstrual cycle; secondly, their TCM diagnosis; next their biomedical condition, then their presenting symptoms. There was a clear privileging of one approach over another, and all acupuncturists involved in the study had the knowledge and skills to implement the approach.
Every time I‘d go in with a different concern - and of course the acupuncturist or whatever would ask where I was at this time [in the cycle] and what I was going through, and then they‘d sort of address where I was at that point. Which I found was really - I mean, obviously that‘s what they need to know, but yeah, I felt it was different. (Felicity)
Patient perspectives, captured as a result of acupuncture treatment, suggest the value of acupuncture as holistic care (Huang, Howie et al. 2012). This finding would seem to confirm Paterson & Britten‘s (2008) conclusion that a holistic approach – being seen as a whole person who manifests differently at different times – is a major strength of acupuncture therapy. In patient-centred care, the intention and needs of the patient are paramount. Our research suggests that holism – being treated as a whole person – is most important to patients with complex problems, especially where there is co- morbidity and emotional upset (Paterson and Britten 2008:275). Another study of ‗medically unexplained physical symptoms‘ found that patients receiving acupuncture valued the treatment for the amount of time allotted with a caring practitioner who listened and responded, as well as for the interactive and holistic nature of the sessions (Rugg, Paterson et al. 2011). The researchers report that this encouraged many patients to take an active role in their treatment. These participants interviewed here also reported a recruitment into their own bodily awareness. Gould and MacPherson (2001) described patients‘ experience of acupuncture as ‗holism-in-action‘, even when presenting to the acupuncturist with a ‗simple‘ physical problem..
1 (c) Embodiment
Chinese medical practices occur within the context of a discussion between patient-practitioner that foregrounds the task at hand – the qi is blocked and needs to be moved, dampness has accumulated and needs to be dispersed, the yang is weak and needs support, the blood is in need of nourishment – even if not transmitted in these terms to the patient, the intention is in the room via the acupuncturist‘s mind. By opening the opportunity for transformation, the acupuncture session creates the time and space for it to occur.
Because I have noticed the difference in the blood flow in my first period, right after the first three or four treatments. I did feel the difference in the quality, colour, shine-ness of the blood that came down.(Mandy)
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Attention to particular details at each interaction (however puzzling or embarrassing to the patient) builds layered multiple pictures of the working body. Participant Linda found examining the tongue each week the most puzzling aspect of each encounter. When informed by the acupuncturist of the value of this activity, Linda reflected on what the weekly review of her body meant to her:
I think the recapping of how I feel and what's been happening is really good, because for it, it serves as a bit of a benchmark as to how did I feel last week, what happened. It's a bit of a touching base of how my week's been, so it's good centring. (Linda)
Like these respondents many acupuncture patients report what they experience as a fundamental change in both their bodies and their state of mind/emotions during and following acupuncture. Although neuroscience recognises this inter(intra)-transforming interaction, it does not explain why acupuncture is a vehicle for transformative imagining. The body as organic substrate is actively present in an acupuncture session. It is carefully observed, touched and its pulses felt. When acupuncture points are located, the acupuncturist‘s hands feel for anatomical landmarks and perhaps other sensations that guide the location of a needle. The needles themselves are extremely ‗present‘ – the process of giving or receiving an acupuncture needle and feeling for the deqi sensation is acutely physical. Some report waves of sensation or spreading feelings when the acupuncture needle remains in situ for a period of time. One commentator who studied with the Yolmo Sherpa people of Nepal (Robert Desjarlais) described a similar sensation as ‗kinaesthetic attentiveness‘, being in the sensible present, rather than dwelling in the past or future. The importance of corporeal attentiveness is reflected in the way in which people feel themselves to be unwell through its absence (Rothfield 2008:226). This is in contrast to the common experience in the West of people only noticing their embodiment when it is faulty a common theme in reproductive health literature. Ivan Illich (1975) early identified the impact of medicalisation on our lives. Towards the end of his life he raised the issue again noting that the ability to live (and die) in an ‗unmanaged‘ way depends on the depth of one's embodiment. Medicalisation spelled dependence, not disembodiment. …Lives do not die; they break down… Medicalisation led people to see themselves as two legged bundles of diagnoses. It did not, however, disembody self perception; today, systems thinking does (1995). Self-perception was also examined by Emily Martin (2001) when she interviewed women in relation to their experiences of reproduction. She found that women represent themselves as fragmented – lacking a sense of autonomy in the world and feeling carried along by forces beyond their control (Martin 2001:194). One woman she interviewed reported that she ‗felt like her
[177] body had failed her‘ because she could not give birth in the manner she had planned (that is, without excessive medical intervention).
Perhaps receiving (and giving) acupuncture draws participants‘ awareness to their bodies and activates kinaesthetic attentiveness, which precipitates a bodily reordering or integration25. Action happens through our bodies which understand what to do: incarnate knowledge moves beyond speaking of the physicality of bodies, instead speaking within a body that is somatically perceptive (Moore and Kosut 2010:21).
Conceiving of the body as in process, that is, not static or fixed, is fundamental to Chinese medical theorising. It is also emerging as a strong theme in contemporary thinking about the body (Blackman 2008; Campbell, Meynell et al. 2009; Moore and Kosut 2010). Some would argue that it was feminists who reinserted the body back into European culture, and certainly feminists have been the main theorists writing in this field. They seek to engage the body not merely as the tool of the agent but the site of agency. It is a challenging perspective, elaborated predominantly by philosophers and sociologists. However, as Blackman (2008:126) points out, new biological and life sciences also disturb and disrupt the idea of a machine-like body, and identify processes that are, ‗fluid, plastic and subject to modification and change‘. The body is not a self- enclosed system, but rather is in-process, and it is at least partly enacted by the practices which perform or ‗do‘ the body differently26.
One qualitative study on acupuncture treatment (Alraek and Malterud 2009) indicated that there may be cross-culturally consistent patient experiences, across different conditions being treated. The Chinese medical approach to taking a history corresponds well with the experience of a ‗lived body‘, where the personalised descriptions of symptoms fit well into a Chinese medical theoretical framework. The framework becomes the basis of a diagnostic strategy, and it may also make the patient aware that the acupuncturist‘s focus is on ‗wholeness‘ rather than on one symptom only. Hence, patients are open to express health changes bodily and emotionally, along the treatment course and when asked…This information can help us in planning future acupuncture studies including patient- centered outcomes and thereby increase our knowledge of how acupuncture may affect the body and body– mind manifestations… (Alraek and Malterud 2009:156).
25 A discussion of ‗holism‘ below further extends this issue. 26 AnneMarie Mol & John Law have examined arteriosclerosis and hypoglycaemia through which different health care practices ‗do‘ the body differently.
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Women with entrenched PCOS which responded to acupuncture treatment were surprised that their body in particular had responded (Billhult and Stener-Victorin 2012). A disordered body such as one with PCOS is perhaps considered beyond reach of therapy (and is often represented as untreatable). Another study (Baarts and Pedersen 2009) of complementary and alternative medicine (CAM) use in Denmark identified this very issue of embodiment as the key driver for people to seek out and continue CAM treatments such as acupuncture. Thus, through body work (CAM treatments) and body talk (dialogue during CAM treatments), normal modes of bodily ‗disappearance‘ become disrupted. The clients‘ mode of bodily understanding is transformed from the tacit to the explicit. The body is indeed present (Baarts and Pedersen 2009:724). An increased and more reflective body awareness, and perhaps ‗self-mastery‘ or changed relationship to one‘s body, becomes foregrounded through the practice of acupuncture. The capacity for ‗self-healing‘, or the body as both a site and an agent for internal repair, becomes potent.
1 (d) Physical changes (Symptom relief) Many of the respondents reported physical changes that they were confident were a result of the acupuncture treatment. Some of these, such as the return of menses, were clearly connected to the treatment purpose and principles; others, such as headaches, were ancillary outcomes and may have resulted from the general systemic treatments or from the researcher‘s request for acupuncturists to address immediate pressing problems in their intervention. Chinese medical theory easily embraces the idea that the pattern that produces a headache, low back pain or abdominal bloating can also encompass menstrual irregularities and fertility problems. Participants reported the importance of having these immediate concerns included in treatments:
My neck and my lower back, … I was having a lot of pain. It felt good that I got some relief from it. I mean, it lasted well and truly after I left here. It lasted probably for a couple of days, but no, I look forward coming to the next one. (Teresa)
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I think it just makes me feel a lot calmer and it helped me out a lot with like headaches and all that. I hardly get them anymore ...(Annabelle)
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I felt clearer if that makes sense…I felt more positive. But I don't know whether that was a psychological thing - whether you know the trial had just started and I was quite excited…
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But I didn't get nearly as bloated the first time when I had my period and I thought that it was - and again it could be all psychological - but I just felt more relaxed. (Elaine)
Clinical trial outcome measures are specific to those changes that are expected or considered likely. Interviews such as these allow the perceived changes to emerge from participants‘ voicing of their experiences. The changes in their bodies are important measures of transformation and reinforce an expectation of continued change. Previous studies have found similar results where patients of traditional acupuncturists experienced benefits beyond the alleviation of their presenting condition, including improvements in physical/mental health, emotional well-being and changes in personal identity and lifestyle (Huang, Howie et al. 2011:19). There is a sense in which a physical manifestation of change confirms a response to acupuncture as ‗real‘. Patients too have been schooled in mind- body dualism recognising a physical change as more significant than an emotional one.
Gale (2011) refers to the concept of ‗body-talk‘ which she argues expresses the idea that the embodied patient is not a passive recipient of healthcare, but that the ‗body‘ is able to communicate its distress and its needs. Body work, as that undertaken by CAM modalities, she identifies as particularly able to respond to ‗body-talk‘ in both the diagnostic interview process and through treatment. She further identifies this as a direct challenge to mind/body dualism.
2. The therapeutic relationship is uniquely constructed in acupuncture
The therapeutic alliance or relationship has been the subject of much deliberation in the field of psychotherapy (Porter and Ketring 2011; Taber, Leibert et al. 2011; Arnd-Caddigan 2012; Del Re, Flückiger et al. 2012). The quality of the alliance has been shown to have a significant effect on therapeutic outcomes. There is some indications in Chinese medicine, and acupuncture in particular, that the therapeutic alliance is critical to the success of the clinical encounter and hence accounting for the repeated poor performance of acupuncture in strictly controlled trials which downplay the engagement of acupuncturist and patient. Ethnographic work undertaken by Zhang (2007)and research by Miller and Greenwood (2011) indicate that the acupuncture and Chinese medicine clinical engagement may offer more than that expected from other ways of working with people‘s health problems. As discussed above the participants in this study insisted that there was more happening than a kind acupuncturist.
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2 (a) Therapeutic relationship As indicated in Chapter 4, the acupuncturist is acutely aware of the centrality of the relationship between acupuncturist and patient. In this trial, unlike usual clinical practice, the researcher rather than the patient nominated the treating practitioner, primarily to accommodate the patient‘s travel from home or work to the nearest clinic. For a few women, this resulted in them receiving acupuncture from more than one acupuncturist in a multi-practitioner clinic. For the majority who received their 9 treatments sequentially from the same practitioner, the patient- practitioner relationship figured large in their discussions of the experience. Some focused on aspects of her (all were women) care:
Facilitator: So you've been to several acupuncturists. Do you think the style of the acupuncturist, in terms of how they relate to you, does that matter?
Yes, people are different, everybody's different. I think it's more about personality and temperament and all of that, but when you go to a fertility clinic people there are passionate and I went to the best, to the best women. So yes and they're very different in style, very, very, different in style. But X is more reserved but very, very caring, very, very caring. Y, she's more outgoing, more a little bit, not aggressive, but you know, a little bit assertive. But I still don't look - I connect with both, but basically because of what they do. Because they're helping me.
Facilitator: Because they have that expertise.
Because they have that expertise and they're helping me. (Karin)
Karin identified the relationship as the vehicle through which she would receive assistance, whilst Nicki (below) saw it more as the stable ground upon which ‗therapy‘ proceeded.
I think the relationship was important. Once we have established a relationship and I was comfortable, then it wasn't so important because I was already comfortable, I was relaxed and I knew what was going to happen…. So I wanted to have someone that I like, someone that will like me as well and that we'll have a good chemistry I suppose. (Nicki)
The eleven women had various histories of experience of acupuncture. Despite this diversity, it seems that all respondents had a general understanding of what acupuncture was prior to commencing the treatments, as reported in the media and through conversations with family and friends, even if they could not necessarily explain it. Most had no or minimal prior experience of acupuncture, so their relationship with their practitioner was necessary to support and explain the new experience.
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2 (b) Imagination Imagining the process of healing or repair may be a powerful factor in effective treatment. It was not an explicit instruction to trial acupuncturists to foster or avoid engaging their patient‘s imagination in the clinical sessions. One participant (Felicity) reported being told by her acupuncturist to lie back and relax and empty her mind of her concerns. Instead, she engaged her imagination in the process of treatment:
One of the [acupuncturists] said try and think about anything else but what you‘re here for. But to me, I would actually lie there and think, this is generating nourishment to my uterus, or this is doing this, or whatever the case may be and this is actually helping me. So I‘d mentally think how it was actually working for me….
They‘d often say, just relax and think about something nice, sort of, holiday or whatever the case may be, but I mean, there‘s obviously a reason why you‘re there and for me it was just, you know, Right - I‘m going to get this job done [laughs]. (Felicity)
This woman did ‗get the job done‘ and is now pregnant. She had had several failed IVF embryo transfers (ET); she had another ET during the course of the acupuncture intervention and successfully retained her pregnancy. She wondered whether she had conceived naturally because there was doubt about dates: the dates of my pregnancy are sort of not quite consistent. They‘re two days different from what an IVF cycle would be.
A second respondent (Karin) reported having a vision during an acupuncture treatment:
I was lying there and I actually had a vision. You know sometimes when you go kind of in between the sleep and the wakefulness type of state and I just saw, it was just like a metaphor, just a picture of - it's hard to put into words, but it was something like my desire to have a baby and my disbelief that I will have it. Then it was like, how do you call it, you have a bottle and then unscrewing the bottle, the plastic cap.
So I saw the disbelief, it was just like that, it was just a plastic cap that I put on that desire, on that wealth of my love. It was then and I unscrewed it and I was like, so what do I do with it now? I don't want to throw it because I will contaminate the earth, I thought, just silly things. I just had it in my hand and at that time I looked at it more awake kind of state. But I was not sleeping, it was more of a...
Facilitator: That's quite a powerful vision, isn't it?
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Yes.
Facilitator: I think you shouldn't worry about contaminating the earth because...
But that's what came to my mind at that point. I know, I was just standing with it and what do I do with it, what do I do with it? Do I throw it away? (Karin)
At this point, both respondent and facilitator were crying. Unlike Felicity, this woman did not get pregnant; she had been told that she had only one developing follicle and therefore only one chance to conceive (in this cycle or perhaps forever). She was facing a childless future. Perhaps her vision gave her an explanation. As she had been given little biomedical explanation of her fertility failure, she was struggling to locate a cause or find meaning in her situation. The vision prompted her to locate her problems in conceiving to something she was or was not doing.
Varela and Depraz (2003) refer to imagination as having an ‗inextricably nondual quality‘. The purpose of their explorations of imagination has been to embrace the entire phenomenon in all its complexity and weave it as a unity with its many dimensions, which need and constrain each other without residue …(:195). By means of the differing perspectives of neuroscience and phenomenology (what Varela calls neurophenomenological analysis) and Buddhist use of first-person experience for human transformation, these authors conclude that imagination is a mixed object – not open to reductive analysis, although as a phenomenon its differing qualities include the experiential and the organic. Importantly, they conclude our minds are enmeshed in multilevel causalities in the material basis of our bodies, just as much as this organic basis is the substrate from which our mind can be said to emerge (Varela and Depraz 2003:224). Simply put, our minds and our bodies create each other. And there is increasing evidence that by consciously applying Buddhist and other meditation techniques we can actively change ourselves. Listening to stories requires attending to the first- person experience without which such insights would be lost.
2 (c) Trust Although no participant named ‗trust‘ as a theme, it was implicit in their discussion of the importance of the patient-practitioner relationship. A trusting relationship implied that the practitioner had the appropriate skills and knowledge, that they would behave ethically when one was physically vulnerable, and that they were trustworthy repositories of personal information.
I was fearful of [acupuncture] before the trial but now appreciate it and recognise the full benefits (Rhoda)
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[The acupuncturist] would leave me for 20 minutes. I was in a room by myself …she‘s very gentle…I enjoyed it and I looked forward – that was a high point of my week (Andrea)
[The acupuncturists] I had most of the time …were really lovely…I think that‘s really important …because I think you need to feel comfortable…[there was] a connection. (Elaine)
One interviewee (Julie) reported being frightened of the needles and tense during treatments but she also was at pains to tell the researcher that she thought she had the best acupuncturist because she seemed so knowledgeable and skilled so she confidently attended each session.
Healthcare professional (HCP)–patient relationships are prime examples of trust relationships. The interactions between patients and HCPs normally involve uncertainty about prognosis, diagnosis, and treatment of disease and are characterised by a degree of dependency that arises from an imbalance of power between the participants (Hallowell 2008:427). Hallowell interviewed women who were managing ovarian cancer and concluded that patients wanted to be treated with respect - they wanted to be taken seriously - and respect led to trust which in turn generated respect which consolidated trust. Trust can also emerge from the ‗embodiedness‘ of the interaction between professionals and patients, as reported by interviewees in one study (Brown, Alaszewski et al. 2011). Trust can also improve health outcomes (Lee and Lin 2009) and does not necessarily indicate dependency or lack of autonomy. The possible differences between how trust is built and managed in Chinese medical encounters and with other health care practitioners is a fertile area for future research.
2 (d) Narratives There is tremendous drama in the meeting between doctor and patient - ‗an ocean of story‘ as Rushdie27 would describe it. Hearing the patient‘s story or narrative is a central plank in the construction of a diagnosis (Marcum 2008:161-67). More than this, the medical interaction is effectively an exchange of stories or an interweaving of narratives sourced from the patient, the practitioner and contemporary society and its institutions.
Facilitator: So do you have an understanding yourself other than what [the acupuncturists] told you about what acupuncturists do?
27 Salman Rushdie in his children‘s story ‗Haroun and the Sea of Stories‘ has his young protagonist taken by a Water Genie to the ‗Ocean of the Streams of Story‘.
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Not really. I mean, realistically - I could be wrong but I see it as being sort of I guess opening energy ports and making the body move as it's supposed to and I guess it's got a lot to do with digestion and that sort of thing so that's really as much as I know. I know that there are nice relaxation points. I quite like these ones. (Elaine)
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Facilitator: Do you have an understanding of what actually happened, like why acupuncture works?
I mean, not really to be honest. I know there‘s particular pressure points and it is quite scary when [pause] I don‘t know. Sometimes they put a pressure point in somewhere and you actually feel it run up your leg or completely feel it go different places. I find that incredible that there‘s spots on your feet that affect - so I know, they‘d explain to me why they were putting things in certain areas, because it helped with uterus or blood flow. At this particular time of the month you need to have more support for this and all that sort of thing. (Felicity)
In this interaction, the influence of the practitioner‘s narrative should not be underestimated and when asked by the interviewer all women reported being guided by their acupuncturist‘s understanding of the encounter. The explanatory story of what the needles were doing was reported as very influential, even to the point of obscuring the capacity of the women who received the treatment to articulate their own experience of it. For many, the attraction of Chinese medical theory, and the basis of its resilience, is its similar commitment to identify the patterns and processes at work within the complex and chaotic human body in interaction with its environment.
My last session I had with [the acupuncturist], at the beginning I had hope to have babies. But at the end of it I said to [her], at the end of this experience that I've had, I actually know I have hope. But it's totally different. At the beginning, I gave up and things like that but at the end of it, I feel like there is hope.
Facilitator: That was particularly having the period?
Yes and just the whole experience of it. I think it's made me more in tune with my body because there were things that she explained to me about my body which I didn't even understand or didn't know about. So it was an experience for me but it was also a learning experience to understand my body. Taking my temperature and doing all those things and checking and tick, those are the things that I just didn't - for me, it was let nature take its course or whatever but actually if I did pay attention to it, then I can
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understand it more. So at the end of it, it was just learning a bit more about how my body works and things that I can do to improve it …(Andrea)
Most women came to this study with the notion of theirs being a ‗faulty‘ body. Many came with the experience of years of fertility issues. When they were speaking about their experience of the process of the acupuncture intervention, their new more holistic understanding of their body began to replace the image of a ‗faulty‘ body. The majority of them spoke about how their approach to their fertility issues had changed – as though, following acupuncture, they were able to approach the issue in a different way. Mandy, for example, quoted above says the problems are still the same, the preoccupations are still the same, but the reaction towards them just changed after the treatments. Others supported this view that the issue was the same, but their thoughts and behaviours toward it were markedly different. This is an outcome that cannot possibly be measured within a purely quantitative RCT. An increased feeling of wellbeing, reduced stress and more energy, was confirmed by the positive change in the MYMOP wellbeing measure discussed in Chapter 5. The change of approach to their fertility issues was a longer term outcome connected to their transformation.
While the cluster of narratives which give meaning to and shape these women‘s lives were diverse, there were, however, themes, such as the notion of a faulty body, their learning from the acupuncture about their body, and adopting their acupuncturists‘ views of body functioning, which were common across all the women. Harter and her colleagues point out that, discourses both enable and constrain the human spirit, health communication and health care decision-making (Harter, Kirby et al. 2005:87). There is the ‗master‘ narrative/discourse of the importance of reproduction to fulfil womanliness, a pervasive and deeply felt message that life is incomplete without biological reproduction. The women who nominated themselves as trial subjects in this study reported the desperation they experienced at not being able to ‗naturally‘ fall pregnant. Many spoke of the difficulties they experienced when family, friends and others within their social milieu asked questions about when they would be pregnant. One woman from South Asia dreaded the weekly phone call from her parents-in-law whose first question was whether she had become pregnant with their desired grandchild. Although childlessness is the major cause of distress inherent in infertility, the complex difficulties of negotiating a serviceable autobiographical narrative for infertile women must not be underestimated (Kirkman 2001:534). Within the suite of ‗legitimate‘ narratives available to women of reproductive age, a version that confers meaning and value to personal experiences is important to find. Both the notions of ‗pronatalism‘ and ‗the biological clock‘ (terms offered by Harter et al,2005) are dominant within contemporary society and were
[186] reinforced here by the nature of this study. Focusing on female fertility, and the possibility of a therapy that would restore a reproductive body to full functioning, reinforced these social narratives and further shaped these women‘s sense of themselves.
Linde (1993) claims that we need a simple and coherent life story to exist in the social world and our story frames our conversations. A personal narrative is an unfolding process of autobiography. In a broader social perspective, there is not one reality and each of us find multiple meanings in our own reality/experience – we make stories or construct narratives and receive other people‘s stories and those generated by a society over time. There are at least …two perspectives on the creation of accounts or narratives:… [one] emphasises a process arising within an individual, attributing meanings to events and creating a story to contain and explain personal experience: our knowledge of ‗reality‘ is considered to be a story we tell ourselves. The second focuses on social perspectives and how meanings are negotiated with an individual to create a narrative, co- constructed by the individual interacting with those around him (Roberts 2000:433). The idea of narratives also leads back to the difficulty of science accepting the stories generated by qualitative research methods. Czarniawska (2004), drawing on the work of Lyotard28, refers to the paradox that, while science requires narrative for its own legitimation (there has to be a story to tell why scientific knowledge is important at all), …it fiercely denies narrative its legitimacy as a form of knowledge (Czarniawska 2004:15). The mainstreaming of science has led to the marginalisation of narrative knowledge to side eddies or the devalued lower rungs of hierarchies of evidence.
3. Transformation after acupuncture is multi-faceted and complex.
As the participants report a range of changes they experienced during and after the acupuncture intervention in the study their voices reinforced the research of others, for example (Sointu 2006; Paterson and Britten 2008; Baarts and Pedersen 2009), that CAM outcomes are different from the outcomes from biomedicine and that these differences give a more complex view of health, wellbeing and disease.
3 (a) Transformation
28 ‗knowledge is not the same as science‘
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I believe this [acupuncture] works, as my PCOS syndrome, hormones and insulin resistance has now all gone and I am naturally ovulating. (Rhoda)
Acupuncture recipients report that they have experienced some transformation that they attribute to receiving acupuncture. Rhoda had been diagnosed with polycystic ovarian syndrome (PCOS) following extended use of a drug to control her weight. Prior to her receiving the acupuncture intervention in this trial, she needed pharmaceutical medication to manage her insulin resistance and to precipitate a regular menstrual period. In Chinese medicine there is a sophisticated understanding of what is going on when acupuncture is applied to a living body. What happens is difficult to explain if we only deploy scientific methods of analysis (or philosophic inquiry), because it goes to that central conundrum of the connection or correlation of the mind and body or consciousness and the brain – and their separation as different entities. After interviewing many theorists on consciousness, Blackmore (2006:4) found that almost everybody agrees...that classical dualism does not work; mind and body – brain and consciousness – cannot be two different substances...Yet dualities of various kinds keep popping up all over the place, in spite of people‘s best efforts to avoid them. Does Rhoda‘s transformation to a naturally ovulating woman after a course of acupuncture require a dualistic analysis to explain it?
Andrea is another respondent diagnosed with PCOS whose first husband had left her because of her failure to bear children. She reported feeling deeply depressed at the commencement of the trial, and found the diet and exercise regimes recommended for PCOS sufferers hard to sustain. She said that being randomised to the acupuncture intervention was a turning point which gave her hope for her second marriage and for her fertility:
Towards the end of it, I think, just two treatments before we finished, I actually got my very first period. In the years, I've never had and I actually… had an actual full period for - I can't remember the last time I actually had one. So that was, I think, the most exciting point out of the whole thing was to actually starting to get my period back. I had energy. I had lot of energy. I didn't feel as tired or as sleepy as I used to. I don't know. I just felt good. (Andrea)
The process of assessing and reassessing the women‘s circumstances at each appointment (a central aspect of Chinese medical practice) seemed to assist the women to reflect upon themselves – their physical and emotional selves – and to use that reflection to further their transformation.
Having that person there, monitoring you weekly and just seeing the improvement that comes up to it, it's a very - I think it complements the treatment. (Mandy)
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The mix of being seen and seeing in a self-reflective manner appeared to offer these women a sense of being fully ‗embodied‘, when many aspects of their lives urged them to be disembodied29 or at least possessed of a faulty body.
3 (b) Emotional change The non-dualistic basis of Chinese medical theory makes it a fully ‗psychosomatic‘ or ‗functional‘ medicine. Because emotions reflect the state of a person‘s ‗qi‘ and can be identified as a symptom, a desired outcome, a contributing cause and a constitutional tendency, they are an essential part of the therapeutic discourse. Chinese medicine hypothesises a direct ‗channel/meridian‘ connection between the heart (as the seat of emotions) and the uterus (the origin of reproductive function), and therefore posits emotional change as necessary for fertility improvement.
You know, it affects a little bit of my mood as well. I felt that throughout the treatment, I was always stressed. I'm looking at myself this week different than what I was feeling two, three weeks ago. There's this sense of calmness and wellbeing. I just can't explain exactly what it is because the problems are still the same, the preoccupations are still the same, but the reaction towards them just changed after the treatments. (Mandy)
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I think it touched other parts of myself [other than just physically] and I think that's a lot for me to say because I haven't always been so open to alternative medicine. It's only in the recent months that I've started exploring the options. (Nicki)
……………………….
I think it just made me feel happier and brighter. I can say that having the experience, it could be just from the company as well, talking as well as having the treatment that you walked out of the office very happy, yeah. (Teresa)
Emotional changes did not figure highly in the MYMOP list of desired change (see Chapter 5), third on the list behind tiredness and weight management. Increased emotional buoyancy was
29 See the discussion in Cousineau, T. M. and A. D. Domar (2007). "Psychological impact of infertility." Best Practice & Research Clinical Obstetrics and Gynaecology 21(2): 293-308. for an understanding of how increasing medicalisation of care for infertility lessens a woman‘s sense of control of her life. Also in McCarthy, M. P. (2008). "Women‘s lived experience of infertility after unsuccessful medical intervention." Journal of Midwifery & Women‘s Health 53(4): 319-324.
[189] evident in the voices of most of the women interviewed. With physical change and relaxation these symptom changes were woven into the core of the transformational experience expressed by the women interviewed.
3 (c) Relaxation In physics relaxation refers to a return to equilibrium. In psychology, it refers to a reduction in stimulation and excitation. In this fertility study, when these women talked about relaxing, they were not referring just to their muscles relaxing, or being removed temporarily from their worlds of care. Of course there was the component of muscle relaxation, the physicality of letting go of muscle tension30 – but ‗relaxing‘ meant more for these women.
it just - I don't know - it's just weird - it just - I feel like a different person every time I come out of the room and it feels really good.( Annabelle)
…………………………..
If I wanted to go and have a nice time out, just improve on general well-being and relax, I probably would choose acupuncture now over remedial massage or anything like that. Because I think it just works better and deeper.
I remember, I think the first two or three sessions I had, I would come home and I would just feel so blissfully relaxed and just really happy. All I wanted to do is just go and sleep. I was just so relaxed. Nothing mattered. It was a really lovely feeling. (Nicki)
………………………..
I found I'm always really relaxed when I leave. I feel really good, it has an immediate buoyancy effect that I like.
Facilitator: That's good. So it's not just a physical sensation, it touches other aspects of yourself?
Absolutely. It has an emotional impact as well, a feeling of - it's almost like a centeredness. I drive home and I have clarity and I feel much more at ease. I feel very relaxed. It's the sort of feeling that I have had when I've been on a really good holiday. (Linda)
It was an experience that women said they had not achieved outside the experience of acupuncture. Several thought that a long-term meditation practice might achieve the same result. Explaining the meditative process, Wallace (2009) refers to the experience of substrate
30 One woman reported that she couldn‘t relax with the needles in – she felt anxious in anticipation of receiving needles and then having to not move while they were inserted in case she experienced pain.
[190] consciousness as appearing to be: an innate quality of the mind when it has settled in its natural state, beyond the disturbing influences of conscious and unconscious mental activity (:91). The possibility that acupuncture can facilitate the sought-after feeling of ‗bliss, luminosity and nonconceptuality‘, however fleetingly, and without the rigour of meditative practice is a phenomenon worth further research. The depth of this experience for participants did not emerge from the questionnaires conducted in conjunction with the trial, nor does such a perspective emerge from most acupuncture research.
3 (d) Self-identity As discussed in Chapter 1, women who do not receive treatment for their infertility report less distress than women who have had treatment (Greil, McQuillan et al. 2011). There is some evidence now that acupuncture used as an adjunct to biomedical infertility treatment ameliorates this tendency. Important research (de Lacey, Smith et al. 2009; Smith, Ussher et al. 2011) has found that acupuncture builds resilience, improves self-efficacy and lessens anxiety. In this study, the women‘s report that the process of the acupuncture intervention undermined their conception of their body as faulty reinforces that research finding. Increased relaxation, reduced physical discomfort, a safe therapeutic relationship, an explanatory narrative personalised to their bodily experience could all be explanatory factors.
3 (e) Responsibility Responsibility was also an emergent theme, often referred to in relation to following the diet and exercise regimes recommended in the trial intervention, or simply as learning to relax and think positive thoughts. Undertaking ‗self-responsible‘ behaviours were part and parcel of the experience, and many seemed to identify this as an outcome.
[Plans for future] continue to eat in a healthy manner and exercise. I have also now stopped all medication (Diabex) and will continue with acupuncture when required. (Rhoda)
…………………………
it does take time. I've noticed that now. You do have to make sacrifices like I'm not eating junk food and all that, exercising regularly and all that…. I try and go to the gym like five days a week but if not, it's probably about four times a week. (Annabelle)
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I really need to find - I think if anything this trial has shown me the importance of taking time out and the importance of reflection and being able to switch your mind off to sort of give yourself a kick start or
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something. I like that about yoga and acupuncture that it forces you - it's sort of scheduled timing to relax. I know that I need to do that. (Elaine)
……………………
I think maybe I am just a little bit more aware now that I have to just relax a bit more because everything else I'm doing, everything else is as it should be. I think it's the stress that perhaps is making me infertile…
I do blame myself a little bit. I should work harder, maybe I should. My mum often tells me…you just have to relax and I think, but mum, it's really difficult because I want to relax but it's like maybe telling a sick person, cure yourself suddenly. It's harder. (Nicki)
……………………
I‘d like to try [acupuncture] longer … give it a go and because of exercise and stuff, I mean I‘m a bigger person anyway. My journey to lose a lot of weight is going to take a lot longer than if I only had to lose 5 kilos. I mean, I can lose 5 kilos in a relatively quick period of time, but overall it‘s just a small step compared to what – it‘s going to take a long time. (Teresa)
As discussed elsewhere, the use of a diet and nutrition-based lifestyle modification approach in this study generated its own difficulties. By nominating weight management as a major desired change in the MYMOP questionnaire, the participating women flagged that they were making or adopting changes as a task they needed to accept for themselves. But it also indicated that implementing changes held challenges not addressed in these interviews. For some reason the women who had the acupuncture intervention did find that they were more able to engage in desired activities (as found in the MYMOP results). Many reasons for this can be hypothesised but the interviews did not directly elicit answers to this question.
3 (f) Reconceptualisation The majority of women interviewed spoke of how their approach to their fertility issues had changed – as though they were able to approach the issue in a different way.
Even though I'm disappointed I didn't get a pregnancy out of it, I actually feel as though it was a very positive step for me. Because I actually feel more positive about my chances and it didn't feel as invasive as IVF does…
There is still that, for me, a feeling that there is something wrong with me because it's so hard and feelings of failure and not being complete as a woman.
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Also nearing my 40th I'm starting to panic. Although I think I've been panicking for a while. I think there is - but what I found very interesting is, I feel as though I've relaxed a lot more about it. I haven't been as uptight, even though I've been disappointed, my anxiety levels have definitely dropped. I don't know whether it's because of this, whether it's because I've felt generally much better. Or whether I am getting to the point where I think, well I've tried lots of things, maybe I should just accept that it may not happen. (Linda)
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Before I was like, Oh my god, I want a baby, I want a baby, I want a baby but now when I see [my sister-in-law] it's like well if I have a baby, I have a baby but if it's not meant to be, it's not meant to be. That's how I just see it. Even though my doctors did say after 25 it's going to be hard for me it's like well other people can do it. If they can, I can, if not, I can always adopt. Get a surrogate mother…. I'm not stressing over it any more. (Annabelle)
While some participants entered this study with an ‗open mind‘ and without specific expectations, many reported it was part of their journey of praying for a miracle baby or steps closer to having one31. The public perception of acupuncture as helpful for fertility drew women into the study. Their reported increased options and hope echoed a similar finding from another acupuncture trial, some reported despair at what they saw as their last option. Being able to reconfigure views of the future has, however, been recorded as an outcome in other studies; for example: Some themes were more commonly mentioned by participants receiving particular treatments. Acupuncture participants were more likely to note an increased sense of having a new option for treating their [condition] (Hsu, BlueSpruce et al. 2010:162). ‗Different- from-the-biomedical‘ and ‗natural‘ were nominated positive aspects of acupuncture: I was willing to try anything. Acupuncture is natural and this was the main attraction32. At some level seeing acupuncture as ‗natural‘ is bizarre because of its practice of inserting fine needles in mystifyingly inexplicable parts of the body to produce systemic change. It is testimony to the potency of holism implicit in this medical approach, and the encompassing process of acupuncture-in- practice, that it is perceived so positively. ‗Feeling better‘, in all its complexity, was also a powerful driver in such positive reports of these women‘s experience of acupuncture.
31 This is a quote taken from a participant‘s Experience of Acupuncture questionnaire. 32 Also taken from the Experience of Acupuncture questionnaire responses.
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Discussion
The complex interplay of beliefs, emotions, bodily change and social engagements play out within these women‘s lived experiences. Such complexity in itself becomes a lure into reductionism and tempts us to privilege one particular ‗cut‘ or analytic frame above all others. The study participants expressed an engaged and changing complexity which required analytic methods that can encompass and respond, without reducing the women‘s experience to reductive slogans. Undertaking a diffractive method is designed to disrupt linear and fixed causalities, and to work towards ‗more promising interference patterns‘, both between words and things …and between theoretical schools…. (van der Tuin 2011:26-27). Diffractive methodologies place the ‗knower‘ or observer inside what is being sought to be known. Diffraction challenges the notions of objectivity and subjectivity, and suggests that the patterns/configurations/intra- actions that differing ideas or relationships or bodies or objects make on and between each other are more informative than any representation made by an ‗external‘ independent observer. Representing the object or body as a fixed thing denies the fluidity of matter and the ways matter interacts and is understood. We do not uncover pre-existing facts about independently existing things as they exist frozen in time like little statues positioned in the world. Rather, we learn about phenomena – about specific material configurations of the world‘s becoming (Barad quoted in van der Tuin 2011:28). The acupuncture intervention exemplifies intra-activity at work – the acupuncturist, the patient, the needles, the treatment environment, any observer, the time of day, the season, the beliefs held about acupuncture, the quality of the relationships formed, the Chinese medical beliefs about this body at this time, the acupuncturist‘s skills and, in this study, the measuring researcher framing the intra-actions - a soup of materiality and discourse. To attempt to understand this ‗soup‘, different theories are brought to bear - affirmatively rather than critically - by engaging Barad‘s approach to place the understandings that are generated from different (inter)disciplinary practices in conversation with one another (Barad 2007:90-91).
It could be argued that it is at the messy margins and intersecting boundaries of bodies of knowledge that the richest vein of scholarship can be mined. The encounter between biomedicine and Chinese medicine has been an unfolding project of many centuries (as so carefully documented by such scholars such as Scheid, Unschuld, Sivin, Lei, Andrews), and the examination of it is often ill-received by a reversion to cultural roots or opposition to globalizing Western modernity (Breslau 2001:253). When traditionally-trained practitioners engage with modern patients (in the West but often too in Asia), they (we) are forced to stand at this boundary, in a
[194] potentially conflictual field of competing ideas and practices. It is an experience that could be akin to that phenomenon popularly characterised as a ‗left brain/right brain‘ dualism.
The demand to overcome dualistic methods is strong. It is the patients who require us to understand Western physiological concepts, such as follicle stimulating hormone (FSH), as much as core Chinese medical concepts such as yuan qi, and to work with their bodily presentation – bodies shaped by culture as much as biology, patterned by biomedical diagnostic tests and interventions, by folk beliefs and personal histories, and climate, season and geography. Some practitioners have found it much easier to draw only on classical understandings; for example, one has stated if it is not in the
Conclusion The stories told by the participants are very like the historical case reports from classical China. The Chinese medical literature relies heavily on sharing knowledge through case examples (Furth, Zeitlin et al. 2007; Furth 2009) and these cases became the bases of evidence of efficacy (as well as rhetorical devices). The particular has value of its own without having to be aggregated into populations or categories. Contemporary efforts to focus only on the forms of evidence encompassed by ‗evidence-based medicine‘ has glossed over the strength and meaning expressed in experiential data.
Chapter 7 will discuss the emergent data from both the qualitative and quantitative arms of this study, and how and where they reinforce and contradict each other. The qualitative results clearly indicate that this acupuncture intervention facilitated a move for many of these women from a puzzled desperate hopelessness to a more nuanced understanding of themselves and their situated fertility problems. A few have achieved their ideal of giving birth and becoming parents. For the continuing childless, the intervention appears to have at least shifted their experiences of involuntary childlessness.
33 A classic Chinese medical text from around 200 AD.
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One of the values of seeking the perspectives of study participants is that the limitations of measurement tools used in the trial have been exposed as not sufficiently nuanced or responsive to their experiences. The wealth of data from the interviews reinforces the importance of a mixed method approach.
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Chapter 7: Threads in the weave
Something‘s doing. That much we already know. Something‘s happening. Try as we might to gain an observer‘s remove, that‘s where we find ourselves: in the midst of it.
– Brian Massumi34
The fabric of my thesis has evolved and changed from the ‗simple‘ question of - Does acupuncture assist women with fertility problems? - to the need to explore which acupuncture intervention would be better for this task, what is a meaningful comparator, how can reproductive change and preparedness for fertility be measured, how can acupuncture be understood from the perspective of both the acupuncturist and the client/patient….there are many new questions that have emerged in layered and interactive patterns. The issue of research methodology has arisen as primary. As asked in the Preface ‗What research tools are considered credible or valid for such an endeavour? Were the tools used in this study useful and to whom?‘ Has the sequential, multistranded quasi-mixed methods design adopted offered anything meaningful to current knowledge? This final chapter examines the threads of outcomes and their implications for practice and research. It considers the results from the studies described in the chapters of this dissertation, re-examines the research problem and methodological solutions, and proposes possible implications for theory, policy, practice and research.
The most difficult task in completing this thesis to a standard acceptable to the author and her supervisors has been in the writing of it. Not because writing is alien or unfamiliar to the author but because finding an authorial voice that suits both quantitative and qualitative research methods appears impossible. Halcomb and Andrew (2009) caution that mixed methods projects are relatively new in higher degree research, and there are many issues of timing, data size and skill sets which must be considered. They do include thesis writing as an identifiable problem and point to the lack of templates that are adapted to report mixed methods projects. While recognising the opportunity for creativity, they state such creativity, however, needs to be tempered by
34 Massumi, B. (2011). Semblance and Event: Activist Philosophy and the Occurrent Arts., Massachusetts Institute of Technology.
[197] what is considered an acceptable scholarly standard for the discipline (Halcomb and Andrew 2009:160). Is there a mixed methods voice? Addressing this topic in depth and having reviewed the literature, O'Cathain (2009) identifies a number of issues: a lack of templates, a standard format or ordering the presentation, style, language and voice, the problem of different audiences, the challenge of displaying and achieving credibility and the restriction of journal word limits. Different formatting styles, language and voice are associated with quantitative and qualitative research (Sandelowski 2003; Johnstone 2004; Creswell and Plano Clark 2007). Scientific reports require the separation of findings and interpretation, and the third-person passive voice (Sandelowski 2003). Qualitative research can involve iterative relationships between sampling and analysis, and analysis and interpretation, and an informal personal voice. Researchers can face the dilemma of which to use in their reports, dissertations or articles (O'Cathain 2009:109). I have tried to weave a path between the ‗objective scientist‘ and the ‗engaged person-in-dialogue‘ in the hope that my findings are comprehensible to any reader and able to be taken seriously by readers of all persuasions.
The meeting of biomedical and Chinese medical methods (and of quantitative and qualitative methods) The clinical trial within this research study gave a clear message that the acupuncture intervention was active. The pragmatic design did not allow the ‗active ingredient‘ of acupuncture to be disassociated from the ‗whole package‘ of an engaged therapeutic intervention with acupuncture at its centre. It did, however, approximate verum clinical practice similar to what one would expect from one‘s neighbourhood acupuncturist who was experienced in treating women‘s fertility difficulties. The outcome measures with statistical significance, and the less statistically significant trends that emerged, point to this acupuncture intervention as having a strong impact on participants‘ fertility awareness, wellbeing and agency and a weaker impact on the time it took them to conceive and on their menstrual health. Reading the trial data in tandem with the qualitative results extends the data substantially. To hear that the trend to improved menstrual regularity actually meant that three women who suffered from PCOS experienced natural menstrual cycles and full periods for the first time in many years (or in one case in her lifetime) throws into sharp relief the difference in what we can learn from different research methods. Another example is that the improvement of a few points on a wellbeing measure translated for individual women being able to understand their situation quite differently and find themselves, still childless, but accepting that this was an ‗okay‘ situation not one riven with despair. The ‗pure‘ science view is that measuring changes across a population has far more
[198] meaning than information from individuals. An RCT aims to be impersonal, value-free, precise and reliable (Pietroni 1992:25) and to speak to the analytic scientist. Combining this ‗knowledge‘ with what Pietroni calls the knowledge of the Particular Humanist which is personal, value-constituted, partisan, non-rational and political (Pietroni 1992:25) (that is, inevitably the embedded perspective of the health practitioner of whatever persuasion), has to enlarge our understanding of health, disease and how to intervene for the best.
This study offers a window into the value of finding a meeting ground – between Chinese and biomedicine understandings of the body and the process of healing, and between the objective gaze of quantitative analysis and the encompassing inclusion of the qualitative approach to analysis. To turn to Jullien (2009), he contrasts the European quest for truth through the apprehending gaze as a search for greater objectivity to the Chinese approach of making oneself available so that one is fluidly open to each new ‗so‘ as it hatches ‗on its own‘. …the diffusion- diffraction effect of that [availability] stands opposed to the rigidity and unilateralism of every ‗position‘, which is always more or less delimiting and closed off (Jullien 2009:165). This perspective becomes apparent first in the interviews with acupuncturists (detailed in Chapter 4). The evident discomfort all three displayed when asked what they do when they do acupuncture speaks to this divide between ‗objective‘ and ‗subjective‘ knowledge and practice. The practice of acupuncture presents no difficulties because one simply ‗does‘ it without struggling to find words to describe what is being done – acupuncture is enacted and firmly embodied. As a Western practitioner at least (and I imagine this may also be the case in modern Asia), to discuss with an ‗objective‘ questioner what is happening, what you are doing, immediately elicits a discomfort – how do we conceptualise that mix of being present, engaging energetically, holding a sum of details about pulse, tongue, menstrual patterns, visual cues, etc – allowing oneself to be available to another and inserting needles in them? How do you describe the moment which is the ‗onset of the current of intentionality, yi‘ – when the hand is free to enact the purpose/intention that has emerged from that mess of detail and, dare I say, intuited or sensed direction? Jullien (2009)describes yi as something that can be ‗blocked‘ or ‗cleared‘ – it is the authenticity of the inner artless movement that comes to light (2009:224) – it is emergent.
Not every acupuncture encounter is engaged in this way; however, I understood from the three experienced fertility acupuncturists interviewed that they worked to achieve such an engagement and this could be at a cost to themselves. One described leaving clinical work because she found it personally unsustainable, another that she needed an extended daily meditation practice to
[199] remain at work, and the third used laughter in clinic and exercise out of clinic to be able to engage in this way. Yi does not come without a cost and it requires discipline.
The experiences of the women trial participants echoed that of the acupuncturists in several ways. One was how difficult they found it to describe what happens in an acupuncture treatment – finding suitable words. The one interviewee who had the least trouble was of Chinese origin and found it self-evident – acupuncture influenced her qi which in turn influenced her menstrual and emotional expression. Most struggled, and resorted to words and phrases such as ‗it was cool‘. In addition, several women had received acupuncture from more than one acupuncturist and they were able to describe different levels of ‗engagement‘, ‗presence‘ or ‗yi‘. One woman who had treatment from different acupuncturists described the experience of having needles ‗stuck‘ in her in a mechanical or instrumental fashion, and compared it with another acupuncturist who took the time to be present and to relate to her during the treatment.
…
Have I just described the importance of using mixed methodology research? Is a MMR approach enough to bridge the quant/qual, objective/subjective divide? In this research process, has there been a substantial common ground? The results from the process to develop a fertility acupuncture protocol (Chapter 4) fed directly into the clinical trial as the acupuncture intervention (Chapter 5) and the themes that emerged from the interviews with acupuncture recipients (Chapter 6) deepened and added flesh and new perspectives to the data that emerged from the clinical trial. Certainly, two methods of inquiry coexist here within the same document but they do so in different chapters and, although there is some resonance between them, the interactions (or intra-actions) are not strong or dense. For this reason, the study is described in Chapter 3 as a ‗sequential, multistranded quasi-mixed methods design‘ – two voices singing a capella in a kind of duet. The challenge is to find a methodology that does not leap from quant to qual and back but is a fully-fleshed and valuing integration of the two – a fully harmonised orchestra with choir.
My work, I anticipate, has made a contribution to confronting the damage inherent in research methods that ignore the dualism (between quant/qual and Chinese medicine/biomedicine) and thus perpetuate a blindness to the value of different ways of knowing and of doing, and their contributions to health care. Finding a ‗common ground‘, I hope, does not mean levelling the landscape of diverse and varied features. Methodologies must reward and acknowledge diversity.
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Main findings from this exercise This section will highlight the main findings from each arm of the study followed by their principal implications for theory, policy, practice and research.
Fertility problems cause multiple difficulties for women and their partners (Chapter 1). Women arrive at fertility problems through different pathological pathways (as do their partners) but consistently experience significant distress from not meeting their own or others reproductive expectations.
Standard biomedical care is expensive, demanding, stressful and not always successful (Chapter 1). There has been tremendous progress in biomedical care in the last 20 years and science has made significant contributions to understanding and resolving fertility problems. Mostly this has been through ART which is very expensive: Australia remains the only country where ART services are subsidised from the public purse.
Lifestyle changes can improve fertility outcomes but require much support to be successful (Chapter 1). Evidence is building that lifestyle behaviours such as smoking, alcohol consumption, stress reduction, diet and exercise having an impact on reproduction. Although these findings are not yet conclusive, changing such behaviours appears to improve fertility. What is apparent, however, is that to make desired changes women need support beyond the advice to make the change.
Chinese medicine has a unique perspective on women‘s reproductive health and a history of treating fertility (Chapter 2). Not only does Chinese medicine contribute a unique understanding of women‘s health and fertility but it also has a range of interventions, including acupuncture, that come with a substantial body of case evidence and, increasingly, evidence from research studies of the last 30 years.
Laboratory studies of acupuncture have shed light on some of the physiological mechanisms related to acupuncture‘s effects on women‘s reproductive health (Chapter 2). Many of these laboratory studies use rigorous methodology which is acceptable to science.
Acupuncture research is complex and difficult to do well for many reasons (Chapter 2). The short history of acupuncture research demonstrates a sharp learning curve for researchers. From the early assumption that acupuncture could be isolated as the simple insertion of needles, researchers have recognised the myriad and complex factors that constitute an acupuncture intervention. Most researchers now call for research methods that encompass complexity.
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Research methods (qualitative/quantitative) – currently cast as ‗either/or‘ - need to be recast as ‗both/and‘. The growing acceptance of a ‗mixed method‘ is a movement toward a dialogue that allows both methods to be valued – perhaps as equals in the future? (Chapter 3). Pietroni (1992) echoes my view that medicine and health care are beautifully positioned to benefit from the generalisable measured findings of science and the humanistic nuanced explorations of uncertainty offered by the social sciences. The ethical application of both sets of knowledge in the service of the patient must be the aim of all practitioners.
Findings about research questions An acupuncture protocol to guide a research trial was successfully developed through a consensus of the views and experiences of leading Western fertility acupuncturists (Chapter 4). In-depth interviews as a means to furnish material to guide an online focus group worked well. The issues that emerged from the interviews acted as both a stimulus and guide to the focus group participants. The smooth functioning of the focus group was marred by technological failures but these factors did not prejudice a successful outcome.
The pragmatic clinical trial (Chapter 5) suited the acupuncture protocol arising from the first phase. The acupuncturists were required to adjust the treatments according to the presenting situation of the trial participants. The women experienced this as positive and said that it resulted in a productive therapeutic engagement.
Randomisation and the study design, although necessary for the research purpose of creating two roughly equivalent groups of women participants and reducing selection bias, precipitated difficulties for some participants as they did not consider the lifestyle-modification-only intervention equivalent to the acupuncture-plus-lifestyle-modification intervention. This affected the willingness of participants to remain in the project and a proportion were lost to follow-up or did not adhere to the study protocol. The offer of free acupuncture drew recruits to the study but disappointed those not assigned to receive acupuncture.
The acupuncture intervention, compared to the non-acupuncture intervention, did succeed in increasing the participants‘ awareness of their own fertility. It increased the ability of the recipients to engage in desired activities, such as exercise or rest. It further increased their sense of well-being. There were trends in participants‘ menstrual pictures which indicated the intervention was active on menstrual health and shortened the time to conception by half although these changes were not sufficient to register as statistically significant. The manualised
[202] acupuncture protocol chosen for the intervention could be the basis of further studies. More attention to adequate dose is necessary for future studies. Also outcome measures that are both easier to comply with and sensitive to menstrual changes are needed. Networked electronic versions of the measures used in this study may be appropriate.
The complexity of acupuncture as an intervention emerged clearly from the interviews with participants who received it in the study (Chapter 6). They reported that the experience of the intervention influenced them in a wide spectrum of ways – adjusting their period, relieving headaches and back pain, achieving a level of relaxation unattainable before, changing their understanding of their reproductive functioning, and changing their relationship to their experience of infertility. Although they acknowledged that the information sharing, a caring therapeutic relationship, being helped to make sense of their condition, were valuable aspects of the intervention, participants located the key ‗active ingredient‘ as the acupuncture – having needles placed in different locations in their bodies.
Findings about the research methods The implicit research problem in this thesis is how to effectively research an acupuncture intervention. What constitutes quality acupuncture research? My participation in the development of a quality assessment scale for acupuncture research has exposed how, even within the clear guidelines of RCT methodology, there are many challenges to achieving quality research. The NICMAN scale (Smith, Zaslawski et al. 2011), when finalised, will apply to RCTs only. It will at least offer a means to assess quality in acupuncture research within RCTs and prevent many of the misuses and misunderstandings of what is an adequate acupuncture intervention. When the NICMAN scale is applied to the trial component of this study, the trial rates quite highly on those indicators applicable to pragmatic trials [see Appendix 20].
The problem of finding an adequate comparator for acupuncture is difficult to resolve. There is now substantial evidence that sham acupuncture is not inert and that blinding of practitioner and patient and delivering adequate acupuncture is extremely difficult to achieve. Blinding can, however, still be achieved, as in this study, in relation to those collecting outcomes and undertaking the data analysis which are valid and important counters to bias and important in a pragmatic design. Because an outcome in this study was the objective measure of pregnancy, it also could be argued that blinding in this situation was not important. My own pragmatic study, which avoided using a ‗no intervention‘ comparator because, at least partly, it would be unacceptable to the researched population, ran into difficulties with the control. As mentioned in Chapter 5, lifestyle modification was not equally valued by participants, although it should be
[203] noted that adherence to lifestyle interventions reported in other studies can be as low as 55% (discussed in earlier chapters), which may indicate that the difficulties encountered in this study are not unique and less dramatic than in other equivalent interventions. The presence of a placebo effect in any health intervention is acknowledged and it is apparent that acupuncture with its ritualised practice and ‗exotic-to-the-West‘ language and concepts can facilitate and enhance placebo effects. In clinical practice this is of little consequence. In research studies it does have consequence. The acupuncturists and the acupuncture patients interviewed for this study clearly indicates that the effects of acupuncture are substantive, can be influenced by how it is done, and the effects are both physiological and psychological.
There is increasing use of qualitative methods in CAM and in acupuncture research. There remains, however, a suspicion that such methods import subjective bias into a research project. Ezzy (2001) discusses it as an unhappy marriage between qualitative methods and natural science epistemology, with the interpretative methodology of qualitative methods sitting uneasily within the positivist methodologies of most health and medical research. More difficult again will be to bring what Ezzy calls ‗poststructuralist innovations‘ and the more recent posthumanities perspectives (such as Stengers (2011) ‗ecology of practices‘) into health research. As long as natural science methods are regarded as the ‗gold standard‘ to assess all health practice, acupuncture and similar practices will not be effectively evaluated for their contribution to people‘s health and wellbeing.
Implications for theory At the 2011 conference on ‗The Quest for Personalised Health: Exploring the emergent interface of East Asian medicines and modern system sciences‘35, systems biologists present made a plea for Chinese medicine to de-mystify itself so it could be better understood by science. On face value, this appears a reasonable request – drop the foreign language and the foreign concepts and what should remain is a body of knowledge open to systematic objective analysis. There are, however, many problems with this approach that have been well documented by Lloyd and Sivin (2002) and at the core is that the Western medicine tradition and the Chinese medical tradition focus, and thus operate, differently when conceiving of health and disease in the human body. Should we conclude that they are ‗incommensurable‘ – that it is impossible to measure or compare sciences (however systems-oriented) and traditional medicines (however integrated into contemporary health care systems)? Acknowledging that the way biomedicine differs from Chinese medicine is a complex issue, Hanson (2010:241) locates it as an ongoing historical
35 organised by EASTmedicine Research Centre at the University of Westminster and the School of Life Sciences
[204] conundrum since the Jesuits arrived in China in the late sixteenth century and, more recently, as explored in theoretical, historical and anthropological studies. She identifies the ongoing dyadic frameworks to locate one in relation to the other: [biomedicine] is more reductionist and atomistic and [Chinese medicine] is more holistic and system oriented. Perhaps looking for commonalities with scientists who are also moving beyond reductionism toward systems thinking is a useful endeavour. Dr Volker Scheid opened the conference with a Latourian challenge for us to form hybrid networks through focusing on translation of our different conceptions and practices, in order to break out of our need to purify and refine our differences to locate ourselves within our own boundaries.
A solution, and perhaps the only one evident to this researcher, is to continually bring theoretical considerations back to actual practice – to look for practical and pragmatic ways that biomedicine and Chinese medicine can work together with this patient at this time. It has been gynaecology practitioners who have offered leadership in practical endeavours to further a working relationship. Whether this has arisen through the efforts of particular individuals36, because of the nature of women‘s health or because of the efficacy of Chinese medicine in this field, is not yet clear.
Implications for policy and practice
Women‘s menstrual health prior to conception is not a central concern in standard health care. ART practice replaces the natural menstrual cycle with an artificially induced process designed to maximise ovulatory output and control the timing of menstrual events. Chinese medicine emphasises normalising menstrual health, both as an indicator of overall health and as a way to promote fertility. The contrasting approaches of ART and Chinese medicine have implications for using both medicines at the same time, although there are no research studies of this interaction other than the acupuncture and IVF studies discussed in Chapter 2. Experienced TCM practitioners working in fertility (Liang 2003; Lyttleton 2004) caution that Chinese medicine treatment strategies need to be modified to mirror rather than contradict ART procedures.
Western medical practice would benefit from increased focus on enhancing menstrual health rather than chemically replacing the body‘s own mechanisms. A preliminary assessment that establishes whether the menstrual mechanisms require enhancement or replacement would be a
36 There are outstanding examples of individuals who have pushed the boundaries – amongst others, Xia Gui-cheng, Yu Jin, Elizabet Stener-Victorin, Caroline Smith, Dianne Cridennda, Jane Lyttleton, Brandon Horn, Andrew Flower
[205] useful addition to biomedical fertility strategies. Currently, time is the major assessment tool – how long has this woman tried to conceive and how old is she?
The importance of enhancing a woman‘s emotional and physical health in the lead up to conception is evident from the research and a major issue identified by the participants in this trial. Acupuncture‘s proven record in contributing to people‘s sense of wellbeing was confirmed in this study, and there is a strong argument for it to be included in lifestyle recommendations for women who are using ART to assist them improve fertility. It could also be used in standard care to ameliorate the impact of stress and anxiety on reproductive health.
Acupuncture Practice and Research There are surprisingly few reports of acupuncturists being interviewed about their practice apart from occasional biographical articles on luminaries who have established a particular school or style of acupuncture. As two acupuncture researchers (Lao and Ezzo 2003) state, practitioners are critical to the practice of acupuncture: the practitioner aspect is likely to play a more central role in TCM than in conventional medical practice. This is because of TCM‘s exclusive reliance on the skills of the practitioner for both diagnosis and treatment. They comment on the failure of researchers to systematically address the issue of the practitioner‘s qi and support this aspect of practice as central, by quoting from what they describe as the ‗first text‘37:
Regardless of how deep or shallow the point, or whether it is distal or proximal, when acupuncturing you must focus your qi and your shen or spirit as if facing an abyss 1000 ft deep. Everything must be done with delicate care. When manipulating the needles with your fingertips, you should handle the needles as if handling a fierce tiger. Focus all your attention (Lao and Ezzo 2003: 219).
Charlotte Paterson has been the main researcher to identify practitioners‘ practice as an issue, asking patients to assess their practitioners and finding different outcomes between medical acupuncturists and classically trained practitioners (Paterson and Britten 2008). She also interviewed acupuncturists participating as trial practitioners about their experiences (Paterson, Zheng et al. 2008) and, more recently, examined the conversational patterns of the acupuncture consultations (Evans, Paterson et al. 2011). Acupuncturists in research studies judged their practice as varying depending on whether they were in the trial and delivering verum or sham
37 Ni M.S. The Yellow Emperor‘s classic of medicine: a new translation of the Neijing Suwen with commentary. Boston: Shambhala, 1995 (Chapter 25: The preservation of health).
[206] acupuncture (Paterson, Zheng et al. 2008). Indeed, this issue of how acupuncture is practised in research settings is frequently discussed by clinicians, one commenting:
Matsumoto made a great aside when asking what a ‗Sham‘ point was. When she finally understood, she said, ―should be called A Shame point, because when the practitioner does a sham point he is ashamed that nothing happens!‖ (Seem, Cassidy et al. 2004: 158)
Including these perspectives on good practice into an assessment of acupuncture would require the development of novel and creative methodologies. This would be a fertile field for further research. Beginning conversations with senior practitioners in this study about their work and their practice have yielded insights into the value of such research.
Limitations The limitations of this research have been discussed throughout this thesis. The clinical trial was underpowered, the acupuncture dose was smaller than desirable, the interviews with participants were limited to those least known to the researcher, the protocol focus group had no members from East Asia or Europe outside the UK, and a fully integrated mixed methodology study was not achieved.
Integration through mixed methods is acknowledged as difficult to do (Bryman 2008:160). The difficulty of mixed methods could be the absence of guiding exemplars or the difficulty of having both sets of skills within one researcher or research team. Still, at the end of this process, I feel that science-oriented readers will assess the qualitative work as an add-on to the core business of a clinical trial, and that the readers experienced in qualitative work similarly will see the richness of the qualitative work standing taller than the quantitative results. Perhaps this is inevitable until such time as there is a range of researchers in this field with experience in mixed methods. But the issue goes deeper than that - to what is valued in CAM or Chinese medicine research. Grypdonck (2006) argues that EBHC38 is an ideology (Miettinen, 1998) but one that violates its own ideology. Indeed, one of the basic tenets, very fundamental to EBHC, is that only what has been scientifically proven in RCTs is credible, and it is a matter of faith that only what has been proven in such research is safe to be used in health care to improve health (Sackett, Straus, et al., 2000). Evidence-based medicine is for believers, as they themselves state (Evidence-Based Medicine Working Group, 1992). However, there are no RCTs to substantiate the contribution of EBM (evidence-based medicine) to public health, as the proponents of
38 Evidence based health care
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EBHC have to admit (Haynes, 2002; Sackett, Straus, et al., 2000). There has been no RCT that proves the superiority of EBHC, and it is even inconceivable that such a trial could ever be carried out (Sackett, Straus, et al., 2000). EBHC adepts will be in the belief state forever. It is not a transient stage, not one that could be expected to be redressed in the near or far future. She goes on to say that qualitative studies can contribute to assessing appropriateness of care – assessing whether the chances are maximized that the care will contribute to the well-being of the person who needs it at reasonable cost for society. Certainly the current public debates about CAM therapies in Australia and the UK display the ideological fervour of science pitted against the ‗non-scientific‘ quacks of CAM, and are testimony to the limits of tolerance and open-mindedness in science and academe.
Implications for further research The development of ‗best practice‘ guidelines for supportive care and self-care prior to conception would enhance current clinical practice in both biomedicine and Chinese medicine. Using a ‗consensus-between-experts‘ method of achieving such guidelines is a transparent way to develop protocols that are appropriate for both acupuncture research and clinical practice.
A fully powered study is justified on the results, including trends and indications, displayed by the underpowered feasibility study. The clear benefits to the women involved of increased awareness of their fertility, improved sense of wellbeing and being able to engage in desired activities may flow on to improved fertility outcomes. There are trends that indicate this may be the case: reduced time to conception, reduced incidence of menstrual clotting, reduced length of pain and intensity of pain, normalisation of the length of the menstrual cycle and the increased heaviness of menstrual flow in the acupuncture intervention participants.
Future research should build in an evaluation of both the recipients‘ expectations and subsequent experiences of acupuncture and a similar evaluation of the participating acupuncturists‘ perspectives prior to and following the administration of the trial protocol. This approach to evaluating expectancy needs to be approached carefully as the influence of asking patients to report their expectancies and both when and how expectancies should be assessed need to be addressed empirically in order to determine the most appropriate method of assessing expectancies (Colagiuri and Smith 2012:10).
A further study could examine the value of an acupuncture intervention such as this one as a preliminary preparation for ART. Although few participants were IVF patients, those who were
[208] during the trial or immediately following the trial had improved outcomes. The value of attaching a research project to an ART clinic is that access to biomedical diagnostic and outcome measures is greater and follow-up can compare both fertility outcomes and also differences in the experiences of the ART intervention itself.
Further study of this kind could usefully involve the potential target population in developing appropriate outcome measures and tools and also be consultants to assist in the design of appropriate interventions. A critical review of research designs by those they are designed to assist would be a useful addition to any further research.
Conclusion As this thesis has exemplified, there are different understandings of quantitative and qualitative research approaches. Similarly, there are the parallel paths and essential differences between Greek-origin and Chinese-origin medicine and thought. Constantly examining the inner structure of different ideologies or thought systems or ‗rocks‘ - that are founded differently, grown differently, constituted differently- is perhaps fruitless: why globalise/synthesise/fully integrate? Both medicines are designed with, the core topic [as] …the misery of those who are ill, the pity of those who become healers for those who are in misery, and the unwillingness by either to tolerate such pitiful misery (Csordas 2006). Sometimes there is more knowledge to be gained from what isn‘t ‗rock‘ – what is excluded from the definitions of biomedicine and Chinese medicine?
The diffraction of water as it moves around and between two immoveable rocks is informative. By examining the pattern of movement around the fixed different entities - for example, by using the patient experience as guide to how we proceed, the practitioner experience, the harm generated by an intervention, the relationships that are generated by defining a person as a disease entity, how an embodied practice influences other bodies – these are all sideways or diffractive ways of assessing a healthcare practice.
From a global perspective, biomedicine is the bright searing incisive light that cuts through to the detail of disease mechanisms. Focusing just on this light will cause us to overlook the emanating wisdom of traditional medicines. Can each allow the other ?
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In an underdetermined world, we should look for measures that allow us to separate ‗what to do‘ from ‗what is real‘ and find other measures to determine how we do medicine.
The mind‘s far edges twitch, sensing kinships beyond reach.
Too much unseen, unknown, unknowable, Assumed missing therefore:39
39 Denise Levertov ‗Beyond the Field‘ in This Great Unknowing: Last Poems. 1999 A New Directions Paperback.
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Appendices
Contents Appendices ...... 1 Appendix 1: Notional script for interviews of acupuncturists who specialise in fertility ...... 2 Appendix 2 Questionnaire for focus group discussion ...... 4 Appendix 3 Protocol for trial ...... 6 Appendix 4 Participant Information Sheet ...... 12 Appendix 5 Participant Consent Form ...... 15 Appendix 6 Trial Entry Form ...... 16 Appendix 7 Measures of Primary Outcomes form ...... 21 Appendix 8 Diagnostic Assessment form ...... 26 Appendix 9 MYMOP preintervention form ...... 35 Appendix 10 Basal body temperature chart ...... 38 Appendix 11 Research sheet on lifestyle behaviours implications for fertility ...... 39 Appendix 12 Fertility Awareness Information Kit ...... 44 Appendix 13 Fortnightly contact form ...... 79 Appendix 14 Postintervention MYMOP form ...... 82 Appendix 15 Experience of acupuncture questionnaire ...... 84 Appendix 16 12 Month follow-up form ...... 86 Appendix 17 Monthly record of menstrual changes ...... 89 Appendix 18 Sample BBT charts ...... 92 Appendix 19 Notional interview script ...... 96 Appendix20: Proposed scale to assess the quality of acupuncture intervention ...... 97 Appendix 21 Publication related to thesis ...... 111
Appendix page 1
Appendix 1: Notional script for interviews of acupuncturists who specialise in fertility
What do you do when you do acupuncture?
When you’re working with women on fertility issues do you conceive of your task differently?
Do you use a particular approach with sub-fertile or infertile women?
Do you set up a particular environment in which to treat these people?
So what are the elements of that? What is a nurturing environment? Is it about colour?
And is there a particular style of acupuncture that you use more for fertility than you would for other things?
How you talk to that person, is that just as important as the actual points you use?
Do you work just with women or do you do couples? Do you work with them together?
Do you give a lot of information and advice?
What about the biomedical knowledge, is it really important for your practice?
Do you usually get women to do their BBT’s?
What’s sort of weighting do you give to acupuncture and herbs and lifestyle?
Are there particular acupuncture protocols that you use?
Are there particular acupuncture points that are critical to fertility?
Is there any lifestyle advice you give for a woman with fertility problems?
Are there particular food proscriptions or prescriptions that you use?
What do you think is exchanged during an acupuncture treatment?
Do you get something out of it?
How much is the relationship with you central to the success of treatment?
On a particular day do you think that the outcomes of any treatment depend on how you are?
Are there things that you do to prepare yourself for a treatment?
What practices, skills, stratagems, methods of operation do you employ?
Do you choose your treatment according to the menstrual cycle and all those sorts of things?
What else is minimum adequate treatment?
Appendix page 2
Is there anything else that you think I should include as a basic, or a minimum, or an adequate protocol for fertility?
What do you think would be the key elements of such a protocol?
Do you have an idea of what is an adequate length of time to treat, in terms of the individual treatment and then in terms of a course of treatment?
Appendix page 3
Appendix 2 Questionnaire for focus group discussion
1. The definition of acupuncture.
What constitutes 'acupuncture'? What do you do when you do acupuncture?
2. Acupuncture treatment and menstrual cycle
What do you each think is essential in an acupuncture treatment of a woman designed to promote conception?
Is the stage of her menstrual cycle the key indicator of which treatment principle, point selection and needling technique you use?
How precise is it necessary to be? For example, is a Day 8 treatment very different from a Day 10 treatment?
3. TCM/OM diagnosis
How important is the differential diagnosis to acupuncture point choice?
4. Timing of acupuncture
Does timing matter? in relation to the menstrual cycle? season? time of day? What timing is important if women are intending to undertake ART? or acupuncture between ART cycles?
5. Number of acupuncture treatments
How many treatments are necessary to be adequate (for maximising fertility)? Would you expect to give acupuncture weekly? more than weekly? monthly?
6. Needling technique
In reporting on acupuncture research it is important to specify details such as needling depth, needle direction, insertion mode, retention time, manipulation, order of insertion, unilateral or bilateral. Are there particular techniques which you would deem essential in acupuncture for fertility management?
7. Relationship with patient
How important is the therapeutic relationship in fertility acupuncture? Is this more important than when treating other disorders?
8. Lifestyle components
How important is lifestyle change? Do you give specific diet and exercise recommendations to fertility patients? Does this advice vary with differential diagnosis or is it standard? What is it?
9. Collaboration with other therapies
Do you work collaboratively with other modalities? E.g. Herbalism, homeopathy, counselling, nutrition. Does this non-acupuncture health care make a major contribution to the treatment package?
10. Importance of biomedicine
How important is a biomedical diagnosis to your choice of acupuncture treatment? Do you require a full biomedical work-up (blood tests, ultrasounds, laparoscopy) prior to treatment?
Appendix page 4
11. Referral on
At what point do you advise a patient to stop treatment? refer on to ART or adoption services? what are the indicators that you use to seek other treatment options?
12. Treatment environment
Have you created a special environment in which to treat women with fertility problems? What are the components of that place?
13. Personal agency
How important is your personal style or how you are on the day/at the point of treatment?
14. Specific Acupuncture Points
Are there particular acupuncture points that are essential to fertility treatment? ______
Appendix page 5
Appendix 3 Protocol for trial Acupuncture Treatment Protocols
Frequency Weekly
Number of treatments 9
Timing 1 hour [include front(anterior) & back(posterior) treatment per session]
Point location as per Deadman’s A Manual of Acupuncture
Needle depth as per Deadman’s A Manual of Acupuncture
Manipulation Achieve deqi on insertion, renew qi sensation 10-15 minutes after insertion
Retention time 20-30 minutes
Needling Bilateral unless on Ren & Du channels
Needles Use needles supplied by Helio Supply Co., that is, Acuglide & Vinco
Heat If heat is necessary apply using TDP lamp or smokeless moxa
Treatment principles a. by TCM diagnosis b. according to time of menstrual cycle c. according to emotional state or shen presentation d. biomedical condition e. add points according to presenting signs & symptoms Termination On pregnancy of treatment For 2 weeks after embryo transfer or on negative pregnancy test
Select an appropriate set of acupuncture points according to time in cycle and TCM diagnosis from the table below:
Treatment according to time of cycle should make special note of the beginning and end of the cycle. Giving acupuncture during the period and just prior to the period should only be undertaken if considered appropriate; that is, if there is period pain or clotting then acupuncture during the period is necessary or if there is a likelihood of pregnancy cautious treatment only should be used prior to the period.
Appendix page 6
Diff Dx/ Phase Phase 1 Phase 2 Phase 3 Phase 4 During period Post-period Ovulation Post-ovulation Core Sp 10, 6,8 Ren 4,7 Liv 3,5 A. [boost yang points(Lyttleton by 2004) LI 4 Ki 3,4,5,6,8,13 Ki 13,14,8,5,4 supplementing yin] St 28 St 27,30,36 Sp 13,8,6,5 Ren 2,4,5,7,15 Ki 14 Bl 23,32 Pc 6,5 Ki 3,6 Liv 3 Ht 7,5 Bl 23 Sp4,6,10 Yintang B. [boost yang Zigong promoting qi] GB 26 Ren 4,5,6,12 St 25,36 Sp 6 Ki 3 Bl 20, 23 C. [boost yang by nourishing blood] Ren 4,12 St 36 Sp 6,10 Ki 5 Bl 17
Kidney yin xu + Ki 2 + Ren 4 A. + Ki 2 Ki 3,6 Kidney yang xu + Bl 23 + Ren 6,4 + moxa Ren 3 St 29 Ren 2 Bl 32
Kidney jing xu + Ki 12 + Ren 4 A pts
Appendix page 7
Ki 12 St 27 Liver / Heart + Liv 2 + C pts Stagnation Ht 5,7 + Liv 2,3,4,5,8,9,11 Pc 6,7 Pc 5,6,7 Ren 3 Blood + Ki 16 + St 29 C pts stagnation Ren 3 Sp 10 + St 28,29 Sp 12 Liv 8 Liv 8,5 St 29 Bl 17 Sp 6,8 Liv 5 Ki 4,5 Sp 8 baliao Phlegm-Damp + GB 26 + Bl 22,28 B pts Sp 5 GB 27,28 + Ren 3, 6,9 Bl 28 Sp 9 GB 27,28 Ki 7 Bl 32 St 29 Sp 6,9 Shen disorder + GV 20, + GV 20, + GV 20, + GV 20, Yintang, Ht 7, Yintang, Ht 7, Yintang, Ht 7, Yintang, Ht 7, Pc 6, Kidney Pc 6, Kidney Pc 6, Kidney Pc 6, Kidney chest pts: Ki chest pts: Ki chest pts: Ki chest pts: Ki 23, 24, 25 23, 24, 25 23, 24, 25 23, 24, 25 Pts related to Pts related to Pts related to Pts related to each element, each element, each element, each element, eg.: Wood (GB eg.: Wood (GB eg.: Wood (GB eg.: Wood (GB 13,24,40, Liv 13,24,40, Liv 13,24,40, Liv 13,24,40, Liv 2,13,14); Fire 2,13,14); Fire 2,13,14); Fire 2,13,14); Fire (Ht 4,7, SI (Ht 4,7, SI (Ht 4,7, SI (Ht 4,7, SI 11,17 Pc 1,2, SJ 11,17 Pc 1,2, SJ 11,17 Pc 1,2, SJ 11,17 Pc 1,2, SJ 10,23); Earth 10,23); Earth 10,23); Earth 10,23); Earth (St 8,25,40 Sp (St 8,25,40 Sp (St 8,25,40 Sp (St 8,25,40 Sp 4,15) Metal (Lu 4,15) Metal (Lu 4,15) Metal (Lu 4,15) Metal (Lu 1,2,3 LI 17,18) 1,2,3 LI 17,18) 1,2,3 LI 17,18) 1,2,3 LI 17,18) Water (Bl Water (Bl Water (Bl Water (Bl 10,52, Ki 10,52, Ki 10,52, Ki 10,52, Ki 1,21,23,24,25) 1,21,23,24,25) 1,21,23,24,25) 1,21,23,24,25)
Appendix page 8
Ren, Du mai & Ren, Du mai & Ren, Du mai & Ren, Du mai & extra pts: Ren extra pts: Ren extra pts: Ren extra pts: Ren 1,4, 6,17,22, Du 1,4, 6,17,22, Du 1,4, 6,17,22, Du 1,4, 6,17,22, Du 4,10,20,24, 4,10,20,24, 4,10,20,24, 4,10,20,24, yintang(Hicks, yintang(Hicks, yintang(Hicks, yintang(Hicks, Hicks et al. Hicks et al. Hicks et al. Hicks et al. 2004) 2004) 2004) 2004) Extraordinary Opening & meridian closing pts as presentation appropriate, eg. Chongmai Sp 4 + Pc 6
In the event of a specific biomedical diagnosis consider including the following points:
Acupuncture for use with specific biomedical diagnoses
Condition Tubal infertility Zigong, BL 32, ST 30, ST 29, SP 12, KI 12. (Wang and Li 2005) Endometriosis Post-period: Ki 13, 14, 18 Ren 3,4,7,12 Sp 6 Liv 8 Ovulation: Liv 3, 11 Sp 6,4,12,13 St 29 Ki 4,8 Pc 6 Ht 7 Zigong Post-ovulation: Ren 4 Ki 3 St 29 Bl 23 Pc 7 Liv 2 Sp 1 Ht 7 Period: St 28,29 Sp 12,13,8,6,10 Ki 14 Ren 6 Bl 31-34, 26, 28,22 Shiqizhuixia Liv 2,8 Li 4 Pc 5(Lyttleton 2004) Bl 18,20,23, Liv 13,14, GB 25(Chen, Yue et al. 1996) Ovulation failure St 29, Ren 4,3 Zigong, LI 4, Sp 6 . Ki xu + Bl 23, Ki 3
Appendix page 9
.liver constraint + Liv 3 .blood xu + Sp 10 .phlegm-damp + Sp 9, St 40 .blood stasis + Bl 17(Chen and Li 2008) Anovulation or delayed Ren 3, Sp 10 & Ki 12(Zheng and Qian 2002) ovulation Salpingemphraxis/ Sp 6, Zigong, Ren 6, 3, LI 4, Ki 3 blocked tubes .qi stagnation & blood stasis + Bl 17,18 Liv 3 .damp-heat & stasis Ren 3 (xiefa) .cold-damp & stasis + moxa to Bl 21 .phlegm & stasis + St 40 (ping bu ping xiefa)(Chen and Li 2008) PCOS Sp 6, Zigong, Ren 3,4, Bl 20,23,18 .if obese use Ren 4,6, 10, 12 Sp 15, St 24, St 26
Immune infertility Bl 15,17,18,23, Liv 3, Sp 10, Ki 3, Ht 7 (ping bu ping xie)(Chen and Li 2008) Premature ovarian failure Ren 3,4,6,10,12 zigong, Ki 12, Bl 23, jiaji T5- L4 .liver & kidney xu + Sp 6,9, Bl 18, Ht 6, Ki 7 .spleen & kidney yang xu + Bl 20,32, Du 4, Sp 8(Chen and Li 2008)
Guidelines for choosing acupuncture points for treatments
A TCM diagnosis will be provided following subject’s intake interview with Sue Cochrane. Do not change this diagnosis without consultation with Sue first.
Appendix page 10
1st choose points suited to the time of the menstrual cycle
Eg. Zigong for ovulation time or
Sp10 during period
2nd choose points suited to the TCM diagnosis
Eg. Ren 4 + Ki 3 for Kidney yin xu
3rd choose points suited to the biomedical diagnosis
Eg. Sp 6 for PCOS
4th choose points on presenting symptoms
Eg. GB 20 for occipital headache
Appendix page 11
Appendix 4 Participant Information Sheet
Appendix page 12
Appendix page 13
Appendix page 14
Appendix 5 Participant Consent Form
Appendix page 15
Appendix 6 Trial Entry Form
Office use only Date Signed
LOG ID
CHECK
DATA Entry
QUERIES resolved/updated
First name: ………………………………………... Address: ……………………………………………
Surname: ………………………………………….. ……………………………………………………….
Post code
Date of birth: Phone number: (……..) ……………………… day month year
Age Mobile……………………………………….
Appendix page 16
ENTRY CRITERIA EXCLUSION CRITERIA 1. Women aged 15-44 years? 5. Diagnosis of non-patent fallopian tubes, no uterus or primary anovulation
Yes 1 Must be yes Yes 1 No 2
No 2 (Must be no) 2. Trying unsuccessfully to conceive for 12+ months 6. Partner sperm defect on sperm analysis Yes 1 Must be yes
Yes 1 No 2
No 2 (Must be no) 3. Diagnosis of causes of infertility Yes 1 Must be yes 7. Planning to use acupuncture in the next 3 No 2 months
Yes 1
Diagnosis______No 2 (Must be no)
4. Consent form signed
8. Unable to attend for at least 7 of 9 1 Yes 2 No (must be YES) acupuncture sessions.
Yes 1
No 2 (Must be no)
9. Date of study entry 10. . Time of study entry
day month year 24 hr clock
11. NUMBER allocated
12. Group 1 1 Group 2 2
Please complete all questions on the reverse side
Appendix page 17
13. Age 22. Currently enrolled in ART Yes 1 No 2
14. Gravida
23. Number of IVF cycles
1 1 2 2 3 3 4 4 5+ 5 15. Parity
16. No.of pregnancy losses:
24. Current weight . kgs u/k Miscarriage
25. Current height . cm u/k Stillbirth
TOP 26. BMI
17. Length of pregnancy for miscarriage weeks 27. Previous use of acupuncture
Yes 1 No 2
28. Are you currently using any CM to assist fertility?
Yes 1 No 2 If yes which CM? 18. Duration of infertility ______
years ______
29. Medical history 19. Reason for infertility Have you been diagnosed with any major conditions?______
Male factor 1 30. Are you currently on any medication? Female factor 2 ______
Combined 3 ______
Unexplained 4
Unknown (not investigated) 5
Appendix page 18
20.WM Fertility diagnosis
PCOS 1
POF 2
Recurrent miscarriage 3 Endometriosis 4 33. Have you completed any tertiary education?
High FSH 5 Yes 1 No 2
Tubal blockage 6 If yes Qualification from a TAFE or similar 3
Inherited chromosomal disorder 7 University degree 4
Fibroids 8 34. Race 1 Caucasian 5 Maori
Immune factors 9 2 Asian 6 Unknown 3 Aboriginal/TSI 7 Other – Unknown 10 4 Polynesian specify______
35. Which of the following best describes your current situation? 21. Interventions used Single 1 Married 2
Defacto 3 Separated but not divorced 4 Clomiphene citrate 1
Donor sperm 2 Divorced 5 Other 6 (please specify)…………
Intra uterine insemination with 3
controlled ovarian stimulation
IVF 4
Other 5
None 6
DEMOGRAPHIC DETAILS Now I would like to ask some questions about your background. This helps us to describe the diversity of women taking part in the survey.
31. Which of the following best describes your current employment status? 1. working full time (permanent or contract)
Appendix page 19
2. working part time (permanent or contract) 3. unemployed 4. home duties 5. student 6. permanently unable to work/ill 7. casual: full time 8. casual part time 9. other if usually working (full or part time), what is your usual occupation? Job position……………………….. industry…………………………….
32. Did you finish high-school?
Yes 1 No 2 NA 3
Appendix page 20
Appendix 7 Measures of Primary Outcomes form
Office use only Date Signed
LOG
ID CHECK
Measures of primary outcomes form DATA Entry [to be completed by investigator] QUERIES resolved/updated
Menstruation heavy 1 (excessive flow) 1.1 Age at menarche years moderate 2 1.2 Number of days bleeding in period
days light 3 (scanty)
inconsistent flow 4 1.3 Days in cycle days 1.8 Menstrual clotting
1 .4 Date of last menstrual period none 1 / / small 2
large 3 1.5 Current day in cycle 1.9 Menstrual colour
1.6 Regularity pale red 1
regular 1 bright red 2
dark red 3 irregular, tend to early 2
varies throughout 4 irregular, tend to late 3
irregular, varies early/late 4 1.10 Incidence of pain with menses 1.7 Nature of menstrual flow Yes 1 No 2
Appendix page 21
If yes – 2.5 Do you think any of these factors influence fertility? Frequency days Yes 1 No 2 which?______Intensity: mild 1 2 3 4 5 severe 3. Exercise
3.1 In the last 2 weeks did you engage in Nature: vigorous exercise (eg.which made you dull 1 sharp 2 fixed 3 spreading 4 breathe hard)?
Yes 1 No 2 Ameliorated by: no./2 weeks,time hrs
cold 1 warmth 2 rest 3 exercise passage of clots 4 5 3.2 In the last 2 weeks did you engage in other 6______less vigorous exercise that did not make you breathe hard? 1.11 Regularity of sexual intercourse Yes 1 No 2 (unprotected) no./2 weeks,time hrs times per cycle 3.3 In the last 2 weeks did you walk for recreation or exercise? Yes 1 No 2 no./2 weeks, time hrs
3.4 Which of the following best describes your walking speed at the moment? 2. Lifestyle Very slow 1 Stroll at easy pace 2 2.1 Smoking Yes 1 No 2 Normal speed 3 Fairly quick 4 no./day Fast 5
2.2 Alcohol Yes 1 No 2 no./day no./week 3.5 Do you think any of these exercise factors influence fertility?
Yes 1 No 2 2.3 Caffeine Yes 1 No 2 which?______no.cups/day
2.4 Rec drugs Yes No 1 2 4. Diet no./day no./week 4.1 Do you generally eat 3 meals a day?
Yes 1 No 2 no./day
Appendix page 22
4.5.6 extras or indulgences 4.2 Do you generally eat a balanced diet? no./day Yes 1 No 2 Describe______
4.3 Do you drink fluid regularly through the day?
Yes 1 No 2
no.cups/day 5. Stress
5.1 Current levels of stress 4.4 Do you think any of these diet factors influence fertility? mild 1 2 3 4 5 severe
Yes 1 No 2 which?______5.2 Factors that cause stress
5.2.1 work/job Yes 1 No 2 4.5 Dietary Assessment [attached food pyramid] 5.2.2 money Yes 1 No 2
Does your food intake approximate the food pyramid guidelines attached? 5.2.3 relationship Yes 1 No 2
Yes 1 No 2
If no, estimate how many serves of each 5.2.4 health Yes 1 No 2 food group consumed a day: 4.5.1 meats and their alternatives 5.2.5 fertility Yes 1 No 2
no./day
5.2.5 other Yes 1 No 2 4.5.2 milk and milk products
no./day 5.3 Do you think any of these stressful factors influence fertility? 4.5.3 fruit Yes 1 No 2 which?______no./day
4.5.4 vegetables 6. Fertility awareness 6.1 Do you know when you are ovulating? no./day Yes 1 No 2 4.5.5 breads and cereals how?______
no./day
Appendix page 23
6.2 Do you check your cervical mucus?
Yes 1 No 2
6.3 Do you record your BBT?
Yes 1 No 2
6.4 Do you chart other changes through your cycle?
Yes 1 No 2 what?______
Appendix page 24
Attachment to ‘Measures of primary outcomes form’
1
The 12345+ relates to the number of serves you should eat, on average, every day from each of the five main groups of foods, namely:
• meats and their alternatives - 1 serve a day
• milk and milk products – 2 serves a day
• fruit – 3 serves a day
• vegetables - 4 serves a day
• breads and cereals. – 5 + serves a day
1 http://www.nano.csiro.au/proprietaryDocuments/12345_Plan.pdf Appendix page 25
Appendix 8 Diagnostic Assessment form
Office use only Date Signed
LOG ID
CHECK
Date:__/__/____ Time:______Practitioner:______DATA Entry
QUERIES resolved/updated
GIT Sleep
Emotions Musculoskeletal
Heat/cold Energy/fatigue
Respiratory Palpitations/chest pain
Bowel movements Urine
Appendix page 26
Skin Gynaecological
Headache/dizziness Perspiration
Interventions used :
______
______
Last menstrual period / /
Day of menstrual cycle
Abdomen
Firm/soft Cool/warm
Tense/slack Marks
Tongue
Shape :
Appendix page 27
Large
Narrow
Teethmarks
Deviated
Swollen sides
cracked
quiver
Other______
Moisture:
Dry
Moist
other
Colour:
Pale
Pink
Red
Purple
Red tip
Red sides
Red spots
Other
Coat:
Appendix page 28
thin
thick
peeled
greasy
other
Coat colour:
white
yellow
grey
black
other
Underside:
dark veins
swollen veins
purple
other
Pulse
Fast Slow Floating Deep Has force Has no Other force qualities
Fast slow Floating Deep Has force Has no Wiry force
Skipping choppy empty Weak Full Weak slippery
Racing Relaxed Soft/soggy Hidden Tight Fine Long stirring bound Hollow Confined Large Empty short
Appendix page 29
Regularly Surging faint Soggy/soft intermittent
Scattered hidden
Drumskin
Rate: Overall quality:
Outstanding pulse:
Right Left
Cun Guan Chi Cun Guan Chi
Diagnosis:
Kidney jing xu
Kidney yang xu
Kidney yin xu
Blood stasis
Blood xu
Liver qi stagnation
Heart qi stagnation
Heart yin xu
Spleen qi xu
Heat
Appendix page 30
Damp/Phlegm
Shen disorder
Extraordinary meridian presentation
Other______
Treatment Principle:
First treatment:
Points used: Advice given:
______
2nd Treatment: Date-/_/__
Feedback:
Points used: Advice given:
Appendix page 31
3rd Treatment: Date _/_/__
Feedback:
Points used: Advice given:
4th Treatment: _/_/__
Feedback:
Points used: Advice given:
5th Treatment：Date_/_/__
Feedback:
Points used: Advice given:
Appendix page 32
6th Treatment: _/_/__
Feedback:
Points used: Advice given:
7th Treatment: Date_/_/__
Feedback:
Points used: Advice given:
8th Treatment: Date_/_/__
Feedback:
Points used: Advice given:
9th Treatment: Date_/_/__
Appendix page 33
Feedback:
Points used: Advice given:
Appendix page 34
Appendix 9 MYMOP preintervention form
Office use only Date Signed
LOG ID
CHECK
Date __/__/____ DATA Entry
QUERIES Preintervention Questionnaire resolved/updated
This questionnaire is to be completed by participant.
Choose one or two symptoms (physical or mental) which bother you the most. Write them on the lines. Now consider how bad each symptom is, over the last week, and score it by circling your chosen number.
SYMPTOM 1: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
(eg. This could be anything such as tiredness, depression, etc as long as it is important to you)
SYMPTOM 2: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
Appendix page 35
Now choose one activity (physical, social or mental) that is important to you, and that your problem makes difficult or prevents you doing. Score how bad it has been in the last week.
ACTIVITY: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
Lastly how would you rate your general feeling of wellbeing during the last week?
0 1 2 3 4 5 6
As good as it As bad as it
could be could be
How long have you had Symptom 1, either all the time or on and off? Please circle:
0 - 4 weeks 4 - 12 weeks 3 months - 1 year 1 - 5 years over 5 years
Are you taking any medication FOR THIS PROBLEM ?
Please circle: YES / NO
IF YES:
1. Please write in name of medication, and how much a day/week ......
2. Is cutting down this medication: Please circle:
Not important a bit important very important not applicable
Appendix page 36
IF NO:
Is avoiding medication for this problem:
Not important a bit important very important not applicable
Appendix page 37
Appendix 10 Basal body temperature chart
Appendix page 38
Appendix 11 Research sheet on lifestyle behaviours implications for fertility
The impact on fertility of lifestyle modification, diet & exercise
A study conducted in 1995 by Foresight showed that if both parents can improve their general health and avoid some common lifestyle factors and environmental hazards in the months preceding conception they can greatly improve reproductive outcomes and improve the future health of their child. (Foresight – The British Association for the Promotion of Preconception Care)
Age
Getting older is the major cause of not falling pregnant and there is little anyone can do about this except start trying early!
Smoking
Smoking tobacco is one of the most clearly indicated lifestyle factors that will cause problems for your fertility and chance of a healthy baby. “Cigarette smoking has been association with adverse effects on fertility, although this is not widely recognized. There is strong evidence of the adverse effects of smoking on fertility operating through a range of pathways in both the general and infertile population”(Homan, Davies et al. 2007).
As well as causing difficulties in achieving pregnancy smoking also causes problems during pregnancy. “Fetal effects of exposure to maternal smoking include intrauterine growth retardation, prematurity, low birthweight, and sudden infant death syndrome (SIDS). Maternal complications include premature rupture of membranes, placenta previa, and placental abruption with suggestive evidence for an association between smoking and ectopic pregnancy and spontaneous abortion”(Floyd, Jack et al. 2008). Other researchers found “compelling evidence for a significant negative effect of cigarette smoking upon clinical outcomes of ART and should be presented to infertility patients who smoke cigarettes in order to optimize success rates” (Waylen, Metwally et al. 2008).
Stopping or reducing smoking is difficult but worth the effort to increase your chance of getting pregnant and then improving the life chances of your baby.
Appendix page 39
Alcohol
There is no clear evidence about drinking alcohol affecting your fertility. “Moderate levels of alcohol consumption (seven to eight drinks per week) have been associated with reduced fertility and an increased risk of spontaneous abortion. Levels as low as one drink per week have also been associated with reduced conception” (Homan, Davies et al. 2007). The problem arises when you do fall pregnant as there is clear evidence that alcohol is not good for your baby in the womb. “There is no established safe level of alcohol consumption during pregnancy… Alcohol use levels prior to pregnancy are the strongest predictor of alcohol use during pregnancy…. The US Department of Health and Human Services, Office of the Surgeon General, released an updated Advisory on Drinking and Pregnancy in 2005 advising women who are pregnant, planning to become pregnant, or at risk of becoming pregnant to abstain from alcohol use..” (Floyd, Jack et al. 2008).
Coffee/Caffeine
Caffeine has been linked to decreased fertility but there is not yet enough evidence to show that a no caffeine diet is clearly better for women who want to be pregnant. “The consumption of caffeine has been associated with reduced fecundity in the general population. A prospective study of 104 women attempting pregnancy found strong evidence of a reduced chance of pregnancy with increasing caffeine consumption” (Homan, Davies et al. 2007). Sensible advice would be to reduce caffeine intake before conception and throughout pregnancy (CARE Study Group 2008).
Note that decaffeinated coffee could aggravate the immune system more than the caffeinated variety (Mikuls, Cerhan et al. 2002).
Drugs
There are problems with both illicit drugs and some pharmaceutical drugs. The use of Cannabis by women in the year before IVF treatment is associated with a reduction of the number of eggs collected (Klonoff-Cohen 2006). There has not been a lot of research into the impact of illegal drugs, such as marijuana, cocaine and amphetamines, on fertility but there is evidence that they can damage a growing baby. The safest advice would be to stop using such drugs. If this is hard to do then seek some advice and get some help.
In relation to your legal drugs make sure you discuss with your doctor if any of your medications could be interfering with your ability to get pregnant and carry a pregnancy.
Weight
Appendix page 40
Being overweight or underweight can affect normal ovulation, reduce the chance of getting pregnant, increase pregnancy complications and the risks associated with anaesthesia etc. If your body mass index is above 30 you need a supervised weight loss program involving dietary advice and exercise. Overweight women take longer to conceive and are at higher risk of miscarriage than ordinary women. If your body mass index is less than 20 then you may also need to go on a sensible eating program to correct it. Restoration of body weight may help resume ovulation and restore fertility.
Being both overweight and underweight can impair a woman's odds of getting pregnant. Being underweight often leads the reproductive system to shut down because of the body's inability to maintain a pregnancy. On the other hand, being overweight or obese also reduces a woman's chances of getting pregnant. Studies have found that a weight loss of just 4.5 kg (10 pounds) can improve an overweight or obese woman's odds of getting pregnant. In order to maintain a healthy weight while getting pregnant, follow a healthy, balanced diet. Your weight can be affected by a variety of poor lifestyle choices, such as smoking, stress and drug use.
Alternatively, obesity can also have a negative impact on a woman's ability to get pregnant. In fact, 12% of infertility cases are due to being overweight or obese. This is because fat increases the amount of oestrogen produced by the body. Since 30% of oestrogen comes from fat cells, having higher levels of fat leads to an increased production of oestrogen, which can affect ovulation, menstruation and fertility. Obesity also increases the risk of being resistant to insulin, which results in the body's overproduction of insulin, a process that in turn prevents ovulation.
Food
Although many women are aware of the fact that maintaining a well-balanced, nutritious diet and practising regular exercise is important to their overall health, it is a lesser known fact that a healthy diet and overall healthy lifestyle is crucial to your reproductive health and your chances of getting pregnant. Whether or not you maintain a healthy diet and lifestyle can greatly impact your odds of getting pregnant. Maintaining a healthy diet, full of nutritious foods, such as lean protein, fruits and vegetables and whole grain products, is important to maintaining your overall health, as well as your reproductive health by providing you with important nutrients and vitamins crucial to your overall health. Eating a healthy breakfast is especially important to improving your chances of getting pregnant via a well-balanced diet.
It is essential to eat a balanced healthy diet with fresh fruits, green vegetables and plenty of water. Avoid eating processed food as it contains flavouring and additives.
Exercise
Exercising while trying to conceive is an important contribution, especially for those wishing to reduce their weight. However, studies show that frequent, strenuous exercise may reduce potency in men and fertility in women, which does not provide optimum sperm and eggs. While trying to be pregnant, a person should participate in low-impact exercises, such as walking, swimming or bicycling. Activities such as running or playing full-impact sports, such as football or basketball, should be avoided. Men should also avoid post-workout saunas or soaks in hot tubs, as this can
Appendix page 41
harm semen production in the body.
Exercise affects the amount of body fat that a woman has; having a body fat level that is between 10 and 15 percent above or below normal levels (between 20 and 27 percent) can lead to infertility. Therefore, it is important to consider the effects of exercise on your fertility, as exercise can either improve your chances of getting pregnant or decrease them.
Stress
Stress of course is a normal part of life. There is some evidence that too much stress can be a problem for fertility. The failure to fall pregnant when you want to is in itself stressful and there is research evidence that shows that infertile couples have increased stress. Stress can lead to anovulation and hence infertility.
One of the most effective ways to reduce the impact of stress on your health is to have a good sleep each day. Sleep renews your mind and body. Good sleep habits can be learned whatever your history of sleep problems.
Gentle exercise and meditation which focuses on breathing slowly and deeply can be very calming and a technique that has been proved to settle the mind and relieve stress. There are many alternatives available like yoga, tai chi, pilates or different varieties of meditation or mindfulness training to explore until you find a method that suits you.
Environmental toxins
“Certain environmental exposures have been implicated in adverse effects on reproduction”(Homan, Davies et al. 2007). Chemicals used in homes and workplaces can affect the fertility of both men and women. For example, fumes from photocopiers and printers, dry cleaning fluids, petrol, ammonia, and nail polish remover can interfere with conception in susceptible people. Avoid chemicals as much as possible. Stay away from weed killers, dry cleaning fluid and household cleaners, paints, solvents, etc. Do not have your house or garden treated for pests or fumigated while you are there.
There is evidence that exposure to heavy metals can interfere with conception and may injure the unborn child. Mercury, lead and cadmium have all been associated with pregnancy loss through miscarriages.
References
CARE Study Group (2008). "Maternal caffeine intake during pregnancy and risk of fetal growth restriction: a large prospective observational study." British Medical Journal 337: a2332.
Appendix page 42
Floyd, R. L., B. W. Jack, et al. (2008). "The clinical content of preconception care: alcohol, tobacco, and illicit drug exposures." American Journal of Obstetrics & Gynecology Supplement: S333-S339.
Homan, G. F., M. Davies, et al. (2007). "The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review." Human Reproduction Update 13(3): 209-223.
Klonoff-Cohen, H. S. N., Loki Chen, Rosa Victoria (2006). "A prospective study of the effects of female and male marijuana use on in vitro fertilization (IVF) and gamete intrafallopian transfer (GIFT) outcomes." American Journal of Obstetrics and Gynecology. 194(2).
Mikuls, T. R., J. R. Cerhan, et al. (2002). "Coffee, tea, and caffeine consumption and risk of rheumatoid arthritis: results from the Iowa Women's Health Study." Arthritis Rheum. 46(1): 83-91.
Waylen, A. L., M. Metwally, et al. (2009). "Effects of cigarette smoking upon clinical outcomes of assisted reproduction: a meta-analysis." Human Reproduction Update 15 (1): 31-44
Appendix page 43
Appendix 12 Fertility Awareness Information Kit
Material reproduced from website http://www.fertilityuk.org/nfps25.html
For the woman experiencing fertility problems
The short cycle showing early ovulation, or the long cycle showing late ovulation, may highlight the mis-timing of intercourse.
This commonly occurs in women who have been told that they should have intercourse on the 14th day or mid-cycle.
In the examples below, all the charts show consistent length luteal phases of around 14 days, but greater variability in the length of the pre-ovulatory phase.
The temperature shifts vary from day 12 in the 25 day cycle, to 18 in the 30 day cycle and as late as day 23 in the 35 day cycle.
This highlights the importance of women having increased awareness of mucus symptom as an indicator of fertility.
The temperature is of imperfect value in predicting ovulation.
Appendix page 44
This series of charts also highlights the importance of the accurate timing of diagnostic tests.
For example a „Day 21 Progesterone‟ to assess the occurrence of ovulation, must be carried out some days after ovulation regardless of the day of cycle.
If a progesterone assay was taken on day 21 in the 35 day cycle, it would have been taken before ovulation occurred.
Appendix page 45
Similarly, a sperm-mucus compatibility test must be performed prior to ovulation regardless of the day of cycle, and when a woman has highly fertile mucus - increased wetness or slipperiness and a transparent stretchy mucus secretion.
Short luteal phase
The short luteal phase is significant - Fertilisation may occur but implantation does not occur if the luteal phase is less than eight days.
In this example, the temperature shift occurs on day 14, but the shift is minimal and is not sustained.
A monophasic chart indicates that there has been no ovulation in this cycle.
The temperature remains on one level.
The bleed, not a true period, is often lighter than usual.
Appendix page 46
Faulty technique
This erratic temperature chart is the result of poor technique.
There is no value in recording the BBT unless it is done accurately.
Women also need to understand the implications of disturbances, such as illness, alcohol, medication, or disturbed sleep patterns and note their occurrence.
A temperature chart showing erratic and abnormally low readings usually indicates faulty technique.
Achieving pregnancy
Appendix page 47
This woman was planning pregnancy. Her cycles varied from 25-33 days.
She recorded her period for the first five days and then felt dry on day 6.
On day 7, she felt moist at the vaginal lips and noted some white mucus later in the day.
She knew her fertile phase had started.
Her mucus pattern continued, becoming cloudy and then clear and slippery on days 10-12.
She recognised this as highly fertile mucus, and had intercourse to coincide with this.
She noted her temperature shift on day 13, confirming ovulation.
On day 21, her temperature showed a further increase (possibly coinciding with implantation).
Her temperature remained high and her period did not arrive as she might have anticipated on day 26/27.
A sustained high temperature for more than 20 days indicates pregnancy.
This was confirmed with a pregnancy test.
Appendix page 48
PLANNING PREGNANCY
This section on planning pregnancy assumes knowledge of the section on Fertility Indicators - Temperature, Cervical Mucus and changes in the Cervix.
As many as one couple in six experience some difficulty in conceiving.
Fertility awareness is particularly valuable for couples with fertility problems as this can help to:
assess the occurrence and timing of ovulation predict the days of maximum fertility optimise the timing of intercourse to conceive time tests used for investigation of fertility problems
Research has shown that the chances of conception are limited to the five days before, and the first day after the temperature rise. The most fertile day was found to be two days preceding the temperature shift which approximates to peak mucus day.
To conceive For the normal fertile couple, conception is possible at any time during the fertile phase, but intercourse is most likely to lead to conception on days when highly fertile mucus is present, when there is a wet or slippery sensation at the vulva, and the cervical mucus is clear and stretchy like raw egg white. The most abundant fertile
Appendix page 49
mucus normally occurs one or two days prior to peak day and is a time of very high fertility. Peak day, the last day when highly fertile mucus is present, frequently coincides with the day of ovulation. The temperature shift confirms that ovulation has taken place. At the time of maximum fertility, the cervix is high, short, straight, soft open and flowing with fertile mucus.
Aim to have intercourse during the fertile phase:
When highly fertile mucus is recognised As close to peak mucus day as possible
Temperature Temperature charts can be a valuable aid to conception when used correctly. They have no value in predicting ovulation but are a reliable means of confirming ovulation. (The temperature shifts by around 0.2 deg. C following ovulation)
A biphasic chart indicates that ovulation has taken place A post-ovulatory phase of less than about nine days, may indicate a disturbance in implantation. A monophasic chart (all temperatures on one level) indicates the absence of ovulation
The temperature chart can also help to confirm pregnancy. Many women will record a second increase in temperature to an even higher level, several days after the ovulation shift due to an increase in progesterone production following implantation. A raised temperature lasting more than twenty days almost certainly indicates pregnancy. A pregnancy test can be done to confirm this.
Appendix page 50
Cervical mucus Observing the changes in cervical mucus gives the most accurate means of timing intercourse to optimise the chances of conception. This is particularly beneficial for women with irregular cycles or with very short mucus pattern possibly lasting only a number of hours.
Overview of Fertility Fertility Awareness Awareness Recognising the changes in a woman„s fertility cycle Understanding ovulation and the viability of the egg Understanding that sperm are viable for a number of days in optimum conditions Using this knowledge to plan or avoid pregnancy and control fertility
Overview of Fertility Awareness
Understanding fertility Fertility and reproductive health are largely neglected areas in health education. This ignorance and the lack of easily available accurate information about the increasingly popular natural methods of family planning, means that women are frequently denied the full range of family planning choices.
The results of a survey carried out in 1993 in six Western European countries found that the majority of women lacked knowledge concerning basic facts about menstruation, fertility and pregnancy.
One fifth of women had no idea what was happening when their periods started. There was misunderstanding regarding the process of ovulation and the timing of conception. In the UK, one third of the women questioned believed that :
Appendix page 51
'ovulation occurs during menstruation'.
The number of fertile days in the menstrual cycle was over estimated. In the UK, 21% of women thought that :
'there were more than 21 fertile days'
(the average number is 7)
What is fertility awareness?
Understanding basic information about fertility and reproduction. Identifying the signs and symptoms of fertility during the woman„s fertility cycle. Applying this information to oneself, discussing it with a partner, and with health professionals.
Why is fertility awareness important?
Fertility Awareness is fundamental to understanding and making informed decisions about family planning choice and reproductive health. Fertility Awareness is fundamental to understanding and using natural family planning, whether to plan or avoid pregnancy. Fertility Awareness helps women to value their fertility, which can be easily damaged by infections, especially sexually transmitted diseases, many of which can result in fertility problems.
Fertility Awareness is relevant throughout a woman‘s fertile life -
Puberty and adolescence Considering an appropriate method of family planning. Preparing for pregnancy Following childbirth and during breast-feeding Approaching the menopause
Efficiency - When motivated couples are taught by experienced teachers, natural methods can be up to 98% effective. (Range 85-98% effective - FPA 1996)
Appendix page 52
INDICATORS OF FERTILITY
This section provides information on observing, recording and interpreting the indicators of fertility. When a combination of indicators is used, this is often called a multiple indicator approach. The method used here is the sympto-thermal method, in which temperature charting is combined with observation of the cervical mucus symptom. Checking for changes directly at the cervix is optional. Other secondary or minor indicators of fertility may be observable as additional signs.
With time and experience the fertility indicators can be used to determine the fertile and infertile phases of the cycle. This knowledge can be used for planning or avoiding pregnancy.
TEMPERATURE
A sustained rise in the basal body or waking temperature will confirm ovulation. Following ovulation, the hormone progesterone raises the waking temperature by around 0.2 deg.C and maintains it at the higher level until the next period. The rise or shift in temperature helps to identify the start of the post-ovulatory infertile phase.
Temperature readings have no value in predicting ovulation.
RECORDING AND CHARTING THE BASAL BODY TEMPERATURE (BBT)
The temperature should be taken immediately on waking before getting out of bed, drinking tea or any other activity, and at about the same time each morning. 1. If the recording time varies by more than 1 hour, this must be noted.
2. The temperature may be taken by the mouth, vaginal or rectal routes.
Appendix page 53
Mouth or oral route. The silvery end of the thermometer is placed under the tongue, with the lips closed for the appropriate time. Vaginal route. The thermometer is inserted gently into the vagina. Rectal route. A trace of Vaseline or KY jelly is smeared on the silvery end which is inserted gently into the rectum, while lying on one side with the knees drawn up.
For accuracy, whatever route has been chosen should be followed throughout the cycle.
Oral temperatures usually give satisfactory results if exact instructions are followed, but for some women internal temperatures tend to be more reliable.
The chart is marked with the temperature reading by a dot in the centre of the appropriate square. The dots should be joined to form a continuous graph.
If one or more temperature reading are missed do not join non-consecutive dots. 3.
Fertility thermometer - If the mercury stops between two marks the lower reading should be recorded. Digital thermometer - Only record the reading to the first decimal place.
5. The thermometer should be cleaned with cotton wool and cold water
A new chart is started on the first day of menstruation (fresh red bleeding).
6. This is Day 1 of the cycle.
If menstruation starts during the day, that morning's temperature should be transferred to a new chart.
Anything unusual should be noted on the chart, such as a cold, a late night, drinking alcohol, or 7. any stressful situation.
THERMOMETERS
There are two types of thermometer in common use:-
Glass / mercury fertility thermometer
Appendix page 54
Digital thermometer
Fertility Thermometer
This mercury and glass thermometer is like a clinical thermometer, but it covers only the range from 35-39 deg. C.
This makes it easier to detect the minimal changes which occur.
Because of its fragility, special care has to be taken in using the fertility thermometer.
A woman should have two fertility thermometers available in case of breakage.
(The use of a new thermometer should be recorded on the chart).
It must never be put in hot water It should not be used if a woman suspects she has a fever It should be kept away from children Care must be taken when shaking it down after use. The mercury should be shaken down below 35 deg. C the night before.
The time taken to record the temperature :-
Oral temperatures - 5 minutes Internal temperatures (vaginal or rectal) - 3 minutes
Digital Thermometer
Battery-operated digital thermometers are now chosen by many women because although they are more expensive, they are safer, being virtually unbreakable and there is no restriction on air travel.
They are easy to read and the recording time is reduced.
Digital thermometers give an audible bleep when the temperature has stabilised (after about 1 minute). This useful feature avoids the need for clock watching.
Appendix page 55
Many digital thermometers also have a ‘last memory recall’ feature. This is particularly useful as it avoids the necessity for recording the reading immediately if this is inconvenient.
It is important to follow the manufacturers instructions and replace the battery as indicated.
INTERPRETING THE TEMPERATURE READINGS
Ovulatory cycles - Identifying the temperature shift
A cycle in which ovulation has occurred is characterised by a biphasic temperature chart. The temperature remains at the lower level until the time of ovulation, when a rise or shift occurs of about 0.2 deg. C or more. The rise usually takes place abruptly between one day and the next. The temperature remains on the higher level until just before, or at the onset of, the next period.
To determine the post-ovulatory infertile phase
If pregnancy is to be avoided, intercourse cannot be resumed immediately the temperature shift is recorded. The ovum or egg can be fertilised for up to 12 hours after ovulation and allowance must be made for the possibility of a second ovulation within 24 hours of the first, a rare phenomenon which occurs in twin pregnancies.
Rule of 3 over 6
The post-ovulatory infertile phase begins after the third high temperature has been recorded.
There must be three undisturbed high temperatures above the level of the previous six daily temperatures.
The shift need only be 0.1deg.C but one of the three high temperatures should be at least 0.2 deg. C above the coverline.
Appendix page 56
To identify the relevant temperatures when applying the rule of 3 over 6, a horizontal coverline is drawn on the line immediately above the highest of the low temperatures. A vertical line is then drawn forming a cross on the chart between the two days when the temperature shifts from the lower to the higher phase. This is illustrated above with the three higher temperatures in the upper right quadrant and the previous six in the lower left quadrant. As soon as the third high temperature has been recorded, intercourse can be resumed and the rest of the cycle will be infertile.
The 3 over 6 rule is very efficient and simple to use and for this reason is the method adopted here for identifying the post-ovulatory infertile phase for women of normal fertility.
There may however be circumstances where the use of a coverline technique may help to avoid errors of interpretation, when there is any doubt about the accuracy of the 6 low temperatures. This may occur when there is a particularly disturbed chart, or in special circumstances such as during breast-feeding, post-pill or during the pre- menopause.
Coverline technique
A horizontal coverline is drawn over all the low phase temperatures excluding temperature recordings on the first four days of the cycle, and any disturbances.
There must be a minimum of six low temperatures.
Appendix page 57
The three high temperatures must all be above the coverline.
At least one on the three high temperature should be a minimum of 0.2 deg.C
The post-ovulatory infertile phase commences after the third undisturbed high temperature has been recorded.
As a woman gains experience in recording her temperature, she will learn to recognise her usual coverline and the normal range for her low phase temperatures and then the higher phase temperatures. The experience of past cycles can be very helpful particularly in interpreting a more difficult chart.
Variations in the temperature rise or shift
An abrupt rise is the most common with the temperature showing a sharp rise between one day and the next, although other variations may occur.
A slow rise is one in which the temperature rises slowly over several days.
A step rise is goes up in a series of steps.
These may easily be interpreted using the rule of 3 over 6.
Appendix page 58
A saw tooth rise goes through a series of peaks and troughs and although very rare is more difficult to interpret - experienced help is needed.
By drawing a coverline, identify the beginning of the rise. The post-ovulatory infertile phase begins after the fifth temperature has been recorded.
Variations in shift day
Cycle lengths will vary considerably, but as the temperature shift occurs 12-16 days before the next period it follows that it will occur earlier in shorter cycles and later in longer cycles.
The length of the pre-ovulatory infertile phase will vary accordingly but the post- ovulatory infertile phase will remain constant.
Variations in Shift Day. Arrows show the Temperature Shift
Appendix page 59
A Temperature Spike
A temperature spike is defined as a single recording which is 0.2deg.C or more above its immediate neighbours.
It may be caused by a disturbance from alcohol, a late night, oversleeping, minor illness or stress. Sometimes there may be no obvious cause for a spike.
When interpreting the chart it is often helpful to circle the spike so that the disturbance is easily recognised.
Appendix page 60
One temperature spike may safely be ignored when determining the six temperatures on the lower level, but where possible there should be an explanation for the temperature disturbance.
If more than one spike is present, then it is advisable to wait a further few days until the position becomes clear again.
If a disturbance affects one of the three higher temperatures, it is advisable to wait for a fourth high temperature to ensure infertility.
Short post-ovulatory (luteal) phase
Some women will experience cycles with a shortened post-ovulatory phase.
If the post-ovulatory phase lasts less than nine days, the cycle will be infertile as there is insufficient time for implantation to take place. This can only be seen retrospectively.
Short luteal phases may be observed during times of stress or during special circumstances (breast-feeding, post-pill or pre-menopausally)
The short luteal phase is of particular significance for couples planning pregnancy.
Appendix page 61
Anovulatory cycles
In a small proportion of cycles, ovulation does not occur.
Anovulatory cycles are characterised by a monophasic chart, that is the temperature readings remain on one level throughout the cycle. This may be contrasted with the distinct biphasic pattern demonstrated by the ovulatory cycles.
Anovulatory cycles are more common at the extremes of the fertile life, adolescence and the pre-menopause. They may also occur after childbirth, and after coming off the contraceptive pill.
Faulty recording technique
A very erratic temperature chart may indicate faulty recording technique.
It differs from a chart affected by illness, by showing frequent subnormal readings as well as high readings.
Appendix page 62
Erratic temperature readings are most frequently seen during the learning phase
Temperature-taking and recording techniques need to be accurate.
Common errors include:
Failing to leave the thermometer in place for the required length of time · Alterations in recording time (with no explanation) · Alterations in route mid-cycle · Change of thermometer mid-cycle · Possible battery failure - digital thermometer · Failing to shake the mercury down properly - glass / mercury thermometer
If the temperature is being taken orally, it may be wise to change to the vaginal or rectal route at the beginning of the next cycle, if this is acceptable. This tends to give a more stable pattern which is easier to interpret.
RECOGNISING THE CHANGES IN CERVICAL MUCUS
During the menstrual cycle changes take place in the mucus produced by the cells lining the cervical canal. Cervical mucus can be recognised by sensation, by appearance and by testing with the finger-tip.
Sensation
Appendix page 63
Sensation is very important and often the most difficult to learn. Throughout the day the presence or absence of mucus will be recognised by the sensation at the vulva (the vaginal lips), the way the beginning of a period is noticed. The sensation may be a distinct feeling of dryness, of dampness or moistness, stickiness, wetness, slipperiness or lubrication.
Appearance
Soft white toilet tissue should be used to blot or wipe the vulva. There may be dampness only on the tissue resulting from vaginal moistness. This moistness soaks into the tissue and any cervical mucus will appear raised as a blob on the tissue. The colour should be noted. It may be white, creamy, opaque, or transparent (clear).
Mucus is often noticed on underclothing, where it will have dried slightly causing some alteration in its characteristics.
Finger Testing
A finger-tip can be lightly applied to the mucus on the tissue and then pulled gently away to test its capacity to stretch. It may feel sticky and break easily, or it may feel smoother and slippery like raw egg white and stretch between the thumb and first finger, from a little up to several inches before it breaks. This stretchiness is described as the Spinnbarkeit or Spinn effect, and shows that the mucus is highly fertile.
Sensation Finger Test Appearance at Vulva
Early Mucus Scanty Moist Thick or White Sticky Sticky Holds its shape
Appendix page 64
Transitional Mucus Increasing Amounts Wetter Thinner Cloudy Slightly Stretchy
Highly Fertile Mucus Profuse Thin Slippery Transparent Stretchy (like raw egg white)
CHANGES IN CERVICAL MUCUS DURING THE FERTILITY CYCLE
Pre-ovulatory relatively infertile phase
Following the menstrual period there may be several dry days.
These days may be absent in short cycles and numerous in long cycles.
A feeling of dryness or a positive sensation of nothingness at the vulva will be experienced. There will be no visible mucus.
Appendix page 65
The fertile phase
As the oestrogen levels rise, cervical mucus will be felt at the vulva.
At first it will give a sensation of moistness or stickiness and will appear in scant amounts - white or creamy-coloured.
On finger testing the mucus will hold its shape and break easily.
The mucus goes through a transitional phase where increasing amounts of cloudy mucus secretion may be observed.
It may be slightly stretchy on finger testing producing a wetter sensation at the vulva.
As the oestrogen levels continue to rise with approaching ovulation, the mucus will become more profuse, and there may be up to a tenfold increase in volume.
It will give a sensation of lubrication or slipperiness at the vulva.
The appearance will be similar to that of raw egg white, thin, watery and transparent.
On finger-testing this highly fertile mucus may stretch for several inches before it breaks.
Fertile mucus maintains the life of sperm, nourishes it and allows it to pass freely through the cervix.
In fertile mucus, sperm may live for up to three days, in rare circumstances for five days or even longer.
Peak day
Peak day denotes the LAST day on which this highly fertile-type slippery, transparent, stretchy mucus is either seen or felt.
Post-ovulatory completely infertile phase
During the post-ovulatory phase, following peak day the slippery sensation is lost and there will be a relatively abrupt return to stickiness or dryness again.
This subjective symptom reflects the presence of progesterone, which thickens the mucus again forming a plug at the cervix acting as an impenetrable barrier to sperm.
The amount and quality of mucus will vary from woman to woman and also from one cycle to the next.
Appendix page 66
A woman should be alert to any changes in sensation and to even relatively small amounts of mucus. If a woman is finding difficulty detecting mucus externally, it is often recognised more easily after exercise or a bowel movement. It may also help to use the Kegel exercise or a slight bearing down action to expel any mucus.
RECORDING CHANGES IN CERVICAL MUCUS
RECORDING MUCUS ON THE SYMPTO-THERMAL CHART
Mucus should be observed throughout the day and the chart marked each evening. This allows changes to become apparent during the day.
Each day of a period or blood loss, including spotting, i marked with a P
Each day when there is a dry sensation at the vulva, and no visible mucus is marked with a D
Each day of sticky white/creamy mucus is marked wit an M
Each day of highly fertile wet or slippery, transparent, stretchy muc s is marked with an F
A woman should describe the mucus in her own words.
Sensation: e.g. moist, sticky, wet, lubricative, slippery. Appearance or colour on soft, white toilet tissue: e.g. white, creamy, cloudy, or transparent.
Appendix page 67
Fertile-type mucus may be slightly blood-tinged.
The finger-test. Consistency may be described as sticky, thready or stretchy.
In practice the characteristic mucus changes may not be well defined.
There may be a combination of two types of mucus, e.g. cloudy, thready mucus with some transparent stretchy mucus.
The mucus possessing the more fertile characteristics should be recorded.
Peak day
This is marked with a cross through the last F .
Remember that peak mucus day denotes the last day of highly fertile mucus (symbolised by an F), i.e. last day of wetness or lubricative sensation, when slippery, transparent, stretchy mucus is present.
Peak day is not necessarily the day of the most profuse mucus.
Peak day will only be known in retrospect. On the day following peak there will be a change to the thick, white, sticky mucus again, or to dryness.
Additional signs
Any additional signs (secondary or minor indicators) are recorded, for example one-sided abdominal pain, bloated abdomen, mood variations including increased libido.
Intercourse
Each act of intercourse is marked with an I or by circling the appropriate day.
If avoiding pregnancy the significant acts to be recorded are the last before, and the first intercourse after the fertile phase.
Appendix page 68
INTERPRETING CHANGES IN CERVICAL MUCUS DURING THE FERTILITY CYCLE
The following charts illustrate variations in individual mucus patterns.
The period and dry days in a 28 day cycle
The first day of menstruation (fresh red bleeding) is the first day of the cycle.
A variable number of dry days marked D may follow the period.
Onset of mucus immediately after the period in a 25 day cycle
Days marked M indicate the presence of mucus and the absence of pre-ovulatory dry days.
This is more common in short cycles.
Onset of mucus after dry days in a 27 day cycle
Appendix page 69
Dry days marked D are followed by the onset of mucus on day 8.
It is important to recognise the change in sensation at the vulva from true dryness to moistness.
Days of moist or sticky sensation or appearance of sticky white or cloudy mucus are marked with an M and described appropriately.
Recording a wet day the day after intercourse in the pre-ovulatory phase.
During the learning phase the day after intercourse is marked as wet (M) because of the difficulty in distinguishing mucus from seminal fluid.
Note: Intercourse during the early dry days is unlikely to lead to pregnancy, although there is always some risk in the pre-ovulatory phase.
Mucus pattern approaching peak day.
Appendix page 70
Any days of highly fertile clear stretchy mucus giving a wet or slippery sensation are marked with an F.
The last F day is peak mucus day and is marked with a cross through the F.
Peak day and the change after peak.
After peak day, there is an abrupt change to sticky mucus or dryness.
If relying on mucus symptom alone, four days marked 1,2,3,4, must elapse before intercourse can be resumed on the fourth day
Mucus changes throughout the cycle.
Complete cycle showing typical pattern of menstruation, pre-ovulatory dry days, mucus days with increasingly fertile characteristics approaching peak day, the abrupt change back to less fertile characteristics, the count of four after peak day and post-ovulatory dry days.
Appendix page 71
Guidelines for achieving pregnancy - Using mucus symptom only
Couples wishing to achieve pregnancy should have intercourse on any day when highly fertile-type mucus is present. Frequently the day of maximum amount of highly fertile mucus precedes peak day by one or two days.
Peak day and the two days preceding peak are the days of maximum fertility
.
The First and Second Indicators of Fertility (temperature and cervical mucus) can now be combined to allow a double check.
Combining the temperature and mucus recordings
This is a 28 day cycle with a five day period.
The first mucus is recognised on Day 9 as a moist sensation.
Peak day is Day 14 (the last F day).
Appendix page 72
The temperature shift is observed on day 15.
The mucus on days 27 and 28 is related to hormonal fluctuations prior to the next period. Any mucus observed during the post-ovulatory infertile phase can be disregarded.
The couple are using Fertility Awareness to avoid pregnancy. They had intercourse on alternate dry evenings 6 and 8 and then abstained from the onset of the mucus symptom until the post-ovulatory infertile phase was confirmed by the third high temperature past peak day on day 17.
The rest of the cycle was then available for unrestricted intercourse
Where double check of temperature and mucus is used:
The beginning of the fertile phase is recognised by the first mucus symptom The post-ovulatory infertile phase starts after the third high temperature has been recorded provided all three temperatures are past the peak mucus day.
The Third Indicator -INTERPRETING CHANGES IN THE CERVIX
Guidelines for interpreting cervical signs:
A low, long, tilted, firm, closed, dry cervix indicates infertility A high, short, straight, soft, open, wet cervix indicates fertility
To conceive - Intercourse should coincide with the signs of maximum fertility
To avoid pregnancy - Intercourse should be avoided from the onset of fertile signs until the third evening of the post-ovulatory infertile cervix.
Cervical signs alone should not be relied upon as a means of avoiding pregnancy.
The following chart show how the changes in the cervix can help to confirm the other indicators of
Appendix page 73
fertility to ensure the highest degree of efficiency.
Length of this cycle - 28 days
The fertile phase starts on day 9, as indicated by :
First sign of mucus First sign of change in the cervix - (softening)
The post-ovulatory infertile phase is confirmed on day 17:
Following the third high temperature past peak day After the cervix has returned to its infertile state - low, firm, closed and tilted.
Cervical signs may be helpful as a double check with mucus symptoms, especially at times when the temperature cannot be considered a reliable guide such as during illness.
In such circumstances intercourse should not be resumed until the fourth evening after peak day which usually corresponds with the third evening of an infertile cervix.
Appendix page 74
The cycle illustrated above was recorded by an experienced user who has limited her observations to the necessary part of the cycle - from the end of the period (unless a woman has very short cycles) until post-ovulatory infertility is established.
There is no benefit in continuing to record cervical signs or mucus symptoms during the post-ovulatory infertile phase, as this is both unnecessary and potentially confusing.
The Third Indicator - Changes in the Cervix
CHANGES IN THE CERVIX
To use the sympto-thermal method effectively, it is not essential to check the cervix.
Temperature and mucus observations give a woman adequate information about her state of fertility. However, some women find that monitoring changes directly at the cervix gives additional supportive information.
In special circumstances, such as during breast-feeding and the pre-menopause, it can give valuable early warning signs of approaching fertility.
Changes in the cervix are due to the effect of the hormones oestrogen and progesterone.
During the infertile phases of the cycle, the cervix is low in the vagina, and easily within reach of the fingertip. o It appears to be long and may be off-centre, tilted, to lie against the vaginal wall. o It will feel firm, like the tip of a nose. o The cervical opening (os) will be closed, giving the sensation of a dimple to the touch, and it will feel dry. As ovulation approaches, the rising oestrogen levels cause the cervix to rise higher in the vagina. o It appears shorter, straighter and more centrally positioned in the vagina. o It may be difficult to reach. It will feel softer, more like the texture of the lower lip. o The cervix relaxes slightly allowing the os to open enough to admit the finger- tip. o It will feel wet and flowing with mucus. Following ovulation, the cervix returns to its infertile state within 24-48 hours.
Changes in the Cervix - in Relation to Ovulation
The changes in the cervix take place over an interval of around ten days. Approximately six days
Appendix page 75
before the shift in temperature the cervix will begin to show fertile characteristics. Following ovulation, the cervix returns to its infertile state within 24-48 hours.
The subtle changes in level, position consistency and dilatation of the cervix occur gradually and may seem confusing at first, but with experience a woman will be able to recognise at least one of the characteristics which will give clear indication of her state of fertility.
.
Self-Examination of the Cervix
A woman can detect changes in the cervix by feeling gently with the fingertip. A delicate touch is all that is required to distinguish the subtle day-to-day changes.
The cervix should be examined at the same time each day, for example while washing in the morning, after emptying the bladder. The same position should be used, either standing with one leg raised (e.g. on the side of bath), or squatting. If the position is varied then the cervix
Appendix page 76
will appear to be at a different level.
The hands should be washed and dried (the fingernails should be short). The right index finger is gently inserted into the vagina until the cervix can be touched.
It will feel like a smooth indented ball.
The vaginal walls feel soft, moist and ridged in comparison.
If the cervix is difficult to reach, the uterus may be pushed down by pressing on the abdomen with the left hand, just above the pubic bone.
With experience this examination should only take a few seconds.
Some women find it easier to use two fingers, the index and middle fingers to examine the very subtle changes in the cervix.
Other women find that their partner is more in tune with these changes and is so is able to be actively involved and share the responsibility. It is important that cervical observations are made in the same way, by the same person. It generally takes two or three cycles for cervical changes to be interpreted accurately.
Detection of mucus at the cervix
While checking the cervix, some cervical mucus may come away on the examining finger.
This should be recorded on the chart separately.
Women who have difficulty distinguishing mucus changes externally or have a very short mucus build up may find it useful to take mucus directly from the cervix in this way.
This avoids the delay in transit time from cervix to vulva and gives an earlier warning of approaching fertility.
An interval of a day or two may occur before thick, sticky mucus noted at the cervix is visible externally.
The more liquid, fertile mucus appears at the vulva within hours.
Some women find that mucus becomes trapped in the ridged vaginal walls, and it appears as a long thread on the finger.
Appendix page 77
The Third Indicator - RECORDING CHANGES IN THE CERVIX
RECORDING CERVICAL CHANGES ON THE CHART
The infertile cervix is represented by a solid black circle placed low on the baseline to show that it is low, firm and closed. A slanted line below shows the tilt.
The fertile cervix is represented by an open circle to show softness. The symbol is placed appropriately within the space provided to show the level.
The highly fertile cervix is represented by an open circle with an inner ring to show the cervix to be open. A straight line below shows the cervix straight in position. The raised level of the fertile cervix is represented by the appropriate symbol being placed higher in the
space.
Changes in the cervix shown in the space provided on the sympto-thermal chart.
Appendix page 78
Appendix 13 Fortnightly contact form
Office use only Date Signed
LOG ID CHECK
DATA Entry Record of fortnightly contact with all participants QUERIES resolved/updated
Date Contact 1.1 General health Good Not good Detail______
1.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
1.3 Diet maintenance - - Regular Irregular Stopped
1.4 Exercise - Regular Irregular Stopped
1.5 Other______
2.1 General health Good Not good Detail______
2.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
2.3 Diet maintenance - - Regular Irregular Stopped
2.4 Exercise - Regular Irregular Stopped
2.5 Other______
3.1 General health Good Not good Detail______
Appendix page 79
3.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
3.3 Diet maintenance - - Regular Irregular Stopped
3.4 Exercise - Regular Irregular Stopped
3.5 Other______
4.1 General health Good Not good Detail______
4.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
4.3 Diet maintenance - - Regular Irregular Stopped
4.4 Exercise - Regular Irregular Stopped
4.5 Other______
5.1 General health Good Not good Detail______
5.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
5.3 Diet maintenance - - Regular Irregular Stopped
5.4 Exercise - Regular Irregular Stopped
5.5 Other______
6.1 General health Good Not good Detail______
6.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
6.3 Diet maintenance - - Regular Irregular Stopped
6.4 Exercise - Regular Irregular Stopped
6.5 Other______
Appendix page 80
7.1 General health Good Not good Detail______
7.2 Menstrual diary/BBT maintenance - Regular Irregular Stopped
7.3 Diet maintenance - - Regular Irregular Stopped
7.4 Exercise - Regular Irregular Stopped
7.5 Other______
Appendix page 81
Appendix 14 Postintervention MYMOP form
Office use only Date Signed
LOG ID CHECK
Post intervention Questionnaire DATA Entry
QUERIES Date__/__/____ resolved/updated
Please circle the number to show how severe your problem has been IN THE LAST WEEK.
This should be YOUR opinion, no-one else’s!
[Use the symptoms nominated by you when you started in the study.]
SYMPTOM 1: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
SYMPTOM 2: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
ACTIVITY: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
WELLBEING: 0 1 2 3 4 5 6
How would you rate As good as it As bad as it
Appendix page 82
your general feeling could be could be of wellbeing?
If an important new symptom has appeared please describe it and mark how bad it is below.
Otherwise do not use this line.
SYMPTOM 3: ...... 0 1 2 3 4 5 6
...... As good as it As bad as it
...... could be could be
The treatment you are receiving may not be the only thing affecting your problem. If there is anything else that you think is important, such as changes you have made yourself, or other things happening in your life, please write it here (write overleaf if you need more space):
Are you taking medication FOR THIS PROBLEM ?
Please circle: YES/NO
IF YES:
Please write in name of medication, and how much a day / week
......
......
Appendix page 83
Appendix 15 Experience of acupuncture questionnaire [Completed by participant]
Office use only Date Signed
LOG ID Date__/__/____ CHECK
DATA Entry Experience of Acupuncture Questionnaire QUERIES resolved/updated
Please complete the following questions:
1. How much do you think acupuncture has helped your fertility?
A great deal
Only a little
Not at all
Don’t know
2. Do you think acupuncture has contributed to your health and wellbeing during this study?
No
Yes If yes please provide further details
3. What did you expect from participating in this study?
Appendix page 84
4. Acupuncture treatment involves needling of specific acupuncture points, in addition acupuncture may involve other aspects of care. In this study were any of the following important to you? A positive relationship between yourself and the practitioner Inviting and sharing of information Being listened to Helping you to make sense of your condition
5. Did you experience any side effects from acupuncture? No
Hard to judge
Yes If yes please provide further details
6. Are there any other comments you would like to make______
______
Appendix page 85
Appendix 16 12 Month follow-up form
Office use only Date Signed
LOG ID CHECK
Post 12 Month Follow Up Form DATA Entry
QUERIES resolved/updated Since the completion of the trial: 1. How is your general health Good Not good Detail______2. Have you had further WM diagnosis?
Yes 1 No 2
PCOS 1
POF 2
Recurrent miscarriage 3
Endometriosis 4
High FSH 5
Tubal blockage 6
Inherited chromosomal disorder 7
Fibroids 8
Immune factors 9
3. Have you undertaken any other treatments for fertility?
Yes 1 No 2
Clomiphene citrate 1
Appendix page 86
Donor sperm 2
Intra uterine insemination with controlled ovarian stimulation 3
IVF 4
Other 5
2.1 Number of IVF cycles
1 1 2 2 3 3 4 4 5+ 5 ______3. Current weight . kgs ______4. Current height . cm ______5. BMI ______
6. Your last menstrual cycle
6.1 Length of period days 6.2 Length of cycle days
7. Lifestyle
7.1 Have you changed your lifestyle?
Yes 1 No 2 7.2 In relation to Diet Exercise Stress management Use of acupuncture
7.2 In what way?______
8. Pregnancy status
8.1 Did you become pregnant?
Yes 1 No 2
If yes, confirmed by blood test ?
Appendix page 87
Yes 1 No 2 no.of wks
Confirmed by ultrasound?
Yes 1 No 2 no.of wks
8.2 Pregnancy loss?
Yes 1 No 2 no.of wks
Appendix page 88
Appendix 17 Monthly record of menstrual changes
Office use only Date Signed
LOG
CHECK ID DATA Entry
Record of monthly report of menstrual changes QUERIES resolved/updated
Date __/__/__
[to be completed by investigator]
1. Have you completed your BBT chart this month? Yes 1 No 2 [Attach]
2. Menstruation
2 .1 Regularity
regular 1
irregular, tend to early 2
irregular, tend to late 3
irregular, varies early/late 4
2.2 Nature of menstrual flow
heavy 1 (excessive flow)
Appendix page 89
moderate 2
light 3 (scanty)
inconsistent flow 4
2.3 Menstrual clotting
none 1
small 2
large 3
2.4 Menstrual colour
pale red 1
bright red 2
dark red 3
varies throughout 4
2.5 Incidence of pain with menses
Yes 1 No 2
If yes – Frequency days
Intensity: mild 1 2 3 4 5 severe
Nature: dull 1 sharp 2 fixed 3 spreading 4
Ameliorated by:
cold 1 warmth 2 rest 3 exercise 4 passage of clots 5 other 6______
Appendix page 90
3. Did you notice whether you ovulated this month? Yes 1 No 2
What indicators of ovulation were present?
Fertile mucus 1 temperature change 2 cervical change 3 ovulation discomfort 4
other 5 ______(specify)
Appendix page 91
Appendix 18 Sample BBT charts
Appendix page 92
Appendix page 93
Appendix page 94
Appendix page 95
Appendix 19 Notional interview script
Recorded interviews were conducted outside the clinic setting, for example, at respondent’s home. These questions are notional and for guidance only, as it was intended that the interviews be open-ended and responsive to any issues raised by respondent.
1. before the trial had you any experience of acupuncture? 2. if yes, was the acupuncture you received in this trial different to your previous experience? In what way? 3. what do you think happens when acupuncture is used on your body? 4. is this like any other experience you have had? 5. is it just a physical sensation or does it touch other aspects of yourself? 6. what do you think was most important to you about acupuncture sessions? 7. what was the least important aspect of the sessions? 8. did you find any aspect of the sessions unpleasant or unsettling? 9. what do you think or feel about using acupuncture to improve fertility? 10. has the experience of the trial changed your ideas about fertility? 11. has your experience of the trial changed your ideas about acupuncture? 12. what are your plans now for pursuing your fertility goals?
Appendix page 96
Appendix20: Proposed scale to assess the quality of acupuncture intervention
Definition for rating of items:
Yes: is based on the item being reported and your assessment that the item meet the standard.
No is based on the item being reported and your assessment that the item does not meet the standard.
Unclear: the item is not mentioned or reported and you are unable to make a judgement.
Not applicable: the item may meet the non applicable criteria if the study is of a pragmatic design and items are not relevant. NA also applies to studies where no differential diagnosis was undertaken.
Domain Statement Item Yes No Unclear Not applicable No. (not mentioned or reported)
1 1 The research question X of the study is clearly described in terms of population
2 The research question X of the study is clearly described in terms of intervention
3 The research question X of the study is clearly described in terms of comparator
4 The research question X of the study is clearly described in terms of outcome
Appendix page 97
2 5 The study design is X appropriate for the research question.
3 6 The acupuncture X intervention is designed to address the research question
4 7 The active intervention X is justified by a description of the diagnosis and treatment as per the stated acupuncture paradigm
5 8 Justification of the X diagnostic process is provided by evidence linking to the treatment paradigm
9 Justification of the X diagnostic process is provided by evidence linking to clinical reasoning
6 10 Acupuncture points X needled are consistent with treatment paradigm
11 Acupuncture points X needled consistent with differential diagnosis
12 Acupuncture points X needled are consistent with literature review or other evidence
7 13 Needle brand and X gauge is used consistently across all participants and sessions.
8 14 Point location: X published standard acupuncture location
Appendix page 98
texts are used as reference or location described in anatomical terms
15 Point location: an X accurate proportional method for locating acupoints used where appropriate
9 16 Symmetrical or X asymmetrical needling sites are justified according to the clinical condition.
10 17 Depth of needle X insertion expressed in millimetres as a range and is justified or referenced to a standard text
11 18 Number of treatments: If X a chronic condition a minimum of six treatments are administered, if fewer treatments are delivered appropriate justification is documented.
19 Number of treatments: If X an acute or subacute condition no minimum of treatments are specified, but appropriate justification is to be provided.
12 20 Needle manipulation X must be standardised. Manipulation should be expressed in terms of the number of times the needle was manipulated.
Appendix page 99
21 In the absence of X needle manipulation justification is provided of the decision not to undertake needle manipulation
13 22 Electro acupuncture X machine should demonstrate approval status and compliance for the country where study is being undertaken.
14 23 The acupuncturist X administering intervention, is registered with a regulatory authority, or meets at least the minimum WHO standard (WHO 1999).
24 When a traditional X diagnosis is undertaken evidence is provided that the practitioner has undertaken a full training course as per WHO guideline (WHO 1999).
Yes or No only apply to Yes No Q. 25 and 26
25 Evidence is provided of X prior clinical training by study personnel relevant to the acupuncture intervention and health condition.
26 Evidence is provided of X monitoring the administration of acupuncture in the
Appendix page 100
clinical trial setting
.
PART B
.
Checklist Items
Items: 1-4.
A research question clearly expresses the essential components and the aim of the clinical trial/study. The next four items assess whether items 1-4 clearly identify the population with the clinical condition, the acupuncture intervention, the comparator or control used in the study and the primary outcome measure. These components should easily be identified in the title, introduction or background of the study.
For example, does manual acupuncture versus standard care improve pain and function in elderly patients with chronic mechanical low back pain? In this case the population is elderly patients with chronic mechanical low back pain, the intervention is manual acupuncture (rather than electro-acupuncture), the comparator is standard care and the outcome measure is described as improvement in pain and function.
Item 5
The study design is appropriate for the research question.
This item refers to the need to state how the components of the research question explicitly align with the study design. The type of study can be determined by:
a) Whether the evaluator can quantify the relationship between two or more variables, that is, the effect of an intervention (I) on an outcome (O), and compares the outcomes in a comparison (C) group as well as the intervention or exposed group. The use of acupuncture as the intervention determines that this study is experimental (active involvement of researcher). b) Further determination of the study design will require reference to a description in the methods of the journal article. If the study was experimental, was the intervention controlled? If yes, the study design is a clinical trial, if no the study design is an observational study. c) The type of observational study will be influenced by the timing of the measurement of outcome. If outcome measurement is recorded after the exposure or intervention, the study design is a cohort or prospective study. If the measurement is made at the same time as the exposure or intervention, the study design is a cross sectional study or a survey.
Item 6
Appendix page 101
The acupuncture intervention is designed to address the research question
There are many types of clinical trials.
Efficacy trial: is a trial conducted in a highly controlled setting, with an optimal administration of treatment (Sherman et al 2007). The aim of which is to determine whether the intrinsic therapeutic action of needling directly causes the improvement or whether it is due to some other factor (White P et al 2007) Effectiveness trial: is a trial conducted to examine if there is a therapeutic effect when the intervention is delivered in practice in the real world (Sherman et al 2007).
It is important that the description of the acupuncture intervention, and control is aligned with the rationale for the study design.
Example of effectiveness trial
Research question: Is traditional Chinese acupuncture effective with reducing knee pain compared to pharmacological pain relief, in people with grade two osteoarthritis. In this study a flexible acupuncture treatment protocol (e.g. semi standardised or individualised treatment), and an active control is used.
Item 7
The active intervention is supported by a description for the diagnosis and treatment as per the stated acupuncture paradigm.
Acupuncture as currently practised is characterised by a diverse number of paradigms, for example TCM acupuncture, trigger point acupuncture, or Japanese acupuncture. Each paradigm is different with each having a different underlying theoretical framework. Therefore it is important that diagnosis and treatment associated with the active intervention is supported by the underlying acupuncture paradigm.
For instance, within the TCM paradigm the diagnosis and treatment is related to the use of channels or syndromes, however within the dry needling paradigm the use of palpation and knowledge of the central nervous system is used as a basis for diagnosis and treatment.
For example: all women recruited to a trial of dysmenorrhea underwent a TCM diagnosis to identify the TCM pattern. Acu-points for each TCM pattern were selected according to the TCM framework.
Appendix page 102
Items 8 and 9
Justification of the diagnostic process is provided, by evidence linking to:
1. the treatment paradigm (see definitions)
2. clinical reasoning (see definitions)
The acupuncture treatment should be justified according to stated acupuncture paradigm e.g. TCM or neuro-anatomical framework.
For example, the treatment of low back according to the TCM can be diagnosed as kidney qi deficient, stasis of qi and blood or damp cold bi syndrome. Conversely according to a western medical diagnosis lower back pain can be diagnosed as a bulging disc at lumbar 4 and degeneration at lumbar 2, 3 and 4.
For example, subjects were classified into one of either three TCM diagnostic categories for lower back pain: kidney qi deficient, stasis of qi and blood or damp cold bi syndrome.
An example of clinical reasoning: subjects diagnosed with nonspecific low back pain due to mechanical dysfunction and no evidence of inflammatory disorders.
Item 10
Acupuncture points needled are consistent with treatment paradigm
The sites of needling should be based on the treatment paradigm,
For example trigger point needling is based on neuro-anatomical framework, whilst selection of TCM acupoints are commonly based on modern TCM point function, or anatomical palpation along the channels.
Item 11
Acupuncture points are needled consistent with differential diagnosis
The acupoints used in the study should be selected according to the differential diagnosis.
Appendix page 103
For example, the acupoint BL23 was needled to supplement the Kidney qi.
A trigger point located in the erector spine muscle and quadratus lumborum was needled for posterior lower back and leg pain
Item 12
Acupoints needled consistent with literature review or other evidence
Acupoints may be listed in a standardised protocol based on as a review of acupoints used in several published studies.
For example, the acupoint PC6 was needled for a trial of vomiting because several studies have shown positive results to treat nausea using this acupoint. Alternatively, the acupoints LI 10, LI11 and TH5 were needled in a tennis elbow trial because a review of six previous tennis pain studies have consistently used this set of acupoints.
Item 13
Needle brand and gauge is used consistently across all participants and sessions.
(Please note that this question does not apply for pragmatic and effectiveness studies)
It is important that the needle brand and gauge are used consistently within the study across all participants and sessions.
For example, Serein needles (Japan) 0.3 x 40mm were consistently used at body points, and Serein auricular press tacks 0.22 X 1.5mm gauge were consistently used at auricular points.
Item 14
Point location: published standard acupuncture location texts are used as reference or location described in anatomical terms
Appendix page 104
The location of the acupoints used in the study should be accurately described in terms of modern anatomy, and as described in a standard acupoint location text for example, Deadman A Manual of Acupuncture (2007), or the WHO Standard Acupuncture Point Locations in the Western Pacific Region (2007). Alternatively the site is described in anatomical terms. For example, the trigger point needled was located in the supraspinatus muscle.
Item 15
Point location: an accurate proportional method for locating acupoints used where appropriate
If a proportional method to located acupoints is used the use of a calibrated elastic ribbon, or Newman ACI locator device would be appropriate.
For example: the acupoints LI10 and CV6 were located using the Newman ACI locator device for accurate proportional measurement.
Item 16
Symmetrical or asymmetrical needling sites are justified according to clinical condition.
When symmetrical or asymmetrical needling sites are used it should be justified according to the clinical condition.
For example LI10 for unilateral elbow pain, whereas LU9 would be used bi-laterally to treat dyspnoea.
Item 17
Depth of needle insertion expressed in millimetres as a range and is justified or referenced to a standard text
Example, LU7 5mm (Deadman,2007) , and CV12 15-20mm (WHO, 2007).
Appendix page 105
Items 18 and 19
Number of treatments: If a chronic condition a minimum of six treatments are administered, if fewer treatments are delivered appropriate justification is documented.
The number of treatments in the study should reflect the nature of health condition being treated. If a chronic condition a minimum of six treatments should be administered, if fewer treatments are delivered appropriate justification should be given. The minimum of six treatments was based on reviews of the research literature conducted by Ezzo et al 2000. and Sherman et al. In these reviews they reported at least six treatments were necessary to optimise a therapeutic effect from acupuncture (Ezzo et al 2000; Sherman et al 2001).
If an acute or subacute condition no minimum of treatments are specified, but appropriate justification should be provided. For example post operative nausea four sessions of acupuncture were given for post operative nausea based on the management of side effects from pain medication.
For example, the subject received acupuncture treatments for 5 weeks, in total 10 sessions.
Item 20
Needle manipulation must be standardised. Manipulation should be expressed in terms of the number of times the needle was manipulated.
For example; during the treatment session all needles were manipulated once and midway through the treatment the needle was rotated 90-180 degrees for 10 times within 10 seconds.
Item 21
In the absence of needle manipulation justification is provided of the decision not to undertake needle manipulation
For example we did not employ vigorous manipulation in order to elicit a strong de qi sensation (Schnyer et al 2008). Practitioners focussed instead on the response to stimulation as an “echo” sensation experienced on the receiving hand, while the active hand performed the actual needling.
Appendix page 106
Item 22
Electro acupuncture machine should demonstrate approval status and compliance for the country where study is being undertaken.
The physical specifications of the device should be defined and reported. This would include the name and model of device, the name of the manufacturer and the device approval status (e.g. for Australia that the electro stimulator has been approved by the Therapeutic Goods Administration as a medical device).
For example, CEFAR Model 44 (Acustim Pty Ltd, Sweden), approved by the TGA as a medical device.
Item 23 The acupuncturist administering intervention, is registered with a regulatory authority, or meets at least the minimum WHO standard (WHO 1999).
If a non medical acupuncturist is administering the intervention, they should be registered with a regulatory authority, or meet the minimum WHO standard (WHO 1999).
For example, the acupuncture researcher was registered with the Victorian Chinese Medicine Registration Board, British Acupuncture Council, or the National Certification Commission for acupuncture and oriental medicine, or meets the WHO standard of 2500 training hours.
For example, the acupuncturist administering the treatment was registered with British Acupuncture Council.
If a medical acupuncturist is administering the acupuncture they should be registered with a regulatory body e.g. Australian Medical Acupuncture Society or meet the minimum WHO standard of 200 hours.
For example, the acupuncturist administering the treatment had received training of 240 hours.
Appendix page 107
Item 24
. When differential diagnosis is undertaken evidence is provided that the acupuncturist has undertaken a full training course as per WHO guideline (WHO 1999).
The researcher/practitioner undertaking the Asian differential diagnosis (TCM, Japanese, Korean, 5 elements) should be registered with a regulatory authority (e.g. Victorian Chinese Medicine Registration Board, or the National Certification Commission for acupuncture and oriental medicine), or meet the minimum WHO standard (WHO 1999). For example, the acupuncture researcher was registered with the or meets the WHO standard of 2500 training hours.
The researcher/practitioner graduated from a five year full time course in China and was accredited by the China State Academy.
Where a western scientific approach is being used as a basis for diagnosis (e.g. trigger point, neuroanatomical concepts) the acupuncturist/researcher should be registered with a regulatory body (e.g. Australian Medical Acupuncture Society) or meets the minimum WHO standard of 200 hours.
For example, the acupuncturist administering the treatment was a member of the American Academy of Medical Acupuncture.
Item 25
Evidence is provided of prior clinical training by study personnel relevant to the acupuncture intervention and health condition
Prior clinical training or experience in the acupuncture techniques used for treating the condition should be clearly stated.
For example, the acupuncturist had five years clinical experience in the rehabilitation of stroke using Zhu’s scalp acupuncture.
Item 26
Evidence is provided of monitoring the administration of acupuncture in the clinical trial setting Appendix page 108
Monitoring of the administration of the acupuncture is important especially in multisite trials.
For example the acupuncture administered at the London trial site was randomly assessed on three occasions while the Beijing trials site was assessed on only two occasions Both treatment assessments involved video taping and a checklist. On all five occasions all treatment items were compliant.
Term definitions
Paradigm: "a philosophical and theoretical framework of a scientific school or discipline within which theories, laws, and generalizations and the experiments performed in support of them are formulated; broadly : a philosophical or theoretical framework of any kind” The Merriam-Webster Online dictionary)
Clinical Reasoning: “the thinking and decision making processes associated with clinical practice.[2-5] This reasoning is influenced by: the personal context of the client; the context of the clinical setting; the personal and professional framework of the clinician; and the context of the health care system. Clinical reasoning is comprised of three interactive components: knowledge, cognition and meat-cognition. Cognition relates to the thinking skills of analysis, synthesis and evaluation of data whereas meta-cognition is the awareness of thinking and the ability to assess one's knowledge base.
https://otl.curtin.edu.au/tlf/tlf2000/ladyshewsky.html (accessed 14th April, 2010)
References:
Deadman, P. Al-Khafaji M.,with Baker, K. (2007) A Manual of Acupuncture (Edition with thumb-indents) Journal of Chinese Medicine, London.
Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB. Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain 2000;86:217-25.
Han J-S. Recent Advances in the Mechanisms of Acupuncture Analgesia. World Journal of Acupuncture (no date).
Appendix page 109
Sherman KC, Hogeboom, CJ Cherkin, DC. How traditional Chinese medicine acupuncturists would diagnose and treat chronic low back pain: results of a survey of licensed acupuncturists in Washington State. Complement Ther Med. 2001 Sep;9(3):146-53.
Sherman K, Linde K, White A. Comparing treatment effects of acupuncture and other types of healthcare. In Acupuncture Research strategies for establishing an evidence base. MacPherson H, Hammerschlag, Lewirth G, Schyner R Churchill Livingstone 2007.
White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology. 2007;Mar;46(3):384-90.
White P, Linde K, Schyner RN. Investigating the components of acupuncture treatment. In Acupuncture Research strategies for establishing an evidence base. MacPherson H, Hammerschlag, Lewirth G, Schyner R Churchill Livingstone 2007.
WHO Traditional Medicine Unit, Technical Units. Guidelines on Basic Training and Safety in Acupuncture. I999 Geneva, SBN-13 9789241597685
Appendix page 110
Appendix 21 Publication related to thesis
Appendix page 111
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