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How to cite this thesis

Surname, Initial(s). (2012) Title of the thesis or dissertation. PhD. (Chemistry)/ M.Sc. (Physics)/ M.A. (Philosophy)/M.Com. (Finance) etc. [Unpublished]: University of Johannesburg. Retrieved from: https://ujdigispace.uj.ac.za (Accessed: Date). A COMPARATIVE STUDY OF THE EFFEC'fS OF VITEX AGNUS CASTUS UPON PREMENSTRUAL SYNDROME IN A MOTHER TINCTURE PREPARATION AND IN A 3X HOMOEOPATHIC PREPARATION

by

Gillian Woodcock

Dissertation submitted in partial compliance with the requirements for the Master's Degree in Technology: Homoeopathy, in the Department of Homoeopathy at the Technikon Witwatersrand.

I, Gillian Woodcock, do declare that this dissertation is representative of my own work

If

G.Woodcock

*Submis~~r9vedfor examination

Supervisor: Dr D.J. Fourie (B.A., B.Ed., M.Ed., T.H.O.D., VDO, N.D. D.Hom., D.O., FSAHA)

Co-supervisor: Dr B.R ~~.Hom.. D.Hom.Med.• N.D.• D.O.)

a3 dQlA/VACVY ;998

Place Date This dissertation is dedicated to my husband, Guy. and our son. Gabriel.

i ACKNOWLEDGEMENTS

Special thanks go to Dr Fourie, Dr van Olden. Dr Solomon and Professor Boyd for their guidance and assistance in formulating and completing this work.

ii ABSTRACT

The purpose of this study was to compare the effectiveness of a mother tincture preparation of Vitex agnus-castus and a hornoeopathic 3x preparation of Vitex agnus-castus in the treatment of premenstrual syndrome.

A sample of 15 subjects suffering from premenstrual syndrome was selected. The subjects were selected according to the diagnostic criteria ofpremenstrual syndrome and certain other criteria requtred for the study. The subjects were given questionnaires to complete regarding their medical history and menstrual details. All subjects signed a consent form before participating in the study. The subjects recorded their premenstrual symptoms on a PMS chart over two months.

After the diagnosis of premenstrual syndrome was made. the subjects were then randomly divided into three equally sized groups by a neutral homoeopath. The first group received placebo medication. the second received a homoeopathic 3x preparation of Vitex agnus-castus and the third received a mother tincture preparation of Vitex agnus-eastus. Each subject was given Instructions on how and when to take her medication. At no stage did either the researcher or the subjects know which medication they were receiving.

The subjects took their medication for three months. during which they continued to record their symptoms daily. After three months. the PMS charts were again collected and the scores compared to the pre-treatment scores. The Kruskal-Wallis test was used to statistically analyse the results.

The homoeopathic 3x preparation of Vitex agnus-eastus was found to bring about a statistically significant improvement in symptoms. while the mother tincture preparation of Vitex agnus-castus was not.

The common name of Vitex agnus-castus used in homoeopathy is Agnus castus. For the sake of consistency. the name Vitex agnus cestus. as used in the German Homoeopathic Pharmacopoeia. shall be used throughout.

ill TABLE OF CONTENTS

Dedication i

Acknowledgements ii

.Abstract iii

Table of contents iv

., Appendices...... V1l

List oftables and graphs viii

Chapter 1: Introduction 1 1.1 The problem statement 1 1.2 The hypothesis 2 1.3 DeliIIlitations 2 1.4 Assumptions 2 1.5 Definition of terms 3

Chapter 2: Review of the related literature 4 2.1 Overview 4 2.2 Premenstrual syndrome 8 2.2.1 Deflnitons ofpremenstrual syndrome 8 2.2.2 Aetiology ofpremenstrual syndrome 9 2.2.3 Clinical picture ofpremenstrual syndrome.. 12 2.2.4 Diagnosis of premenstrual syndrome 16 2.2.5 Differential diagnosis 18 2.2.6 Medical treatment ofpremenstrual iv syndrome 19 2.3 Homoeopathy 31 2.3.1 The definitions and principles of homoeopatby 32 2.3.2 The homoeopathic treament of premenstrual syndrome 34 2.3.3 Vltex agnus castus : 36

Chapter 3: Materials and methods 45 3.1 Study design 45 3.2 Subjects 45 3.3 Efuics 46 3.4 Interventions 47 3.5 Measurements 47 3.6 Statistical analyses 49

Chapter 4: Results '" 51 4.1 Introduction 51 4.2 Results 53 4.3 Total ofall symptoms 56 4.4 Irritability' 58 4.5 Depression 60 4.6 Anxiety '" 62 4.7 Breast swelling 64 4.8 Breast tenderness 66 4.9 Abdominal bloating 68 4.10 Headache 70 4.11 Food craving 72

Chapter 5: Discussion 74 v Chapter 6: Conclusion and recommendations 76

References 79

Appendices 91

vi APPENDICES

Appendix A ....PMS Blues

Appendix B.....Consent form

Appendix C.....Personal details

Appendix D.....Medical history

Appendix E .....PMS chart

Appendix F.....How to take your PMS medication

vii LIST OF TABLES AND GRAPHS

Figure 2.1 Typical basal body temperature and plasma hormone concentrations during a normal 28-day human menstrual cycle _ 7

Table 4.1 Monthly totals ofeach symptom and average totals for the two months before treatment and the three months during treatment for the five subjects in the group receiving placebo medication...... 53

Table 4.2 Monthly totals of each symptom and average totals for the two months before treatment and the three months during treatment for the five subjects in the group receiving Vitex agnus castus 3x medication 54

Table 4.3 Monthly totals ofeach symptom and average totals for the two months before treatment and the three months during treatment for the five subjects in the group receiving Vitex agnus castusmother tincture medication 55

Table 4.4 Monthly totals ofall symptom scores for the placebo. 3x and mother tincture groups 56

viii Figure 4.1 Line graph representing values in Table 4.4 56

Table 4.5 Average monthly total scores for the two months before treatment and the three months during treatment for the placebo, 3x and mother tincture groups ~ 57

Figure 4.2 Bar graph representing values in Table 4.5 57

Table 4.6 Monthly totals ofirritability scores for the placebo. 3x and mother tincture groups 58

Figure 4.3 Line graph representing values in Table 4.6 58

Table 4.7 Average monthly irritability scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups 59

Figure 4.4 Bar graph representing values in Table 4.7 59

Table 4.8 Monthly totals of depression scores for the placebo. 3x and mother tincture groups 60

ix Figure 4.5 Line graph representing values in Table 4.8...... 60

Table 4.9 Average monthly depression scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups 61

Figure 4.6 Bar graph representing values in Table 4.9 61

Table 4.10 Monthly totals ofanxiety scores for the placebo. 3x and mother tincture groups 62

Figure 4.7 Line graph representing values in Table 4.10 62

Table 4.11 Average monthly anxiety scores for the two months before treatment and the three months during treatment for the placebo, 3x and mother tincture groups...... 63

Figure 4.8 Bar graph representing values inTable 4.11. 63

Table 4.12 Monthly totals ofbreast swelling scores for the placebo. 3x and IIlother tirlctttre groups 64

x Figure 4.9 Line graph representing values in Table 4.12 64

Table 4.13 Average monthly breast swelling scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups 65

Figure 4.10 Bar graph representing values in Table 4.13...... 65

Table 4.14 Monthly totals ofbreast tenderness scores for the placebo. 3x and mother tincture groups 66

Figure 4.11 Line graph representing values in Table 4.14 66

Table 4.15 Average monthly breast tenderness scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture group 67

Figure 4.12 Bar graph representing values in Table 4.15 67

Table 4.16 Monthly totals of abdominal bloating scores for the placebo. 3x and mother tincture groups 68

xi Figure 4.13 Line graph representing values in Table 4.16 68

Table 4.17 Average monthly abdominal bloating scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups .... 69

Figure 4.14 Bar graph representing values in Table 4. 17...... 69

Table 4.18 Monthly totals ofheadache scores for the placebo. 3x and mother tincture groups 70

Figure 4.15 Line graph representing values in Table 4.18. 70

Table 4.19 Average monthly headache scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups 71

Figure 4.16 Bar graph representing values in Table 4.19 71

Table 4.20 Monthly totals offood craving scores for the placebo, 3x and mother tincture groups 72 xii Figure 4.17 Line graph representing values in Table 4.20.. 72

Table 4.21 Average monthly food craving scores for the two months before treatment and the three months durtng treatment for the placebo. 3x and mother tincture groups 73

Figure 4.18 Bar graph representing values in Table 4.21. 73

xiii CHAPTER 1 INTRODUCTION

1.1 THE PROBLEM STATEMENT

Premenstrual syndrome is a complex disorder suffered by many women. The exact aetiology of premenstrual syndrome is not yet known. Allopathic treatment is largely symptomatic and often causes unwanted side effects. No single allopathic treatment is yet available to treat all aspects of premenstrual syndrome. A simple. safe. effective and affordable treatment for premenstrual syndrome is still to be discovered.

Homoeopathy is a system of healing that corrects imbalances within the human body. It stimulates the body's own defense system to initiate healing. without the side effects of chemical drugs. Homoeopathic medicines are extremely cost effective in comparison to most herbal and allopathic medicines.

Extract of the Vitex agnus castus plant. particularly of the fruit and seeds. has been used to treat many female disorders. including premerrstrual syndrome (Beckham. 1994; Brown. 1994; Kustrak, 1994). Vitex agnus castus is also used as a homoeopathic remedy. called Agnus castus. The effectiveness of the mother tincture form. made from dried ripe fruits. on premenstrual syndrome has previously been studied (Brown. 1994). but how this compares to the effectiveness ofthe more diluted and succussed 3x homoeopathic form is not yet known.

1 The purpose ofthis placebo-controlled study is thus to determine the effectiveness of the homoeopathic 3x form of li1tex agnus castus upon premenstrual syndrome compared to the effectiveness of the mother tincture form of Vitex agnus eastus. The efficacy of both treatments will be measured in terms of the patients' perceptions of the treatment.

1_2 THE HYPOTHESIS

It is hypothesised that there will be a statistically significant improvement in subjects experiencing premenstrual syndrome after both mother tincture and homeopathic treatment.

1_3 DELIMITATIONS

The study will not attempt to explain the mechanism ofaction of Vitex agnus cestus. or investigate the aetiology of premenstrual syndrome.

1 A ASSUMPTIONS

The subjects ofthe study will take the treatment in the manner. dose and frequency prescribed. The subjects will accurately. conscientiously and honestly observe and record all symptoms and changes that occur. The subjects will not deviate from their normal lifestyle or dietary habits immediately prior to or during the study. The subjects will not take any other medication ofany sort to alleviate their premenstrual symptoms during the study. The subjects will not have been on any hormonal therapy (including hormonal contraception) for at least three months prior to the

2 study. The preparations used in the study have been accurately prepared according to the German Homoeopathic Pharmacopoeia. The subjects are indeed suffering from premenstrual syndrome and not from any other condition which may mimic the symptoms of PMS.

1.5 DEFINITION OF TERMS

PLACEBO: Dummy medicine. a non-medicated substance. For the purpose of this study. it will take the form of 20% alcohol.

MOWERTINCTURE: Soluble raw materials extracted. using alcohol. from the dried ripe berries of the Vitex agnus castus plant. then diluted further using one part of extract to nine parts alcohol. (according to Method 4a in the German Pharmacopoeia).

TI-lIRD DECIMAL POTENCY (3x): The third step of serial dilution of the mother tincture with alcohol on a scale 1:9 with succussion (shaking) at each step. having in effect a concentration of 1/1000.

3 CHAPfER2 REVIEW OF THE RElATED LITERATURE

2.1 OVERVIEW

This study examines the effect ofa homoeopathic treatment upon premenstrual syndrome (PMS). PMS is a complex syndrome that affects many women worldwide. Despite much research, the cause of PMS is not yet clearly understood. Treatment is largely symptomatic and is not yet able to eliminate all the symptoms of PMS.

To understand the treatment of PMS, one needs to know details about the syndrome itself. This review covers literature on the definitions ofPMS, its aetiology. the clinical picture of PMS, its diagnosis. its differential diagnosis and the medical treatment of PMS.

As the study involves homoeopathic treatment ofPMS, a description of homoeopathy. its nature and its treatment of PMS will be given. Particular emphasis will be placed on Vitex agnus cestus; the specific treatment used in this study.

The menstrual cycle involves many hormonal events. To prevent confusion. a summary ofthe hormonal changes throughout the cycle has been included:

The menstrual cycle is controlled by a complex interaction of hormones ofthe hypothalamus. pituitary. and the ovaries. The

4 hypothalamus is the actual centre of control. producing a gonadotropin-releasing hormone (GnRH) that stimulates the anterior pituitary to release gonadotropins called follicle stimulating hormone (FSH) and luteinising hormone (LH). Pulsatile secretion ofGnRH is needed for the pituitary to respond with adequate production of LH and FSH. If there is continuous release or a disturbance in the pulsatile secretion. the stimulus for follicle maturation is absent. and sterility results.

FSH is primarily responsible for the maturation of follicles into fertile ova and for the increased production ofoestrogen by the ovaries. LH causes release ofthe ovum. conversion ofthe follicle into the corpus luteum, and the production of progesterone.

The timing ofthe release ofthese pituitary hormones. oestrogen and progesterone. during a normal menstrual cycle is illustrated in Figure 1. At midcycle, oestrogen is at its peak level and the progesterone level begins to rise. It is at this point that the FSH level decrease and the LH level surge to cause ovulation. In the ovary. the corpus luteum releases progesterone. This hormone regulates sufficient blood supply to the endometrium so that the fertilised ovum can implant and survive in the uterus. If fertilisation does not occur. the corpus luteum will recede. hormone production will decrease. the endometrium will not be sufficiently supplied with blood and the menses will occur. FSH and LH levels decline until the beginning ofthe next menstrual cycle.

A third hormone, prolactin. is produced by the pituitary. Prolactin levels are regulated by an inhibitory factor (PIF) produced by the

5 hypothalamus (as opposed to FSH and LH which are controlled by stimulatory factors). Prolactin regulates the development ofthe breast and milk secretion. In non-lactating women, it is important that this hormone be in balance with FSH and LH. Excessive production of prolactin can inhibit the maturation of follicles in the ovary and induce menstrual abnormalities and sterility.

Oestrogen and progesterone formed by the ovary have a self­ regulating effect on the hormones produced by the pituitary and hypothalamus via a feedback mechanism. Androgens. like testosterone, also playa part in this feedback mechanism (Brown, 1994).

6 Follicular phase Luteal phase

36.8 Degrees C 36.64---~---=----~-".L-----~t-- 36.4 Progesterone 2.0 20 nq/rnl, / 17-Hydroxy- I _." ng/mL 17-Hydroxy­ 1.0 progesterone "'": '.-' 10 Progesterone progesterone ._._._. -._._e_._ ._._... /

200

pq/rnl, 100

0 lnhibin 1500 Ull 1000 500 0

50

40

30 lUlL 20

r">;,. 10 M M ol...,...... -r-.....)II....lIot-r...... -rT"-r-T""...... h-.,....-,..,...,.-r-r-r"T...,...... -rlI....~ 25 27 1 3 5 7 9 11 13 15 17 19 21 23 25 27 1 3 5 Day of cycle

Figure 2.1. Typical basal pody temperature and plasma hormone concentrations during a normal 28-day human menstrual cycle (Midgley. 1973, cited by Ganong. 1993).

7 2.2 PREMENSTRUAL SYNDROME

2.2.1 DEFINITIONS OF PREMENSTRUAL SYNDROME

Premenstrual syndrome has been observed for centuries and described by doctors for sixty years. but has only recently been accepted as a syndrome worthy of investigation and therapy (Jones et el., 1988). When one considers how many women appear to suffer from premenstrual syndrome, it seems strange that little precise knowledge is known about the extent or aetiology of the syndrome. and that it is still vaguely defined (Van Keep and Lehert. 1981).

A connection between the menstrual cycle and physical and emotional symptoms is thought to have been first recorded by Hippocrates. He used the term "hysteria" to describe cyclical menstrual dysfunction, which he attributed to a "wandering" uterus that caused symptoms in the area in which it became lodged (Parker, 1994).

In 1931 Frank, a gynaecologist, labelled the disorder "premenstrual tension." He described it as a syndrome of"indescribable tension and irritability" occuring from seven to ten days before menstruation and relieved by the onset ofmenstruation (Dennerstein et al.. 1981). Frank claimed to successfully treat his patients by irradiation ofthe ovaries (O'Brien, 1992).

In 1953 Katharina Dalton expanded on Frank's work and named it "premenstrual syndrome." This label recognises the variable nature of the condition, and the fact that it may not involve

8 tension. She later defined premenstrual syndrome as "a wide variety ofsymptoms which regularly recur in the same phase of each menstrual cycle. followed by a symptoms-free phase in each cycle." (Dalton. 1977).

Severino and Moline (1995) define premenstrual syndrome (PMS) as " a legitimate illness consisting of the cyclic recurrence of symptoms (physical. mental and behavioural) in the late luteal phase ofthe menstrual cycle ofsufficient severity to require treatment. The syndrome has a yet unknown aetiology. an uncertain and variable course. and an unidentified family history."

Lewis et al. (1995) defmed PMS as a "set of symptoms that occurs premenstrually. subsides within the first two to three days of menstruation. recurs on a cyclical basis in the premenstrual phase. is not systematically present in the postmenstrual phase. demonstrates at least a 30% change in severity score from postmenstrual to menstrual. and is severe enough to disrupt relationships with family. friends and/or co-workers."

2.2.2 AETIOLOGY OF PREMENSTRUAL SYNDROME

Despite advances in the understanding of PMS. its precise aetiology is still unclear. although there has been no shortage of hypotheses to explain PMS. Not one theory has been confirmed (in fact. rnost have been contradicted). and it is possible that different aetiologies apply to different women. Gardner and Sanders (1993) state that PMS is most likely the result of a combination of physiological. psychological and social factors. all ofwhich will be discussed under their relevant headings. Double-blind studies

9 have shown placebo treatment to be very effective in the treatment of PMS, suggesting that psychological factors playa role in the aetiology of PMS (Dennerstein et al., 1981).

Most researchers consider PMS to be a result ofbiophysiologic or endocrine conditions. Gardner and Sanders (1993) list existing theories on the aetiology of PMS as "variations in levels of ovarian hormones, endorphin changes, abnormalities ofother neurotransmitters, and abnormalities in prostaglandin pathways, To these can be added nutritional theories, including deficiencies of pyridoxine and essential fatty acids. hypoglycaemia, low magnesium levels, and various psychological and social theories."

Parker (1994) reports that various studies have demonstrated altered levels of hormones (ovarian and other) in sufferers of PMS. These hormones include: • oestrogen, • progesterone, • prolactin, • growth hormone, • thyroid hormones, • follicle-stimulating hormone (FSH), • luteinising hormone (LH), • antidiuretic hormone, • insulin, • prostaglandins and • cortisol. Few ofthese studies were done in a thorough scientific manner, and few can be reproduced. In fact, many results have subsequently been contradicted (Parker, 1994).

10 It does seem likely that the symptoms of PMS are a direct consequence ofthe hormonal events of the ovarian cycle. Evidence for this is that both bilateral oophorectomy and suppression of the menstrual cycle completely eliminate the symptoms ofPMS. Furthermore, administration ofoestrogen and cyclical progesterone to postmenopausal women often induces PMS-like symptoms. There is no evidence that women suffering from PMS have abnormal levels ofovarian hormones. PMS may be an exaggerated response to the physiological levels ofovarian hormones through the cycle (O'Brien, 1992). Chandraiah (1996) suggests that symptoms may be caused by the fluctuation of hormone levels over the menstrual cycle, rather than basal hormone levels. O'Brien (1992) states that factors other than individual hormone levels must be involved, for example interactions with other endocrine or biochemical systems, or differences in receptor status during the menstrual cycle. A link with ovarian hormones (particularly progesterone) is likely however, as the temporal relationship between progesterone secretion and PMS symptoms is close (Bancroft and Backstrom, 1985).

More recent studies have been conducted on neurotransmitters and their role in PMS. Changes in levels of endorphins, serotonin and monoamines have been observed in altered physiologic and behavioural states. Serotonin is linked to irritability, aggression and depression, while monoamines are linked to anxiety (Parker, 1994). It has been hypothesised that variations in the levels of oestrogen and progesterone during the menstrual cycle cause a decrease in the brain levels ofserotonin and dopamine, and an increase in the levels ofserum prolactin (MacKay et al., 1983).

11 Many of the theories regarding the aetiology of PMS have been based on the study ofthe efficacy ofvarious treatments and their known biochemical effect. Often these theories explain some. but not all. of the symptoms of PMS.

The major theories of the aetiology of PMS can be summarised as follows: • pyridoxine deficiency. • prostaglandin deficiency. • prostaglandin excess. • prolactin excess. • fluid retention. • hypoglycaemia. • progesterone deficiency or oestrogen excess. • endogenous opiate withdrawal, • serotonin deficiency. • psychiatric origin, • sociological origin. and • stress (Parker. 1994; Severino and Moline. 1995; Chandraiah. 1996). (These will be discussed further under "Treatment of Premenstrual Syndrome").

2.2.3 CLINICAL PICTURE OF PREMENSTRUAL SYNDROME

PMS involves the cyclical occurrence of physical and psychological symptoms. The symptoms begin at ovulation or later in the luteal phase, and resolve over the course ofmenstruation. and are followed by a symptom-free follicular phase after menstruation. Symptoms can begin any time after ovulation. Some women

12 experience symptoms for a day or two during ovulation. which subside and then re-appear closer to menstruation. Various typical patterns of symptom appearance have been identified (Severino and Moline. 1995).

Premenstrual symptoms occur in an estimated 30 - 40% of women. Approximately 10% ofwomen suffer from PMS so severely that the symptoms cause significant impairment of their work. home. or social activities. PMS has been reported in many different cultural and ethnic groups. Symptoms reported may vary to a degree between different cultures. but this is attributed to different attitudes towards PMS and different ways ofcommunicating complaints. PMS appears to be experienced by women ofall socio­ economic status (MacKay et ai.. 1983).

Women tend to seek help when their symptoms interfere with their lives and with their relationships with family. partners and children (Gardner and Sanders. 1993). Statistically. there is a higher incidence ofcrimes committed. attempted suicides. child battering. examination failures. absence from and poor performance at work and alcohol abuse by women during the luteal phase of their menstrual cycle (O'Brien. 1992). Abramowitz et ai. (1982) and Jonowsky et ai. (l969) reported a striking elevation in the rate of admission ofwomen into psychiatric hospitals on the day before and the first day of menstruation.

PMS can occur at any time between puberty and menopause, affecting predominantly women in their 20's and 30's. Symptoms end at menopause (usually worsening with age until menopause). or with other conditions that interrupt ovulatory cycles, such as

13 pregnancy or amenorrhoeic lactation. PMS may, however, occur without menstrual bleeding in cases in which ovarian cyclicity still exists. Thus PMS may be experienced in women following a hysterectomy if their ovaries are still remaining intact (Severino and Moline, 1995).

Certain triggers of PMS have been identified. These include birth of a child, tubal ligation. the use of oral contraceptives or discontinuation of their use, and stress (Chandraiah, 1996). Women with irregular menstrual cycles, and whose bleeding lasts for seven days or more, are more likely to experience PMS (Van Keep and Lehert, 1981).

Daughters ofmothers suffering from PMS are more likely to experience premenstrual symptoms than those of mothers not suffering from PMS. Furthermore, mothers and daughters tend towards specific symptom correlation. Monozygous twins have a significantly higher concordance rate of PMS than dizygous twins. These facts may demonstrate a hereditary pattern in PMS (Severino and Moline. 1995).

There appears to be a link between general psychological health and PMS, as women who suffer psychiatric illnesses tend to experience PMS more commonly and more frequently than . psychologically healthy women (Gardner and Sanders, 1993).

The severity of symptoms may vary from one cycle to the next, and symptoms may remit spontaneously for months or years. More than 150 symptoms have been documented in studies ofPMS, ranging from mild to severe to the extent that they interfere with

14 normal activities and relationships. The most common symptoms of PMS are as follows:

Physical sym.ptoms

• Bloating ofhands. feet and abdomen • Breast tenderness and swelling • Headache or migraine • Backache • Muscle aches and pains • Acne. cold sores or styes • Constipation

Emotional symptoms

• Mood swings • Irritability • Anger • Depression • Anxiety • Physical aggressiveness • Decreased self-esteem • Tearfulness

Other symptoms

• Fatigue • Sleep changes - hypersomnia or insomnia • Clumsiness

15 • Decreased concentration • Libido changes • Increased appetite and food cravings • Decreased interest in usual activities • Lowered work/school performance or efficiency • Social avoidance - (Parker. 1994; Severino and Moline. 1995; Chandratah, 1996; Dalton. 1977).

2.2.4 DIAGNOSIS OF PREMENSTRUAL SYNDROME

Methods available for diagnosis of PMS include a reliable history. physical and mental examinations. laboratory tests to exclude other possible causes of symptoms. and daily symptom charting to confirm symptom patterns (Parker. 1994). A positive diagnosis requires at leasttwo consecutive symptomatic cycles. Diagnosing PMS can be challenging to the health professional. as PMS includes emotional and/or physical symptoms. lasts days to weeks and may vary from month to month. Although certain sub-types of PMS have been differentiated. women tend to report symptoms in their own unique grouping (Gardner and Sanders. 1993).

Before a diagnosis can be made. other medical and psychological causes for symptoms must be ruled out. It is important to evaluate whether symptoms experienced are due to PMS and not due to premenstrual exacerbation ofanother disorder. for example depression. anxiety. allergies. asthma. seizures or herpes (Severino and Moline. 1995).

16 The use of retrospective diagnosis leads to over-diagnosis of PMS. Patients recall their past PMS symptoms with greater intensity and duration than actually experienced. For that reason daily charting of symptoms is essential. Various PMS charts have been devised. Well-known charts include the: • Visual Analogue Scale of common PMS symptoms (Rubinow et a1., 1984), • Moos Menstrual Distress Questionnaire on 47 PMS symptoms (Sampson and Prescott. 1981). • Premenstrual Assessment Form of95 PMS symptoms (Sampson and Prescott, 1981), • PMT-cator used to measure five symptoms for up to six weeks (Magos and Studd, 1988).

Daily charting of symptoms ensures an accurate diagnosis, recording symptoms experienced and the time of their occurrence in cycle. The type ofrating scale is of minor importance. but should be quick and easy for the patient to use, and should be sensitive to changes within the patient (Hammarback et a1., 1989).

Katharina Dalton (1977) uses the following criteria to diagnose PMS: • Symptoms occur exclusively during the second half ofthe menstrual cycle. • Symptoms increase in severity as the cycle progresses. • Symptoms must be relieved by the onset offull menstrual flow. • There must be an absence ofsympioms in the postmenstruum. • Symptoms have been present for at least two consecutive cycles.

17 The National Institute ofMental Health (NIMH) Premenstrual Syndrome Workshop in 1983 suggested that at least a 300/0 increase in PMS symptoms in the five days prior to menstruation as compared with the five days after menstruation is required in at least two ofthree cycles for diagnosis ofPMS (Stout, 1989). The criterion required for diagnosis of PMS used in this study is based on this measurement. All subjects experienced at least a 30% increase in PMS symptoms in the five days prior to menstruation as compared with the five days after menstruation over two consecutive months. There is no clear agreement on the duration of symptoms required for a symptom to be included as cyclic. The DSM-III-R criterion is approximately one week of symptom duration (Steege, 1993). There are no worldwide accepted numerical criterion to diagnose women with PMS (Budeiri et a1., 1994).

Some authors do not believe exact values to be of such importance in diagnosis, due to the subjectivity ofthe syndrome and the patient's expression ofit. Chandraiah (1996) claims that ifthe premenstrual pattern is confirmed clinically. with at least a moderate impact on social or occupatlonal functioning, it is sufficient to diagnose PMS. Gardner and Sanders (1993) state that women tend to seek help for their premenstrual symptoms only if they are severe enough to interrupt their regular lives, thus warranting observation and suitable treatment.

2.2.5 DIFFERENTIAL DIAGNOSIS

Chandraiah (1996) states that the history and examination of the medical, gynaecological and psychiatric aspects of the patient are

18 relevant to identify any conditions running alternately or concurrently with PMS. No specific laboratory test is available to diagnose PMS. but testing haemoglobin. thyroid-stimulating hormone and fasting blood sugar levels can eliminate other possible causes ofsymptoms.

PMS symptoms may be mimicked by endometriosis. ovarian cysts and fibroids, breast cancer. fibrocystic breast disease. thyroid abnormalities. subclinical diabetes mellitus. anaemia, or hypothalamic-pituitary-adrenal axis abnormalities. Psychiatric disorders including anxiety. depression, personality disorder. and substance abuse must also be considered as possible aetiologies in the differential diagnosis (Chandraiah. 1996).

Many physical and psychiatric illnesses are aggravated premenstrually. and need to be differentiated from PMS. These illnesses include migraines. epilepsy. asthma. acne. panic attacks. and depression (Chandraiah, 1996).

2.2.6 MEDICAL TREATMENT OF PREMENSTRUAL SYNDROME

Severino and Moline (1995) discuss the benefit ofdaily charting of symptoms. They claim it to be an important step in the management ofsymptoms. By charting their symptoms. women gain a sense ofcontrol over them. By being able to predict the severity. type and timing. symptoms may become more manageable. This sense ofcontrol may be enough to relieve some ofthe distress ofthe symptoms and make medical treatment unnecessary. The benefits oftreatment can be assessed easily if charting is continued during the months of treatment (MacKay et

19 aI.• 1983). For this reason it is important to include an untreated cycle in clinical trials (Sampson and Prescott, 1981).

Initial management of symptoms involves dietary and lifestyle changes. Education ofwomen. as well as their families. helps create a supportive environment and gives women a sense of control [Keye, 1993). Restricting the intake of caffeine premenstrually may reduce symptoms. particularly tension. irritability and insomnia. Alcohol and other recreational drugs generally aggravate emotional lability. so should be avoided. Decreasing salt consumption may minimise premenstrual bloating due to water retention. Supplementing vitamin E consumption may reduce breast symptoms. Eating small. regular meals avoids hypoglycaemic episodes. Exercise may also ease fluid retention. as well as promote a sense ofwell-being. Regular sleep patterns should be encouraged to ensure adequate rest (Gardner and Sanders. 1993; Parker. 1994; Severino and Moline. 1995).

However. should further treatment be required. medical science has various treatments available. As there is no known aetiology of PMS. treatment involves symptomatic management of the specific symptoms experienced. This means that treatment usually attends to certain symptoms only. Parker (1994) states that the aim oftreatment is to control symptoms so that the patient is able to function equally at all stages ofher menstrual cycle. The practitioner should first choose the least toxic treatments with the least side effects. such as essential fatty acids or pyridoxine. If these are not sufficient. further treatments should be considered according to individual symptoms and adverse side effects

20 (Gardner and Sanders, 1993). These treatments will be discussed according to their biochemical action and reported benefits:

Pyridoxine deficiency

Pyridoxine (vitamin B6) acts as a cofactor in the conversion of tryptophan to neurotransmitters including noradrenaline, serotonin and dopamine, which regulate emotions including depression, aggression, initability and anxiety. A deficiency could thus result in these symptoms. Pyridoxine also acts as an antagonist to prolactin, which could cause premenstrual breast symptoms. However, no deficiency of pyridoxine has been recorded in PMS sufferers specifically. Clinical studies on the benefits of pyridoxine for PMS have been contradictory, and the most recent review ofits efficacy lends weak support (Kleijnen et al., 1990). Furthermore, a long-term high dose of 1OOmgjday or more has been reported to be neurotoxic, causing peripheral neuropathy. If women do use pyridoxine, they must be monitored for muscle weakness. numbness, clumsiness and paraesthenia (Keye, 1993 and Magos, 1989).

Prostaglandin deficiency

Prostaglandins are a group of unsaturated fatty acid mediators (Youngson,1992). Prostaglandin E1 attenuates the action of prolactin, and a deficiency may be a cause of the breast symptoms ofPMS particularly. An essential fatty acid called y-linoleic acid, is a precursor of prostaglandin E 1. Treatment with Evening Primrose Oil which consists largely ofy-linoleic acid was conducted. Studies have shown efficacy largely on breast symptoms. but results have"

21 not been consistent (O'Brien, 1993) and no deficiency ofy-linoleic acid has been noted during PMS [Bruesh et el., 1984).

Prostaglandin excess

Prostaglandins act in various ways on the ovary, and also playa role in the functions of the breast. central nervous system, kidney and gastrointestinal system. An increase in the prostaglandin level during the premenstrual phase may result in symptoms including pain, oedema and thirst. Prostaglandin levels fluctuate according to changing levels of oestradiol and progesterone (O'Brien, 1993). Mefenamic acid, a non-steroidal analgesic and anti-inflammatory drug, acts as a prostaglandin inhibitor. It has been shown to reduce pain symptoms like fatigue, backache. abdominal cramps and headaches. It has also been shown to slightly reduce depression and irritability, although this may be due to the relief from pain. Side effects included gastrointestinal disorders (Mira et el., 1986).

Prolactin excess

A theory exists that prolactin may cause breast symptoms and fluid retention in PMS. Bromocriptine is an ergot derivative drug with a prolactin inhibitive action. It has been demonstrated to ease primary breast pain (Andersen et al., 1977). This drug should only be used in serious cases of breast pain, as several side effects may occur (Day and Taylor, 1981). Furthermore, Rubinow et ai. (1984) reported no difference in the prolactin levels of PMS sufferers and normal controls.

22 Fluid retention

Various mechanisms have been thought responsible for fluid retention premenstrually. These include dietary salt excess, altered capillary permeability and changes to levels ofthe following hormones: aldosterone, oestrogen, progesterone, prolactin, dopamine and vasopressin (Chandraiah, 1996). The use of diuretic drugs, particularly spironolactone (an aldosterone antagonist), in PMS has been studied, with positive results, despite the fact that no differences between aldosterone and renin levels have been found between PMS sufferers and asymptomatic controls. Diuretics reduce symptoms ofweight gain or bloating, and some psychological symptoms. Actual weight gain (not just a perceived weight gain or bloating) seems to be required for a diuretic to ease symptoms (Faratian et al., 1984). Practitioners must always beware of the risk ofhypokalaemia and aldosteronism associated with diuretic use (O'Brien, 1993).

Hypoglycaemia

This theory has been formulated from the observation of PMS symptoms ofincreased appetite, cravings for sweets. fatigue, headaches. shaking and dizziness. These symptoms are similar to those experienced by hypoglycaemics. However, studies indicate that women suffering from PMS do not have a reduced glucose tolerance or insulin resistance. Hypoglycaemia-like symptoms may result from high levels ofcatecholamines in the late luteal phase of the menstrual cycle (Reid. 1993).

23 Progesterone deficiency or oestrogen excess

In 1931 Frank proposed an oestrogen-progesterone imbalance, with increased oestrogen due to decreased renal excretion (Dennerstein et el., 1981). Backstrom et al. (1976) reported a raised level ofoestrogen and a decreased level ofprogesterone during the five days before menstruation in women experiencing PMS. The oestrogen-progesterone ratios ofwomen with PMS were shown to be significantly higher than controls between the third and sixth day prior to menstruation (Backstrom and Carstensen, 1973). These results have, however, been contradicted. O'Brien et al. (1980) reported no significant difference in the premenstrual levels of total serum progesterone in symptomatic and control groups. Dalton (1977) criticized this study, saying it is the proportion offree progesterone that is ofconcern, not the total serum progesterone levels. Hammarback et al. (1989) suggested that women with PMS are more sensitive to hormonal provocation than women without. He observed endocrine indications that the hypothalamo-pituitaIy units of PMS sufferers are more sensitive than those ofthe women who are symptom-free. Progesterone is at its highest levels in the luteal phase, and a relative deficiency premenstnIally has been suggested to be the cause ofsymptoms.

Katharina Dalton has been a pioneer in the use of progesterone therapy for PMS. She has successfully treated a large number of patients with progesterone. but sound conclusions cannot be made from her studies since none have been controlled. However, since 1953, progesterone has been the treatment most extensively used for all symptoms ofpremenstrual syndrome.

24 A study using danazole, a synthetic progesterone, has shown improvements in PMS symptoms ofdepression, anxiety and breast pain. Danazole reversibly eliminates the menstrual cycle (O'Brien, 1993).

While many reports ofsuccess with progesterone therapy have been recorded (Dalton, 1977; Dennerstein et al., 1985; Haspels, 1981; O'Brien, 1993 and Strecker, 1981), some double-blind studies involving administration of progesterone in the luteal phase have shown no benefit (Sampson, 1979). Extended use of progesterone has systemic side effects such as menstrual irregularities and liver changes (Chandraiah, 1996).

Tamoxifen, an oral nonsteroidal anti-oestrogen drug, may help particularly for breast symptoms. This drug has possible carcinogenic effects in animals, and so should not be used without caution (Severino and Moline, 1995).

Combined oestrogen/progesterone contraceptives may reduce PMS, although the contraceptives themselves may initiate or aggravate PMS symptoms. No consister..t effect of treatment with combination pills has been observed, however it is known that a pill with a high dose ofprogesterone causes fewer negative symptoms than one with a low dose. This finding is consistent with the findings oflow progesterone levels in PMS sufferers (Backstrom et al., 1993). Possible side effects oforal contraceptives must be considered, particularly cardiovascular risks. Oral contraceptives may also precipitate migraines, and raise plasma triglyceride levels (Severino and Moline, 1995).

25 Gonadotrophin-releasing hormone (GnRH) agonist analogue drugs. such as buserelin, reduce PMS by preventing ovulation or even completely eliminating the menstrual cycle (Hammarback and Backstrom. 1988; Mezerow et aJ.• 1994 and Muse et aJ.• 1984). GnRH agonist analogues create a medical menopause. with the long-term risks ofosteoporosis and coronary artery disease. Further hormones added may reduce side effects. but also efficacy of GnRH agonist analogues [Chandraiah, 1996).

Magos et a1. (1986) discuss the use of oestradiol implants to abolish ovulation and therefore prevent PMS. This treatment was successful in treating premenstrual anxiety. bloating. lack of concentration. migraines and breast pain. However. when progesterone was added to allow menstrual flow. premenstrual symptoms returned to a degree. Skin irritation is a common reason why patients discontinue progesterone treatment.

Androgens decrease the production ofsex steroids. and may thus be useful in the treatment ofphysical or psychological symptoms of PMS. Androgens are not suitable for long-term use due to their masculinising affects [Including hirsuitism and deepening of the voice). alterations in the serum lipid profile. depression. weight gain and bloating (Severino and Moline. 1995).

A bilateral oophorectomy eliminates symptoms of PMS. It is an option for patients with severe. incapacitating PMS. It results in the unwanted effects of lowered oestrogen levels. including decreased libido and lowered bone density. For this reason oestrogen replacement therapy is required. which itself holds health risks to the patient. No long-term outcomes of

26 oophorectomy have been published, and this treatment remains a drastic option used only for debilitating premenstrual syndrome (Casper and Hearn, 1990). Hysterectomy alone does not reduce symptoms of PMS, as neither the uterus nor menstruation are necessary for the occurrence ofPMS (Backstrom et aI.. 1981).

Endogenous opiate withdrawal

Endorphins are morphine-like substances naturally produced in the body. They all contain a similar opioid core of five amino acids [Youngson, 1992). A substantial decrease in the peripheral B­ endorphin levels has been observed durmg the luteal phase of women experiencing premenstrual syndrome. It has been suggested that the symptoms of PMS are due to more intense endogenous opiate (endorphin) exposure in the early luteal phase followed by rapid withdrawal. This is explained to cause the symptoms ofdepression. fatigue, sweet cravings and constipation in the early premenstruum, and irritability and anxiety in the late premenstruum (Petraglia et el., 1987). A study by Chuong et a1. (1988) tested the hypothesis that inhibition of opiate withdrawal would aid in the treatment of PMS using an oral opiate antagonist. naloxone. This study demonstrated improvement in concentration problems and negative behavioural changes in PMS. It has side effects ofnausea, decreased appetite and dizziness.

Aerobic exercise increases the release ofendorphins and catecholemines. Regular aerobic activity has been reported to ease some symptoms of PMS, possibly for this reason.

27 Serotonin deficiency

Monoamine neurotransmitter deficiencies are seen in major depression. As depression is a common premenstrual symptom, the theory of a monoamine neurotransmitter deficiency as an aetiology has been proposed. There is some evidence of a serotonin (neurotransmitter) deficiency in PMS sufferers. Abramowitz et al. (1982) speculate that the low levels of oestrogen just before menstruation may cause high levels of monoamine oxidase. resulting in neurotransmitter depletion. and triggering depression in predisposed women.

Studies using fluoxetlne. a selective serotonin re-uptake inhibitor. throughout the cycle have demonstrated reduced premenstrual depression. Buspirone. a serotonin partial agonist. has also been shown to be ofbenefit in treatment of anxiety. although further research is required (Severino and Moline. 1995).

A diet high in complex carbohydrates and low in protein. which increases tryptophan absorption and therefore potentially increases brain serotonin levels. has been shown to decrease depression. fatigue and tension (Chandraiah, 1996). Tryptophan. an anti-depressant drug. was recommended for its sedative effects until recent years. It is no longer available without prescription due to concerns about eosinophilia and blood dyscrasia (Severino and Moline. 1995).

28 Psychiatrical origin

Early papers on the psychology behind PMS have suggested that women suffering from PMS have rejected the feminine role. are sexually repressed. have conflicting mother-daughter relationships or negative menarche experiences. Increased neuroticism and marital problems have also been reported in PMS sufferers. The role ofsocial indoctrination regarding menstruation and the association of negative symptoms with it has also been suggested. Long-term psychiatric illness. especially depression, occurs at an increased percentage of PMS women than normal controls. Most of these theories were studied in women who complained ofPMS symptoms. but were not necessarily diagnosed (Chandraiah, 1996).

Nortriptyline. a tricyclic antidepressant drug. has been shown to be of benefit in treatment of severe depression premenstrually. although side effects were reported by every subject (Harrison et ai.. 1989). Lithium carbonate (used to treat bipolar depression) has been shown to be of no benefit for symptoms of PMS. Alprazolam, a benzodiazepine anti-anxiety drug, has been shown to be ofbenefit particularly f01" PMS symptoms of depression, with or without anxiety and irritability. This drug is problematic however. in that dependence and tolerance develop. Furthermore, the drug needs to be tapered gradually during menstruation to avoid possible SIde effects such as anxiety. shakiness. palpitations. tremor and seizures (Harrison et ai.• 1989).

Further treatments offered included support groups. relaxation therapy and cognitive therapy. Goodale et ai. (1990) demonstrated that regular elicitation ofthe relaxation response is an effective

29 treatment for physical and emotional premenstrual syndrome. particularly in women who experience severe symptoms.

Table of the medical treatments offered for PMS

Symptom Treatment options

• pain symptoms mefenamic acid (a NSAID and antiprostaglin)

• headache aspirin paracetamol mefenamic acid (a NSAID and antiprostaglin) oestradiol implants

• breast symptoms evening primrose oil tocopherol (a vitamin E constituent) bromocriptinc (a prolactin inhibitor) tamoxifen (an anti-oestogen drug) oestradiol implants

• fluid retention spironolactone (a diuretic drug) oestradiol implants

• anxietyjirritability pyridoxine (vitamin B6) oestradiol implants alprazolam (a benzodiazepine drug) busiprone (a serotonin partial

30 agonist) naltroxone (an opiate agonist)

• depression pyridoxine fluoxetine (a serotonin re-uptake inhibitor) alprazolam nortriptyline (a tricyclic anti­ depressant) naltroxone

• multiple symptoms oral contraceptives danazole (a synthetic progesterone) buserelin (a GnRH agonist analogue)

31 2.3 HOMOEOPATHY

2.3.1 THE DEFINITIONS AND PRINCIPLES OF HOMOEOPATHY

Jouanny (1994) defines Homoeopathy as "a therapeutic method which clinically applies the Law ofSimilars and which uses medicinal substances in weak or infinitesimal doses." This Law of Similars can be phrased as "like cures like" - an illness should be treated by a substance that can (in a healthy person) produce similar symptoms to those experienced by the patient. The symptoms that a substance can cause (and cure) is called the drug picture of the substance. This principle of "likes curing likes" dates back to the writings of Hippocrates during the fourth century B.C. (Lockie and Geddes, 1995). Hahnemann, the founder of Homoeopathy, wrote "When the correct medicine is selected for its ability to exactly mimic the illness under treatment, it is found that only the most minute dose is required for cure. The process of cure can be so gentle as to be imperceptible and yet the cure can be rapid," (Hamlyn, 1980). Homoeopathy stimulates a return to health in the patient, with long-lasting results (Vithoulkas, 1980).

Homoeopathic medicines are largely acquired from nature, from the plant, animal and mineral kingdoms. A few are based on chemical compounds. Some are made from "morbid matter" or disease products, and are called nosodes [Koehler, 1989).

Homoeopathic remedies are very precisely manufactured. Remedies that are made from plants (including Vitex agnus castus), are made by placing the section of the plant required in an alcohol/water mixture. This mixture is left to stand for up to four

32 weeks and then strained. The strained liquid is then mixed with alcohol in the ratio ofone part extract to nine parts alcohol. to form a mother tincture (German Homoeopathic Pharmacopoeia. 1993).

Insoluble substances first undergo a process called trituration. in which they are continually ground together with lactose before being mixed with alcohol/water.

The mother tinctures are then further diluted and succussed to form homoeopathic remedies. Dilution is performed along either the decimal (x) or centesimal (C) scale. This means that dilution is either in the ratio 1:9 or 1:99. As mother tincture is already diluted 1:9. it is equivalent to the first decimal dilution. One drop of mother tincture is placed in either 9 or 99 drops of alcohol and shaken vigorously (succussed) to produce a 2x or 2C potency respectively. This process ofdiluting and succussing is repeated until the desired potency is reached (Lockie and Geddes. 1995). The more a remedy is diluted and succussed. the higher its homoeopathic potency. Low potencies are used for organic diseases. medium potencies for functional disorders. and high for mental symptoms (Koehler. 1983).

Some Homoeopathic substances are toxic in their undiluted states. for example arsenic. However. in a diluted and potentised form arsenic is able to cure extreme fevers. Other remedies may be used in their mother tincture form. Arnica has been used as a healing herb for muscular aches and bruises since the 16th century. It is well-known today as a diluted homoeopathic remedy for injury. joint and muscle problems (Lockie and Geddes. 1995).

33 2.3.2 THE HOMOEOPATHIC TREA1MENT OF PREMENSTRUAL SYNDROME

Homoeopathy offers many remedies that include PMS in their drug pictures. Prescriptions need to be accurate as each remedy is indicated for a specific individual expression ofsymptoms only. The following are commonly indicated remedies. with a description ofthe PMS symptoms they can treat:

Calcarea Carbonica

PMS with much breast swelling before and during the menstruation. Menstruation tends to be too long or too heavy and may be induced prematurely by emotional stress or physical exertion. Menstruation is accompanied by cramping uterine pain. especially in the region of the right ovary.

Cuprum Metallicum

Cramping pain before and during menstruation. Cramps may be associated with amenorrhoea

FollicuIinum

PMS symptoms include breasts that are swollen and painful to touch. diarrhoea. depression. mood swings. panic attacks. indecision. hyperactivity and apathy.

34 Lac Caninum

Breasts become painful before menstruation. They are engorged. lumpy and sensitive to the leastjar orjolt. Menstruation may be painful. with pain spreading from the pelvis into the thigh or back.

Lachesis

Pelvic pain occurs premenstrually. but is eased as soon as the flow begins. Pain is usually left-sided. The breasts may become inflamed and bluish.

Lycopodium clavatum

Depression and irritability occur before menstruation. and are relieved when the period begins. Menstruation tends to be irregular. with heavy. dark blood that contains clots. The right ovary may become painful before and during menstruation.

Pulsatilla

PMS occurs with marked tearfulness. Menstruation is often late and flow is scanty.

Sepia

The Sepia patient displays a marked indifference towards her family premenstrually. Great exhaustion is experienced during menstruation. Menstruation is often late. with scanty flow.

35 Sulphur

Headaches commonly occur premenstrually. Menstruation is irregular. stopping and then starting again. Menstrual flow is often very dark in colour.

Zincum Metallicum

Premenstrual symptoms include abdominal distention. nervous agitation and back pains. These disappear durmg menstruation. when there is a feeling ofincreased energy and well-being.

The action ofthe above mentioned remedies has been taken from Assilem, 1994; Boericke. 1994 and Gibson. 1994.

Although the action of Vi/ex agnus cas/us. known to homoeopaths as Agnus castus. is known to be in the sexual region, it is not, as yet, well documented in Homoeopathic textbooks for treatment of premenstrual syndrome specifically. Its phytotherapeutic treatment of PMS has been more thoroughly studied.

2.3.3 VITEXAGNUS CASWS

Family

Verbenaceae

36 Synonyms

Chaste tree. Agnus Castus, monk's pepper. wild lavender (Lockie and Geddes. 1995).

Description

Vitex agnus castus is a graceful, aromatic shrub. It is deciduous and grows up to three metres high. Its leaves are divided into five to seven leaflets. dark green on the upper surface and grayish underneath. with a strong odour. The flowers are numerous in long spikes. blue or purplish in colour. in dense clusters. The berries have a sage-like odour and a hot, peppery taste. They are elongated. three to five millimetres in diameter and blackish brown or olive black. The fruit is partially closed in a cap-like calyx. Alcohol-based mother tincture is prepared using dried ripe berries (Bremmer. 1992; German Homoeopathic Pharmacopoeia. 1993; Rosart, 1991).

Habitat

Native to Southern Europe and Asia. particularly the shores of the Mediterranean. naturalised in warm areas. including the USA (Lockie and Geddes. 1995; Rosart, 1991).

Historical use

..Agnus" means "lamb" and "castus" means "pure" in Latin. The plant's common names "monk's pepper" and "chasteberry" indicate the plant's historical reputation as an anaphrodisiac.

37 Herbal texts from the Middle Ages recommended placing the plant in the beds ofvestal virgins and Christian nuns to keep them pure. Monks sprinkled ground berries onto their food to ensure chastity! This reputation is not still held. and some herbalists claim that Vitex agnus castus actually increases sex drive (Rosart. 1991)~ Beckham (1994) claims to have used Vitex agnus castus extensively without any patients noting any differences in·sex drive. However. it has been clear over the ages that ..the most effective point ofattack ofAgnus upon the organism is the sexual organism" (Boericke, 1994).

Vitex agnus castus is mentioned in the works of Hippocrates. Pliny. Dioscorides and Theophrast. Hippocrates wrote of Vitex agnus castus "Ifblood flows from the womb. let the woman drink dark red wine in which the leaves of the chaste tree have been steeped. A draft of chaste leaves in wine also serves to expel a chorion held fast in the womb." (Beckham. 1994; Brown. 1994 and Rosart, 1991).

During the 17th century, a herbalist named Gerard wrote that the seeds and leaves helped with pain and inflammation of the uterus (Rosart, 1991).

Vitex agnus castus was introduced into homoeopathic practice by Stapfin 1831. Vitex agnus castuswas proved by Hahnemann between 1826 and 1830 (Lockie and Geddes, 1995).

38 Constituents

Plant extracts are complex mixtures of substances. Oils of Vitex agnus castus leaves. flowers and berries. obtained by hydrodistillation. were analysed by capillary gas chromatography by Kustrak et ai. (1994). The highest oil content was found in the berries. making the berries the most medicinally active part of the plant. It is for this reason that ripe berries are used in the production ofmother tincture. This fruit oil contained the following active ingredients:

• monoterpene hydrocarbons - I.B-deole + limonene sabinene

• oxygenated monoterpene compounds - terpineols

• sisquiterpenes- (E)-B-Farnesene Bvcaryophyllene

Brown (1994) reports further constituents:

• primary flavinoids - castican orientin isovitexin

• iridoidglycosides - agnuside aucubin

39 • delta-3-ketosteroids (which may contain progesterone and 17­ hydroxyprogesterone)

Medicinal use

Vitex agnus cestus. in the form of mother tincture, herbal extract, tablet or tea, is used to treat menstrual and menopausal complaints. Herbalists classify it as a female hormone balancer. It has an effect on hormone levels. Beckham (1994) states that it works whether hormones are deficient or in excess by acting on the pituitary gland to restore imbalances. Thus its action is amphoteric - it can have opposite effects, depending on individual needs. She states that the effects tends to be progestagenic, with a decrease in oestragen levels. Brown (1994) discusses Dr. Rudolf Fritz Weiss's discovery that Vitex agnus castus acts on the diencephalo-hypophyseal system, in other words, the hypothalamus and pituitary. The hypothalamus produces GnRH, which stimulates the pituitary to release luteinising hormone (LH) and follicle stimulating hormone (FSH). Prolactin is secreted by the pituitary gland. Prolactin levels are controlled by prolactin inhibitory factor, produced by the hypothalamus. It is critical for this hormone to be in balance with FSH and LH.

The specific active components ofthe substance that have an effect on hormones have not yet been identified. A number ofstudies do confirm, however, that Vitex agnus castus does change the levels ofcertain horrnones (Brown, 1994; Beckham, 1994).

Jarry et al. (1994) reported that Vitex agnus castus inhibits in vivo prolactin release in women as well as in in vitro rat pituitary cells.

40 They stated that Vitex agnus castus compounds bind to the D2 receptor, similar to dopamine, a neurotransmitter with an adrenalin-like action. One ofthe theories of the aetiology of fluid retention associated with PMS is prolactin excess. This theory explains why Vitex agnus castus may be used to treat premenstrual breast tenderness and swelling and abdominal bloating.

The overall effect of Vitex agnus castus is reported to be progestagenic. with a decrease in oestrogen levels. Vitex agnl/s castus stimulates the secretion of LH by the pituitary and inhibits the release of FSH. LH results in the production of progesterone and FSH causes increased production of oestrogen. Thus Vitex agnus castus causes a shift in the ratio of oestrogen to progesterone in favour of progesterone (Brown. 1994). One of the major medical theories on the aetiology of PMS is progesterone deficiency or oestrogen excess. This explains why Vitex agnus castus may be used to treat premenstrual syndrome.

Apart from PMS, Vitex agnus castus can be used to treat a wide variety of menstrual disorderc. including menorrhagia (heavy menstruation), metrorrhagia (too frequent menstruation), anovulatory cycles (cycles without release ofan ovum), secondary amenorrhea (lack ofmenstruation), infertility, and hyperprolactinaemia (excessive prolactin levels) - all ofwhich may be linked to hormone imbalances. Similarly, it can also be used to treat poor lactation (milk production), uterine fibroids and cysts and menopausal symptoms. It may be used during the first three months of pregnancy to prevent miscarriage and morning sickness. Vitex agnus castus can help normalise menstruation after the use

41 oforal contraceptrves (Beckham, 1994; Rosart, 1991; Kenton, 1996).

The majority ofcliJ1ical studies conducted on Vitex agnus castus have been non-coritr-clled studies with large populations of patients in European gynaecology practices. Two monitoring studies of the effect of vuex a/fl1t1s cas/us on PMS symptoms have been ­ completed in Germany (Brown, 1994).

In the first. 154Z f'~S sufferers used a product called Agnolyt that was made from a fllDther tincture of Vi/ex agnus castus. The mean age ofthe study W~& 34,7 and the patients ranged in age from 13 to 62_ Each patierit took 40 drops ofAgnolyt daily. The benefit of treatment was aSS€&.sed by patients and their doctors. Over 90% of the patients reported a complete relieffrom symptoms. It took an average of 25,3 daJs before symptom improvement was noted. Side effects were reported by only 2% of patients.

Another study Iriel tided 36 women with diagnosed PMS, using 40 drops ofAgnolyt ove:r three cycles. A reduction in the following symptoms was repor-ted (Brown, 1994):

• ph.ysical syrnPti>QlS - headaches breast swelling and tenderness bloating fatigue

• psychological sytnptoms - nervousness restlessness anxiety

42 irritability lack of concentration depression mood swings aggressiveness increased appetite craving for sweets

More recent a solid extract equivalent of the mother tincture has been developed (Brown. 1994).

Dosage

The recommended dosage is between 30 and 45 drops ofmother tincture daily over several months without interruption (Brown. 1994; Beckham. 1994; Rosart, 1991). The recommended dosage of the homoeopathic 3x form is not known. however. homoeopathic remedies are generally given in lower doses (for example five to ten drops daily).

Generally Vitex agnus cestus mother tincture needs to be used for three to six months. after which time the patient should take it intermittently. Patients should continue treatment for several weeks after improvement is noticed before reducing their dosage. Improvement may be permanent (Beckham. 1994; Brown. 1994; Kenton. 1996).

43 Precautions

The use of Vitex agnus castus may result in alterations of hormone levels. For this reason Vitex agnus castus should be avoided during pregnancy and by patients receiving exogenous sex hormones including oral contraceptives. The use of Vitex agnus castus may delay the onset ofmenstruation by a few days (Rosart. 1991).

44 CHAPTER 3 MATERIALS AND METHODS

3.1 STUDY DESIGN

The objective ofthis study was to evaluative the effect of Vitex agnus castus 3x and Vitex agnus castus mother tincture with regard to the subjects' perception of their experience of premenstrual syndrome. Subjects were required to record their symptoms daily, so as to monitor their response during three months of treatment. Fifteen subjects were selected and placed randomly into three equally sized groups: placebo group, Vitex agnus castus 3x group and Vitex agnus cas/us mother tincture group.

3.2 SUBJECTS

The individuals who responded to posters advertising the study were between the ages of 19 and 36. However, those finally selected for the study were all in their twenties. Subjects were asked details oftheir menstrual history and premenstrual SYndrome. The PMS symptoms chosen by the researcher to be measured in the study were: irritability, depression, anxiety, breast swelling, breast tenderness, feelings ofabdominal bloating, headache and food cravings. A differential diagnosis was completed to exclude other ailments which might mimic PMS. This was done through questionnaires (Appendices C and 0) and a physical examination ofblood pressure, lymph nodes and the abdomen. Ailments that needed to be excluded were

45 endometriosis. ovarian cysts and flbroids. breast cancer. thyroid abnormalities. subclinical diabetes mellitus and anaemia. Once the possibility ofother ailments was ruled out. subjects were required to record daily their symptoms ofPMS on PMS charts designed by the researcher (Appendix E). Subjects rated the intensity of their symptoms on a scale of one to nine. beginning at "No experience of symptoms" and ending at "Extreme." Subjects recorded their symptoms over two months. Their forms were assessed. and only subjects who experienced a 30% increase in the total of all symptoms in the five days before menstruation as compared to the five days immediately after menstruation in both ofthe recorded months. were included in the study. Subjects were selected only ifthey fitted this diagnosis ofpremenstrual syndrome and suffered from no other pathology that might influence results. The 300/0increase required to diagnose PMS was based on the criteria stipulated by the National Institute of Mental Health Premenstrual Syndrome Workshop in 1983 (Stout 1989). Subjects were only included in the study ifthey were not using any hormo}~al c

3.3 ETHICS

The nature of the study was explained fully to all the subjects. Those who agreed to participate signed a consent form. All subjects were aware that their participation was voluntary.

46 3.4 INTERVENTIONS

The subjects were divided into three groups, namely a placebo group, a 3x group and a mother tincture group. This division into groups was randomly done by a neutral homoeopath in the study. The medicines were placed in an amber coloured bottle to minimise mild colour difference between the mother tincture and the 3x and placebo medications. Although the I11()th~:r.tinctll:r~Il?:edicati()I1did haveadtstinctive taste, all three medications taste strongly of alcohol. Each subject was explained that the medications all had a ---~ strong taste and were difficult to differentiate. The homoeopath placed each subject's relevant medication in a sealed paper package. The researcher dispensed the medication in its packaging to each subject with instructions on how to take the medicine at home. Subjects agreed to discuss neither their medication nor their perceived response to it with anyone else involved with the study (including the researcher). Neither the subjects nor the researcher knew who received mother tincture, 3x or placebo medication, maintaining the double blind standards of the study.

3.5 MEASUREMENTS

The following steps were taken in the execution ofthe study:

Posters advertising the study were placed in the Technikon Witwatersrand campus buildings and in the women's residences. The researcher assessed whether those who responded were

47 On the first visit, all subjects were asked to complete forms containing information regarding their personal details and medical history (Appendices C and D). A physical examination was concluded. Only those who appeared to be suffering from no other ailment that may mimic or influence PMS continued with the study. Each subject describe her experience of PMS, discussing with the researcher which of the symptoms in the study she experienced and the approximately intensity and duration. Once a possible diagnosis of premenstrual syndrome was made, the researcher explained the study and what was required from participants to the subjects. Subjects then signed a consent form (Appendix B). The researcher gave each participant two PMS charts (Appendix E) to fill in daily over the following two months, and explained how to complete the charts. The charts enabled the researcher to assess whether each subject experienced premenstrual symptoms severely enough to be included in the study group.

Once these charts were completed, the researcher and participants met again. The researcher calculated whether the subjects had experienced the 30% worsening ofsymptoms premenstrually required for the diagnosis of PMS. If this criterion was met, the researcher gave the subject her personal package of medicine and explained how to use the medicine at home.

Sufficient medication was given for use over a three month period. Subjects were required to take Irnl (approximately 15 drops) three times daily. either 30 minutes before a meal or two hours after a meal. Thus a total of3m! (approximately 45 drops) was taken

48 daily. The dosage was administered from a Irnl dropper given to each subject. They were to take the medicine directly or diluted in a little water. They were told to use it only with a clean taste in their mouth - with no taste offood. drink or toothpaste. As strong scents like perfume. menthol and eucalyptus, as well as sunlight, can reduce the action ofhomoeopathic medicine, the subjects were told to store the medicine away from these.

Caffeine, in the form of coffee, tea, chocolate and certain painkillers, is also thought to reduce the action ofhomoeopathic medicines. However. as caffeine may have an effect on water retention, such as abdominal bloating and breast swelling and tenderness, subjects were asked to not deviate from their normal consumption ofcaffeine-containing products. They were asked to take the homoeopathic medicines separately from these substances. to avoid interference.

Subjects were told to begin taking the medicine immediately, as prescribed, and to continue taking it for three months. They were told to use the medicine throughout their menstrual cycle, even while menstruating.

Once the three months oftreatment was completed. the subjects and researcher met for the last time. The subjects returned their PMS charts for analysis.

3.6 STATISTICAL ANALYSES

All the PMS charts were assessed. In each month's chart the sum ofeach symptom was calculated. as well as the total sum ofall

49 symptoms per month. This enabled the researcher to assess monthly which symptoms had responded to treatment. As each group contained only five subjects. averages per group needed to be calculated before any clear pattern emerged. For the purpose of statistics. the average of the two months ofscreening before treatment. and the average ofthe three months oftreatment were used.

The Kruskal-Wallis test was used to determine whether a significant difference existed in the location of the distributions of change in average ratings (of all symptoms) between the first two months and the last three months. The Kruskal-Wallis.test is an independent samples location test for two or more independent samples. It is a non-parametric test, which is suited to small sample groups such as those in this study (Stoodley et el., 1980). Once a significant difference was calculated over all three groups. the same test was used to determine whether a Significant difference existed between the placebo and 3x groups. and the placebo and mother tincture groups.

The results of the study are presented in chapter four.

50 CHAPTER 4 RESULTS

4.1 IN1RODUCTION

This chapter includes tables of each subject's monthly total of each symptom recorded, as well as the total sum of all her symptoms. The results obtained after statistically analysing the data collected from the measurements obtained in the PMS charts are also covered. Visual representation of all results is supplied in the form ofline and bar graphs.

The Kruskal-Wallis (or H) test was used to compare the averages of the two months before treatment and the three months of treatment. The test is a non-parametric test used to test the null hypothesis that the three independent samples come from identical populations against the alternative that the means ofthese populations are not all equal. Unlike the standard one-way analysis ofvariance, the Kruskal-Wallis test does not require the assumption that the samples come from normal populations have the same variance (Freund and Williams, 1972). This test is thus suited to the small sample groups ofthis study.

The H-value regarding all three groups was calculated to be 6.395.

Since this is greater than 5.991, the )f.05 value. we reject the null hypothesis and conclude that the means ofthe three groups are not all equal. A significant difference (at the 95% fractile level) in comparing all three groups is indicated (Freund and Williams, 1972).

51 To identify whether both orjust one groups differ from the placebo group, the test was repeated, comparing the placebo and 3x groups, and the placebo and mother tincture groups.

The H-value for the placebo and 3x group was calculated to be

5,835. This is greater than 5,024, the XLI value. therefore we again reject the null hypothesis that the means of the two groups are equal. A significant difference (at the 97,5% fraetile level) is indicated (Freund and Williams, 1972).

The H-value for the placebo and mother tincture group was calculated to be 2,48. This is smaller that 5,04, the X21 value, therefore we accept the null hypothesis that the means of the two groups are equal. A significant difference is not indicated (Freund and Williams, 1972).

52 4.2 RESULTS Placebo . I o A BS BT AB H Fe Total Case 1 Month 1 79 78 91 30 30 59 46 53 466 Month 2 122 137 112 30 30 33 40 48 552 Month 3 94 105 108 30 30 45 36 50 498 Month 4 94 86 100 30 30 37 41 57 475 Month 5 82 74 91 30 30 43 39 63 452 Ave 1+2 100 108 102 30 30 46 43 51 509 Ave 3+4+5 90 88 100 30 30 42 39 57 475 Case 2 Month 1 60 77 77 113 56 97 54 91 625 Month 2 127 61 121 98 71 116 62 49 705 Month 3 112 121 147 113 30 100 51 77 751 Month 4 133 86 120 93 39 95 30 149 745 Month 5 129 115 134 134 60 147 60 123 902 Ave 1+2 94 69 99 106 64 107 58 70 665 Ave 3+4+5 125 107 134 113 43 114 47 116 799 Case 3 Month 1 56 48 30 30 36 54 30 30 314 Month 2 68 57 30 34 38 50 30 30 337 Month 3 52 43 30 32 35 50 30 30 302 Month 4 49 47 30 34 30 50 30 30 300 Month 5 48 49 30 30 33 49 30 30 299 Ave 1+2 62 53 30 32 37 52 30 30 326 Ave 3+4+5 50 46 30 32 33 50 30 30 300 Case 4 Month 1 47 47 40 38 38 42 31 43 326 Month 2 84 84 78 72 74 76 68 81 617 Month 3 99 99 72 69 79 69 65 63 615 Month 4 47 42 30 46 57 43 42 38 345 Month 5 40 43 30 57 59 54 45 37 365 Ave 1+2 66 66 59 55 56 59 50 62 472 Ave 3+4+5 62 61 44 57 65 55 51 46 442 • CaseS Month 1 50 65 34 46 51 83 52 40 421 Month 2 53 47 30 35 39 108 36 30 378 Month 3 78 30 30 • 58 50 104 73 74 497 Month 4 171 160 42 30 30 147 38 30 648 Month 5 42 52 46 63 30 30 35 52 350 Ave 1+2 52 56 32 41 45 95.5 44 35 400 Ave 3+4+5 97 81 39 50 37 94 49 52 498

Table 4.1 Monthly totals ofeach symptom and average totals lor the two months before treatment ami the three months during t rcatmcnt lor the five subjects in the group rccclving placebo medication. 3x I. D A BS BT AB H FC Total Case 6 Month 1 52 54 40 122 30 37 41 60 436 Month 2 40 50 43 88 42 47 37 53 400 Month 3 46 42 30 88 30 30 30 50 346 Month 4 37 56 52 39 30 35 38 53 340 Month 5 55 94 40 46 36 40 30 71 412 Ave 1+2 46 52 42 105 36 42 39 57 418 Ave 3+4+5 46 64 41 58 32 35 33 58 366 Case 7 Month 1 56 38 30 30 45 77 35 73 384 Month 2 77 53 43 30 48 84 43 55 433 Month 3 44 32 30 30 43 38 53 41 311 Month 4 57 49 45 30 58 51 59 50 399 Month 5 92 75 57 30 88 56 58 90 546 Ave 1+2 67 46 37 30 47 81 39 64 409 Ave 3+4+5 64 52 44 30 63 48 57 60 419 Case 8 Month 1 36 30 30 30 39 35 30 42 272 Month 2 36 30 30 33 67 36 30 70 332 Month 3 30 30 30 30 49 30 38 36 273 Month 4 33 30 30 30 36 34 32 30 255 Month 5 33 30 30 30 30 37 30 30 250 Ave 1+2 36 30 30 32 53 36 30 56 302 Ave 3+4+5 32 30 30 30 38 34 33 32 259 Case 9 Month 1 62 36 30 41 70 46 30 62 377 Month 2 30 33 30 41 77 42 30 30 313 Month 3 30 30 30 43 30 31 30 30 254 Month 4 30 30 30 37 38 30 30 30 258 Month 5 38 30 30 34 36 58 30 42 298 Ave 1+2 46 35 30 41 74 44 30 46 345 Ave 3+4+5 33 30 30 38 35 40 30 34 270 Case 10 . Month 1 72 30 30 38 39 54 50 54 367 Month 2 59 30 30 82 82 55 54 51 443 Month 3 87 30 30 42 42 62 89 60 442 Month 4 55 30 30 40 40 67 30 54 346 Month 5 38 30 30 34 36 58 30 42 298 Ave 1+2 66 30 30 60 61 55 52 53 405 Ave 3+4+5 60 30 30 39 39 62 50 52 362

Table 4.2 Monthly totals of each symptom and average totals for the two months before treatment and the three mont hs during treatment for the five subjects in the group rcccivlng Vi/ex agnlls cas/lis :3x medication. Mother I o A BS BT AB H Fe Total tincture Case 11 Month 1 119 87 119 72 81 117 121 96 812 Month 2 101 78 96 67 67 92 86 86 673 Month 3 98 105 92 68 72 95 70 106 706 Month 4 107 90 95 73 70 102 121 121 779 Month 5 96 97 98 78 82 111 88 119 769 Ave 1+2 110 83 108 70 74 105 104 91 743 Ave 3+4+5 100 97 95 73 75 103 93 115 751 Case 12 Month 1 36 30 36 39 30 39 30 30 270 Month 2 36 46 30 39 30 39 30 30 280 Month 3 32 34 32 32 30 32 30 30 252 Month 4 34 31 36 32 30 30 30 30 253 Month 5 30 38 30 30 30 30 30 30 248 Ave 1+2 36 38 33 39 30 39 30 30 275 Ave 3+4+5 32 34 33 31 30 31 30 30 251 Case 13 Month 1 48 51 40 46 53 59 44 30 371 Month 2 39 34 39 71 80 77 39 38 417 Month 3 36 40 30 34 30 44 50 30 294 Month 4 30 35 30 80 80 65 34 30 384 Month 5 51 56 55 67 68 56 53 34 440 Ave 1+2 44 43 40 59 67 68 42 34 394 Ave 3+4+5 39 44 38 60 59 55 46 31 373 Case 14 Month 1 122 42 192 81 114 42 40 173 806 Month 2 102 30 174 69 72 54 30 163 694 Month 3 128 74 138 104 104 51 38 150 787 Month 4 149 82 69 95 95 57 37 134 718 Month 5 138 111 114 89 94 62 45 138 791 Ave 1+2 112 36 183 75 93 48 35 168 750 Ave 3+4+5 138 89 107 96 98 57 40 141 765 Case 15 Month 1 71 130 144 30 34 49 48 64 570 Month 2 73 85 122 40 65 75 54 68 582 Month 3 82 95 112 30 32 45 30 51 477 Month 4 71 134 98 t 30 39 48 30 51 501 Month 5 99 113 127 30 53 34 65 39 560 Ave 1+2 72 108 133 35 50 62 51 66 576 Ave 3+4+5 84 114 112 30 41 42 42 47 513

Table 4.:~ Monthly totals of each symptom and average totals for the two months before treatment ann the three months during treatment for the five subjects in the group rccctving Vi/ex ngrnrs

CdS/liS mother tincture medication. 4.3 TOTAL OF ALL SYMPTOMS

Month Placebo -3x Mother Tincture 1 2152 1836 2829 2 2589 1921 2624 3 2663 1626 2516 4 2513 1598 2635 5 2368 1804 2808

Table 4.4 Monthly totals ofall symptom scores for the placebo. 3x and mother tincture groups.

Total of all symptoms

3000 r------;------:------. ,I 2800 ------J~·--"------~1------~------t------=__~ I -

~ 2400 f---/ L-__

~ 2200 b""------t------+------,----

! 2000 ,------11'------1 ! 1800 I § 1600 ------j-----~==----__l~=-----I rn 1400

I - .. - 1200 -- .-+-Placebo 1000 1------..:..-----....:...------'- ---1 -a--3x 1 2 3 4 5 -ft-Mother tincture Month

Figure 4.1 Line graph representing values in Table 4.4.

56 Group Average of Average of treated untreated months months Placebo 2370 2514 ~)X 1878 1676 Mother tincture 2737 2653

Table 4.5 Average monthly total scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Month Total

3000 r------~

2500

2000

1500

o L-...;=~--==--- Placebo 3x Mother tincture

Figure 4.2 Bar graph representing values in Table 4.5.

57 4.4 IRRITABILIlY

Month Placebo 3x Mother Tincture 1 292 278 396 - 2 454 242 351 3 435 237 376 4 494 212 391 5 341 256 414

Table 4.6 Monthly totals of irritability scores for the placebo. 3x and mother tincture groups.

Irritability 500 ,------;------;------,..,..------,

I 450 '------II~---.;:;:=~==~-;;------>- ~ 400 F:::::::2r--r-----=j======~p= :E E 350 ~---:/----=~=:..:-----+-----~-----~I c.o [300 :V------j------t------'------I (/) -o ~ 250 I---.:=----=*======~::=_---:--_=:::::::;:;;--_j

2001---

150 1-- -'-- --1

---- 1 2 3 4 -+-Placebo Month -G-3x --A-Mother Tincture

Figure 4.3 Line graph representing values in Table 4.6.

58 Group Average of untreated Average of treated months months Placebo 373 423 3x 260 235 Mother tincture 373 393

Table 4.7 Average monthly irritability scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Irritability

450 .------., 400 f------{§§l.------350 300 250 .f--~~-- 200 150 100 50 0L.-....t;;;;;=L.----=="'----- Placebo 3x Mother tincture

Figure 4.4 Bar graph representing values in Table 4.7. 4.6 DI<::PRESSION

:~x Month Placebo - Mother tincture 1 315 188 340 2 386 196 273 3 398 164 348 4 421 195 372 5 333 259 415

Table 4.8 Monthly totals ofdepression scores for the placebo. 3x and mother tincture groups.

Depression 450 r------;------~

400 ------~--=.=-=--..:::.--==-=-::--::.:-;.:;:-~~---=----·-·------T---',

Z. I "iii : ! § 350 __-LI.------' ------.------1-- § I i~ I [ ! I ~ 250 1------.,------f------t------Cf) i I 200 ---- I 150 I.- ---:.-I ...J

1 2 3 4 , ------__-- _ ') , -+-Placebo Month ! -a-3x : --A-Mother Tincture

Figure 4.5 Line graph representing values in Table 4.8.

f>O Group Average of untreated Average of treated months months Placebo 350 384 - 3x 192 206 Mother tincture 306 378

Table 4.9 Average monthly depression scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Depression

400 ....------, 350 300 t---t=====! 250 t--~~I__--E~I__------~l

200 -J..--E§3I---~~~I__-_==.______--! 150 J---E~--§~-­ 100 50

OL-...E:::~__....t:==__

Placebo 3x Mother tincture

Figure 4.6 Bar graph representing values in Table 4.9.

f) I 4.6 ANXIElY

Month Placebo -3x Mother tincture 1 272 160 531 - 2 371 176 461 3 387 150 404 4 322 187 328 5 331 187 424

Table 4.10 Monthly totals of anxiety scores for the placebo. 3x and mother tincture groups.

Anxiety 550 .------:---:------,.------,

500 t-----:=-.::----if------'"------>- ; .~ 450 t------"j"c=-.-=:------c------;- ,------­ : C , II> : :E 400 t------~f__------<;1~::__-----f-----~ ; E ! 0 i Q. 350 t------::/=----J------t----=~~=___+~~---­ ;. >-E : U'J 300 I---~~---___t------_+_------___+_------___i :0 ____,L ,_ § 250 ------'--+- lJ) ,! 200

150 4:::======~====::::::::::::==-_o_~::::====~l.------J 1 2 3 4 -+-Placebo Month -G-3x 1 ~M()ther Tin<:ture :

Figure 4.7 Line graph representing values in Table 4.10.

62 Group Average of untreated Average of treated months months Placebo 321 346 3x 168 174 Mother tincture 496 385

Table 4.11 Average monthly anxiety scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Anxiety

500 r------r---r------, 450 400 1------· 350 1------.==""'" 300 250 200 150 100 50 OL-..s-=---==-- Placebo 3)( Mother tincture

Figure 4.8 Bar graph representing values in Table 4.11.

63 4.7 BREAST SWELLING

Month Placebo -3x Mother tincture 1 257 261 268 2 269 274 286 3 302 233 268 4 233 176 310 5 314 174 294

Table 4.12 Monthly totals of breast swelling scores for the placebo. 3x and mother tincture groups.

Breast Swelling

330 ~-----~------_:__-----___,

310 1------>------:;;A:Jr~=_----/T >- ~90 t---.--=-;::::::l~==:::;:::;~""'--_r-" c . ~70 ~~§::=~r~==_...:::::::::::"'"---_r=---~C-_r___=T~____j ~50 J------+----...... ~-__+_----~ ...... --+-.lr-----f a. ; E230 1------+------...... ------...------1 >­ (f) 0210 f------t------;----...... :-----+------f _------I------'------~ §190 ...... -___,_-----___l (f) L _ 170 . . ; 150 l- --'- -.J

1 2 3 -+-Placebo Month . --IlI-3x -l:r-Mother Tincture

Figure 4.9 Line graph representing values in Table 4.12.

64 Group Average of untreated Average of treated months months Placebo 263 283 3x 267 194 Mother tincture 277 290

Table 4.13 Average monthly breast swelling scores for the two months before treatment and the three months durtng treatment for the placebo. 3x and mother tincture groups.

Breast Swelling

300 ~------;::==~

250 ~E§3----1~§--­

200

150 l--{§§---1=

100

50 o 1.--.==----'=---- Placebo 3x Mother tincture

Figure 4.10 Bar graph representing values in Table 4.13.

65 4.8 BREAST TENDERNESS

Month Placebo -3x Mother tincture 1 211 223 312 2 252 316 314 3 224 194 268 4 186 202 314 5 212 226 327

Table 4.14 Monthly totals of breast tenderness scores for the placebo. 3x and mother tincture groups.

Breast Tenderness

330 I----~;-----I-----L======::::::~ 310 /r======~~ :>. ~ 290 c C1 £ 270 t-----;/ g 250 l---,,~---c::;""'--"';::---y----+------+------~ 230 ..v~--::;.>""--=------j--- 1------~ 210 ~------i------...... :-+-----",-;;;;;::------::I~=--=,------c~'" o § 1901--­ ~====-::s::::-:Ce------f/l i! i, 170 ~ --_._. __ ._--~---~------+---~_._--_._ .. - ---

150 L- --:.. ~ __J

1 2 3 4 _ 5 i -+-Placebo Month . ---a-3x • -ft-Mother Tincture.

Figure 4.11 Line graph representing values in Table 4.14. Group Average of untreated Average of treated months months Placebo 231 207 3x 269 207 Mother tincture 313 303

Table 4.15 Average monthly breast tenderness scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Breast Tenderness

350 300 I------~--- 250 200 150 100 50 0 Placebo 3x Mother tincture

Figure 4.12 Bar graph representing values in Table 4.15.

67 4.9 ABDOMINAL BLOATING

Month Placebo -3x Mother tincture 1 335 249 306 2 383 264 337 3 368 191 267 4 372 219 302 5 323 246 293

Table 4.16 Monthly totals of abdominal bloating scores for the placebo. 3x and mother tincture groups.

Abdominal Bloating

400 ..------,------,

>. ~ 350 .--- ~ c CI 'E E 300 o ii. [ 250 rL-=:::::::::::===~~""_::_-----+------~-----~ rn '0 § 200 rn

150 L....- -...l

1 2 3 4 5 Placebo Month , -+- -m----3x . ~ Mother Tincture.

Figure 4.13 Line graph representing values in Table 4.16.

68 Group Average of untreated Average of treated months months Placebo 359 354 3x 256 219 Mother tincture 321 287

Table 4.17 Average monthly abdominal bloating scores for the two months before treatment and the three months durmg treatment for the placebo. 3x and mother tincture groups.

Abdominal Bloating

400 ...------, 350 300 I-----t===i 250 200 150 100 J--~a_--g§-- 50 o L..--==--~=--- Placebo 3x Mother tincture

Figure 4.14 Bar graph refJresenting values in Table 4.17.

69 4.10 HEADACHE

Month Placebo 3x Mother tincture 1 213 186 283 2 236 194 239 3 255 240 218 4 181 189 252 5 209 178 281

Table 4.18 Monthly totals ofheadache scores for the placebo. 3x and mother tincture groups.

Headache 290 ~------:------;------;------. _____L: L_.I . _ i:' 270 'iii I I ~ 250 ~------E E 230 l----~-=--;-----===--_.;;;;;::~~___t_-'~~---i------~ ~ 210 I '0 190 .k.:::=----....-~-:=::'f'------.-t------.- E I j I (J) 170 ------;------. ------. _.- .-

150 1--- --'-- ---'

A • _ 2 3 5 1 . -+-Placebo Month . ----Q-3x --tx- Mother Tincture

Figure 4.15 Line graph representing values in Table 4.18.

70 Group Average of untreated Average of treated months months Placebo 224 215 3x 190 202 Mother tincture 261 250

Table 4.19 Average monthly headache scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Headache

300

250

200

150

100

50

0 Placebo 3x Mother tincture

Figure 4.16 Bar graph representing values in Table 4.19.

71 FOOD CRAVING

Month Placebo 3x Mother tincture 1 257 291 393 2 238 259 385 3 294 217 267 4 304 217 366 5 305 275 360

Table 4.20 Monthly totals of food craving scores for the placebo. 3x and mother tincture groups.

Food Craving f======~=====J:====:[=====l >- 400 i ~ 350 ------, -l------t------sc i c i I I_~ _ E 300 l------+------j~=---~'======T

sCo ~ 250 F=---=;::;:;;;;;;::::~:;>-<:;;-;::::_--_t------!-/~ (/) '0 § 200 ------~------+------~ (/) 150 l- ...:....- --: ----'

1 2 3 4 _ 5 -+--Placebo Month • -m-3x ~MotherTIncture,

Figure 4.17 Line graph representing values in Table 4.20.

72 Group Average of untreated Average of treated months months Placebo 247 301 - 3x 275 236 Mother tincture 389 364

Table 4.21 Average monthly food craving scores for the two months before treatment and the three months during treatment for the placebo. 3x and mother tincture groups.

Food Craving

400 r------==~----__. 350 f------·----· 300 f------e 250 f---==,----i=~ 200 f---§~---E~J--­ 150 f---§~--~~ 100 J----t======lf---E~=""1---- 50 01---==---'""""=---

Placebo 3x Mother tincture

Figure 4.18 Bar graph n!presenting values in Table 4.21.

73 CHAPTER 5 DISCUSSION

The results show that there was an overall improvement in patients with premenstrual syndrome who received Vitex agnus castus 3x compared to the patients who received placebo medication. The patients receiving Vitex agnus castus mother tincture did not. however. shown a statistically significant overall improvement.

On average. the placebo group's monthly total of all symptoms increased from 2370 during the untreated months, to 2514 during the treated months. The 3x group's total of all symptoms decreased from 1878 to 1676 and the mother tincture's total of all symptoms decreased from 2737 to 2653. These figures demonstrate a 6% increase in symptoms during the months of treatment in the placebo group. a 11% reduction of symptoms during treatment in the 3x group and a 3% reduction ofsymptoms during treatment in the mother tincture group. The mother tincture group did therefore respond positively to medication, --_.•---«._--- although not enough to be statistically significant. Furthermore, as subjects recorded a score ofone for "No experience of symptoms" on their PMS charts. it is impossible for the total of all symptoms to drop beyond the minimum score of 1200 per month (5 subjects x 8 symptoms x 30 days = 1200). Taking this into consideration. the more relevant change in symptomsexperienced i~_<:t_ I20{~ll.1creasein the placebo group. a 30% reduction in the 3x grouP_Cl!-lcl_ ~~.§Ojo reduction in the mother tincture group. ~- --

74 While this discrepancy is of note in regard to percentage change over the months of treatment. it does not influence the statistical interpretation of the results.

The.placebo group experienced a slight improvement in breast swelling. abdominal bloating and headaches. The Vitex agnus castus 3x group showed a slight improvement in irritability and headaches. and a marked improvement in breast swelling. breast tenderness and abdominal bloating. The Vitex agnus castus mother tincture group showed a slight improvement in breast tenderness. headaches and food craving. and a marked Improvement in abdominal bloating.

The mother tincture and 3x groups thus showed marked improvement in physical symptoms related to water retention. The researcher suggests that these symptoms are not as easily influenced by external factors. as the emotional symptoms such as depression. irritability. and anxiety. are. Emotional symptoms are influenced strongly by life events and circumstances. and are therefore difficult to study accurately.

The placebo group experienced a worsening of symptoms during treatment. A possible explanation given by the researcher is that 11 out of 15 of the subjects were students. and as the study progressed into the year. the strain ofincreased academic pressure resulted in an exacerbation of symptoms experienced by the subjects.

75 CHAPI'ER6 CONCLUSION AND RECOMMENDATIONS

The---_.-studysupports the hypothesis that Vitex agnuscastus 3x is effective in the treatment ofpremenstrual syndrome. It does not. however. support the hypothesis that Vitex agnus castus mother tincture is effective in the treatment of premenstrual syndrome. Comparing the 3x and mother tincture forms of Vitex --... , agnus castus demonstrated the more diluted and potentised 3x

- _.--"'--- ,. form to be far more effective in treatment of premenstrual syndrome. While the improvement caused by mother tincture was not statistically significant. it was an improvement.

The physical water retention symptoms of abdominal bloating. breast swelling and breast tenderness improved markedly in the 3x group. An improvement in abdominal bloating and breast tenderness also occurred in the mother tincture group. This may indicates a hormonal influence by Vitex agnus cestus, as reported by Brown (1994) and Jany et ai. (1994). A study incorporating blood tests of oestrogen and progesterone may confirm this.

Problems that were encountered during the study include that the study was subjective. Subjects recorded their symptoms according to their experience ofthem. No objective method ofcontrol was present as most of the symptoms are impossible to measure externally. These symptoms. including emotional symptoms. are. however. integral to premenstrual syndrome. therefore they cannot be disregarded.

76 ~'I1!e sample groups were very small."'This made statistical '".-._-~--.. .------_. ~ interpretation ofresults difficult. Fluctuations in only one subject's monthly ratings influenced the entire group's ratings. For this reason averages of the pretreatment and treatment months needed to be made before any clear pattern emerged. Some symptoms worsened during treatment and this may be due to the small size of-the sample groups allowing personal fluctuations and external influences to effect the entire group. The researcher recommends that future studies involve a larger sample size.

The researcher recommends that future PMS charts measure symptoms on a scale beginning at zero for "No experience of symptoms." This will eliminate the problems encountered in calculating percentage change as in Chapter 5.

The three groups did not experience the same intensity of symptoms. as was indicated by their average total of all symptoms of the untreated months (placebo group = 2370. 3x group = 1878 and mother tincture group = 2737). Only the relative response to treatment was regarded and not the initial intensity of symptoms.

Since the effectiveness of Vitex agnus eastus 3x in the general treatment of premenstrual SYndrome has been demonstrated in this small study. further larger and more detailed studies are recommended.

The homoeopathic principle of "like cures like" has not directly been studied by this project. This study is concerned about which form of Vitex agnus cestus, the mother tincture or the 3x form. is more effective in treatment of PMS. A homoeopathic trial of the

77 effect of Vitex agnus castus on healthy individuals (what it can cause it can cure) will add to the body of knowledge of Vitex agnus castus. A study ofwhich symptoms respond best to treatment with Vitex agnus cestus. and ifa certain personality type responds best. will make the remedy easier to prescribe accurately by homoeopathic practitioners.

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90 APPENDICES

91 APPENDIX A PMS BLUES 7 Many women suffer from premenstrual syndrome. This means that they experience unpleasant symptoms for some days before their menstrual period. These symptoms include:

-irritability, - depression, -anxiety, -feelings of abdominal bloating, - breast swelling, - breast tenderness, -headaches, and .food cravings

A clinical study of homoeopathic treatment of PMS is being conducted through Technikon Witwatersrand's School of Homoeopathy. If you suffer from PMS every month and are interested in taking part in the study, contact Gillian at 7281837.

• Painful periods are not included under PMS .Women in the study may not be taking the oral contraceptive pill

92 APPENDIXB

CONSENT FORM

I, the undersigned, hereby agree to take part in the discussed study conducted through Technikon Witwatersrand. I understand that I am in no way obliged to participate in the project conducted by Miss G. E. Woodcock and that all Information that I volunteer will be regarded as confidential.

NAME OF VOLUNTEER: _ SIGNATURE: _ DATE: _

NAME OF RESEARCHER: _ SIGNATURE: _ DATE:------

93 APPENDIXC

PERSONAL DETAILS

Please complete the following:

1. Name: _ 2._ Age: _ 3. Marital status:------4. Occupation: _ 5. Residential address:------

6. Telephone number: _ 7. Age at which menstruation began: _ 8. Length ofmenstrual cycle: _ 9. Duration ofmenstrual bleed: 10. Cycle regularity: ------_ 11. When are your symptoms worst?:------12. How long do the symptoms last?: _ 13. Do you take any medication to alleviate the symptoms?:--- 14. If so, what do you take and what do you take it for?:----

15. Do you have any children, and ifso, how many?:----- 16. Do you use the oral contraceptive pilI?: _ 17. Have you suffered any psychiatric illness during the past two years?: _

94 APPENDIXD

MEDICAL HISTORY

Name:'------Date: _

What symptoms do you experience premenstrually?: _

At what age did you begin suffering from PMS?: _ Is your menstruation light or heavy?: _ Do you ever bleed between your periods?: _ Do you experience menstrual cramps?: _ Do you ever experience pain during sexual intercourse?: _ When was the first day ofyour last period?: _ Have you ever had any changes in the amount, colour or odour ofyour normal vaginal discharge?: _ What method ofcontraception do you use?: _ Have you ever had any discharge from your nipples?: _

Are you on any medication?: _ Do you take aspirin?: _ Do you ever use diuretics (water pills)?: _ Are you allergic to anything?: _ What is your past medical history?: _

Have you ever been in hospital?: _

How much do you weigh?: _ Have you experienced any unexplained weight loss?: ------How is your appetite?: __-:- _ Are you on, or have you ever been on a special diet?: _ Have you ever had any problems with vomiting or diarrhoea?: _ How frequently do your bowels work?: _

Have you ever had unexplained fevers?: _ Do you sweat profusely?: _

95 Have you ever noticed any swelling around your ankles?: _ Do you have a problem with unwanted hair on your face?: _

Do you suffer from depression?: _ Do you suffer from fatigue?: _ Would you describe yourselfas an anxious person?: _

Blood pressure: _ General examination: ------

Abdominal examination: ------

96 APPENDIXE

PMSCHART

Name...... Month .

Date MP I D A BS BT AB H Fe Total 1 - 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Total

97 MP = Menstrual period 1 = No experience ofsymptoms I = Irritability 2 = Barely noticeable D = Depression 3 = Very mild A= Anxiety 4 = Mild BS = Breast swelling 5 = Moderate BT = Breast tenderness 6 = Fairly strong AB = Feeling ofabdorninal bloating 7 = Strong H=Headache 8 = Severe - Fe = Food cravings 9 =Extreme

98 APPENDIXF

HOW TO TAKE YOUR PMS MEDICATION:

You will need to take Irnl ofmedicine three times daily. Measure out the lrnl dosage with the dropper that has been provided for you. You can either take the medicine directly, or dilute it with a little water.

Take your medicine either 30 minutes before a meal or 2 or more hours after a meal. It is important that your mouth be free ofany other taste, like toothpaste, peppermint or tobacco.

It is best to avoid substances containing caffeine while taking homoeopathic medicines. This includes coffee, soft drinks that contain caffeine, and painkillers

Store your medicines at room temperature in a place away from direct sunlight. They should not be stored close to strong smelling substances like perfumes, menthol, or camphor. Make sure your containers are tightly sealed.

WHEN TO START TAKING YOU MEDICATION:

You can start taking your medication immediately. It doesn't matter where you are in your menstrual cycle. Start charting your PMS symptoms everyday (as you did during the 2 months ofscreening) on the same day you begin taking your medication. Continue taking the medication, and charting for the following 3 months. Each bottle ofmedication supplied will last you one month. Each bottle contains the same medication, so it doesn't matter which one you start using first. You should take the medication, and chart all month, even during your menstruation.

Ifyou have any questions, contact Gillian at tel. 728-1837. THANK YOU!

99