University of Alberta Pharmacists’ Beliefs about Bioidentical Hormone Therapy by Tasneem Siyam A thesis submitted to the Faculty of Graduate Studies and Research in partial fulfillment of the requirements for the degree of Master of Science in Pharmacy practice Faculty of Pharmacy and Pharmaceutical Sciences © Tasneem Siyam Spring 2012 Edmonton, Alberta Permission is hereby granted to the University of Alberta Libraries to reproduce single copies of this thesis and to lend or sell such copies for private, scholarly or scientific research purposes only. Where the thesis is converted to, or otherwise made available in digital form, the University of Alberta will advise potential users of the thesis of these terms. The author reserves all other publication and other rights in association with the copyright in the thesis and, except as herein before provided, neither the thesis nor any substantial portion thereof may be printed or otherwise reproduced in any material form whatsoever without the author's prior written permission. ABSTRACT OBJECTIVE: To identify pharmacists’ beliefs about bioidentical hormone therapy (BHT) and determine factors influencing these beliefs. METHODS: This was a cross-sectional survey targeting practicing pharmacists in Alberta. Participants completed a 54-item, online questionnaire, designed to capture their demographics, as well as their beliefs about BHT. Summary statistics and multivariate regression were used for analyses. Qualitative components were analyzed using phenomenological approach. RESULTS: Over half of respondents believed BHT had equal efficacy and risks as non-bioidentical hormones. Beliefs on estriol, natural progesterone, and saliva testing however, were more diverse with many do not know responses (40%). In multivariate analysis, BHT compounding practice was associated with beliefs about BHT. Qualitative analysis identified contrasting themes between pharmacists who practiced in a BHT compounding pharmacy versus those who did not. CONCLUSION: Results from this survey indicated that pharmacists had varying beliefs on BHT. This study helps identify areas for targeted education. ACKNOWLEDGEMENTS This thesis would not have been possible without the help and patience of my supervisor Dr. Nese Yuksel. Dr. Yuksel has been an excellent source of encouragement, guidance, and support throughout my master’s program. I am especially grateful for her advice and unsurpassed experience in practice-based research. I owe my deepest gratitude to Dr. Scot Simpson for his valuable contribution to the study design and reliable advice on the data analysis of the research project. He also has been very helpful in answering many of my research-related inquiries. Thanks go out as well to Dr. Ayman Elkadi for his good advice, support and recommendations. I am very appreciative to Dr. Anne Marie Whelan and Dr. Tannis Jurgens, our collaborators in the College of Pharmacy, University of Dalhousie, Nova Scotia, for their participation in developing the research project questionnaire. I am also grateful to all the pharmacists who were involved in the peer review of our data collection tool. Their comments and feedback helped us to revise and develop our final survey tool draft. My acknowledgment also extends to all the pharmacists who participated in our online survey. This work would not have been accomplished without their valuable input. I would like to acknowledge the technical support of the Academic Information and Communication Technologies (AICT) team at the University of Alberta, especially Margarita Stewart for her remarkable role in administering the online survey. I also wish to thank Deborah Waldman, my writing advisor at the Writing Resources Centre at the University of Alberta, for dedicating her time and effort to editing my thesis. Lastly, and most importantly I owe my loving thanks to my entire family: my parents, Naeima Salem and Abdelmageed Siyam, and my siblings for all their endless love, care, and emotional and spiritual support. To them I dedicate this thesis. TABLE OF CONTENTS ABSTRACT ………………………………………………………… ii ACKNOWLEDGEMENTS …………………………………………. iii TABLE OF CONTENTS …………………………………………… iv LIST OF TABLES …………………………………………………… viii LIST OF ABBREVIATIONS ………………………………………. ix INTRODUCTION 1.1 Menopause …………………………………………………… 1 1.2 Long-term health risks after menopause ……………………... 2 1.3 Management of menopause ………………………………….. 3 1.4 Hormone Therapy ……………………………………………. 4 1.4.1 Role of hormone therapy ………………………………. 4 1.4.2 Hormones used in HT …………………………………… 4 1.4.2.1 Estrogens ……………………………………… 4 1.4.2.2 Progestogens ....................................................... 5 1.4.3 Shift in HT use ………………………………………… 5 1.5 Bioidentical Hormone Therapy ……………………………… 7 1.5.1 Confusion with the term ………………………………... 8 1.5.2 Compounded BHT ……………………………………... 9 1.5.3 Controversy over BHT ………………………………… 10 1.6 Efficacy of BHT ……………………………………………… 11 1.6.1 BHT and menopausal symptoms ………………………. 11 1.6.2 BHT and prevention of osteoporotic fractures ………… 12 1.7 Risks of BHT …………………………………………………. 12 1.7.1 BHT and cardiovascular risks …………………………. 12 1.7.2 BHT and endometrial cancer ………………………….. 13 1.7.3 BHT and breast cancer ………………………………… 14 1.8 Controversy over saliva testing ……………………………… 14 1.9 Beliefs on BHT ………………………………………………. 15 1.10 Research question and Objectives ……………… ………… 17 1.10.1 Research Question …………………………………… 17 1.10.2 Objectives ……………………………………………… 17 PILOT STUDY 2.1 Introduction …………………………………………………... 18 2.2 Materials and Methods ………………………………………. 20 2.2.1 Study design …………………………………………… 20 2.2.2 Survey instrument ……………………………………… 21 2.2.3 Data analysis ……………………………………………. 21 2.3 Results ………………………………………………………... 22 2.3.1 Respondents characteristics ……………………………. 22 2.3.2 Knowledge of hormone therapy and information sources.. 22 2.3.3 Beliefs on bioidentical hormone therapy ………………... 23 2.3.4 Confidence in bioidentical hormone therapy …………… 23 2.3.5 Factors associated with beliefs …………………………. 24 2.4 Discussion ……………………………………………………. 24 2.5 Conclusion …………………………………………………… 28 2.6 Tables ………………………………………………………… 29 2.7 References ……………………………………………………. 33 METHODS 3.1 Study design and participants ………………………………... 37 3.2 Research procedure ………………………………………….. 37 3.3 Questionnaire ………………………………………………… 38 3.3.1 Questionnaire sections and measures of constructs …… 38 3.3.1.1 Demographics and practice related questions … 38 3.3.1.2 Knowledge on BHT ………………………………. 39 3.3.1.3 Beliefs about BHT …………………………………. 39 3.3.1.4 Confidence level and learning needs …………. 41 3.4 Validity and reliability of questionnaire ……………………… 41 3.5 Sample size …………………………………………………... 42 3.6 Quantitative data analysis …………………………………….. 43 3.6.1 Creating outcome variables …………………………… 43 3.6.1.1 Knowledge on BHT ……………………………….. 43 3.6.1.2 Beliefs about and confidence in BHT…………..... 43 3.6.2 Independent variables …………………………………… 45 3.6.3 Multivariate analyses …………………………………... 46 3.6.4 Comparisons by BHT compounding practice …………. 46 3.7 Qualitative Analysis …………………………………………… 47 RESULTS 4.1 Demographics and practice related characteristics …………... 48 4.2 Knowledge and classification of BHT ………………………… 48 4.3 Pharmacists beliefs …………………………………………… 49 4.3.1 Beliefs about BHT ………………………………………. 49 4.3.2 Beliefs about estriol, natural progesterone and 50 compounded progesterone cream……………………………………... 4.3.3 Beliefs about saliva testing ……………………………… 50 4.4 Confidence level and learning needs ………………………… 51 4.5 Factors associated with BHT knowledge ……………………. 51 4.6 Factors associated with BHT beliefs and confidence ………… 51 4.7 Comparisons by BHT compounding practices ……………… 52 4.8 Evidence of reliability and validity …………………………... 53 4.9 Qualitative data analysis ………………………………………. 54 4.9.1 General themes …………………………………………. 54 4.9.1.1 Confusion with term………………………………. 54 4.9.1.2 Lack of knowledge and need for education ……… 56 4.9.1.3 Supportive of compounding BHT ………………… 58 4.9.1.4 Not supportive of compounding BHT ……………. 63 4.10 Tables ………………………………………………………... 66 DISCUSSION AND CONCLUSIONS 5.1 General Discussion ……………………………………………. 76 5.1.1 Knowledge on BHT ……………………………………. 76 5.1.2 Beliefs about BHT ………………………………………. 77 5.1.2.1 Beliefs about efficacy………………………………… 78 5.1.2.2 Beliefs about risks …………………………………… 79 5.1.2.3 Beliefs about compounded progesterone cream… 81 5.1.3 Beliefs about saliva testing ……………………………… 82 5.1.4 Confidence with BHT …………………………………. 83 5.2 Pharmacists practice and beliefs …………………………….. 83 5.3 Insights from qualitative analysis …………………………….. 85 5.3.1 Challenges expressed by pharmacists …………………… 85 5.3.2 Opposing views on compounding BHT practice ……….. 85 5.4 Limitations …………………………………………………… 86 5.5 Comparison of results with the initial pilot study …………… 87 5.6 Practice implications …………………………………………. 88 5.7 Conclusion ……………………………………………............. 90 5.8 Future directions………………………………………………… 90 5.9 References …………………………………………………….. 91 APPENDICES APPENDIX A: Survey tool ………………………………………. 107 APPENDIX B: A table highlighting constructs, measures of constructs, items’ coding and Cronbach’s alpha values………………. 114 APPENDIX C: Quotes from qualitative analysis …………………. 115 APPENDIX D: Details of multivariate regression analyses ……… 124 LIST OF TABLES Number Title Page Table 1 Characteristics and Practices of Respondents 29 Table 2 Knowledge of Respondents and Information Sources Used 30 Table 3 Respondents Beliefs on Bioidentical Hormone Therapy 31 Table 4 Respondents’ Beliefs About Use of Transdermal Progesterone Cream and 32 Saliva Testing Table 5 Demographic