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FINAL Poster Prsentation

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Kathy Chow

This survey examined patients' opinions on three types of hormone replacement therapy (HRT): bioidentical hormone replacement therapy (BHRT), standard hormone replacement therapy (SHRT), and no therapy. The majority of patients using BHRT reported positive views (86%) and experienced relief of menopausal symptoms, while more patients using SHRT reported neutral or negative views. Fewer adverse effects were reported for patients using BHRT compared to SHRT. The results suggest patients may be more satisfied with BHRT due to increased monitoring by physicians and pharmacists, though limitations include variability in compounded formulations and lack of large studies on BHRT safety and efficacy.

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Hormone Replacement Therapy: Survey of patients regarding their opinion of symptom relief Kathy Chowa, Dieter Steinmetz, R.Ph.b aWestern University of Health Sciences College of Pharmacy, Pomona, CA bCoast Compounding Pharmacy, Oceanside, CA Background Many women who are experiencing menopause suffer from hot flashes, vaginal dryness, night sweats, depression, irritability, sleep disturbances, changes in memory and cognition.1 These symptoms can be unbearable and decrease quality of life, hence many women turn to hormone therapy replacement to help relieve their symptoms. There are two types of hormone replacement therapy FDA approved standard hormone replacement therapy (SHRT) and compounded bioidentical hormone replacement therapy (BHRT). However, the FDA approved products that are considered standard of care raised safety concerns when the Womens Health Initiative found that they increased breast cancer, stroke, venous thromboembolism, coronary heart disease, dementia; therefore, the risk outweigh such benefits as preserving bone health and endometrial cancer.2 Women who seek out alternative treatment turn to bioidentical hormone therapy compounded by compounding pharmacies which are advertised as safer, better, and a more natural way to treat menopause symptoms.3 A paper written by the American College of Obstetricians and Gynecologists claim that compounded products are inferior to FDA approved products and that they lack safety and efficacy data which poses additional risks.4 Currently, there are no large scale studies done on the safety and efficacy of compounded bioidentical hormone therapy. Hence, the idea of surveying current patients on all hormone replacement products and their experience on bioidentical hormone therapy and standard hormone therapy came about. The results from this survey can give us more insight and information on bioindentical hormone therapy itself. Hypothesis Objective My objective is to survey patient opinion for each class of hormone replacement therapy available in todays market. The study includes an exploration of patients symptom relief and number of self reported ADRs. There may be more negative views about HRT for those who have not tried it, including mixed views from patients who have tried standard HRT and very positive views for those who have tried BHRT. Acknowledgements References I would like to thank patients at Coast Compounding and Rite Aid pharmacy that participated in the survey. And many thanks to Dr. Dieter Steinmetz, Dr.Rasial Hamid, Reginald Villacorta, and Dr.Klotz for all your guidance and help that made this project possible. 1. Jones M.D., M.A., F.A.C.O.G, Lisa M. "Menopause and Menopause Treatments Fact Sheet." Womenshealth.gov. Ed. Songhai Barclift, M.D., F.A.C.O.G. U.S. Public Health Service, 16 July 2012. Web. 01 Apr. 2014. 2. "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women's Health Initiative Randomized Controlled Trial."Http://jama.jamanetwork.com/article.aspx?articleid=195120. Jama-Express, 17 July 2002. Web. 24 Mar. 2014. 3. What are bioidentical hormones? Natural. Bioidentical. Compounded. Confusion about these terms is only adding to the confusion over hormone therapy. Harv Womens Health Watch 2006; 13:1-3. Print. 4. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice and American Society for Reproductive Medicine Practice Committee. "Compounded Bioidentical Menopausal Hormone Therapy." Fertility and Sterility 98.2 (2012): 308-12. Print. Study Population Inclusion Criteria Menopausal or post- menopausal women who have not used, have used, or are using HRT w/wo a hysterectomy Bioidentical Hormone Replacement Therapy (BHRT) N= 72 No Therapy N = 47 Standard Hormone Replacement Therapy (SHRT) N= 39 Exclusion Criteria - Men - Perimenapausal women - Women who have menses. Methods Methods are IRB approved. Many self reported anonymous surveys were done. Each survey asked the patients for the type of their hormone replacement medication, treatment time frame in years, medical conditions (stroke, blood clots, breast cancer, uterine cancer), symptoms before and after treatment using a scale from 1 to 5 (1 no symptoms, 5 severe symptoms), and their opinion on the hormone therapy they are currently on (positive, neutral, negative). The setting for the survey was both at Coast Compounding pharmacy and at a retail pharmacy at a chain pharmacy(with the managers approval). Study Design Results 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% BHRT SHRT No Therapy 86% 49% 2% 11% 13% 57% 3% 38% 40% Positive Neutral Negative Table 1: Average years of patients on Hormone Replacement Therapy Table 2: Frequency of self-reported adverse drug events (Stroke, Blood Clots, Breast Cancer, Uterine Cancer) *Three patients reported being diagnosed with breast cancer Bioidentical Hormone Replacement Therapy (BHRT) 4.60 Standard Hormone Replacement Therapy (SHRT) 6.22 No Treatment BHRT SHRT Before After Before After 2 3 1 1 5* Table 3: Averages of Self reported symptoms before/after therapy (5 = severe; 1 = no symptom) No Treatment N=47 Bioidentical N=72 Standard N=39 Before After Before After Hot Flashes 2.81 3.39 1.46 3.74 2.03 Night Sweats 2.91 3.44 1.50 3.33 1.82 Vaginal Dryness 2.32 2.63 1.67 2.82 2.05 Depression 1.94 2.42 1.56 2.15 1.67 Headache 1.81 2.22 1.56 2.36 1.77 Foggy Thinking 1.96 2.78 1.74 2.49 1.82 Anxiety 2.21 2.76 1.76 2.31 1.85 Irritability 2.34 3.10 1.75 2.67 1.97 Insomnia 2.30 3.47 2.04 2.90 1.97 Decreased Libido 2.17 2.86 1.89 2.62 1.79 Fatigue 2.38 3.15 1.90 2.69 1.92 P-value <0.05. P-value was determined by chi-square test. Discussion Patients may be more satisfied with BHRT therapy due to more frequent patient monitoring from the physician and pharmacists. For patients in the SHRT group, patients rated that they obtained relief from SHRT (table 3), but felt more negatively towards it. Possible reasons are due to the reports from WHI being harmful may have women feeling more negatively towards it.2 Physicians and pharmacists may not have monitored the patient, including spending less time with them on their medication as well. Results in the no therapy group did not meet expectations as majority felt neutral about HRTs rather than more negative. Possibly due to less severe symptoms than in patients in the SHRT and BHRT group. Limitations in the study are of the following: patients who come to a compounding pharmacy may also be the ones who are satisfied their compounded medication and the discontinued population was not available for survey. Compounded medications are customized medication to the patient, so it is very hard to generalize bioidenticals since each patient is getting a different dose, different active ingredients, and using ifferent cream bases. What was unanticipated was the amount of self reported relief patients in the BHRT were responding. The American College of OBG/YN speak of compounded products in a negative light, claiming that dose is inconsistent and efficacy is questionable yet in table 3, patient reported relief using BHRT are similar to SHRT group.4 Interesting to note, even though less patients were surveyed in the SHRT group compared to BHRT group, frequency of self reported ADRs were higher in the after-SHRT group than in the after-BHRT group. Potential studies can focus on the efficacy and safety of compounded products compared to standard of care hormone replacement products. Challenges for future experiments that may present would be the money to fund such a large study, choosing what cream base, what dose and what ingredients to use for the compounded products.

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FINAL Poster Prsentation

  • 1. Hormone Replacement Therapy: Survey of patients regarding their opinion of symptom relief Kathy Chowa, Dieter Steinmetz, R.Ph.b aWestern University of Health Sciences College of Pharmacy, Pomona, CA bCoast Compounding Pharmacy, Oceanside, CA Background Many women who are experiencing menopause suffer from hot flashes, vaginal dryness, night sweats, depression, irritability, sleep disturbances, changes in memory and cognition.1 These symptoms can be unbearable and decrease quality of life, hence many women turn to hormone therapy replacement to help relieve their symptoms. There are two types of hormone replacement therapy FDA approved standard hormone replacement therapy (SHRT) and compounded bioidentical hormone replacement therapy (BHRT). However, the FDA approved products that are considered standard of care raised safety concerns when the Womens Health Initiative found that they increased breast cancer, stroke, venous thromboembolism, coronary heart disease, dementia; therefore, the risk outweigh such benefits as preserving bone health and endometrial cancer.2 Women who seek out alternative treatment turn to bioidentical hormone therapy compounded by compounding pharmacies which are advertised as safer, better, and a more natural way to treat menopause symptoms.3 A paper written by the American College of Obstetricians and Gynecologists claim that compounded products are inferior to FDA approved products and that they lack safety and efficacy data which poses additional risks.4 Currently, there are no large scale studies done on the safety and efficacy of compounded bioidentical hormone therapy. Hence, the idea of surveying current patients on all hormone replacement products and their experience on bioidentical hormone therapy and standard hormone therapy came about. The results from this survey can give us more insight and information on bioindentical hormone therapy itself. Hypothesis Objective My objective is to survey patient opinion for each class of hormone replacement therapy available in todays market. The study includes an exploration of patients symptom relief and number of self reported ADRs. There may be more negative views about HRT for those who have not tried it, including mixed views from patients who have tried standard HRT and very positive views for those who have tried BHRT. Acknowledgements References I would like to thank patients at Coast Compounding and Rite Aid pharmacy that participated in the survey. And many thanks to Dr. Dieter Steinmetz, Dr.Rasial Hamid, Reginald Villacorta, and Dr.Klotz for all your guidance and help that made this project possible. 1. Jones M.D., M.A., F.A.C.O.G, Lisa M. "Menopause and Menopause Treatments Fact Sheet." Womenshealth.gov. Ed. Songhai Barclift, M.D., F.A.C.O.G. U.S. Public Health Service, 16 July 2012. Web. 01 Apr. 2014. 2. "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women's Health Initiative Randomized Controlled Trial."Http://jama.jamanetwork.com/article.aspx?articleid=195120. Jama-Express, 17 July 2002. Web. 24 Mar. 2014. 3. What are bioidentical hormones? Natural. Bioidentical. Compounded. Confusion about these terms is only adding to the confusion over hormone therapy. Harv Womens Health Watch 2006; 13:1-3. Print. 4. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice and American Society for Reproductive Medicine Practice Committee. "Compounded Bioidentical Menopausal Hormone Therapy." Fertility and Sterility 98.2 (2012): 308-12. Print. Study Population Inclusion Criteria Menopausal or post- menopausal women who have not used, have used, or are using HRT w/wo a hysterectomy Bioidentical Hormone Replacement Therapy (BHRT) N= 72 No Therapy N = 47 Standard Hormone Replacement Therapy (SHRT) N= 39 Exclusion Criteria - Men - Perimenapausal women - Women who have menses. Methods Methods are IRB approved. Many self reported anonymous surveys were done. Each survey asked the patients for the type of their hormone replacement medication, treatment time frame in years, medical conditions (stroke, blood clots, breast cancer, uterine cancer), symptoms before and after treatment using a scale from 1 to 5 (1 no symptoms, 5 severe symptoms), and their opinion on the hormone therapy they are currently on (positive, neutral, negative). The setting for the survey was both at Coast Compounding pharmacy and at a retail pharmacy at a chain pharmacy(with the managers approval). Study Design Results 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% BHRT SHRT No Therapy 86% 49% 2% 11% 13% 57% 3% 38% 40% Positive Neutral Negative Table 1: Average years of patients on Hormone Replacement Therapy Table 2: Frequency of self-reported adverse drug events (Stroke, Blood Clots, Breast Cancer, Uterine Cancer) *Three patients reported being diagnosed with breast cancer Bioidentical Hormone Replacement Therapy (BHRT) 4.60 Standard Hormone Replacement Therapy (SHRT) 6.22 No Treatment BHRT SHRT Before After Before After 2 3 1 1 5* Table 3: Averages of Self reported symptoms before/after therapy (5 = severe; 1 = no symptom) No Treatment N=47 Bioidentical N=72 Standard N=39 Before After Before After Hot Flashes 2.81 3.39 1.46 3.74 2.03 Night Sweats 2.91 3.44 1.50 3.33 1.82 Vaginal Dryness 2.32 2.63 1.67 2.82 2.05 Depression 1.94 2.42 1.56 2.15 1.67 Headache 1.81 2.22 1.56 2.36 1.77 Foggy Thinking 1.96 2.78 1.74 2.49 1.82 Anxiety 2.21 2.76 1.76 2.31 1.85 Irritability 2.34 3.10 1.75 2.67 1.97 Insomnia 2.30 3.47 2.04 2.90 1.97 Decreased Libido 2.17 2.86 1.89 2.62 1.79 Fatigue 2.38 3.15 1.90 2.69 1.92 P-value <0.05. P-value was determined by chi-square test. Discussion Patients may be more satisfied with BHRT therapy due to more frequent patient monitoring from the physician and pharmacists. For patients in the SHRT group, patients rated that they obtained relief from SHRT (table 3), but felt more negatively towards it. Possible reasons are due to the reports from WHI being harmful may have women feeling more negatively towards it.2 Physicians and pharmacists may not have monitored the patient, including spending less time with them on their medication as well. Results in the no therapy group did not meet expectations as majority felt neutral about HRTs rather than more negative. Possibly due to less severe symptoms than in patients in the SHRT and BHRT group. Limitations in the study are of the following: patients who come to a compounding pharmacy may also be the ones who are satisfied their compounded medication and the discontinued population was not available for survey. Compounded medications are customized medication to the patient, so it is very hard to generalize bioidenticals since each patient is getting a different dose, different active ingredients, and using ifferent cream bases. What was unanticipated was the amount of self reported relief patients in the BHRT were responding. The American College of OBG/YN speak of compounded products in a negative light, claiming that dose is inconsistent and efficacy is questionable yet in table 3, patient reported relief using BHRT are similar to SHRT group.4 Interesting to note, even though less patients were surveyed in the SHRT group compared to BHRT group, frequency of self reported ADRs were higher in the after-SHRT group than in the after-BHRT group. Potential studies can focus on the efficacy and safety of compounded products compared to standard of care hormone replacement products. Challenges for future experiments that may present would be the money to fund such a large study, choosing what cream base, what dose and what ingredients to use for the compounded products.