Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.

Andres D Ruiz,Christopher R Frei,Kelly R Daniels,John J Carson,Jamie C Barner

doi:10.1186/1472-6874-11-27

Abstract

BackgroundBioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies.MethodsThis was an observational cohort study of women between the ages of 18-89 who received a compounded BHRT product from January 1, 2003 to April 30, 2010 in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events. Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test.ResultsWomen (n = 296) receiving BHRT at Oakdell Pharmacy had a mean (standard deviation) age of 52 (9) years. The most common BHRT dosage forms utilized were topical (71%) and oral (43%). Compounded BHRT regimens were generally initiated at low doses regardless of route. Women experienced a 25% decrease in emotional lability (p < 0.01), a 25% decrease in irritability (p < 0.01), and a 22% reduction in anxiety (p = 0.01) within 3 to 6 months. These women also experienced a 14% reduction in night sweats (p = 0.09) and a 6% reduction in hot flashes (p = 0.50).ConclusionsThis study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.

Highlights

Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; data are needed to support these claims
The majority of women had not received prior hormone therapy; 8% reported prior Conventional Hormone Therapy (CHT) use and 13% reported prior BHRT use. When compared to those women who were excluded, women included in this study were more likely to have had a hysterectomy (p = 0.02), previous BHRT use (p < 0.01), and previous CHT use (p < 0.01) at baseline
This study provides some of the first clinical evidence in support of “compounded” BHRT

Summary

Introduction

Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies. Bioidentical Hormone Replacement Therapy (BHRT) describes supplementation of hormones that are molecularly identical to those hormones produced in the human body. Unlike manufactured Conventional Hormone Therapy (CHT), such as conjugated estrogens (CE) and medroxyprogesterone acetate (MPA), BHRT hormones do not contain extra structural moieties which may alter hormone receptor binding and function in the human body. This study first describes the characteristics and prescribing patterns of compounded BHRT in six community pharmacies. Three specific aims are addressed: (1) determine if compounded BHRT is effective in treating menopausal symptoms, (2) identify which BHRT compounds are most effective, and (3) determine if compounded BHRT is safe

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