Effectiveness of Compounded Bioidentical Hormone Replacement Therapy: An Observational Cohort Study

This 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.Women (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).This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.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.The Professional Compounding Centers of America (PCCA) estimates that 1 in 4 compounded products in the United States are a form of Hormone Replacement Therapy (HRT) [1]. Compounded BHRT is a form of personalized medicine whereby the dose, regimen, and dosage forms are custo