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Open Access Highly Accessed Research article

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

Andres D Ruiz23, Kelly R Daniels123, Jamie C Barner1, John J Carson3 and Christopher R Frei12*

Author Affiliations

1 College of Pharmacy, The University of Texas, Austin, TX, University Station A1900, Austin, TX, 78712, USA

2 Pharmacotherapy Education and Research Center, The University of Texas Health Science Center, San Antonio, TX, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA

3 Oakdell Pharmacy Inc., San Antonio, TX, 7220 Louis Pasteur Dr., Suite 176, San Antonio, TX, 78229, USA

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BMC Women's Health 2011, 11:27  doi:10.1186/1472-6874-11-27

Published: 8 June 2011

Abstract

Background

Bioidentical 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.

Methods

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.

Results

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).

Conclusions

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.