Compounded Bioidentical Hormone Research Articles

Compounded bioidentical menopausal hormone therapy

Although improvement in long-term health is no longer an indication for menopausal hormone therapy, evidence supporting fewer adverse events in younger women, combined with its high overall effectiveness, has reinforced its usefulness for short-term treatment of menopausal symptoms. Menopausal therapy has been provided not only by commercially available products but also by compounding, or creation of an individualized preparation in response to a health care provider's prescription to create a medication tailored to the specialized needs of an individual patient. The Women's Health Initiative findings, coupled with an increase in the direct-to-consumer marketing and media promotion of compounded bioidentical hormonal preparations as safe and effective alternatives to conventional menopausal hormone therapy, have led to a recent increase in the popularity of compounded bioidentical hormones as well as an increase in questions about the use of these preparations. Not only is evidence lacking to support superiority claims of compounded bioidentical hormones over conventional menopausal hormone therapy, but these claims also pose the additional risks of variable purity and potency and lack efficacy and safety data. The Committee on Gynecologic Practice of the American College of Obstetricians and Gynecologists and the Practice Committee of the American Society for Reproductive Medicine provide an overview of the major issues of concern surrounding compounded bioidentical menopausal hormone therapy and provide recommendations for patient counseling.

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

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.

Compounded or confused? Bioidentical hormones and menopausal health

The aim of this article is to focus on compounded bioidentical hormone (BH) formulations for menopausal symptoms and to discuss the impact of these on women's choice of treatment. The practice of compounding BHs for individualized treatment of women with menopausal symptoms has developed in the USA. In spite of claims of superiority, there is no evidence to suggest that these formulations are any more efficacious or safe than conventional hormone replacement therapy (HRT). In fact, there are some concerns about dosing inconsistencies and usefulness of saliva testing that is carried out as part of this type of treatment. While there should be no serious safety issues for women, there is a mismatch between the reality of compounded BH formulations and women's perception of them.

ACOG Committee Opinion #322: Compounded Bioidentical Hormones

ACOG Committee Opinion #322: Compounded Bioidentical Hormones

A holistic programmatic approach to natural hormone replacement.

With an unprecedented number of women reaching midlife, the impact of menopause has become a significant public health issue. Recent findings have left women and practitioners questioning traditional hormone replacement therapy (HRT) and searching for reasonable alternatives. Growing numbers of women in this country are choosing to use natural progesterone and estrogen to treat symptoms of menopause. This article describes a program that focuses on education, client participation, and alternative methodology to support individualized HRT therapy using natural compounded bio-identical hormones.