Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a...

Area of Science:

• Endocrinology
• Pharmacology
• Women's Health

Background:

• Limited published data exists on the efficacy and safety of compounded bioidentical hormone therapy (cBHT).
• A comprehensive synthesis of current evidence is needed for perimenopausal and postmenopausal women.

Purpose of the Study:

• To systematically review and meta-analyze evidence on the safety and efficacy of commonly prescribed cBHT preparations.
• To evaluate cBHT's impact on lipid profile, glucose metabolism, and vaginal atrophy symptoms.

Main Methods:

• Systematic review and meta-analysis of randomized controlled trials (RCTs) from PubMed, ClinicalTrials.gov, and Cochrane.
• Included RCTs compared cBHT to placebo or FDA-approved products in perimenopausal/postmenopausal women.
• Assessed risk of bias using the Cochrane risk of bias tool; primary outcomes were lipid/glucose changes and vaginal atrophy.

Main Results:

• 29 RCTs (1,808 women) were included. Compounded androgens did not alter lipid profile or glucose metabolism.
• No changes in endometrial thickness or serious adverse events were observed; compounded dehydroepiandrosterone showed expected androgenic side effects.
• Compounded vaginal androgens significantly improved vaginal atrophy symptoms (SMD -0.66) and sexual function, with serum hormone level trends consistent with FDA-approved products.

Conclusions:

• Short-term cBHT use in RCTs is not linked to adverse lipid or glucose changes.
• Compounded vaginal androgens appear effective for vaginal atrophy symptoms.
• Insufficient RCT data exists to assess long-term risks of breast cancer, endometrial cancer, or cardiovascular disease; long-term studies are required.