Safety and Efficacy of Bioidentical Hormone Therapy in Menopause: A Literature Review

Vasomotor symptoms (VMS) experienced during menopause can negatively impact a woman’s quality of life, productivity, sleep, and mood. Systemic hormone therapy (HT) is the most effective treatment for moderate to severe VMS, however safety concerns raised by the 2002 Women’s Health Initiative (WHI) trial have led to a decrease in overall HT use and a growing demand for custom-compounded bioidentical HT. Misconceptions regarding the superior safety and efficacy of custom-compounded hormones and lack of clinician expertise in menopause management contribute to ongoing uncertainty and low uptake of United States (U.S.) Food and Drug Administration (FDA) approved bioidentical HT products. This literature review evaluates current evidence regarding the safety and efficacy of bioidentical HT to provide clinical guidance for patient education and prescribing practices. Twenty-eight articles published from 2015-2020 were included in the final review, consisting of systematic reviews, meta-analyses, randomized control trials (RCTs), cohort studies, case control studies, and literature reviews. Current evidence suggests that FDA approved bioidentical hormones are more effective than placebo and equally effective compared to synthetic hormones when used to treat menopausal VMS. Safety of bioidentical HT was evaluated based on its associated risk of breast cancer, endometrial cancer, venous thromboembolism (VTE), stroke, and cardiovascular disease (CVD). Findings suggest that safety profiles depend on the duration of therapy, route, regimen, and individual factors but bioidentical HT is generally safe for women without contraindications if low to medium doses are used for five years or less