Context: Since 2002, when the US Food and Drug Administration (FDA) placed a black box warning on women's hormone replacement products, women and their providers have been struggling with whether to proceed with hormone replacement therapy. Out of the controversy has grown a popular movement promoting the use of bioidentical hormones. Many providers are still unsure if they want to recommend these products and, if so, how to use them appropriately.
Objective: To inform primary care providers (eg, physicians, physician assistants, nurse practitioners) about current data on the safety and efficacy of bioidentical hormone replacement therapy and to provide a context for patient perceptions.
Methods: Literature published between 1999 and 2009 was reviewed through MD Consult's Medline and Ovid search engines. A Google search of popular media was also performed using the same terms.
Results: Randomized clinical trial data are sufficient to support the prescription of only estropipate, estradiol, and progesterone for the relief of menopausal symptoms. Estropipate is approved by the FDA for the management of menopausal symptoms. 17β-Estradiol is FDA approved for menopausal symptoms, may have cardioprotective effects, and may have fewer adverse effects on blood pressure than conjugated equine estrogens. Estriol is not FDA approved but is widely used in Europe and is effective for relieving menopausal symptoms. Progesterone is approved by the FDA for the management of menopausal symptoms and for the prevention of endometrial hyperplasia; it should be used orally to oppose estrogen. Testosterone is FDA approved in combination with estrogen for the management of vasomotor symptoms. Dehydroepiandrosterone is not FDA approved, but small-scale studies indicate it may improve bone mineral density. Data are conflicting about efficacy in improving sexual dysfunction. There is an abundance of misleading information available in the media and on the Internet for our patients. Compounded bioidenticals and salivary hormone testing are unnecessary, are not standardized, and should be avoided.
Conclusion: Bioidentical hormones that are approved by the FDA may be preferred over standard hormone replacement because of their physiologic benefits and safety profile.