Bioidentical hormone therapy: a review of the evidence

Abstract

Bioidentical hormone therapy (BHT) uses bioidentical hormones (BHs), derivatives of plant extracts chemically modified to be structurally indistinguishable from human endogenous hormones. BHTs are available commercially or can be compounded into different dosages and for different routes of administration. Typically, compounded preparations of BHs may include estriol, estrone, estradiol, testosterone, micronized progesterone, and occasionally dehydroepiandrosterone (DHEA). It is generally accepted that estrogen-based hormone therapies share similar efficacies as well as risks. Many FDA-approved and regulated pharmaceutically manufactured and branded conventional hormone therapies (CHTs) employ BHs. Since the publication of the Women's Health Initiative (WHI) trial results publicizing an increased risk of stroke, venous thrombosis, and breast cancer and no beneficial effect on coronary heart disease (CHD), use of CHT has declined, and there has been increased interest in alternative approaches. This review of the literature related to compounded BHT and the practices of its advocates is to determine if sufficient scientific evidence supports claims of greater efficacy and safety and any additional risks and uncertainties not generally associated with CHTs. Compounded BHTs have been promoted by some as natural, safer, and in some cases more efficacious than conventional hormone therapies, but there is a dearth of scientific evidence to support these claims. Compounded BHTs lack well controlled studies examining route of administration, pharmacokinetics, safety, and a critical, science-based rationale for the mixture and ratios of bioidentical estrogens employed in many preparations. Many advocates of compounded BHTs customize prescriptions based on saliva tests or blood sera levels in direct contradiction to evidence-based guidelines, which support tailoring HT individually according to symptoms. Currently, scientific uncertainties associated with compounded BHTs make their use less preferable to that of CHTs, as CHTs have been and continue to be assessed by clinical trials regarding both benefits and risks and are indicated for use according to evidence-based guidelines.