Reiterating the Lack of Evidence Behind "Bioidentical" Hormones

Ever since the Women’s Health Initiative study found that women taking supplemental hormones had an increased risk of breast cancer, heart disease, and stroke, women struggling with menopausal symptoms have searched for safer alternatives. Companies that make bioidentical hormones (also called natural or compounded hormones) have been quick to jump into the void, often claiming that their products are safer and more effective than traditional "synthetic" hormones.

Unfortunately, there is no evidence to suggest that this is true. Yesterday, the American College of Obstetricians and Gynecologists (ACOG) issued a press release on such hormones.

ACOG expressed concern about the lack of testing of these products and also criticized the salivary testing that is often done in bioidentical hormone users under the assumption that it provides information needed for selecting a dosage:

"Despite celebrity testimonials touting scientifically unfounded benefits of compounded bioidentical hormones, the bottom line is that most have not undergone rigorous clinical testing for safety or efficacy, nor are they approved by the FDA. ACOG also stresses that salivary testing of a woman's hormone levels is not useful because they vary within each woman depending on her diet, time of day, the specific hormone being tested, and other variables. Although monitoring salivary hormone levels is promoted by some as a means of 'tailoring' a hormone treatment to an individual, hormone therapy does not require customized dosing. "

The organization previously released a committee opinion in 2005 stating that "There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies," but indicated that recent media attention to the topic led to yesterday's statement.

The FDA has also set up a page for consumers of myths vs. facts about compounded "bioidentical" hormones, and expressed concern that "claims like these [about the effects of the hormones] mislead women and health care professionals, giving them a false sense of assurance about using potentially dangerous hormone products."

Related Posts: Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women’s Health Network.