Nov. 3, 2005 -- The growing popularity of "bioidentical" hormones instead of traditional hormones for menopause has prompted the nation's leading organization of women's health physicians to speak out.
Custom-compounded female hormone preparations are being commercially touted as more effective and safer than the conventional hormone therapy that is approved by the FDA.
The popularity of the custom hormones soared last year following the publication of a book touting their youth-restoring powers by actress and author Suzanne Somers.
But the American College of Obstetricians and Gynecologists (ACOG) says there is no scientific evidence to back up the claim.
An ACOG committee examined the issue of compounded bioidentical hormones. It defined bioidentical hormones as plant-derived hormones that are biochemically similar to those produced by the body.
Claims Are Questioned
The committee warns that women may not be getting what they think they are getting when they take the unregulated formulations. "It is misleading and dishonest to make the claim that this approach is better and safer when there are no data to show this," says Michele Curtis, MD, who led the ACOG committee.
Sales of custom-compounded hormonal preparations took off after the safety of commercially manufactured estrogen and progestin-based treatments were called into question in the summer of 2002. That was when a large government-funded study known as the Women's Health Initiative (WHI) linked their long-term use by older women with an increased risk of heart disease, stroke, and breast cancer.
Tailored to the Individual
The custom-compounded hormonal formulations are supposed to be tailored to a woman's individual hormone needs, generally determined through saliva testing.
But the ACOG committee concluded that there is no evidence that hormonal levels in saliva are biologically meaningful.
North American Menopause Society founding director Wulf Utian, MD, PhD, agrees.
"It is nonsensical to think that you can really get an idea of what is going on hormonally with a saliva sample," he tells WebMD. "You can eat a piece of chocolate or even drink a glass of water and that can cause your hormone levels to change."
The ACOG committee concluded that "given the lack of well-designed and well-conducted clinical trials of these alternative therapies," individually compounded hormones cannot be considered safer than the commercially available products that are regulated by the FDA.
Utian says compounding pharmacies that make up the hormone preparations have broken with tradition and are aggressively marketing them to women and their physicians.
"You can go on the Internet and type in the word "bioidentical" and come up with hundreds of sites selling these products," he says.
Curtis adds that the advertising seeks to convince potential users that the alternative treatment more closely mimics the hormones in a woman's body because they are derived from plants.
But since compounded hormones are not regulated by the FDA, there is no way to know what is in them, she adds.
"When you take these compounded hormones you are trusting that the pharmacist had good hormones to start out with and that they are skilled enough to make them. You are also trusting that you are going to get the same product every time, with no outside entity overseeing the quality."