The Truth About 'Bio-identical' Hormone Therapy

Jan. 31 -- FRIDAY, Jan. 30 (HealthDay News) -- They're marketed as "bio-identical" hormones or "bio-identical hormone replacement therapy," and they claim to do everything from helping menopausal women lose weight to preventing senility.

They're touted as safer and sometimes even more effective than conventional hormone-replacement therapy.

But the U.S. Food and Drug Administration warns that these claims are "unproven" and that the products are "potentially dangerous." What's more, bio-identical hormone replacement therapy -- or "BHRT" -- is a "marketing term not recognized by FDA," the agency said.

Experts also are expressing some concerns about the products.

"We don't know anything [about these products]," said Dr. Suzanne Steinbaum, director of Women and Heart Disease at Lenox Hill Hospital in New York City. "This isn't FDA-approved. It's the same thing as a hormone. What concerns me is that people believe if it's not from a drug company, it's safe."

Added Dr. James Liu, chairman of the department of obstetrics and gynecology at MacDonald Women's Hospital at Case Medical Center, University Hospitals in Cleveland: "Over-the-counter products that are not listed as drugs can make some claims, and they have to be careful about it. Usually these are considered supplements. Suffice it to say, there is science behind some of what they say and a little bit of lack-of-science in other things."

And the Endocrine Society issued this position statement back in October 2006, expressing concerns about these products: " 'Bioidentical hormones,' particularly estrogen and progesterone, have been promoted as safer and more effective alternatives to more traditional hormone therapies, often by people outside of the medical community. In fact, little or no scientific and medical evidence exists to support such claims... Additionally, many 'bioidentical hormone' formulations are not subject to FDA oversight and can be inconsistent in dose and purity."

Since the release in 2002 of a Women's Health Initiative report, hormone replacement therapy (HRT) -- used to relieve symptoms of menopause -- has generated worrisome, and sometimes conflicting, headlines. While linked to a reduced risk of colon cancer and fractures, the therapy has also been associated with an increased risk of breast cancer, stroke, blood clots and heart attack. And -- so far, at least -- there are no indications that HRT has any effect on the development of dementia.