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The Truth About 'Bio-identical' Hormone Therapy


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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.

The not-inconsiderable list of potential risks of hormone-replacement therapy has left an opening for manufacturers of "natural products" to step up with supposedly better and safer versions of hormone therapy, according to the FDA.

Marketers of bio-identical hormones often say the products are identical to hormones produced by the body, and these "all-natural" pills, creams, lotions, and gels don't carry the risks of menopausal hormone therapies approved by the FDA. Agency-approved HRT drugs are typically prescribed to treat symptoms of menopause, such as hot flashes and vaginal dryness.

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But the FDA said it hasn't approved compounded "BHRT" drugs and can't assure their safety or effectiveness.

Liu said that " 'bio-identical' really means that the structure of the compound you're claiming to be identical is biologically identical. It [the term] is applied primarily to female hormones that are used in hormone therapy."

But, Liu added, "the main problem is how a woman would obtain [bio-identicals]. If it's pharmaceutical grade, FDA-grade, it's prescribed. It's just how it's made."

Some of the bio-identical hormones are "compounded," meaning they are mixed specially to meet an individual's needs. For example, some dyes or preservatives may be eliminated if a person is allergic to them, according to the FDA.

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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 1/30/2009

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SOURCES: James Liu, M.D., chairman, department of obstetrics and gynecology, MacDonald Women's Hospital, Case Medical Center, University Hospitals, Cleveland; Suzanne Steinbaum, D.O., director of Women and Heart Disease, Lenox Hill Hospital, New York City; Bio-Identicals: Sorting Myths from Facts, U.S. Food and Drug Administration


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