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Are Bioidentical Hormones Safe?

Menopausal women are increasingly using them instead of hormone replacement therapy

En español | Sharon Rosen is pushing 70, but she has the hormones of a woman half her age, assuming that woman had especially hard-working ovaries. The retired elementary school teacher from South Windsor, Conn., rubs estrogen and progesterone creams on her skin every morning and evening. At bedtime, she applies another cream of estrogen and testosterone with a progesterone pill as a topper.

Are Bioidentical Hormones Safe?

— ClassickStock/Fotosearch

The hormones, she says, have turned her into a new, younger version of herself: Her infernal head-to-toe hot flashes are gone, her libido is back and her mind isn't nearly as fuzzy as it was a few years ago. She'll still occasionally lose a train of thought, she says, "but now I'm doing better than my husband. I tell him that he should be seeing my doctor."

Rosen's pills and creams exactly match the hormones her body once made naturally. That makes them "bioidentical," a buzzword that has been making the rounds through talk shows and magazines and doctors' offices for several years now. In 2008, Endocrine Today reported that a million or more American women were taking bioidentical hormones, and demand for the treatment certainly hasn't waned since then. If anything, it's soared.

Untested, unproven, popular

Many so-called bioidentical hormones haven't been approved or tested by the Food and Drug Administration, but their appeal is obvious. Practitioners — including Rosen's doctor, Alicia Stanton, M.D. — promote them as safe, natural alternatives to traditional hormones such as Premarin, a prescription estrogen that's isolated from the urine of pregnant mares, and Provera, a synthetic version of progesterone.

"They do all of the things they are supposed to do," says Stanton, a board-certified ob-gyn in Hartford and fellow of the American College of Obstetrics and Gynecology. "I don't understand how someone could say that something that's different than what our bodies make could be any better for us."

But are bioidenticals really a healthy option? Cynthia A. Stuenkel, M.D., a clinical professor of medicine at the University of California, San Diego, and former president of the North American Menopause Society, has her doubts — to put it mildly. The problem: Most bioidentical hormones are sold without the controls, safeguards and testing required of prescription drugs. "Are they safe? Do they work? That's never been shown in any real way," she says.

Stuenkel's not the only skeptic. The American Medical Association, the Endocrine Society and the American College of Obstetrics and Gynecology have all taken strong stands against unapproved bioidentical hormones. A position paper from the Endocrine Society — an organization representing over 14,000 hormone experts from around the world — concluded that there are "no published studies in peer-reviewed literature" showing that bioidentical hormones are less risky or more effective than FDA-approved hormones.

The term "bioidentical" usually refers to hormones that have been mixed together or "compounded" at a pharmacy. Following a doctor's instructions, the pharmacist can make the pills and creams extra strong or extra weak or somewhere in between. The pharmacist can customize in other ways, too, such as replacing the usual peanut oil in gel caps with olive oil. The estrogens and progesterone used in these compounded preparations are, in fact, identical in every way to the hormones found in a woman's body. But it's a bit of a stretch to call them natural. They're created in laboratories by chemists who tinker with plant hormones from yams or soy plants.

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