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Oprah is Talking About Bioidentical Hormones for Menopause; Experts Weigh in

Posted Jan 27 2009 3:46pm
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Oprah Winfrey says menopause caught her "off guard" and that she's taking bioidentical hormones that have made a big improvement in how she feels.

Bioidentical hormones are one form of therapy for menopausal symptoms. Winfrey, who turns 55 this month, writes in February's edition of O, The Oprah Magazine that she felt "out of kilter" and had "issues" for two years that she suspected were hormonal. Upon a friend's recommendation, Winfrey went to a doctor who specializes in bioidentical hormones.

Winfrey writes that the hormone specialist told her that her "hormonal tank was empty" and gave her a prescription for bioidentical estrogen.

"After one day on bioidentical estrogen, I felt the veil lift," Winfrey writes. "After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step."

Winfrey isn't recommending bioidentical hormones for every menopausal woman. Instead, she urges women to "take charge of your health" and says it's time to "start the conversation" about menopause and bioidentical hormones.

Oprah writes that bioidentical hormone therapy is controversial and confusing to many people.
What's the controversy about? Are bioidentical hormones better or safer than other hormone therapy? WebMD has answers from experts.

What Are Bioidentical Hormones?
"Bioidentical hormone preparations are compounded medications that contain hormones that are an exact chemical match to those made naturally by humans," says Manson, who is chief of preventive medicine at Brigham and Women's Hospital in Boston and the Elizabeth F. Brigham Professor of Women's Health at Harvard Medical School.

Some bioidentical hormones are made by drug companies, are approved by the FDA, and are sold in standard doses. Other bioidentical hormone preparations are made at special pharmacies called compounding pharmacies, which make the preparations on a case-by-case basis for each patient. Those "custom-made" preparations aren't approved by the FDA.

Why Aren't Compounded Bioidentical Hormones FDA approved?
The FDA doesn't approve any compounded products, for any condition, because those products aren't standardized.

That doesn't mean that compounding is bad. Compounding can be useful for patients who are allergic to an additive in an FDA-approved product, says Kathleen Uhl, MD, the FDA's assistant commissioner for women's health.

But "the purpose of compounding is to do it on a patient-by-patient basis, so there's nothing that's submitted to FDA to evaluate, so they're not FDA approved," Uhl explains.
And because compounded products don't go through the FDA approval process, they don't bear the same warnings as other hormone therapy.

Does That Mean Compounded Bioidentical Hormones Are Safer?
Erika Schwartz, MD, a New York doctor who prescribes FDA-approved biodentical hormones and compounded bioidentical hormones, says there have been studies that support the safety of bioidentical hormones, compared to other hormone therapy.

Schwartz asks, "If NAMS or ACOG says there are not enough studies, well, why haven't you done the studies if you think you need more? If this had been men's health, would we be having this conversation, or would we have answers?"

Schwartz says she has long wanted to see large, government-sponsored studies compare bioidentical and other hormone therapies head to head.

Can You Take Bioidentical Hormones Indefinitely?
Schwartz states that bioidentical hormones are chemically different from the hormone therapy drugs that were linked to health risks, saying "there is no reason to compare recommendations because they're not the same product."

Schwartz says she's been prescribing bioidentical hormones for 14 years and takes them herself, having switched from other hormone therapy years ago. "I feel great and the women I work with feel great," she says. "I have no complaints."

Schwartz says she gives her patients a choice between standardized bioidentical hormones or compounded products made by a lab she has vetted. She stresses the importance of doctors being trained about bioidentical hormones by other physicians who are knowledgeable about bioidenticals. "The physician has to work with the patient and the compounder," Schwartz says.

Are Saliva and Blood Tests FDA Approved?
Yes, those tests are FDA approved for diagnostic purposes -- but not to tailor hormone treatment.

"The tests are not approved for use to measure hormone levels to adjust hormone therapy," says Uhl, who points out that hormone levels can fluctuate throughout the day.
Schwartz says she doesn't believe saliva testing is appropriate and only uses blood tests with her patients.

What About Oprah's Experience?
"I'm happy that Oprah feels better," Schwartz says. Most women, Schwartz notes, feel better when they start on bioidentical hormone therapy.

Compounded or not, bioidentical hormones are only part of the picture, Schwartz says.
"A lot of people just want to follow the celebrity," she says. "Sometimes people come in and what they really need is to address their diet, their exercise, their lifestyle."

"I think bioidentical hormones are great," Schwartz says. "But if you don't address them in the context of the whole person -- with her diet, her exercise, her lifestyle, with her relationships, with her stresses -- and you don't work with everything, you're not really going to be able to come up with the results that women would like to see."
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