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By Miranda Hitti, WebMD Health News Reviewed by Louise Chang, MD

Jan. 15, 2009 — 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 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?
“There is enormous confusion about the meaning of the term ‘bioidentical,’” JoAnn Manson, MD, DrPH, tells WebMD via email.

“Bioidentical hormone preparations are 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.

A woman who gets a prescription for an FDA-approved hormone therapy for menopausal symptoms is “going to get a lot of warning information,” but if she gets a compounded product instead, “you don’t get any of those warnings,” Uhl says. “There’s no requirement for them to provide that because those products are not FDA approved.”

Why Aren’t Compounded Bioidentical Hormones FDA approved? continued…
L.D. King, executive director of the International Academy of Compounding Pharmacists, suggests that patients look for accredited compounding pharmacies listed on the web site of the Pharmaceutical Compounding Accreditation Board (PCAB).

“They make sure those accredited pharmacies are adhering to a very high level of practice, which would include pretty extensive quality control,” King tells WebMD. He also suggests that because there aren’t a lot of PCAB-accredited compounding pharmacies, patients should ask compounding pharmacies what types of quality assurance procedures are in place.

Manson points out that with FDA-approved “bioidentical” drugs available, “most women interested in bioidentical formulations do not need to take custom-compounded products (exceptions would be women with allergies to ingredients, or intolerances to doses, in commercially available products).”

Does That Mean Compounded Bioidentical Hormones Are Safer?
“There is no reason to think that these bioidentical compounded [products] would have a different safety profile than the FDA-approved ones,” Uhl says. She points out that some compounded pharmacies have gotten warning letters from the FDA for false and misleading claims about safety and other benefits.

Isaac Schiff, MD, chief of obstetrics and gynecology at Massachusetts General Hospital, agrees.

Schiff led an American College of Obstetrics and Gynecology (ACOG) committee that reviewed the scientific evidence on compounded bioidentical hormone therapy in 2005. That committee concluded that there wasn’t scientific evidence to support claims of increased efficacy or safety for compounded estrogen or progesterone regimens. The North American Menopause Society (NAMS) and the Endocrine Society have issued similar statements.

“It may be safer, but that study hasn’t been done yet,” Schiff tells WebMD. He says he would like to see a large, lengthy, rigorously designed study on the topic.

“I’m not inherently negative about it,” Schiff says. “I hope they’d be good … and if it turns out to be safer, fabulous. I would like, as a physician, to prescribe the safest hormones to my patients who want to be treated.”

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.

“She’s allowed to have her opinions,” Uhl says. “The evidence that FDA has seen and what’s available in the medical literature leads us to believe that there are the same concerns” with bioidentical and other hormone therapy for menopausal symptoms.

Uhl adds that “the FDA is not prohibiting the compounding of bioidentical hormones. There is definitely a niche for them and certain patients do need this, but it’s not for everybody, and the people who are taking it need to realize that the risks are probably the same for the FDA-approved drugs as they are for the [compounded] bioidentical.”

Can You Take Bioidentical Hormones Indefinitely?
Hormone therapy has been linked to increased risk of breast cancer, so most health experts recommend that women take the lowest dose for the shortest time, if they need it.

That research wasn’t done on bioidentical hormones. But that doesn’t necessarily mean that it’s safe to take them for a longer time, Schiff says.

“If you have the exact same estrogen as one’s own body makes, it doesn’t mean it’s any safer,” says Schiff.

Schwartz counters 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.”

Schiff doesn’t dismiss bioidentical hormones. “If I have a patient who says she wants a bioidentical … then I personally would prescribe a hormone like estradiol, which is what her ovaries made, and I would give it to her in a skin patch by one of the drug companies that I know; it has oversight by the FDA and it has the exact dose that I want her to have,” says Schiff, who has no ties to any drug companies. If a patient is already on a bioidentical hormone, “I try to find out exactly what she’s taking and try to make sure that it’s a safe dose and that she could be followed carefully,” Schiff says.

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.

Recommended Blood Testing Panels for Women
- Women’s Basic Hormone Panel
- Women’s Comprehensive Blood Testing Profile
- Total Health and Wellness Lab Assessment
- Ultimate Health and Wellness Lab Assessment

What About Oprah’s Experience?
“I’m happy that Oprah feels better,” Schiff says. “Every experience is an important experience … but everybody’s individual and they have to work that out with their doctor.”

Some women, Schiff notes, feel better when they start hormone therapy, but he’s not sure if bioidentical hormone therapy would give them an additional boost.

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.”