'Natural' menopause aid touted in best seller is disputed


Menopausal women, scared off traditional hormone therapy by studies showing the pills cause breast cancer and heart disease, are seizing on another approach: "bioidentical" hormones.

A recent best-selling book gave a huge impetus to bioidentical hormones, saying the "natural" substances can cure the insomnia, irritability and indifference to romance that often accompany menopause.

And many converts believe these hormones are safe because they have the same molecular structure as the hormones their bodies produce.

Bioidentical hormones tend to be made up by pharmacists according to a doctor's prescription, which makes women feel that the dose is tailored to fit their individual needs.

Bioidenticals also seem more natural because they are derived from plants such as yams and soy, unlike one of the most common conventional hormones, Premarin, which is made from the urine of pregnant mares.

But experts say there's nothing natural about high levels of sex steroid hormones - estrogen, progesterone and testosterone - in women who are past their childbearing years. And the "natural" products are made in laboratories, just like "synthetic" hormones.

Most important, they say, women could be fooling themselves if they think their new treatments are any safer than the ones they abandoned.

Bioidenticals may have fewer risks, they say - but there's no evidence.

"They haven't proven safety and efficacy," said Dr. Wulf Utian, a reproductive endocrinologist at the Cleveland Clinic and director of the North American Menopause Society. "It's misleading to reassure people it's safe without having proven it's different from what's already available."

Nevertheless, many women undergoing bioidentical hormone therapy believe it's safer than conventional medication.

"I don't worry about the health effects because it's close to what the body produces," said Diane Schafer of Crown Point, Ind., a patient of BodyLogicMD, a Chicago medical practice that specializes in bioidentical hormone therapy. Schafer had been overweight, depressed and unable to sleep and had dangerously high cholesterol, but now she says she feels much better.

Joyce Kyce of La Grange Park, another devotee of BodyLogicMD, acknowledged that "every medication probably has some risks." But she added, "I feel [bioidentical hormone therapy] is safer."

In fact, a small study from the University of Oregon found that 71 percent of women believe these products have fewer or no risks compared with conventional hormones.

The only way to prove they're safer would be to randomly assign thousands of women to receive either conventional hormones or bioidenticals and then follow them for years to see how many in each group develop serious health problems. That would be prohibitively expensive.

All the hormones that go into bioidentical compounds are approved by the federal Food and Drug Administration. But because they've been around for decades, there's no way to patent them except by developing a new delivery system. Only then would a drug company be motivated to conduct expensive studies to prove to the FDA that the new medication is safe.

A large federally funded trial, the Women's Health Initiative, reported this year that Premarin, a popular estrogen preparation, caused a higher rate of strokes in post-menopausal women than a dummy pill. Earlier, the WHI found that Prempro, a combination of Premarin and a synthetic progesterone, or progestin, caused breast cancer and heart attacks, as well as strokes.

As a result of the WHI study, sales of Premarin and Prempro plummeted, and other commercial hormone preparations suffered, too.

Although the trial was confined to those two drugs, WHI researchers said the results should be assumed to apply to other hormones until proven otherwise. But advocates of bioidenticals say their products cannot be compared to estrogen from horses and to a progestin that's known to increase bad cholesterol and make breast cells multiply.

For many women, the result of going off hormones is an abrupt return of often-debilitating menopausal symptoms, including hot flashes, insomnia, mood swings and loss of libido. Some tough it out; others go back on traditional hormones, sometimes in lower doses; still others seek "natural" alternatives, such as herbal remedies sold over the counter and bioidentical therapies.

It's impossible to estimate how many women are taking bioidenticals because many such prescriptions are compounded by small pharmacies. Nevertheless, pharmacists and clinicians alike say the trend is large and growing.

Carter Black of Keefer Pharmacy in Mount Prospect, Ill., said his store has hired additional technicians in the last year and more than doubled its volume of compounding hormones - that is, custom-mixing creams, lozenges or capsules according to a doctor's prescription.

ZRT Laboratory in Portland, Ore., which tests hormone levels in saliva samples to help doctors determine individual doses, has quadrupled its business volume over the last two years.

"The trend is getting exponentially larger," said Laura Berman, director of the Berman Center for women's sexual health in Chicago. "And it's pretty big already, thanks to Suzanne Somers."

Somers, who played the ditzy blonde on the TV sitcom Three's Company, published a popular book this year. Titled The Sexy Years, the book says bioidentical hormone therapy can help middle-age women regain the physical, mental and emotional vitality of their younger years.

In interviews, Somers, who had breast cancer four years ago, said this metamorphosis can be achieved virtually without risk.

"Bioidentical hormones ... are not these synthetic hormones that all the negative reporting is about," Somers told CNBC. "Bioidentical is an exact replica of what your body makes. ... It's not a drug. It doesn't have any of the risk associated with what they can consider hormone replacement therapy."

But experts say that is doubtful.

"If you give biologically equivalent amounts of various estrogens - natural or synthetic - you can expect the same effect," said Dr. Leon Speroff, professor of obstetrics and gynecology at Oregon Health & Science University. "It doesn't matter where the estrogen comes from."

Berman and many other clinicians readily concede they can't say definitively that bioidenticals are safer than conventional hormones. But patients don't always get that message.

One of the attractions of bioidenticals is that they are tailor-made for each woman. That makes many feel safer.

"Every hormone level is checked," said Shelva Wensel of Jersey Shore, Pa., a patient at the Berman Center. "So I'm getting exactly as much estrogen as my body needs."

But tailoring the doses of the various hormones prescribed for a woman based on her blood or saliva levels presupposes that the levels can be reliably measured and that there are "normal" levels of those hormones to which she can be restored.

Advocates of bioidenticals , such as ZRT's David Zava, insist that both those suppositions are true. But mainstream experts disagree.

Hormone levels vary from woman to woman and from hour to hour, Speroff said. And no one knows what the ideal levels are for post-menopausal women, whose bodies naturally produce lower levels of hormones than they did during the childbearing years.

Perhaps more important, hormonal levels can vary from one part of the body to another.

"The hormone levels that you can measure in the bloodstream are just a fraction of what's being synthesized in the tissues - which can't be measured," said Dr. Morris Notelovitz, a gynecologist and clinical biologist from Boca Raton, Fla.

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