Menopausal women, scared off traditional hormone therapy by studies indicating the pills cause breast cancer and heart disease, are seizing on another approach: "bioidentical"...
CHICAGO — Menopausal women, scared off traditional hormone therapy by studies indicating the pills cause breast cancer and heart disease, are seizing on another approach: “bioidentical” hormones.
A recent, best-selling celebrity book gave a huge impetus to bioidentical hormones, saying the “natural” substances can cure the insomnia, irritability and lack of libido that often accompany menopause.
And many women believe these hormones are safe because they have the same molecular structure as hormones produced by their bodies.
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.
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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, 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 past their childbearing years. And the “natural” products are made in laboratories, just like synthetic hormones.
Most importantly, they say, women could be fooling themselves if they think their new treatments are safer than ones they abandoned.
Bioidenticals may have fewer risks, the experts 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 she says she now feels much better.
Joyce Kyce of La Grange Park, Ill., another devotee of BodyLogicMD, acknowledged that “every medication probably has some risks. … 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 expensive: randomly assigning thousands of women to receive either conventional hormones or bioidenticals and then following them for years to see how many in each group develop serious health problems.
All hormones that go into bioidentical compounds are approved by the federal Food and Drug Administration (FDA). Because they’ve been around for decades, though, 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 (WHI), reported this year that Premarin, a popular source of estrogen, caused a higher rate of strokes in postmenopausal women than a placebo. The WHI earlier 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 hormones suffered.
Although the trial was confined to those two drugs, WHI researchers said the results should be assumed to apply to other hormones until proved 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 past 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, which tests hormone levels in saliva samples to help doctors determine individual doses, has quadrupled its business volume over the past 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.”