Enter any health-food store and you will be overwhelmed by an alphabet of products promising menopausal relief. Black cohosh. Chasteberry. Dong quai. Licorice. Red clover. Soy. And then there are the blends of herbs, the creams and the gels.

     Before the National Institutes of Health (NIH) dropped its bombshell in July — a landmark trial of hormone-replacement therapy would be halted early because of slight increased risks of blood clots, heart disease, stroke and breast cancer — hormone therapy was the treatment of choice for many women. But now that thousands have gone off HRT, the spotlight is on alternatives. And confusion is rampant. “It’s very chaotic,” says Dr. JoAnn Manson, chief of preventative medicine at Harvard’s Brigham and Women’s Hospital, and “very difficult for women to get a clear message on what to do.”

        The first thing to do is understand the NIH study. Researchers tested a combination of estrogen and progestin, a synthetic form of progesterone, and found the risks outweighed the benefits long-term. The trial did not examine the short-term benefits of HRT, chief among them: damping down hot flashes, the most common menopausal complaint among American women. Nor did it find similar problems to date in an ongoing trial of estrogen alone, which is given only to women with hysterectomies, who no longer need progesterone’s protective effect on the uterine lining. The consensus now is that HRT should not be prescribed to ward off chronic conditions. But some patients, who have severe hot flashes and no risk factors for heart disease or breast cancer, are staying on short-term. For symptom relief, says Dr. Lorraine Fitzpatrick, of the Mayo Clinic in Rochester, Minn., “there’s really nothing better.”
       
‘BIOIDENTICAL’ HORMONES
       
     There is, however, variation among hormones. The NIH trial, and most other HRT studies before it, tested the drug Prempro, which combines progestin, with estrogen derived from the urine of pregnant horses. Prempro’s estrogen is similar to the human hormone, but it also includes additional equine molecules. An alternative: so-called natural hormones, made from yam and soy, which are available in prescription drugs such as Estrace (estrogen) and Prometrium (progesterone). Proponents believe these “bioidentical” hormones are a safer and more natural option because their chemical structures more closely mimic the hormones in a woman’s body.
       
     Such hormones are also available in customized formulations prepared by special compounding pharmacies. Marla Ahlgrimm founded Women’s Health America in Madison, Wis., where she screens women for factors like diet, bone loss and hormone levels, then mixes bioidentical estrogen and progesterone, adjusting ingredients to match a woman’s individual profile. An overweight woman, for example, may have higher levels of estrogen (produced in fat cells) than a lean woman, says Ahlgrimm, and may do better with less estrogen in her treatment. “It’s really designer,” she says.

     While most doctors agree that a natural and individualized approach to treating menopausal symptoms makes logical sense, there are no reliable long-term data to prove that natural hormones are safer or more effective than drugs like Prempro. “We have to be very cautious about jumping from one hormone to another,” says Dr. Elizabeth Barrett-Connor of the University of California, San Diego. Unfortunately, we may never know how different formulations compare. Trials are time-consuming and expensive and, given the recent NIH results, women may be less than eager to sign up as volunteers. And when it comes to compounding pharmacies, while some do a fine job, there’s no way to be sure that what a pharmacist mixes together is precisely what the doctor ordered — or even that what’s ordered is best for the patient.

       
ARE THEY WORTH IT?
       
     If not hormones, then what? For those who want to go the more conventional route, antidepressants may help control hot flashes. But the herbal market is getting the most attention: last year sales for over-the-counter menopause remedies hit $100 million, according to SPINS, a market-research firm. Are they worth it? Last week, in a paper published in the Annals of Internal Medicine, researchers reviewed 29 studies on complementary therapies and concluded that many popular treatments, including dong quai, evening primrose oil and vitamin E, were ineffective against hot flashes — at least according to the small amounts of reliable data so far. “On most herbs, the jury is still out,” says Fredi Kronenberg, a physiologist at Columbia University and the study’s coauthor. “We need to do more work.”

       One therapy that’s gained significant interest is soy, which contains isoflavones — plant hormones that resemble human estrogen in a much weaker form. Isoflavones can take the edge off hot flashes, but the data are mixed, and no study has shown an impressively strong effect. The critical issue is safety: because isoflavones contain estrogenic compounds, Kronenberg and others worry about capsules or powders that pack isoflavones in high concentrations. Ingesting them through diet in foods like tofu, nuts and soybeans may be the most sensible approach.

        Of all the herbal products on the market, black cohosh has the largest body of data backing it up. German studies have shown that the plant helps alleviate hot flashes with no significant side effects. The NIH is now funding a 12-month trial of the herb, under Kronenberg’s direction. The goal is to look at not just how well it works, but how it affects the body. So far, researchers have found that black cohosh contains no estrogen compounds and does not stimulate breast-cancer cells in the lab. They’re also testing for changes in uterine tissue before and after treatment. Anne Moffat, 60, is one of the first participants to finish the trial. She’s still not sure if she received a placebo or the real thing, but when her hot flashes returned, Moffat began taking Remifemin, a black-cohosh extract, on her own: “I definitely noticed the difference.” More research is taking place at the University of Illinois, where scientists are testing black cohosh against standard HRT and the herb red clover, which contains isoflavones. Theresa Girolami, 50, has been “hot-flash-free” since taking the standardized red-clover supplement Promensil. But more data are needed to judge effectiveness and long-term safety.

        As always, exercise and diet are crucial for a healthy lifestyle and may even ease hot flashes. Swedish studies show that women who exercise suffer fewer hot flashes. Limiting spicy foods and caffeine can help regulate the body’s temperature. And even relaxation therapy, like yoga or meditation, may lower the heat. Right now, says Dr. Marianne Legato, a women’s-health specialist at Columbia, “the whole field is in a half-answered, half-studied state.” Each woman experiences menopause in her own way; her decisions about treatment need to be individual as well.

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With Karen Springen and Joan Raymond
       
© 2002 Newsweek, Inc., Dec. 2, 2002