Tuesday August 28, 2007
For a Low-Dose Hormone, Take Your Pick
By RONI CARYN RABIN
Patches, pumps, pills, low-dose pills and super-low-dose creams and gels: Ever since the landmark Women’s Health Initiative study found that hormone therapy could be harmful, a dizzying array of new low-dose treatment options have been offered to counter the symptoms of menopause.
Some deliver hormones the old-fashion way, by mouth. Others do it through the skin, by patch, cream or gel, or through vaginal rings or suppository tablets. On Aug. 3, the Food and Drug Administration approved yet another treatment, a spray that delivers low-dose estrogen to the skin.
For doctors and patients, the wealth of options can be overwhelming. “There are a trillion products out there,” said Dr. Mary Jane Minkin, professor of obstetrics and gynecology at Yale. “You can take that low dose many different ways, and ultimately it boils down to personal preferences.”
Dr. Minkin said she was not surprised that patients were confused, adding, “So am I.”
The variety reflects the industry’s efforts to win back women with symptoms like hot flashes, night sweats and vaginal dryness who are reluctant to use traditional products because of the Women’s Health Initiative findings, released five years ago.
The large clinical trials found that hormones increased the risk of strokes and potentially life-threatening blood clots, and that combined estrogen and progestin also increased the risk of breast cancer and heart attacks. (Women who have not had hysterectomies must use the combined hormones.)
The current recommendation for troubling menopausal symptoms is to take the lowest hormone dose needed for relief for the shortest possible time. But doctors acknowledge the lack of proof that lower doses are safer. “We assume the lower doses are going to be safer, but we don’t really have any data that has examined that,” said Dr. Michelle P. Warren, founder and medical director of the Center for Menopause, Hormonal Disorders and Women’s Health at Columbia University Medical Center and a consultant for Bradley Pharmaceuticals, the maker of Elestrin.
Many women seeking natural remedies have turned to compounding pharmacies, druggists who promise so-called bioidentical hormones that are chemically synthesized but have the same molecular structure as hormones produced by a woman’s body.
Medical experts and professional organizations point out that just like other hormones, bioidentical hormones are not really found in nature, and that they are available in many commercial hormone products, where they are more likely to be covered by health insurance.
Proponents of bioidenticals suggest that they are safer than other hormones because they mimic a woman’s hormones. Many mainstream medical scientists say there is no conclusive evidence for that. Even a spokesman for the pharmacists’ trade group, the International Academy of Compounding Pharmacists, said it was not clear. “We need more research to see if the risks are different,” said the spokesman, Joshua Wenderoff. “For the time being, we have to assume they’re not.”
Dozens of products on the market offer different dosages and delivery methods. A complete list compiled by the North American Menopause Society is at www.menopause.org/edumaterials/hormoneprimer.htm.
Low doses can be quite effective for symptoms like sweating and hot flashes, though some doctors caution that low doses may take longer than standard ones. A new study of Elestrin, a gel that delivers 0.0125 milligrams a day of the hormone 17-beta-estradiol through the skin, found that it significantly reduced the number and severity of hot flashes compared with a placebo.
Hormone patches have not proved very popular in the United States, but experts suggest that because they bypass the liver they may be safer for women concerned about high triglycerides, heart disease and clots.
Women whose chief complaints are vaginal dryness and irritation may want to consider a vaginal cream or tablet or a vaginal ring, a rubberlike device that releases a steady amount of hormone for several months. Most of these products deliver local relief but not enough hormone to be absorbed in the system.
For women who have had hysterectomies that lead to sudden and severe menopausal symptoms, recent studies showing less heart risk from estrogen to women still in their 50s should be reassuring, said Dr. Jacques Rossouw, chief of the women’s health branch of the National Heart, Lung and Blood Institute. These women can take estrogen alone, which is associated with fewer risks than combination therapy.
Dr. Warren, at Columbia, said anyone taking hormones should be closely monitored by a physician, should have regular breast examinations and mammograms, should be screened regularly for high blood pressure and should be alert for warning signs of a clot.
Even women who plan to stop taking hormones after a few years may be in a quandary. The symptoms often resume when medication stops, said Dr. Wulf Utian, executive director of the North American Menopause Society. “That’s the Catch-22,” he said. “And that’s when the so-called short term therapy becomes long-term therapy.”