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TUESDAY, July 8, 2003 (HealthDayNews) -- Two over-the-counter products are no more effective than a placebo for treating hot flashes and other symptoms of menopause, a new study says.
The products, Promensil and Rimostil, are red clover extracts that contain isoflavones, which are estrogen-like compounds derived from plants.
"This is not a surprise as there were two previous studies on the same products and they found exactly the same thing," says Dr. Wulf H. Utian, a gynecologist at the Cleveland Clinic and executive director of the North American Menopause Society. "This is really just confirming previous studies."
The study detailing the latest findings appears in the July 9 issue of the Journal of the American Medical Association and was funded by Novogen, which makes and markets both products.
According to the study authors, it is the largest randomized clinical trial of red clover extracts in postmenopausal women to date.
One year ago, JAMA reported the arm of the Women's Health Initiative (WHI) studying the effects of the hormones estrogen plus progestin to combat such problems as bone loss and hot flashes had been stopped after the risks were found to outweigh the benefits. Those health threats included increased chances of invasive breast cancer and heart disease.
Since that time, there has been a great deal of debate as to whether hormone replacement therapy should be taken to ease symptoms of menopause.
But even before the WHI trial was halted, researchers and women alike had shown an interest in soy products as an alternative remedy for menopausal symptoms.
"Soy in general has been heavily marketed partly because Asian women experience many fewer hot flashes than women in Western countries," explains study author Dr. Jeffrey A. Tice, an assistant professor of medicine at the University of California, San Francisco School of Medicine.
One hypothesis to explain the difference between Asian and Western women suggests that isoflavones, which are found in soy and are a common part of Asian diets, influence the body's response to changing hormone levels.
The latest study randomly assigned 252 menopausal women aged 45 to 60 who had at least 35 hot flashes a week to one of three groups. The first group received Promensil (containing 82 milligrams of total isoflavones a day), Rimostil (containing 57 milligrams of total isoflavones a day) or a placebo.
After 12 weeks, reductions in average daily hot flashes were similar for all three groups.
Women in the Promensil group had 41 percent fewer hot flashes a week, those in the Rimostil group had 34 percent fewer hot flashes, and those in the placebo group had 36 percent fewer hot flashes a week. Promensil seemed to reduce hot flashes more rapidly than the placebo, and heavier women seemed to receive more benefit. Quality-of-life improvements were comparable in each group, the study says.
"It would be great if we could tell women to eat more tofu and drink more soy milk and menopausal symptoms would be lessened, but I don't think the data to date supports this," Tice says.
Novogen, however, interprets the results differently, stating the 41 percent reduction in symptoms, though similar to the placebo, does "reconfirm that Promensil helps to minimize the symptoms associated with menopause."
Dr. Claude Hughes, a consulting professor in obstetrics and gynecology at Duke Medical Center and an expert on soy estrogens who did research funded by Novogen in 2001, says there are some potential problems with the new study.
It is often difficult to separate the placebo effect from the effect of a product, especially when the placebo effect is high as it is in this study. He also suggests the results might have been more clear-cut if Promensil had been taken two or three times a day, rather than just one.
Possible methodological flaws aside, what's left for women when it comes to alleviating the symptoms of menopause?
Some experts feel hormone replacement therapy is still the best option.
"I think that there has been a gross misinterpretation of the Women's Health Initiative," Utian says. "I don't think it takes a rocket scientist to see that hormones are the most effective and the most indicated treatment for the woman who is suffering symptoms disruptive to her personal lifestyle and quality of life."
Tice is more cautious on the subject: "The [side effects] are not going to affect many women, but those are terrible outcomes."
Other alternatives include antidepressants in the SSRI (selective serotonin reuptake inhibitor) category that are "not as good as the hormones but definitely better than the placebo," Utian says.
Other over-the-counter products tend to be about as effective as a placebo, Utian adds.
The good news is that the majority of women in the United States are not debilitated by menopausal symptoms, Tice says. "They can live with them, and then they pass."
He suggests exercise, biofeedback, wearing layered cotton clothing and avoiding triggers -- such as spicy food and coffee -- as a way to find relief.
More information
For more about menopause, visit the North American Menopause Society. The National Heart, Lung, and Blood Institute has more on the Women's Health Initiative.
