UIC STUDIES HERBAL MEDICINES TO TREAT SYMPTOMS OF MENOPAUSE
UIC researchers have launched the first scientific study to determine whether two herbal medicines-black cohosh and red clover-are safe and effective in treating symptoms of menopause.
Under a five-year, $7.7 million grant from the National Center for Complementary and Alternative Medicine at the National Institutes of Health, researchers at the UIC College of Medicine will conduct two clinical trials.
The first is a short-term toxicity study that builds on extensive research done by the UIC College of Pharmacy to identify the herbs' active ingredients and modes of action. The researchers will test the safety of six dosages of black cohosh and red clover and examine how the human body metabolizes the herbs. Patients are currently being recruited to participate in the study.
The second, and lengthier, clinical trial-to begin next year-will determine whether the two herbs relieve menopausal symptoms such as hot flashes, sleep and mood disturbances and sexual dysfunction. The researchers will also examine whether the herbs provide any of the benefits of hormone replacement therapy, such as retarding bone loss and lowering lipid and cholesterol levels.
Although studies have been conducted in Europe, none has met the "gold standard" of scientific investigation used to design the UIC clinical trials, according to co-investigators Stacie Geller, assistant professor of obstetrics and gynecology, Suzanne Banuvar, manager of the trials, and Dr. Richard Derman, professor of obstetrics and gynecology.
"More and more women are turning to alternative nonprescription drugs, including dietary supplements containing botanical ingredients, to alleviate menopausal symptoms," said Derman. "However, these botanicals have not been uniformly standardized. Their health benefits, as well as their risks, are largely undetermined, particularly over long-term use."
In the clinical trial to test the efficacy of the herbs, a total of 112 women will be randomly assigned to receive black cohosh, red clover, a placebo or Prempro, a combined estrogen and progestin hormone replacement drug. The trial will last a full year, long enough to minimize any placebo effects, which generally occur during the first three to six months. Neither the patients nor the investigators will know which of the four test compounds each woman is receiving.
"We are always looking for the perfect estrogen," said Geller, "one with all the protective benefits of the hormone but none of its risks and side effects."
Only 10 to 25 percent of postmenopausal women take hormone replacement therapy. Although such drugs are widely prescribed in the United States, significant numbers of women choose not to fill their prescriptions or discontinue use of the medication within the first year.
According to Geller, many women avoid taking these drugs because of the fear of cancer or side effects, like breast tenderness and breakthrough bleeding. Some women also prefer not to "medicalize" menopause, seeing it as a natural outcome of aging.
Black cohosh is a wildflower native to forests in North America. It was an ingredient of Lydia Pinkham's Vegetable Compound, a patented remedy for "female complaints" that was popular in the early 1900s. It has been used for a variety of other purposes as well, for example, to treat snakebites. Studies recently conducted in Europe suggest that the herb can be used to treat menopausal symptoms, but none of the studies met strict guidelines for clinical trials. The studies were too brief to determine efficacy or safety; they were too limited in size and scope; or women were not randomly assigned to patient and control groups.
Red clover is a small perennial herb with fleshy red or white flowers that is native to Europe, central Asia and northern Africa. It contains isoflavones, which are being studied as possible agents to fight cancer. A few studies have also suggested that isoflavones may help reduce vasomotor symptoms.
If proven free of risks and side effects, as well as effective in alleviating menopausal symptoms, these herbal treatments could offer women a number of advantages over traditional hormone replacement therapy, the researchers said.
For more information on either UIC clinical trial, contact Suzanne Banuvar at (312) 996-3333.
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