The one-year study -- the only one of its kind in the United States -- will seek to determine whether the botanicals offer an alternative to hormone replacement therapy for relief of hot flashes. Recent studies have linked long-term use of HRT with significant health risks.
"Because of the health scare, lots of women are looking for alternatives, but there's very little scientific information on the botanicals and dietary supplements currently on the market," said Stacie Geller, assistant professor of obstetrics and gynecology and director of the UIC National Center of Excellence in Women's Health.
"This study is designed to see whether botanicals can take the place of HRT, which is still the gold standard for the short-term relief of hot flashes, or at least provide enough relief to improve women's quality of life," Geller said. "We'll also examine whether black cohosh and red clover help reduce a wide range of other symptoms associated with menopause, including sleep and mood disturbances and sexual dysfunction."
A total of 112 healthy menopausal women are being recruited to participate in the study. They will be randomly assigned to one of four groups taking black cohosh, red clover, Prempro (a combined estrogen and progestin hormone replacement drug) or a placebo. Health effects will be closely watched over about 14 clinic visits.
The researchers will determine whether the botanicals can lessen the frequency and intensity of hot flashes or alleviate other menopausal symptoms, including insomnia, joint pain and fatigue. They will also examine whether the botanicals help treat sexual problems associated with menopause, such as vaginal dryness, pain during sex, decreased libido and difficulty achieving orgasm.
Lipid levels, bone turnover and effects on the endometrial tissue in the uterus will be monitored, as well as any longer-term effects and possible risks associated with use of the botanicals.
Geller and her colleagues recently completed a Phase I clinical trial of the two herbal medicines in 30 women, which demonstrated that the compounds were safe for use in an expanded trial.
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. Recent studies in Europe suggest that the herb can be used to treat menopausal symptoms, but none of those studies met strict guidelines for clinical trials.
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 hot flashes.
Photos available on request.
The UIC study is funded by the National Center for Complementary and Alternative Medicine at the National Institutes of Health.
For more information about the study, call 312-413-5819.
For more information about UIC, visit http://www.uic.edu.