Researchers at Northwestern Memorial Hospital, in collaboration with researchers at the UIC/NIH Center for Botanical Dietary Supplements and Northwestern University, are seeking menopausal women to participate in a randomized study to test the effectiveness of two herbal products - black cohosh and red clover - in relieving symptoms associated with menopause. This one-year study, sponsored by the National Institutes of Health (NIH) and the National Center for Complementary and Alternative Medicine (NCCAM), will also test the safety of these products when used for an extended period of time. "Our goal is to determine the role of botanicals in the management of menopause," explains Lee Shulman, chief of the division of reproductive genetics at Northwestern Memorial Hospital. "Furthermore, we will test their ability to relieve additional menopausal symptoms, such as insomnia, mood disturbances and sexual problems."
Black cohosh and red clover are plant-based dietary supplements that act similar to female hormones in the body. "Many women already use these products for the relief of menopausal symptoms; however, studies have not yet been conducted to show these botanicals should replace hormone replacement therapy (HRT) as the first line of treatment for the short-term relief of hot flashes," explains Cate Stika, chief of the division of obstetrics and gynecology, Northwestern Memorial Hospital. "This study is particularly important in light of the recent confusion surrounding the use of HRT. Many women are asking about alternatives and we need to be able to provide a solid, evidence-based response."
Because these products are considered food supplements, they are not regulated by the Food and Drug Administration (FDA) and are commonly obtained at health food stores without a prescription. "Consequently, there are a variety of formulations available and we do not know if these products are truly effective or what effect they have on the body, especially with long-term use," continues Dr. Stika.
The vast majority of women (about 75%) will experience hot flashes during menopause and may exhibit other problems such as depression, mood swings, sleep disorders, vaginal dryness and joint pain.
There will be four blinded treatment groups in this Phase II study. Participants will randomly be assigned to either black cohosh (128 mg), red clover (120 mg), Placebo, or Standard Hormone Therapy (Prempro 0.625 mg CEE / 2.5 MPA) - an FDA approved drug. "Hormone therapy is still a valid choice for women with significant hot flashes because it is proven to work," said Dr. Shulman. "The purpose of this study is to determine if these botanicals are also effective under a rigorous scientific protocol. The majority of previous studies are only short-term."
Health effects and quality of life will be closely monitored over approximately 14 study visits. Lipid levels, bone turnover and effects on the endometrial tissue in the uterus will be assessed, as well as any long-term effects and possible risks associated with use of these botanicals.
Women are eligible to participate in this study if they meet the following requirements:
Healthy menopausal woman
No menstruation for at least six months
No prior hysterectomy
Experiencing a significant number of hot flashes
Non-smoker Participants will receive a stipend for time and expenses. Interested women should contact Northwestern Memorial Hospital at 312-926-8400.
