"Our goal is to determine the role of botanicals in the management of menopause," explains Lee Shulman, M.D., chief of the division of reproductive genetics at Northwestern Memorial Hospital and professor of obstetrics and gynecology, Northwestern University's Feinberg School of Medicine. "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, M.D., chief of the division of obstetrics and gynecology, Northwestern Memorial Hospital, and associate professor of medicine, Northwestern University's Feinberg School of Medicine. "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
Participants will receive a stipend for time and expenses. Interested women should contact Northwestern Memorial Hospital at 312-926-8400.
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.
About Northwestern Memorial Hospital
Northwestern Memorial Hospital (NMH) is one of the country's premier academic medical centers and is the primary teaching hospital of Northwestern University's Feinberg School of Medicine where this research was funded. Northwestern Memorial and its Prentice Women's Hospital and Stone Institute of Psychiatry have 744 beds and more than 1,200 affiliated physicians and 5,000 employees. Providing state-of-the-art care, NMH is recognized for its outstanding clinical and surgical advancements in such areas as cardiothoracic and vascular care, gastroenterology, neurology and neurosurgery, oncology, organ and bone marrow transplantation, and women's health.
Northwestern Memorial was ranked as the nation's 5th best hospital by the 2002 Consumer Checkbook survey of the nation's physicians and is listed in the majority of specialties in this year's US News & World Report's issue of "America's Best Hospitals." NMH is also cited as one of the "100 Best Companies for Working Mothers" by Working Mother magazine and has been chosen by Chicagoans year after year as their "most preferred hospital" in National Research Corporation's annual survey.