This study will assess whether treatment with black cohosh is effective in reducing the
frequency and intensity of menopausal hot flashes. In addition, this study will determine
whether or not black cohosh reduces the frequency of other menopausal symptoms and improves
quality of life.
Most American women will spend the last third of their lives post-menopause. During this
time, chronically low levels of steroidal estrogens may lead to a number of short and
long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and
osteoporosis. While some physicians believe that demonstrated beneficial effects of
estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of
hormone therapy from menopause on, many women choose not to take estrogen replacement
therapy (ERT) and are increasingly exploring alternative approaches to ERT.
For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's
health. Despite its long-standing use, studies of black cohosh have yielded conflicting
data, in part because of lack in study design rigor and the short duration of studies to
date. The primary aim of this study is to correct past shortcomings in study design to
determine whether treatment with black cohosh is effective in treating menopausal symptoms.
Participants in this study will be given black cohosh for a 12-month period. Potential
mechanisms of action of black cohosh will be examined by quantifying the levels of sex
hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an
estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring
the incidence of adverse events and compliance with the study.
- Resident of the New York Metro Area
- Weight within 90% to 120% of ideal body weight