About 65-85% of women experience menopause-related psychological and vasomotor symptoms, and nearly 30% (or 15 million women) seek medical attention for these symptoms. While not life-threatening, menopause can cause substantial distress. To date, most attention has focused on the vasomotor symptoms (e.g., hot flushes). However, nearly 40% of menopausal women do not have hot flushes, while 90% complain of anxiety symptoms (e.g., nervousness, irritability, fatigue, muscle aches, mood liability, depression, and low libido). Until recently, hormone replacement therapy (HRT) has been the mainstay for controlling the symptoms of menopause. Recent reports, however, of increased health risks of HRT (including an increased incidence of breast cancer, heart disease, stroke, and dementia) have had a major impact on the public's perception of the safety and desirability of HRT. Now that there are serious questions regarding the risk/benefit ratio of HRT, increasing numbers of women are seeking alternative treatments. The focus of this R21 grant is to specifically study the benefit of Black Cohosh for the non-vasomotor, psychological symptoms of menopause. There is compelling biochemical and behavioral evidence indicating that Black Cohosh has a direct action on central neurotransmitter and receptor function involved in anxiety, and that it may also have anti-anxiety effect. Results from this study will be used to determine the optimum sample size necessary to establish the efficacy of Black Cohosh in a future, fully powered efficacy trial. In this grant, we will ask: Is Black Cohosh a safe and effective treatment for Generalized Anxiety Disorder (GAD) Due to Menopause (DSMIV 293.89)? To answer this question, 50 women with GAD Due to Menopause, who are not using HRT, will receive randomized, double-blind treatment with either (i) Black Cohosh 20 mg BID, or (ii) placebo. We hypothesize that Black Cohosh will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo. We will also ask: Does Black Cohosh confer an enhanced quality of life (QOL) compared to placebo in women with GAD Due to Menopause? To answer this question, specific QOL, well-being, and sexual performance measures will be obtained during double-blind treatment with Black Cohosh and placebo. We hypothesize that Black Cohosh will result in superior QOL measures compared to placebo.
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