Black cohosh therapy for menopause-related anxiety

描述(申请人提供)：大约65%-85%的女性经历了与更年期相关的心理和血管舒缩症状，近30%(或1500万女性)因这些症状而寻求医疗护理。更年期虽然不会危及生命，但会造成严重的痛苦。到目前为止，大多数注意力都集中在血管舒缩症状(例如，潮热)上。然而，近40%的更年期女性没有潮热，而90%的女性抱怨焦虑症状(例如，紧张、易怒、疲劳、肌肉酸痛、情绪不稳定、抑郁和性欲低下)。直到最近，激素替代疗法(HRT)一直是控制更年期症状的主要手段。然而，最近关于HRT的健康风险增加的报道(包括乳腺癌、心脏病、中风和痴呆症的发生率增加)已经对公众对HRT的安全性和可取性的认知产生了重大影响。由于激素替代疗法的风险/收益比存在严重问题，越来越多的妇女正在寻求替代疗法。 这项R21拨款的重点是专门研究黑升麻对更年期无血管舒缩、心理症状的益处。有令人信服的生化和行为学证据表明，黑升麻对参与焦虑的中枢神经递质和受体功能有直接作用，并可能具有抗焦虑作用。这项研究的结果将被用来确定在未来的全功率疗效试验中确定黑升麻疗效所需的最佳样本量。在这笔赠款中，我们将问：黑升麻是一种安全有效的治疗更年期引起的广泛性焦虑障碍的药物(DSMIV 293.89)？为了回答这个问题，50名没有使用HRT的绝经后广泛性焦虑症患者将接受随机双盲治疗，治疗方案为(I)黑升麻20 mg Bid，或(Ii)安慰剂。我们假设，与安慰剂相比，黑升麻具有更好的抗焦虑效果，并且与安慰剂具有类似的安全性。我们还会问：与安慰剂相比，黑升麻是否能提高更年期广泛性AD患者的生活质量？为了回答这个问题，在使用黑升麻和安慰剂进行双盲治疗期间，将获得具体的生活质量、幸福感和性表现指标。我们假设，与安慰剂相比，黑升麻将产生更好的生活质量指标。

DESCRIPTION (provided by applicant): 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.