MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMS

描述(由申请人提供)：根据《更年期症状新干预措施》(UO1)的规定，这一网络应用程序的主要目标是加速确定缓解潮热的有效疗法。我们已经建立了一个科学家网络，他们对更年期过渡有高度的了解，并在进行女性健康试验方面经验丰富，以实现这一目标：“更年期症状倡议-寻找汗水和潮热的持久答案(MSI-Flash)。”我们的数据协调中心将由Andrea LaCroix和Garnet Anderson共同领导，他们一起担任妇女健康倡议临床协调中心的联合首席研究员已有十多年。MSI-Flash网络有五个临床站点：波士顿(PI：Lee Cohen和Hadine Joffe)、印第安纳波利斯(PI：Janet Carpenter)、奥克兰(PI：Barbara Sternfeld和Bette Caan)、费城(PI：Ellen Freeman)和西雅图(PI：凯瑟琳·牛顿和Susan Reed)。这个多学科研究小组提出了五项随机对照试验，测试一系列治疗潮热的行为、激素和非激素药物干预措施。我们波士顿网站提出的这项具体试验将测试低剂量雌激素治疗和选择性5-羟色胺再摄取抑制剂(SSRI)帕罗西汀治疗潮热的相对疗效。这项随机、安慰剂对照的双盲试验包括：1)对雌激素和帕罗西汀的疗效进行“面对面”比较；2)将每种干预措施与安慰剂进行比较；3)评估同时出现的睡眠障碍、抑郁和焦虑的更年期症状的潜在调节作用；以及4)使用潮热和睡眠模式的主观和客观测量来检查潮热和其他更年期症状之间的复杂相互关系。波士顿临床现场调查员在荷尔蒙和非激素药理学试验以及行为干预方面都拥有丰富的经验，并能够很好地合作进行其他MSI-Flash临床现场调查员提出的试验。我们建议的临床试验结果将通过确定一线药物治疗的相对有效性和确定特定的临床特征是否调节治疗反应来推进潮热的治疗。

DESCRIPTION (provided by applicant): The main objective of this network application, as established by the RFA-New Interventions for Menopausal Symptoms (UO1)-is to accelerate the identification of effective remedies to relieve hot flashes. We have created a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials to fulfill this objective: "The Menopausal Symptoms Initiative-Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)." Our Data Coordinating Center will be led jointly by Andrea LaCroix and Garnet Anderson who have served together as Co-Principal Investigators of the Women's Health Initiative Clinical Coordinating Center for over a decade. The MSI- FLASH network has five clinical sites: Boston (PIs: Lee Cohen and Hadine Joffe), Indianapolis (PI: Janet Carpenter), Oakland (PIs: Barbara Sternfeld and Bette Caan), Philadelphia (PI: Ellen Freeman) and Seattle (PIs: Katherine Newton and Susan Reed). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, hormonal and non-hormonal pharmacologic interventions to treat hot flashes. The specific trial proposed by our Boston site will test the relative efficacy of low-dose estrogen therapy and the selective serotonin-reuptake inhibitor (SSRI) paroxetine for the treatment of hot flashes. This randomized placebo-controlled double-blind trial includes: 1) a "head-to-head" comparison of the efficacy of estrogen and paroxetine; 2) a comparison of each intervention with placebo; 3) an assessment of potential modulating effects of co-occurring menopausal symptoms of sleep disturbance, depression, and anxiety; and 4) an examination of the complex inter-relationships between hot flashes and other menopausal symptoms using both subjective and objective measurements of hot flashes and sleep patterns. The Boston clinical site investigators have extensive experience with both hormonal and non-hormonal pharmacologic trials, as well as with behavioral interventions, and are well-positioned to collaborate on trials proposed by other MSI-FLASH clinical site investigators. Results of our proposed clinical trial will advance the treatment of hot flashes by establishing the relative efficacy of first-line pharmacologic treatments and determining whether specific clinical characteristics modulate response to treatment.