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

MSI-FLASH：激素和非激素干预对 VMS 的相对疗效

• 批准号: 8312525
• 负责人: LEE S COHEN
• 金额: $ 29.57万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8312525
• 关键词: Adverse event; Antidepressive Agents; Anxiety; Behavior Therapy; Behavioral; Boston; Characteristics; Clinical; Clinical Trials; Clinical Trials Network; Complex; Consultations; Data; Data Coordinating Center; Dose; Estrogen Therapy; Estrogens; FDA approved; Goals; High Prevalence; Hormonal; Hot flushes; Intervention; Lead; Measurement; Measures; Menopausal Symptom; Menopause; Mental Depression; Multi-Institutional Clinical Trial; Nature; Paroxetine; Pattern; Perimenopause; Philadelphia; Placebos; Positioning Attribute; Postmenopause; Principal Investigator; Public Health; Randomized; Randomized Controlled Trials; Relative (related person); Research Personnel; Scientist; Selective Serotonin Reuptake Inhibitor; Site; Sleep; Sleep disturbances; Sweat; Sweating; Symptoms; Testing; Woman; Women' s Health; clinical research site; comparative efficacy; double-blind placebo controlled trial; effective therapy; experience; head-to-head comparison; hormone therapy; improved; multidisciplinary; programs; response; treatment strategy

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.

描述（由申请人提供）：该网络应用程序的主要目标，由RFA新干预对更年期症状（UO1）的干预措施确定，以加速鉴定有效的补救措施以缓解潮热。我们建立了一个科学家网络，他们对更年期过渡非常了解，并在妇女的健康试验中经历了实现这一目标的经验：“更年期症状的启动提出了对汗水和潮热（MSI-Flash）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，他们共同担任妇女健康计划临床协调中心的联合主持研究人员已有十多年了。 MSI-Flash网络有五个临床网站：波士顿（PIS：Lee Cohen and Hadine Joffe），印第安纳波利斯（PI：Janet Carpenter），奥克兰（PIS：Barbara Sternfeld和Bette Caan），费城（PI：Ellen Freeman）和Seattle（PIS：Katherine Newton和Susan Newton和Susan Newton和Susan Reed）。这个多学科研究者小组提出了五项随机对照试验，测试一系列行为，激素和非荷尔蒙药理干预措施，以治疗潮热。我们波士顿部位提出的具体试验将测试低剂量雌激素治疗和选择性5-羟色胺 - 再生摄影抑制剂（SSRI）帕罗西汀的相对疗效，以治疗潮热。这项随机安慰剂对照的双盲试验包括：1）雌激素和帕罗西汀疗效的“头对头”比较； 2）每种干预与安慰剂的比较； 3）评估睡眠障碍，抑郁和焦虑的绝经症状的潜在调节作用； 4）检查潮热和其他更年期症状之间的复杂相互关系，同时使用了热闪光和睡眠模式的主观和客观测量。波士顿临床现场研究人员在激素和非荷尔蒙药理试验以及行为干预措施方面都有丰富的经验，并且可以很好地进行其他MSI-Flash临床现场研究人员提出的试验。我们提出的临床试验的结果将通过建立一线药理治疗的相对功效来提高潮热的治疗，并确定特定的临床特征是否调节对治疗的反应。

项目成果

Relapse of vasomotor symptoms after discontinuation of the selective serotonin reuptake inhibitor escitalopram: results from the menopause strategies: finding lasting answers for symptoms and health research network.

停用选择性血清素再摄取抑制剂艾司西酞普兰后血管舒缩症状复发：更年期策略的结果：寻找症状和健康研究网络的持久答案。

• DOI: 10.1097/gme.0b013e31826d3108
• 发表时间: 2013
• 期刊: Menopause (New York, N.Y.)
• 作者: Joffe,Hadine;Guthrie,KatherineA;Larson,Joseph;Cohen,LeeS;Carpenter,JanetS;Lacroix,AndreaZ;Freeman,EllenW
• 通讯作者: Freeman,EllenW