MSI FLASH: An RCT of Yoga and Ultra Low-Dose Estrogen Gel for Vasomotor Symptoms

描述（由申请人提供）：本申请描述了与题为“月经症状倡议-寻找出汗和潮热的持久答案（MSI-FLASH）"的网络申请一起提交的五个提案之一。我们的网络和数据协调中心（DCC）将由妇女健康倡议临床协调中心（西雅图）的两名共同PI共同领导，他们已经合作了十多年（LaCroix，安德森，PI）。MSI-FLASH网络有五个临床研究中心：马萨诸塞州波士顿（Cohen，Joffe，PI）;印第安纳州印第安纳波利斯（Carpenter，PI）;加利福尼亚州奥克兰（Sternfeld，Caan，PI）;宾夕法尼亚州费城（Freeman，PI）;和华盛顿州西雅图（Newton，Reed，PI）。这个多学科的研究小组提出了五项随机对照试验，测试一系列的行为，身心，激素和药物干预。我们的总体目标是实现RFA的主要目标，“月经症状的新干预措施（U 01）”，以加速确定血管痉挛症状（VMS）的有效补救措施。在本中心申请中，我们提出了一项多中心、析因设计、瑜伽、超低剂量雌二醇（E2）凝胶和安慰剂凝胶的RCT，将在西雅图、印第安纳波利斯和波士顿进行。主要目标是：1。评估瑜伽与不瑜伽对以下方面的影响：a）主观VMS频率;和B）VMS困扰;和2。评价超低剂量雌激素（E2）凝胶与安慰剂凝胶对以下方面的影响：a）主观VMS频率;和B）困扰。我们的假设是1.瑜伽的效果将大于没有瑜伽：a）主观VMS频率和B）VMS困扰;和2。超低剂量E2凝胶对以下方面的影响大于无E2凝胶：a）主观VMS频率;和B）困扰。我们的次要目标是：1。评估瑜伽和超低剂量E2凝胶对其他常见绝经期结局的影响，包括：a）客观VMS频率（Bahr监测器）; B）睡眠（PSQI，Actigraph”）;和c）情绪（CESD，HADS）;和2.检查瑜伽和超低剂量E2对我们的主要和次要结果的综合影响是否大于单独使用的影响。为了实现我们的具体目标，我们将：1）招募400名妇女，并随机分配到4个治疗组之一，为期12周（安慰剂凝胶;瑜伽+安慰剂凝胶;超低剂量E2凝胶;瑜伽+超低剂量E2凝胶）; 2）测量基线和12周时的主要和次要结果;和3）比较瑜伽和超低剂量E2凝胶组与安慰剂组的结果变化;和4）比较瑜伽+超低剂量E2凝胶与单独干预的主要和次要结果的变化（如果瑜伽单独有效）。

DESCRIPTION (provided by applicant): This application describes one of five proposals being submitted in conjunction with the network application entitled, "The Menopausal Symptoms Initiative -Finding Lasting Answers to Sweats and Hot Flashes (MSI- FLASH)". Our network and data coordinating center (DCC) will be jointly led by two Co-PIs of the Women's Health Initiative, Clinical Coordinating Center (Seattle) who have worked together for over a decade (LaCroix, Anderson, PIs). The MSI-FLASH network has five clinical sites: Boston, MA (Cohen, Joffe, PIs); Indianapolis, IN (Carpenter, PI); Oakland, CA (Sternfeld, Caan, PIs); Philadelphia, PA (Freeman, PI); and Seattle, WA (Newton, Reed, PIs). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions. Our overall goal is to fulfill the main objective of the RFA, "New Interventions for Menopausal Symptoms (U01)", to accelerate the identification of effective remedies for vasomotor symptoms (VMS). In this site application we propose a multicenter, factorial design, RCT of yoga, ultra low-dose estradiol (E2) gel and placebo gel to be conducted in Seattle, Indianapolis and Boston. The primary aims are to: 1. Evaluate the effects of yoga vs. no yoga on: a) subjective VMS frequency; and b) VMS bothersomeness; and 2. Evaluate the effects of ultra-low dose estrogen (E2) gel vs. placebo gel on: a) subjective VMS frequency; and b) bothersomeness. Our hypotheses are that 1. The effect of yoga will be greater than no yoga on: a) subjective VMS frequency and b) VMS bothersomeness; and 2. The effect of ultra-low dose E2 gel will be greater than no E2 gel on: a) subjective VMS frequency; and b) bothersomeness. Our secondary aims are: 1. To evaluate the effects of yoga and ultra-low dose E2 gel on other common menopause outcomes including: a) objective VMS frequency (Bahr monitor); b) sleep (PSQI, Actigraph"); and c) mood (CESD, HADS); and 2. To examine whether the combined effect of yoga and ultra low-dose E2 on our primary and secondary outcomes is greater than the effect of either alone. To accomplish our specific aims we will: 1) recruit and randomize 400 women to one of 4 treatment arms for 12 weeks (placebo gel; yoga + placebo gel; ultra low-dose E2 gel; yoga + ultra low-dose E2 gel); 2) measure primary and secondary outcomes at baseline and 12 weeks; and 3) compare changes in outcomes in yoga and ultra low-dose E2 gel groups to placebo; and 4) compare changes in primary and secondary outcomes for yoga + ultra low-dose E2 gel to the effects of either intervention alone (if yoga alone is efficacious).