Evaluation of a biobehavioral intervention for hot flashes

描述（由申请人提供）：潮热是普遍与更年期，并可能显着负面影响妇女的生活。研究估计多达80%的女性报告潮热。除了是一种伴随心悸和出汗的生理现象外，潮热还可能伴随着焦虑和恐慌等负面情绪。在高疗效和低副作用方面，治疗选择有限。目前的非激素选择最多提供大约60%的潮热减少，低于激素。这项研究计划的目标是找到改善更年期症状（包括潮热）的药理学和非药理学选择。这项初步研究将测试潜在有效的行为（非药物）干预，催眠，与已知有效的药物干预，文拉法辛ER的组合。文拉法辛已经被很好地研究，发现它可以减少55%的潮热。催眠将测试与两个文拉法辛ER以及安慰剂药丸。同样，我们也将使用对照催眠比较。本研究的目的是评价文拉法辛ER 75 mg催眠与文拉法辛ER 75 mg对照催眠与安慰剂催眠与安慰剂对照催眠相比的效应量，以及评价每种治疗的副作用。我们还将评估预期和催眠的潜在调节变量。初步研究将报告潮热的绝经后女性随机分配至上述四个治疗组之一，持续8周，包括基线周。在整个试验过程中，将使用前瞻性每日日记（包括基线周）每天测量潮热。将比较每组之间基线和治疗最后一周之间潮热减少的差异，并计算效应量和置信区间。在开始研究干预之前和研究结束时，将完成测量次要结局（如睡眠、情绪、潮热干扰和更年期相关生活质量）的量表。根据该试点试验的结果和效应量，计划进行一项更大、更明确的试验。公共卫生相关性：该项目将是评估低剂量文拉法辛（37.5 mg和75 mg）与自我催眠相结合以减少潮热的更大研究的第一步。这是一种新的组合，具有减少潮热的潜力，相当于基于雌激素的治疗，而没有显著的不良副作用。雌激素治疗的风险/益处最近被认为是对潮热管理的负面影响，但潮热会对一个人的生活产生显着的负面影响。因此，需要有效的治疗而没有不必要的副作用。在针对潮热的大型临床试验中，将药物与非药物干预相结合的新奇是前所未有的。这项初步研究将为进行一项大型的、确定性的试验提供数据。此外，还将获得关于期望值和可催眠性的调节变量的信息。

DESCRIPTION (provided by applicant): Hot flashes are prevalent with menopause and can significantly negatively impact a woman's life. Studies estimate as many as 80 percent of women report hot flashes. Besides being a physiologic phenomenon accompanied by heart palpitations and sweating, hot flashes can also be accompanied by negative emotions such as anxiety and panic. There are limited treatment options with respect to high efficacy and low side effect profile. The current nonhormonal options provide, at most, around 60 percent reduction in hot flashes which is lower than hormones. The goal of this research program is to find both pharmacologic and non-pharmacologic options for improvement in menopausal symptoms, including hot flashes. This pilot study will test the combination of a potentially effective behavioral (non-pharmacologic) intervention, hypnosis, with a known effective pharmacologic intervention, venlafaxine ER. Venlafaxine has been well studied and found to provide a 55 percent reduction in hot flashes. Hypnosis will be tested with both venlafaxine ER as well as a placebo pill. Likewise, we will utilize a control hypnosis comparison as well. The aims of this study are to evaluate the effect size of venlafaxine ER 75 mg with hypnosis compared to venlafaxine ER 75 mg with control hypnosis compared to placebo with hypnosis compared to placebo with control hypnosis, as well as to evaluate the side effects of each of these treatments. We will also evaluate potential moderating variables of expectancy and hypnotizability. The pilot study will randomly assign postmenopausal women reporting hot flashes to one of the four treatment arms described above for 8 weeks, including a baseline week. Hot flashes will be measured daily throughout the trial with a prospective daily diary, including the baseline week. Differences in hot flash reduction between baseline and the last week of treatment will be compared between each arm. Effect sizes and confidence intervals will be calculated. Questionnaires measuring secondary outcomes such as sleep, mood, hot flash interference and menopause related quality of life will be completed before starting the study interventions and at the end of the study. A larger, more definitive trial is planned based on the results and effect sizes of this pilot trial. PUBLIC HEALTH RELEVANCE: This project will be the first step to a larger study evaluating the combination of low dose venlafaxine (37.5 mg and 75 mg) with self-hypnosis for reducing hot flashes. This is a novel combination with the potential to reduce hot flashes equal to estrogen based therapy without significant unwanted side effects. The risk/benefit of estrogen therapy has recently been deemed negative with respect to hot flash management, yet hot flashes can significantly negatively impact one's life. Therefore, effective treatments without unwanted side effects are needed. The novelty of combining a pharmacologic with a non-pharmacologic intervention in a large clinical trial for hot flashes is unprecedented. This pilot study will provide the data to go forward with a large, definitive trial. In addition, information regarding moderating variables of expectancy and hypnotizability will be gained.