Evaluation of a biobehavioral intervention for hot flashes

描述（由申请人提供）：潮热是更年期普遍存在的，对女性的生活有显著的负面影响。研究估计多达80%的女性有潮热症状。潮热除了是一种伴随着心悸和出汗的生理现象外，还可能伴随着焦虑和恐慌等负面情绪。在高效率和低副作用方面，有有限的治疗选择。目前的非激素疗法最多能减少60%左右的潮热，这比激素疗法要低。这项研究计划的目标是找到改善更年期症状的药物和非药物选择，包括潮热。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（文拉法辛内质网）的组合。文拉法辛经过充分的研究，发现可以减少55%的潮热。催眠将同时用文拉法辛ER和安慰剂进行测试。同样，我们也将使用对照催眠比较。本研究的目的是评估文拉法辛ER 75 mg与催眠相比文拉法辛ER 75 mg与对照催眠相比安慰剂与催眠相比安慰剂与对照催眠相比的效应大小，以及评估每种治疗的副作用。我们还将评估期望和可催眠性的潜在调节变量。试点研究将随机分配报告潮热的绝经后妇女到上述四个治疗组之一，为期8周，包括基线周。潮热将在整个试验期间每天进行测量，包括基线周。在基线和治疗的最后一周之间，热闪减少的差异将在每个组之间进行比较。将计算效应大小和置信区间。测量次要结果的问卷，如睡眠、情绪、潮热干扰和更年期相关的生活质量，将在研究干预开始前和研究结束时完成。根据这次试验的结果和效应量，计划进行更大规模、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）与自我催眠联合用于减少潮热的更大规模研究的第一步。这是一种新的组合，具有减少潮热的潜力，与雌激素治疗相同，而且没有明显的副作用。雌激素治疗的风险/收益最近被认为是负面的关于潮热管理，但潮热可以显著负面影响一个人的生活。因此，需要无副作用的有效治疗方法。在大型临床试验中结合药物与非药物干预治疗潮热的新颖之处是前所未有的。这项初步研究将为进一步进行大规模、明确的试验提供数据。此外，关于期望和可催眠性的调节变量的信息将得到。

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.