Evaluation of a biobehavioral intervention for hot flashes

潮热生物行为干预的评价

• 批准号: 7761273
• 负责人: DEBRA L. BARTON
• 金额: $ 15.95万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7761273
• 关键词: Adverse effects; Aftercare; Anticonvulsants; Antidepressive Agents; Anxiety; Area; Bathing; Behavior Therapy; Behavioral; Benefits and Risks; Clinical Trials; Clothing; Confidence Intervals; Constipation; Data; Desire for food; Dose; Drug usage; Emotions; Estrogen Therapy; Estrogens; Evaluation; Expectancy; Fluoxetine; Goals; Health Personnel; Heart; Hormone replacement therapy; Hormones; Hot flushes; Hypnosis; Interruption; Intervention; Intervention Studies; Knowledge; Life; Measures; Menopausal Symptom; Menopause; Moods; Nausea; Norepinephrine; Occupations; Palpitations; Panic; Paroxetine; Patients; Pharmaceutical Preparations; Physiological; Pilot Projects; Placebos; Porifera; Postmenopause; Progesterone; Publications; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Role; Serotonin; Sleep; Sweat; Sweating; Symptoms; Testing; Time; Woman; Women' s Health; Work; Xerostomia; arm; base; biobehavior; diaries; effective therapy; expectation; experience; health related quality of life; improved; innovation; meetings; novel; patient expectation; pill; pilot trial; programs; prospective; public health relevance; secondary outcome; standard care; symptom management; theories; venlafaxine

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.

描述（由申请人提供）：潮热在更年期很常见，会对女性的生活产生重大负面影响。研究估计多达 80% 的女性有潮热症状。潮热除了是伴随心悸、出汗的生理现象外，还可能伴随着焦虑、恐慌等负面情绪。就高效和低副作用而言，治疗选择有限。目前的非激素选择最多可以减少约 60% 的潮热，低于激素。该研究计划的目标是找到改善更年期症状（包括潮热）的药物和非药物选择。这项试点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）的结合。文拉法辛经过充分研究，发现可以减少 55% 的潮热。将使用文拉法辛缓释片和安慰剂药丸来测试催眠效果。同样，我们也将利用对照催眠比较。本研究的目的是评估文拉法辛 ER 75 mg 催眠的效果大小，与文拉法辛 ER 75 mg 对照催眠相比，安慰剂对照催眠的效果大小，以及评估每种药物的副作用。这些治疗方法。我们还将评估预期和催眠性的潜在调节变量。该试点研究将随机分配报告潮热​​的绝经后妇女接受上述四个治疗组之一，为期 8 周，包括基线周。在整个试验过程中，将通过前瞻性日记每天测量潮热，包括基线周。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。将计算效应大小和置信区间。在研究干预开始之前和研究结束时，将完成测量次要结果（例如睡眠、情绪、潮热干扰和更年期相关生活质量）的问卷。根据该试点试验的结果和效果大小，计划进行更大规模、更明确的试验。公共健康相关性：该项目将是一项更大规模研究的第一步，该研究评估低剂量文拉法辛（37.5 毫克和 75 毫克）与自我催眠相结合以减少潮热。这是一种新颖的组合，具有与基于雌激素的疗法相同的减少潮热的潜力，并且没有明显的不良副作用。最近，雌激素治疗对于潮热管理的风险/益处被认为是负面的，但潮热会对人的生活产生显着的负面影响。因此，需要没有副作用的有效治疗。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颖性是前所未有的。这项试点研究将为开展大型、明确的试验提供数据。此外，还将获得有关预期和催眠性调节变量的信息。

项目成果

Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

生物行为干预对潮热的功效：一项随机对照试点研究。

• DOI: 10.1097/gme.0000000000000837
• 发表时间: 2017
• 期刊: Menopause (New York, N.Y.)
• 作者: Barton,DebraL;Schroeder,KelliannCFee;Banerjee,Tanima;Wolf,Sherry;Keith,TimothyZ;Elkins,Gary
• 通讯作者: Elkins,Gary