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）：更年期的潮热普遍存在，并且可能会对女性的生活产生负面影响。研究估计，多达80％的女性报告了潮热。除了是一种生理现象外，还伴有心pal和出汗外，还可以伴随着诸如焦虑和恐慌之类的负面情绪。关于高疗效和低副作用特征的治疗选择有限。当前的非激素选项最多可提供比激素低约60％的降低。该研究计划的目的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。这项试点研究将测试潜在的有效行为（非药物）干预术，催眠和已知有效的药理学干预措施的组合，即文拉法辛ER。 Venlafaxine经过了很好的研究，发现潮热降低了55％。催眠将与文拉法辛ER和安慰剂药物一起测试。同样，我们也将使用控制催眠比较。这项研究的目的是评估Venlafaxine ER 75毫克催眠的作用，与Venlafaxine ER 75 mg具有对照催眠的催眠率相比，与安慰剂催眠相比，与对照催眠的安慰剂相比，催眠的效果，以及评估每种治疗方法的副作用。我们还将评估潜在的预期和催眠性变量。试点研究将随机分配绝经后的妇女，向上述四个治疗臂之一，其中8周，包括基线一周。在整个试验期间，每天都会通过预期的每日日记（包括基线周）来测量潮热。每个手臂之间将比较基线和治疗最后一周之间的热闪光减少差异。将计算效果大小和置信区间。在开始研究干预措施之前和研究结束之前，将完成测量次要结果，例如睡眠，情绪，热闪光干扰和与生活质量相关的问卷调查。根据该初步试验的结果和效果大小，计划了更大，更明确的试验。公共卫生相关性：该项目将是评估低剂量Venlafaxine（37.5 mg和75 mg）与自我催眠症的第一步，以减少潮热。这是一种新颖的结合，可以减少与基于雌激素的治疗​​相等的热闪光，而没有明显的不良副作用。最近，雌激素疗法的风险/益处在热闪光管理方面被认为是负面的，但是热闪烁可能会对人们的生活产生负面影响。因此，需要有效的治疗而无需不必要的副作用。在大型临床试验中，将药理学与非药物干预相结合的新颖性是空前的。这项试点研究将提供数据，以进行大型，确定的试验。此外，将获得有关预期和催眠率变量的信息。

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