An AHEI Dietary Intervention to Reduce Pain in Women with Endometriosis

AHEI 饮食干预可减轻子宫内膜异位症女性的疼痛

• 批准号: 10604795
• 负责人: Holly Ruth Harris
• 金额: $ 39.36万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-11 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10604795
• 关键词: AHEI; Dietary; Intervention; Reduce; Pain

PROJECT SUMMARY/ABSTRACT Endometriosis, a disorder characterized by the presence of endometrial-like tissue outside of the uterus, affects approximately 10% of reproductive age women in the US. Despite its prevalence, the etiology of endometriosis has not been fully delineated. It incurs significant health care costs and greatly impacts quality of life (QOL). Over 80% of women with endometriosis report chronic pelvic pain (CPP) and symptoms are often not sufficiently abated with hormonal suppression or surgery. Hence, the identification of other evidenced- based, modifiable factors, that improve pain and QOL are critical to improving the lives of women with endometriosis. The goal of this study is to evaluate the effects of a 12-week dietary intervention among women with laparoscopically-confirmed endometriosis who had a pain score of at least 7 out of 10 on the Visual Analog Scale (VAS) in the month prior to baseline. The intervention will consist of a diet based on the Alternative Health Eating Index-2010 (AHEI-2010) guidelines, as observational research suggests that adherence to the AHEI-2010 may decrease risk of laparoscopically-diagnosed endometriosis among women experiencing pain symptoms. The specific aims of the proposed study are to test the effect of the AHEI-2010 guideline-based dietary intervention on: 1) the VAS pain score, the pain catastrophizing scale, and mean number of pain pills taken per week; 2) physical and mental QOL components measured with the Endometriosis Health Profile (EHP-30) Questionnaire and Short Form Survey (SF-12); 3) circulating levels of inflammatory markers (IL-6, IL- 1β, hs-CRP, sTNFR-1, sTNFR-2). Women with laparoscopically-confirmed endometriosis (n=100) will be randomized to a 12-week dietary intervention or a control group. The intervention group will have meal ingredients shipped to directly to their home during the first 4 weeks of the intervention. For the remaining 8 weeks, meal plans and recipes will be provided. Pain, quality of life, and inflammatory markers will be assessed at baseline, 4, 8, and 12-weeks using validated questionnaires following the guidelines of the World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonization Project (EPHect). In addition, longer-term effects of the intervention will be assessed by examining pain and QOL outcomes at 6 months and 1 year. Many women with endometriosis experience poor QOL due to chronic pelvic pain and other physical and mental sequelae of endometriosis. As symptoms are often not sufficiently abated with hormonal suppression or surgery, the identification of other evidenced-based, modifiable factors, that improve pain and QOL are critical to improving the lives of women with endometriosis.

项目总结/摘要 子宫内膜异位症，一种以子宫内膜外存在子宫内膜样组织为特征的疾病， 子宫，影响了美国约10%的育龄妇女。尽管它的流行， 子宫内膜异位症尚未完全阐明。它会产生大量的医疗保健费用，并极大地影响医疗保健的质量。 生活质量（QOL）。超过80%患有子宫内膜异位症的女性报告慢性盆腔疼痛（CPP），症状通常是 激素抑制或手术不能充分缓解。因此，其他证据的识别- 基础的，可改变的因素，改善疼痛和生活质量是至关重要的，以改善妇女的生活， 子宫内膜异位症 这项研究的目的是评估12周的饮食干预对患有糖尿病的女性的影响。 腹腔镜下确诊的子宫内膜异位症，视觉模拟疼痛评分至少为7分（满分10分） 基线前一个月的VAS评分。干预措施将包括基于替代方案的饮食 健康饮食指数-2010（AHEI-2010）指南，因为观察性研究表明， AHEI-2010可能会降低经历疼痛的女性腹腔镜诊断子宫内膜异位症的风险 症状拟议研究的具体目标是测试AHEI-2010指南为基础的 饮食干预：1）VAS疼痛评分、疼痛灾难化量表和止痛药的平均数量 2）用子宫内膜异位症健康状况量表测量的身体和精神QOL成分 （EHP-30）问卷和简明调查表（SF-12）; 3）炎症标志物（IL-6、IL-12）的循环水平 1β、hs-CRP、sTNFR-1、sTNFR-2）。 经腹腔镜证实的子宫内膜异位症女性患者（n=100）将被随机分配至12周的饮食 干预组或对照组。干预组将有膳食成分直接运送到他们的 在干预的前4周内回家。在剩下的8周里，膳食计划和食谱将 提供了将在基线、第4、8和12周时使用以下方法评估疼痛、生活质量和炎症标志物： 根据世界子宫内膜异位症研究基金会（WERF）的指导方针， 子宫内膜异位症表型组和生物库协调项目（EPHect）。此外，长期影响 将通过检查6个月和1年时的疼痛和QOL结果来评估干预。 许多患有子宫内膜异位症的女性由于慢性盆腔疼痛和其他身体原因而经历较差的生活质量 以及子宫内膜异位症的精神后遗症由于激素治疗往往不能充分缓解症状， 抑制或手术，识别其他基于证据的，可改变的因素，改善疼痛， 生活质量对改善子宫内膜异位症妇女的生活至关重要。