Symptom management for irritable bowel syndrome constipation (IBS-C)

肠易激综合征便秘 (IBS-C) 的症状管理

• 批准号: 8645429
• 负责人: JOYCE K ANASTASI
• 金额: $ 61.98万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-04 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8645429
• 关键词: Abdominal Pain; Acupuncture procedure; Adult; Adverse effects; Affect; American; Blinded; Chinese Traditional Medicine; Chronic; Clinical Trials; Constipation; Defecation; Diagnosis; Diagnostic; Diet Modification; Disease; Distress; Equilibrium; Feces; Gases; Gastrointestinal Diseases; Guidelines; Healthcare; Hour; Individual; Intake; Intervention; Intestines; Irritable Bowel Syndrome; Licensing; Life; Link; Lower Gastrointestinal Tract; Measures; Modeling; Moxibustion; Outcome; Patients; Pattern; Persons; Pharmacologic Substance; Physicians; Placebos; Probiotics; Productivity; Protocols documentation; Provider; Psychotherapy; Quality of life; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Resources; SF-36; Schools; Severities; Solvay brand of moxonidine; Structure; Symptoms; Testing; Time; Training; United States; Visit; Woman; Work; base; blind; clinically relevant; control trial; design; diaries; effective therapy; efficacy testing; follow-up; health care service utilization; improved; instrument; men; novel strategies; patient oriented; placebo controlled study; primary outcome; productivity loss; programs; prospective; psychological distress; response; screening; secondary outcome; sex; success; symptom management; treatment effect; treatment strategy

DESCRIPTION (provided by applicant): Irritable Bowel Syndrome (IBS) is a chronic condition which affects 15% to 20% of North Americans. IBS is defined as abdominal pain/discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns with features of disordered defecation. The chronic symptoms of IBS have been linked with decreased quality of life, decreased work productivity and increased healthcare utilization. Current therapies include dietary modification, psychotherapy, probiotics, and pharmaceutical agents. None of these therapies are curative, some have life threatening side effects and results from research have been equivocal. Acupuncture/Moxibustion (Acu/Moxa), used in traditional Chinese medicine (TCM), is used to manage various GI disorders. However, few acupuncture studies have had the necessary rigor to evaluate this therapy. This application follows accepted standards of rigorous clinical trials with the primary aim to investigate the efficacy of Acu/Moxa in a randomized, blinded, sham/placebo controlled study to reduce abdominal pain/discomfort and IBS secondary supporting symptoms (IBS-SecS) (intestinal gas, bloating, stool consistency). 183 adults, diagnosed with IBS-Constipation (IBS-C) based on the ROME III criteria, will be randomized to one of three conditions: 1) Protocol-oriented Acu/Moxa (Standard); 2) Patient-oriented Acu/Moxa (Individualized TCM diagnosis and point prescription), or 3) Sham Acu/Placebo Moxa (Control). All subjects will attend a screening/intake session, twice weekly treatment sessions for 4 weeks, one weekly treatment sessions for 4 weeks, and 2 long-term non-treatment follow-up sessions at weeks 12 and 24. A Diagnostic Acupuncturist (blinded to treatment assignment) assesses each subject and prescribes Acu-points; a licensed Treating Acupuncturist trained in TCM delivers the intervention according to the randomization assignment; and all subjects complete the same instruments and daily symptom diaries for the duration of the study. Secondary aims assess treatment group differences in patient-rated global improvement, quality of life and psychological distress (SA#2); healthcare resource utilization and work productivity loss (SA#3); and explore the relationship between TCM diagnoses and response to treatment (SA#4). Power analysis to detect clinically meaningful differences in group-by-time interactions with 80% power, 5% alpha, a linear mixed model for repeated measures (baseline, 4, 8, 12 & 24 wks) calls for 55 S/group: total=183 when 18 additional subjects are included for attrition. Intent-to-treat analysis of group differences in primary and secondary outcomes will also use mixed models with fixed effects for group, time and their interaction, and empirically determined covariance structure and baseline level of the outcome as a continuous covariate. Secondary analyses will estimate the influence of baseline confounders and time-dependent variables to the estimate of the treatment effect.

描述（由申请人提供）：肠易激综合症 (IBS) 是一种慢性疾病，影响 15% 至 20% 的北美人。 IBS 被定义为中下胃肠道 (GI) 的腹痛/不适，与排便或肠道模式改变相关，并具有排便紊乱的特征。 IBS 的慢性症状与生活质量下降、工作生产力下降和医疗保健利用率增加有关。目前的治疗方法包括饮食调整、心理治疗、益生菌和药物治疗。这些疗法都没有疗效，有些还具有危及生命的副作用，而且研究结果也模棱两可。中医 (TCM) 中使用的针灸/艾灸 (Acu/Moxa) 用于治疗各种胃肠道疾病。然而，很少有针灸研究具有必要的严谨性来评估这种疗法。本申请遵循严格临床试验的公认标准，主要目的是在一项随机、盲法、假手术/安慰剂对照研究中调查 Acu/Moxa 的功效，以减少腹痛/不适和 IBS 继发性支持症状 (IBS-SecS)（肠道气体、腹胀、粪便稠度）。 根据 ROME III 标准诊断为 IBS 便秘 (IBS-C) 的 183 名成人将被随机分配到以下三种情况之一：1) 面向方案的 Acu/Moxa（标准）； 2）以患者为中心的Acu/Moxa（个体化中医诊断和穴位处方），或3）Sham Acu/Placebo Moxa（对照）。所有受试者将参加筛查/入院治疗、每周两次治疗，持续 4 周、每周一次治疗，持续 4 周，以及在第 12 周和第 24 周进行 2 次长期非治疗随访。治疗分配）评估每个受试者并指定穴位；接受过中医培训的持照治疗针灸师根据随机分配进行干预；所有受试者在研究期间完成相同的仪器和每日症状日记。次要目标评估治疗组在患者评价的总体改善、生活质量和心理困扰方面的差异（SA#2）；医疗保健资源利用率和工作生产力损失（SA#3）；并探讨中医诊断与治疗反应之间的关系（SA#4）。用于检测按时间组间相互作用的临床上有意义的差异的功效分析，具有 80% 功效、5% α、重复测量的线性混合模型（基线、4、8、12 和 24 周），需要 55 S/组：总计当另外 18 名受试者被纳入损耗时，=183。主要和次要结果的组间差异的意向治疗分析还将使用对组、时间及其相互作用具有固定效应的混合模型，以及根据经验确定的协方差结构和结果的基线水平作为连续协变量。二次分析将估计基线混杂因素和时间相关变量对治疗效果估计的影响。