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: 8505034
• 负责人: JOYCE K ANASTASI
• 金额: $ 60.08万
• 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/8505034
• 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.

肠易激综合征（IBS）是一种慢性疾病，影响15%至20%的北美人。IBS定义为中或下消化道（GI）的腹痛/不适，与排便或具有排便障碍特征的肠道模式变化相关。IBS的慢性症状与生活质量下降，工作效率降低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。这些疗法都不是治愈性的，有些有危及生命的副作用，研究结果也不明确。针灸（Acu/艾草），用于传统中医（TCM），用于管理各种胃肠道疾病。然而，很少有针灸研究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，主要目的是在随机、设盲、假手术/安慰剂对照研究中研究Acu/艾草减轻腹痛/不适和IBS继发支持症状（IBS-SecS）（肠气、腹胀、大便粘稠度）的疗效。 183名根据罗马III标准诊断为IBS-C的成年人将被随机分配到三种情况之一：1）方案导向的Acu/艾草（标准）; 2）患者导向的Acu/艾草（个体化中医诊断和穴位处方），或3）假Acu/安慰剂艾草（对照）。所有受试者将参加一次筛选/入组会议，每周两次治疗会议，持续4周，每周一次治疗会议，持续4周，以及在第12周和第24周的2次长期非治疗随访会议。诊断针灸师（对治疗分配设盲）评估每例受试者并开具穴位;接受过中医培训的持牌治疗针灸师根据随机分配提供干预;所有受试者在研究期间完成相同的仪器和每日症状日记。次要目的评估治疗组在患者评定的总体改善、生活质量和心理困扰（SA#2）;医疗资源利用和工作效率损失（SA#3）方面的差异;并探索中医诊断与治疗反应之间的关系（SA#4）。功效分析用于检测组-时间相互作用中具有临床意义的差异，功效为80%，α为5%，重复测量（基线、4、8、12和24周）的线性混合模型要求55 S/组：当额外纳入18例受试者进行脱落时，总计=183例。主要和次要结局组间差异的意向治疗分析也将使用混合模型，固定效应为组、时间及其相互作用，经验确定的协方差结构和结局基线水平作为连续协变量。次要分析将估计基线混杂因素和时间依赖变量对治疗效果估计值的影响。