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: 8834850
• 负责人: JOYCE K ANASTASI
• 金额: $ 54.91万
• 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 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8834850
• 关键词: Abdominal Pain; Acupuncture Therapy; 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(申请人提供)：肠易激综合征(IBS)是一种慢性疾病，影响15%至20%的北美人。IBS的定义是中下胃肠(GI)的腹痛/不适，与排便或以排便障碍为特征的肠道模式改变有关。IBS的慢性症状与生活质量下降、工作效率下降和医疗利用率上升有关。目前的治疗方法包括饮食修改、心理治疗、益生菌和药物制剂。这些疗法都不是根治的，有些有威胁生命的副作用，研究结果也是模棱两可的。针灸(Acu/Moxa)是中医常用的治疗胃肠道疾病的方法。然而，很少有针灸研究有必要的严谨性来评估这种疗法。该应用遵循公认的严格临床试验标准，主要目的是在一项随机、盲目、假/安慰剂对照研究中观察Acu/Moxa的疗效，以减少腹痛/不适和IBS继发性支持性症状(IBS-SECS)(肠气、腹胀、大便稠密)。183名根据罗马III标准被诊断为IBS便秘(IBS-C)的成年人将被随机分为三种情况之一：1)以方案为导向的针灸(标准)；2)以患者为导向的针灸(个体化中医诊断和穴位处方)，或3)假针灸/安慰剂艾灸(对照)。所有受试者都将参加筛查/入院治疗，每周两次治疗，为期4周，每周治疗一次，为期4周，并在12周和24周进行2次长期非治疗随访。一名诊断针灸医生(治疗分配盲目)评估每个受试者并开出穴位；一名受过中医培训的持证治疗针灸医生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。次级目标评估治疗组在患者总体改善、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(SA#4)之间的关系。能量分析检测80%功率、5%阿尔法的逐组交互作用中有临床意义的差异，重复测量(基线、4、8、12和24周)的线性混合模型需要55 S/组：当另外18名受试者被包括在自然减员中时，总数=183。对初次和次要结果的分组差异的意向治疗分析也将使用混合模型，对分组、时间及其相互作用具有固定的影响，并根据经验确定结果的协方差结构和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。