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.

描述（由申请人提供）：肠易激综合症（IBS）是一种慢性病，影响北美人的15％至20％。 IBS被定义为中性或下胃肠道（GI）区的腹痛/不适，与排便或肠模式的变化有关，具有无序排便的特征。 IBS的慢性症状与生活质量下降，工作生产率降低和医疗保健利用率的降低有关。当前的疗法包括饮食改性，心理治疗，益生菌和药剂。这些疗法均未治愈，有些疗法具有威胁生命的副作用，研究结果是模棱两可的。用于传统中药（TCM）的针灸/Moxibustion（ACU/MOXA）用于管理各种GI疾病。但是，很少有针灸研究需要严格评估这种疗法。该应用遵循严格的临床试验的公认标准，其主要目的是研究ACU/MOXA在随机，盲人，假/安慰剂对照研究中的功效，以减轻腹部疼痛/不适和IBS次要支持症状（IBS-SECS）（IBS-SECS）（IBS-SECS）（肠气，膨胀，膨胀，膨胀，脚凳一致性）。 183名根据罗马III标准被诊断为IBS-综合症（IBS-C）的成年人将被随机分为三个条件之一：1）以方案为导向的ACU/MOXA（标准）； 2）面向患者的ACU/MOXA（个性化的TCM诊断和点处方）或3）Sham ACU/安慰剂MOXA（对照）。所有受试者将参加筛查/摄入疗程，每周两次治疗4周，每周一次治疗4周，在第12周和第24周进行2次长期不治疗的随访。在TCM中接受培训的有执照的治疗针灸师根据随机分配进行干预；在研究期间，所有受试者都完成了相同的工具和每日症状日记。次要目标评估治疗组在患者评价的全球改善，生活质量和心理困扰方面的差异（SA＃2）；医疗保健资源利用和工作生产力损失（SA＃3）；并探索TCM诊断与对治疗的反应之间的关系（SA＃4）。功率分析以检测与80％功率的临床相互作用在临床上有意义的差异，5％alpha，一种用于重复测量的线性混合模型（基线，4、8、12和24 wks），要求55 s/group：总计= 183，当包括18个其他受试者进行磨损时。对主要结果和次要结果的群体差异的意图对治疗分析还将使用具有固定效果的混合模型，用于组，时间及其相互作用，并通过经验确定的协方差结构以及结果的基线水平作为连续的协变量。次级分析将估计基线混杂因素和时间依赖性变量对治疗效果的估计。