Protocol- vs Patient-Oriented TCM Practices: A RCT for IBS Symptom Management

方案与以患者为中心的中医实践：IBS 症状管理的随机对照试验

• 批准号: 7799867
• 负责人: JOYCE K ANASTASI
• 金额: $ 67.24万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-06 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7799867
• 关键词: Abdominal Pain; Acupuncture and Oriental Medicine; Acupuncture procedure; Address; Adopted; Adult; Adverse effects; Affect; Aftercare; Age; American; Asia; Asians; Behavior; Behavioral; Blinded; Blood; Case Study; Certification; Chinese People; Chinese Traditional Medicine; Chronic; Clinical; Cognitive; Confidence Intervals; Constitution; Control Groups; Controlled Clinical Trials; Country; Data; Defecation; Diagnosis; Diagnostic; Diarrhea; Diet Modification; Disease; Dose; Early Diagnosis; Effectiveness; Elements; Emotional; Equilibrium; Evaluation; Feces; Foundations; Gases; Gastrointestinal Diseases; Guidelines; Health; Health Care Costs; Health Personnel; Healthcare; Hour; Individual; Intake; Intervention; Intestines; Investigation; Irritable Bowel Syndrome; Lead; Licensing; Linear Models; Literature; Lower Gastrointestinal Tract; Measures; Methodology; Methods; Modeling; Moxibustion; Nature; Outcome; Outcome Measure; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Phase; Philosophy; Physiological; Placebo Control; Placebo Effect; Placebos; Plant Roots; Prevalence; Productivity; Protocols documentation; Psychological Stress; Psychotherapy; Qi; Quality of life; Quality-of-Life Assessment; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regression Analysis; Relative (related person); Reporting; Research; Research Design; Resources; Rome; SF-36; Sample Size; Sentinel; Severities; Shapes; Solvay brand of moxonidine; Structure; Symptoms; Syndrome; Testing; Therapeutic; Therapeutic Intervention; Time; Traditional Medicine; Training; Treatment Efficacy; Treatment Protocols; Woman; Work; absorption; base; cell motility; clinically relevant; compliance behavior; control trial; design; diaries; effective intervention; efficacy testing; experience; follow-up; gastrointestinal; health care service utilization; holistic approach; improved; indexing; information gathering; instrument; men; novel; patient oriented; productivity loss; programs; prospective; protocol development; psychological distress; public health relevance; research study; response; standard care; success; symptom management; theories; treatment effect; treatment strategy

DESCRIPTION (provided by applicant): This study will test the efficacy of Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS). IBS has been defined as abdominal pain/discomfort in the mid or lower gastrointestinal (Gl) tract, associated with defecation or a change in bowel patterns with features of disordered defecation. IBS affects 15 percent to 20 percent of North Americans. Current therapies: dietary modification, psychotherapy and drug therapies, are still under investigation, none are curative and some have significant side effects. The traditional Chinese medicine (TCM) approach of acu/moxa developed over centuries in Asia offers a subtle, holistic approach to symptom management for IBS. Acupuncture (including moxibustion) has been widely used for the treatment of various Gl disorders. However, few IBS acupuncture studies have the necessary rigor to evaluate this treatment. The proposed study is a randomized, blinded, sham/placebo controlled clinical trial of Acu/Moxa to reduce abdominal pain/discomfort and IBS secondary supporting symptoms (IBS-SecS) (intestinal gas, bloating, stool consistency). 171 adults, diagnosed with IBS-diarrhea (IBS-D) according to ROME Ill criteria, will be randomized to one of three conditions: 1: Protocol-oriented Acu/Moxa (standard); 2: Patient-oriented Acu/Moxa (based on individualized TCM diagnosis and point prescription) and 3: Sham acupuncture/ Placebo moxibustion (control group). All subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 long-term non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a Diagnostic Acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignments (by licensed acupuncturists trained in TCM), and complete the same instruments and daily symptom diaries for the duration of the study. The primary intent-to-treat comparison of treatment group differences in abdominal pain/discomfort and IBS- SecS will use linear mixed model analysis with fixed effects of treatment, time, time-by-treatment and random effects of subject and error, and an AR(1) covariance structure. Continuous and categorical confounder influence on estimates of treatment effect will be explored in follow-up efficacy analyses. Secondary aims for treatment group differences in patient-rated overall symptom improvement, quality of life, psychological stress, healthcare utilization and work productivity will be similarly analyzed. Regression methods will identify how changes in IBS symptom severity are differentially associated with functional health outcomes, and will explore which TCM diagnoses should be targeted by practitioners treating IBS patients. Based on the analytic objectives and analyses of our pilot results, this sham/placebo controlled, blinded, randomized study of diarrhea subtype patients, requires 57 subjects for each of three treatment groups (N=171). This provides 80 percent power at a 5 percent Type I error rate and incorporates in the calculation 15 percent attrition and a 30 percent placebo effect. PUBLIC HEALTH RELEVANCE: Irritable Bowel Syndrome (IBS) affects 15 percent to 20 percent of North Americans. Annual U.S. healthcare costs for the evaluation and treatment of lBS exceeds 20 billion dollars. This application will test a symptom management strategy to improve lBS symptoms (abdominal pain, gas, bloating and altered stool consistency). The methodology employed seeks to evaluate a Protocol-oriented (standard) vs. a Patient-oriented (individualized) protocol using traditional Chinese medicine practices in a RCT.

描述（由申请人提供）：本研究将测试针灸/艾灸（Acu/Moxa）改善肠易激综合症（IBS）相关症状的功效。 IBS被定义为中或下胃肠道(GI)的腹痛/不适，与排便或具有排便紊乱特征的肠道模式改变相关。 IBS 影响 15% 至 20% 的北美人。目前的治疗方法：饮食调整、心理治疗和药物治疗仍在研究中，没有一种能治愈，有些还有明显的副作用。几个世纪以来在亚洲发展起来的传统中医 (TCM) 穴位/艾灸方法为 IBS 症状管理提供了一种微妙、全面的方法。针灸（包括艾灸）已广泛用于治疗各种胃肠道疾病。然而，很少有 IBS 针灸研究具有必要的严谨性来评估这种治疗方法。拟议的研究是一项 Acu/Moxa 减少腹痛/不适和 IBS 继发支持症状 (IBS-SecS)（肠气、腹胀、大便稠度）的随机、盲法、假手术/安慰剂对照临床试验。根据 ROME Ill 标准诊断为 IBS 腹泻 (IBS-D) 的 171 名成人将被随机分配至以下三种情况之一： 1：以方案为导向的 Acu/Moxa（标准）； 2：以患者为中心的针灸/艾灸（基于个体化中医诊断和穴位处方）和3：假针灸/安慰剂艾灸（对照组）。所有受试者将参加筛查/入院治疗，然后是每周两次治疗，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。由诊断针灸师（对治疗分配不知情）进行评估，接受适合其病情分配的干预措施（由接受过中医培训的有执照的针灸师），并在治疗期间完成相同的仪器和每日症状日记 学习。对治疗组腹痛/不适和 IBS-SecS 差异的主要意向治疗比较将使用线性混合模型分析，其中包括治疗的固定效应、时间、治疗时间以及受试者和误差的随机效应，以及AR(1) 协方差结构。将在后续疗效分析中探讨连续和分类混杂因素对治疗效果估计的影响。治疗组在患者评价的整体症状改善、生活质量、心理压力、医疗保健利用和工作生产力方面差异的次要目标也将进行类似分析。回归方法将确定 IBS 症状严重程度的变化与功能健康结果之间的差异关系，并将探索治疗 IBS 患者的从业者应针对哪些中医诊断。根据我们的初步结果的分析目标和分析，这项针对腹泻亚型患者的假/安慰剂对照、盲法、随机研究，需要三个治疗组各 57 名受试者 (N=171)。这以 5% 的 I 类错误率提供了 80% 的功效，并在计算中纳入了 15% 的损耗和 30% 的安慰剂效应。公共卫生相关性：肠易激综合症 (IBS) 影响 15% 至 20% 的北美人。美国每年用于评估和治疗 IBS 的医疗费用超过 200 亿美元。该应用程序将测试症状管理策略，以改善肠易激综合征症状（腹痛、胀气、腹胀和大便稠度改变）。所采用的方法旨在在随机对照试验中使用传统中医实践来评估以方案为导向（标准）和以患者为导向（个性化）的方案。