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/莫西司令（ACU/MOXA）的功效，以改善与肠易激综合征（IBS）相关的症状。 IBS被定义为中胃肠道（GL）区的腹部疼痛/不适，与排便或肠模式的变化有关，具有无序排便的特征。 IBS影响15％至20％的北美人。当前的疗法：饮食改性，心理治疗和药物疗法仍在研究中，没有治愈性，有些则具有显着的副作用。 ACU/MOXA的传统中药方法在亚洲几个世纪以来，为IBS提供了一种微妙的整体症状管理方法。针灸（包括moxibustion）已被广泛用于治疗各种GL疾病。但是，很少有IBS针灸研究需要严格评估这种治疗方法。拟议的研究是ACU/MOXA的一项随机，盲目的，假/安慰剂对照临床试验，可减轻腹部疼痛/不适，IBS次要辅助症状（IBS-SECS）（IBS-SECS）（肠气，腹胀，粪便一致性）。根据罗马病态标准，将171名被诊断为IBS-DIARRHEA（IBS-D）的成年人将被随机分为三个条件之一：1：面向协议的ACU/MOXA（标准）； 2：面向患者的ACU/ MOXA（基于个性化的TCM诊断和点处方）和3：假针刺/安慰剂Moxibustion（对照组）。所有受试者将参加筛查/入学会议，然后每周进行两次治疗，共4周，每周一次治疗4周，以及第12周和第24周的2个长期不处理的随访时间。所有受试者均应通过诊断诊断的诊断症状（对治疗任务而盲目）进行诊断和日常培训（由持久性培训）进行诊断和良性培训（by）的诊断症状，并通过限制性培训，且受限制性分配，以实现症状。在研究期间的日记。治疗组在腹部疼痛/不适和IBS-SEC中的主要意图对治疗比较将使用线性混合模型分析，并具有治疗，时间，时间治疗的固定效果，受试者和错误的随机效应以及AR（1）协调结构。在后续功效分析中将探索连续和分类混杂因素对治疗效果估计值的影响。将同样分析次要治疗组的治疗组差异，以改善患者评价的总体症状，生活质量，心理压力，医疗保健利用和工作生产率。回归方法将确定IBS症状严重程度的变化与功能健康结果有不同的相关性，并将探索治疗IBS患者的从业人员应针对哪些TCM诊断。基于我们的试点结果的分析目标和分析，这种假/安慰剂控制，盲目的，随机研究腹泻亚型患者需要三个治疗组中的每个受试者57名受试者（n = 171）。这提供了80％的功率，以5％的I型错误率，并将其纳入计算15％的损耗和30％的安慰剂效果。公共卫生相关性：肠易激综合症（IBS）影响北美人的15％至20％。 lbs评估和治疗的年度医疗保健费用超过200亿美元。该应用将测试一种症状管理策略，以改善LBS症状（腹痛，气体，腹胀和粪便一致性改变）。所采用的方法旨在评估使用RCT中传统的中医实践的面向方案（标准）与以患者为导向的（个性化）方案。