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: 7833948
• 负责人: JOYCE K ANASTASI
• 金额: $ 58.6万
• 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/7833948
• 关键词: Abdominal Pain; Acupuncture procedure; Adult; Adverse effects; Affect; American; Asia; Blinded; Chinese Traditional Medicine; Control Groups; Controlled Clinical Trials; Defecation; Diagnosis; Diagnostic; Diarrhea; Diet Modification; Disease; Evaluation; Feces; Gases; Health; Health Care Costs; Intake; Intervention; Intestines; Investigation; Irritable Bowel Syndrome; Licensing; Methodology; Methods; Modeling; Moxibustion; Outcome; Patients; Pattern; Pharmacotherapy; Placebo Control; Placebo Effect; Placebos; Productivity; Protocols documentation; Psychological Stress; Psychotherapy; Quality of life; Randomized; Rome; Severities; Solvay brand of moxonidine; Structure; Symptoms; Testing; Time; Training; Work; base; diaries; efficacy testing; follow-up; gastrointestinal; health care service utilization; holistic approach; improved; instrument; patient oriented; public health relevance; symptom management; treatment effect

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(申请人提供)：这项研究将测试针灸(针灸)改善肠易激综合征(IBS)相关症状的疗效。IBS被定义为中下胃肠道(Gl)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影响了15%到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调查中，没有一种是治愈的，一些有显著的副作用。亚洲几个世纪以来发展起来的中医针灸疗法为IBS的症状管理提供了一种微妙的、整体的方法。针灸(包括艾灸)已被广泛用于治疗各种G1障碍。然而，很少有IBS针灸研究有必要的严谨性来评估这种治疗方法。这项拟议的研究是一项随机、盲目、假/安慰剂对照的临床试验，使用Acu/Moxa来减少腹痛/不适和IBS继发性支持性症状(IBS-SECS)(肠气、腹胀、大便稠密)。171名符合罗马疾病诊断标准的成人IBS-D将被随机分为三种情况之一：1：以协议为导向的针灸(标准)；2：以患者为导向的针灸(基于个体化中医诊断和穴位处方)；以及3：假针灸/安慰剂艾灸(对照组)。所有受试者都将参加筛查/入院治疗，然后每周两次治疗，为期4周，每周一次治疗，为期4周，并在12周和24周进行2次长期非治疗随访。所有受试者将由诊断针灸医生(对治疗任务视而不见)进行评估，接受适合其情况的干预措施(由受过中医培训的有执照的针灸医生进行)，并在研究期间完成相同的仪器和每日症状日记。对治疗组在腹痛/不适和IBS-SECS方面差异的主要治疗意图比较将使用线性混合模型分析，其中包括固定的治疗效果、时间、治疗时间以及受试者和错误的随机影响，以及AR(1)协方差结构。在后续疗效分析中，将探讨持续的和明确的混杂因素对治疗效果估计的影响。次要目标为治疗组在患者总体症状改善、生活质量、心理压力、医疗保健利用和工作效率方面的差异也将进行类似的分析。回归方法将确定IBS症状严重程度的变化与功能性健康结果之间的差异，并将探索治疗IBS患者的从业者应该针对哪些中医诊断。基于分析目标和对我们试点结果的分析，这项针对腹泻亚型患者的假/安慰剂对照、盲法、随机研究，三个治疗组(N=171)各有57名受试者。这提供了80%的功率和5%的I型错误率，并在计算中包括了15%的损耗和30%的安慰剂效应。公共卫生相关性：肠易激综合征(IBS)影响15%至20%的北美人。美国每年用于评估和治疗LBS的医疗费用超过200亿美元。这个应用程序将测试一种症状管理策略，以改善LBS症状(腹痛、腹气、腹胀和大便稠度改变)。所采用的方法寻求在随机对照试验中评估以方案为导向(标准)与以患者为导向(个体化)的方案，使用传统中医实践。