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（由申请人提供）：本研究将测试针灸（Acu/艾草）改善肠易激综合征（IBS）相关症状的疗效。IBS已被定义为中或下胃肠道（GI）中的腹痛/不适，与排便或具有排便障碍特征的肠模式变化相关。IBS影响15%至20%的北美人。目前的治疗：饮食调整、心理疗法和药物疗法仍在研究中，没有一种是治愈性的，有些有明显的副作用。在亚洲发展了几个世纪的传统中医（TCM）针灸方法为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胃肠道疾病。然而，很少有IBS针灸研究有必要的严谨性来评估这种治疗。拟定的研究是一项随机、盲法、假手术/安慰剂对照的临床试验，研究Acu/艾草减轻腹痛/不适和IBS继发性支持症状（IBS-SecS）（肠气、腹胀、大便粘稠度）。根据罗马III标准诊断为IBS腹泻（IBS-D）的171名成人将被随机分配到三种条件之一：1：方案导向的Acu/艾草（标准）; 2：患者导向的Acu/艾草（基于个体化中医诊断和穴位处方）和3：假针灸/安慰剂灸（对照组）。所有受试者将参加一次筛选/入组会议，随后每周两次治疗会议，持续4周，每周一次治疗会议，持续4周，以及在第12周和第24周进行2次长期非治疗随访会议。所有受试者将由诊断针灸师（对治疗分配设盲）进行评估，接受适合其病情分配的干预（由接受过中医培训的执业针灸师），并在研究期间完成相同的仪器和每日症状日记。腹痛/不适和IBS- SecS治疗组差异的主要意向治疗比较将使用线性混合模型分析，固定效应为治疗、时间、治疗时间和受试者和误差的随机效应，以及AR（1）协方差结构。将在随访疗效分析中探索对治疗效果估计值的连续和分类混杂因素影响。将对治疗组在患者评定的总体症状改善、生活质量、心理压力、医疗保健利用和工作效率方面的次要目标差异进行类似分析。回归方法将确定IBS症状严重程度的变化如何与功能健康结果差异相关，并将探索治疗IBS患者的医生应针对哪些中医诊断。基于分析目的和我们初步结果的分析，这项腹泻亚型患者的假手术/安慰剂对照、设盲、随机化研究需要3个治疗组各57例受试者（N=171）。这在5%的I型错误率下提供了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：肠易激综合征（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IBS症状（腹痛，胀气，腹胀和粪便稠度改变）。所采用的方法旨在评价RCT中使用传统中医实践的方案导向（标准）与患者导向（个体化）方案。