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: 8234885
• 负责人: JOYCE K ANASTASI
• 金额: $ 58.86万
• 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 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8234885
• 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; 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; SF-36; Sample Size; Screening procedure; Sentinel; Severities; Shapes; Solvay brand of moxonidine; Structure; Symptoms; Syndrome; Testing; Therapeutic; Therapeutic Intervention; Time; 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; 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（Acu/Moxa）对改善肠易激综合征（IBS）相关症状的疗效。IBS被定义为中、下胃肠道（Gl）疼痛/不适，伴有排便或肠道模式改变，伴有排便紊乱。IBS影响了15%到20%的北美人。目前的治疗方法：饮食改变，心理治疗和药物治疗，仍在研究中，没有一种是治愈的，有些有明显的副作用。在亚洲发展了几个世纪的传统中医（acu/moxa）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肾小球疾病。然而，很少有肠易激综合征针灸研究有必要的严谨性来评估这种治疗。该研究是一项随机、盲法、假/安慰剂对照的Acu/Moxa临床试验，旨在减轻腹痛/不适和IBS继发性支持症状（IBS- secs）（肠气、腹胀、大便粘稠度）。171名根据ROME ii标准诊断为ibs -腹泻（IBS-D）的成年人将被随机分配到以下三种情况之一：1：面向协议的Acu/Moxa（标准）；2：以患者为导向（基于个体化中医诊断和穴位方剂）和3：假针灸/安慰剂灸（对照组）。所有受试者将参加筛查/摄入阶段，随后是每周两次治疗阶段，持续4周，每周一次治疗阶段，持续4周，并在第12周和第24周进行两次长期非治疗随访。所有受试者将由诊断针灸师进行评估（对治疗方案不知情），接受适合其病情分配的干预措施（由经过中医培训的持证针灸师进行），并在研究期间完成相同的工具和每日症状日记。治疗组腹痛/不适和IBS- SecS差异的主要治疗意向比较将使用线性混合模型分析，该模型具有固定的治疗效应、时间效应、逐治疗时间效应以及受试者和误差的随机效应，并采用AR(1)协方差结构。持续和分类混杂因素对治疗效果估计的影响将在随访疗效分析中探讨。次要目的是分析治疗组在患者评价的总体症状改善、生活质量、心理压力、医疗保健利用和工作效率方面的差异。回归方法将确定肠易激综合征症状严重程度的变化与功能性健康结果的差异，并将探讨哪些中医诊断应该作为治疗肠易激综合征患者的目标。基于分析目标和对我们的试点结果的分析，这项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每组57名受试者（N=171）。这在5%的I型错误率下提供80%的功率，并在计算中包含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）影响了15%到20%的北美人。美国每年用于评估和治疗lBS的医疗保健费用超过200亿美元。该应用程序将测试一种症状管理策略，以改善lBS症状（腹痛、胀气、腹胀和大便一致性改变）。采用的方法是在随机对照试验中评估以协议为导向（标准）和以患者为导向（个性化）的使用传统中医实践的协议。

项目成果

Addressing the Role of Food in Irritable Bowel Syndrome Symptom Management.

解决食物在肠易激综合症症状管理中的作用。

• DOI: 10.1016/j.nurpra.2015.12.007
• 发表时间: 2016
• 期刊: The journal for nurse practitioners : JNP
• 作者: Capili,Bernadette;Anastasi,JoyceK;Chang,Michelle
• 通讯作者: Chang,Michelle

A Clinical Update: Nonceliac Gluten Sensitivity-Is It Really the Gluten?

临床更新：非乳糜泻麸质过敏——真的是麸质吗？

• DOI: 10.1016/j.nurpra.2014.07.036
• 发表时间: 2014
• 期刊: The journal for nurse practitioners : JNP
• 作者: Capili,Bernadette;Chang,Michelle;Anastasi,JoyceK
• 通讯作者: Anastasi,JoyceK

The Treatment of Constipation-Predominant Irritable Bowel Syndrome with Acupuncture and Moxibustion: A Case Report.

针灸治疗便秘型肠易激综合征一例。

• 发表时间: 2012
• 期刊: The Journal of Chinese medicine
• 作者: Anastasi,JoyceK;Capili,Bernadette
• 通讯作者: Capili,Bernadette

Managing irritable bowel syndrome.

• DOI: 10.1097/01.naj.0000431911.65473.35
• 发表时间: 2013-07
• 期刊: The American journal of nursing
• 作者: Anastasi JK;Capili B;Chang M
• 通讯作者: Chang M

Irritable bowel syndrome subtype screening characteristics: constipation subtype patient profiles explored.

肠易激综合征亚型筛查特征：探讨便秘亚型患者概况。

• DOI: 10.4081/gi.2012.e16
• 发表时间: 2012
• 期刊: Gastroenterology insights
• 影响因子: 2.9
• 作者: Anastasi,JoyceK;Capili,Bernadette;Quinn,Jessica;McMahon,DonaldJ;Scully,Colin
• 通讯作者: Scully,Colin