中药（调肠克敏颗粒）治疗腹泻型肠易激综合征的疗效及适应证优化：一项随机对照试验的研究方案

Efficacy and indication optimization of Chinese medicine (Tiao-Chang Ke-Min granules) for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial.

作者信息

Li Qian, Zhang Bei-Ping, Huang Shao-Gang, Ouyang Wen-Wei, Xie Jian-Hui, Wen Ze-Huai, Yang Xiao-Bo

机构信息

Chinese Medicine Syndrome Research Team, Guangdong Provincial Hospital of Chinese Medicine, No. 111, DaDe Road, Guangzhou, 510120, China.

The Second Clinical College of Guangzhou University of Chinese Medicine, No. 12, JiChang Road, Guangzhou, 510405, China.

出版信息

Trials. 2018 Jul 11;19(1):367. doi: 10.1186/s13063-018-2754-9.

DOI:10.1186/s13063-018-2754-9

PMID:29996882

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6042407/

Abstract

BACKGROUND

Irritable bowel syndrome (IBS) is a chronic, recurring condition, prevalent in the general population. Current medication treatments usually leave patients undertreated. Nowadays, Chinese medicine (CM) is being considered as a promising treatment approach for IBS. However, due to methodological limitations, there is no strong evidence to support CM. Although IBS relapses are common, the relapse assessment has always been neglected in CM study designs. Meanwhile, in clinical practice and studies, it has been found that certain CM formulas can only benefit certain kinds of patients. Discovering what population and illness characteristics likely respond to outcomes may help improve the effectiveness of CM. The aims of this study are to evaluate the efficacy and safety of Tiao-Chang Ke-Min (TCKM) granules for IBS, especially in reducing IBS symptoms' relapse, by a high-quality randomized controlled trial and then to optimize the indication of the TCKM granules.

METHODS/DESIGN: This is a parallel-group, randomized, double-blind, placebo-controlled trial embedded with outcome predictive factors. Eligible patients with diarrhea-predominant IBS will be randomized into either a TCKM granule group or a placebo group. Patients from both groups will receive health education. The treatment duration is 4 weeks and the follow-up is 12 weeks. The primary outcome is global improvement measured with adequate relief (AR). The second outcome measures include time until relief, time until first relapse, total relapse times, long-term effectiveness, individual symptoms, IBS-Symptom Severity Score (IBS-SSS), IBS-Quality of Life Questionnaire (IBS-QOL), and Hospital Anxiety and Depression Scale (HADS). Predictive factors associated with patient and illness characteristics have been widely collected. These factors will be embedded in this trial for further identification.

DISCUSSION

This trial may provide high-quality evidence on the efficacy and safety of TCKM granules for IBS and a more accurate indication. Importantly, this trial will provide a new research method for improving the therapeutic effects of CM for clinicians and researchers. To address IBS relapse assessment, a series of special definitions of relapse incidents has been made for this trial.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ID: ChiCTR-IOR-17010600 . Registered on 9 February 2017.

摘要

背景

肠易激综合征（IBS）是一种慢性复发性疾病，在普通人群中普遍存在。目前的药物治疗通常使患者治疗不充分。如今，中药被认为是治疗IBS的一种有前景的方法。然而，由于方法学上的局限性，尚无有力证据支持中药治疗。尽管IBS复发很常见，但在中药研究设计中复发评估一直被忽视。同时，在临床实践和研究中发现，某些中药方剂仅对特定类型的患者有益。发现哪些人群和疾病特征可能对治疗结果有反应，可能有助于提高中药的疗效。本研究的目的是通过一项高质量的随机对照试验，评估调肠克敏（TCKM）颗粒治疗IBS的疗效和安全性，尤其是在减少IBS症状复发方面，然后优化TCKM颗粒的适应症。

方法/设计：这是一项嵌入结局预测因素的平行组、随机、双盲、安慰剂对照试验。符合条件的腹泻型IBS患者将被随机分为TCKM颗粒组或安慰剂组。两组患者均接受健康教育。治疗期为4周，随访期为12周。主要结局是用充分缓解（AR）衡量的整体改善情况。次要结局指标包括缓解时间、首次复发时间、总复发次数、长期疗效、个体症状、IBS症状严重程度评分（IBS-SSS）、IBS生活质量问卷（IBS-QOL）和医院焦虑抑郁量表（HADS）。已广泛收集与患者和疾病特征相关的预测因素。这些因素将被纳入本试验以作进一步识别。