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中药 JCM - 16021 治疗腹泻型肠易激综合征的疗效与安全性：一项多中心、随机、双盲、安慰剂对照临床试验的研究方案

Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial.

作者信息

Zheng Ya, Ching Jessica, Cheng Chung Wah, Lam Wai Ching, Chan Kam Leung, Zhang Xuan, Lam Pui Yan, Wu Xing Yao, Zhong Linda L D, Cao Pei Hua, Lo Cho Wing, Cheong Pui Kuan, Lin Zhixiu, Koh Matthew, Wu Justin, Bian Zhao Xiang

机构信息

Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, SAR, China.

Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Hong Kong, China.

出版信息

Chin Med. 2021 Nov 13;16(1):117. doi: 10.1186/s13020-021-00530-2.

DOI:10.1186/s13020-021-00530-2
PMID:34774080
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8590321/
Abstract

BACKGROUND: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). METHODS: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. RESULTS: A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. CONCLUSION: The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. TRIAL REGISTRATION: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1.

摘要

背景：肠易激综合征（IBS）是一种常见的胃肠功能性疾病。患有IBS的成年人可能会经历腹痛、排便习惯改变和大便形态异常，且无器质性疾病。IBS会严重影响他们的工作效率和生活质量，尤其是腹泻型肠易激综合征（IBS-D）。基于一项小规模临床试验，中药JCM-16021已显示出在改善IBS-D症状方面具有潜在疗效。因此，设计了一项大规模临床研究，以进一步评估中药JCM-16021治疗肝郁脾虚型IBS-D的疗效和安全性。 方法：本研究是一项多中心、随机、双盲、安慰剂对照的临床试验。将招募392名符合条件的参与者，进行为期2周的导入期、8周的治疗期和8周的随访期。在导入期后，参与者将被随机分配接受中药JCM-16021或安慰剂治疗8周，并在治疗后再进行8周的随访。主要结局是第10周时整体改善评估（GAI）的改善率。次要结局包括IBS-D症状的变化、中医证候改善、IBS生活质量（IBS-QoL）、IBS症状严重程度评分（IBS-SSS）、安全性等。结果：已为该研究制定了标准方案。该方案将提供进行临床试验的详细程序，并验证中药JCM-16021是否能通过缓解腹痛、减少排便次数、改善大便性状和提高生活质量，显著改善肝郁脾虚型IBS-D的总体症状。该研究的综合证据可为中药治疗IBS-D提供参考。 结论：该方案将按照SPIRIT声明为研究者提供有关该研究的详细信息。通过严格遵守该方案，将提供关于中药JCM-16021治疗IBS-D的疗效和安全性的高质量证据。 试验注册：ClinicalTrial.gov标识符：NCT03457324。于2018年2月8日注册，https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd3d/8590321/6afe11034c1c/13020_2021_530_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd3d/8590321/13ce31a5ee12/13020_2021_530_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd3d/8590321/6afe11034c1c/13020_2021_530_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd3d/8590321/13ce31a5ee12/13020_2021_530_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd3d/8590321/6afe11034c1c/13020_2021_530_Fig2_HTML.jpg

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引用本文的文献

[1]
Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study.

Front Pharmacol. 2024-6-7

[2]
Evaluation of the effectiveness and mechanism of action of the Chang-Kang-Fang formula combined with bifid triple viable capsules on diarrhea-predominant irritable bowel syndrome.

Front Microbiol. 2023-6-27

本文引用的文献

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