针刺治疗肠易激综合征的多中心随机对照试验研究方案。

Acupuncture for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial.

机构信息

Department of Acupuncture, Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, No 155, Hanzhong Road, Qinhuai District, Nanjing, 210029, China.

Nanjing University of Chinese Medicine, No 138, XianlinRoad, Qixia District, Nanjing, 210000, China.

出版信息

Trials. 2018 Oct 1;19(1):529. doi: 10.1186/s13063-018-2922-y.

DOI:10.1186/s13063-018-2922-y

PMID:30285891

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6166287/

Abstract

BACKGROUND

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology Organization (WGO) points out that IBS can impact the quality of an individual's daily life, cause socioeconomic problems and potentially impair the patient-physician relationship. It remains a problem to treat IBS due to the complicated pathophysiology. Acupuncture is an alternative therapy recommended for IBS. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. We also want to explore the correlation between IBS-gene subtypes and acupuncture effect.

METHODS/DESIGN: A multicenter randomized controlled trial will be performed in seven hospitals. Six hundred participants will be stratified into two strata (IBS-C or IBS-D). Then, patients within each stratum will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture while the control group is treated with Western medicine. All the patients will receive a 6-week treatment and a 3-month follow-up. The primary outcome is the IBS-Symptom Severity Score (IBS-SSS), the secondary outcome is the score of the IBS-Quality of Life (IBS-QoL).The correlation between IBS-gene subtypes and acupuncture effect will be detected based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Outcome measures (including primary and secondary outcome measures) are collected at baseline,1 week, 2 weeks, 4 weeks, and 6 weeks of the intervention, and 12 weeks after the intervention.

DISCUSSION

This is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS. This is the first time ever that the potential mechanism of IBS based on genomics has been investigated.

TRIAL REGISTRATION

Chinese Clinical Trials Register, ID: ChiCTR-IOR-15006259 . First registered on 14 April 2015.

摘要

背景

肠易激综合征（IBS）是一种慢性胃肠道疾病，其特征为腹痛和排便习惯改变，而无器质性疾病。世界胃肠病组织（WGO）的全球视角指出，IBS 会影响个人的日常生活质量，导致社会经济问题，并可能损害医患关系。由于其复杂的病理生理学，IBS 的治疗仍然是一个问题。针灸是一种推荐用于治疗 IBS 的替代疗法。本研究旨在探讨针灸治疗 IBS 患者的疗效和安全性。我们还希望探讨 IBS-基因亚型与针灸效果之间的相关性。

方法/设计：将在七家医院进行一项多中心随机对照试验。600 名参与者将分为两层（IBS-C 或 IBS-D）。然后，在每个分层内，患者将随机分为实验组和对照组。实验组接受针灸治疗，对照组接受西药治疗。所有患者将接受 6 周的治疗和 3 个月的随访。主要结局是肠易激综合征症状严重程度评分（IBS-SSS），次要结局是肠易激综合征生活质量评分（IBS-QoL）。基于聚合酶链反应-限制性片段长度多态性（PCR-RFLP）检测 IBS-基因亚型与针灸效果之间的相关性。在干预前、干预后 1 周、2 周、4 周和 6 周以及干预后 12 周收集结局测量值（包括主要和次要结局测量值）。