Acupuncture for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial.
Acupuncture for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial.
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针灸治疗肠易激综合征：多中心随机对照试验的研究方案
DOI：
10.1186/s13063-018-2922-y
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发表时间：
2018-10-01
期刊：
影响因子：
2.5
通讯作者：
Sun JH
中科院分区：
文献类型：
--
作者：
Pei LX;Geng H;Chen H;Wu XL;Chen L;Zhou JL;Ju L;Lu G;Xu WL;Qin S;Guo J;Yang EM;Sun JH
肠易激综合征（IBS）是一种以腹痛和排便习惯改变为特征的慢性胃肠道疾病，无器质性病变。世界胃肠病学组织（WGO）的全球观点指出，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IBS的病理生理复杂，其治疗仍是一个难题。针灸是推荐用于IBS的替代疗法。本研究的目的是探讨针刺治疗肠易激综合征的有效性和安全性。本研究还探讨IBS基因亚型与针刺效应的相关性。将在7家医院进行多中心随机对照试验。将600名受试者分为两个分层（IBS-C或IBS-D）。然后，将每个分层中的患者随机分为实验组和对照组。实验组采用针刺治疗，对照组采用西药治疗。所有患者将接受为期6周的治疗和3个月的随访。主要观察指标为IBS症状严重程度评分（IBS-SSS），次要观察指标为IBS生活质量评分（IBS-QoL），采用聚合酶链反应-限制性片段长度多态性（PCR-RFLP）技术检测IBS基因亚型与针刺疗效的相关性。在基线、干预1周、2周、4周和6周以及干预后12周收集结果测量（包括主要和次要结果测量）。这是一项在中国开展的治疗IBS的多中心随机对照试验。这可能阐明针灸作为IBS替代疗法的疗效。这是有史以来第一次基于基因组学研究IBS的潜在机制。中国临床试验注册中心，ID：ChiCTR-IOR-15006259。首次登记于2015年4月14日。本文的在线版本（10.1186/s13063-018-2922-y）包含补充材料，可供授权用户使用。
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. 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. 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. Chinese Clinical Trials Register, ID: ChiCTR-IOR-15006259. First registered on 14 April 2015. The online version of this article (10.1186/s13063-018-2922-y) contains supplementary material, which is available to authorized users.
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3.9
作者：
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DOI：
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