Tui Na Department, Zhejiang Hospital, Hangzhou, China.
Surgical Department, The Third Hospital of Zhejiang University of Traditional Chinese Medicine, Hangzhou, China.
BMC Complement Med Ther. 2023 Jun 6;23(1):185. doi: 10.1186/s12906-023-04019-3.
As a common disorder of the gastrointestinal tract, irritable bowel syndrome (IBS) can have negative effects on patients and society, with irritable bowel syndrome with constipation(IBS-C) accounting for a large proportion of these effects. The main clinical manifestations of IBS-C are constipation, abdominal pain, and abdominal distension, which seriously impact the quality of life of patients. The mechanisms of IBS are complex, and the gut-brain axis has been an emerging and recognized theoretical system in recent years. Based on the theory of the gut-brain axis and the theory of Chinese medicine, we designed this study to evaluate the efficacy of one-finger meditation massage in treating IBS-C.
METHODS/DESIGN: This is a randomized controlled trial. Eligible patients with irritable bowel syndrome (IBS-C) wererandomized 1:1 to a test group (massage plus probiotics) and a control group (probiotics). Patients in the test group weretreated once every 10 days for three consecutive courses of treatment (i.e., three months) and weregiven Bifidobacterium trifolium capsules 630 mg/dose three times daily 30 min after meals every day during the treatment period, with follow-up observations at the end of the third and sixth months of the treatment period. The control group weregiven Bifidobacterium trifolium capsules 630 mg/dose, 3 times a day for 3 months, with follow-up observations at the end of the third and sixth months of the treatment period. The primary outcome indicators are the concentrations of 5-HT and substance P and the IBS Severity Scale (IBS-SSS) assessment. Secondary outcomes are the Bristol Rating Scale (BRSA) score, the IBS Quality of Life Questionnaire (IBS-QOL scale) score, and the assessment of the effectiveness of the evidence. The results wereassessed at the pretreatment, posttreatment, and follow-up stages. Any side effects weresubject to assessment.
The aim of this trial is to provide a new method of treatment based on pharmacological treatment that is easy to use, easy to promote and has proven efficacy and to establish the efficacy and safety of treating IBS-C through this trial.
Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022. https://www.chictr.org.cn/bin/project/edit?pid=183461.
作为一种常见的胃肠道疾病，肠易激综合征（IBS）会对患者和社会产生负面影响，其中以便秘型肠易激综合征（IBS-C）为主。IBS-C 的主要临床表现为便秘、腹痛和腹胀，严重影响患者的生活质量。IBS 的发病机制复杂，近年来，肠-脑轴已成为一个新兴的、被认可的理论体系。基于肠-脑轴理论和中医理论，我们设计了这项研究，以评估一指禅按摩治疗 IBS-C 的疗效。
方法/设计：这是一项随机对照试验。将符合条件的 IBS-C 患者按 1:1 随机分为试验组（按摩加益生菌）和对照组（益生菌）。试验组患者每 10 天治疗一次，连续治疗 3 个疗程（即 3 个月），治疗期间每天饭后 30 分钟口服三叶双歧杆菌胶囊 630mg/次，每日 3 次，治疗结束后第 3、6 个月进行随访观察。对照组患者口服三叶双歧杆菌胶囊 630mg/次，每日 3 次，治疗 3 个月，治疗结束后第 3、6 个月进行随访观察。主要结局指标为 5-HT 和 P 物质浓度及 IBS 严重程度量表（IBS-SSS）评估。次要结局指标为布里斯托大便性状评分（BRSA）评分、IBS 生活质量问卷（IBS-QOL 量表）评分和证据有效性评估。结果在治疗前、治疗后和随访阶段进行评估。任何不良反应均进行评估。
本试验旨在为基于药物治疗的易操作、易推广且已证实有效的治疗方法提供新的治疗思路，并通过该试验确立治疗 IBS-C 的疗效和安全性。
2022 年 12 月 5 日在中国临床试验注册中心注册，ChiCTR2200066417。https://www.chictr.org.cn/bin/project/edit?pid=183461。
