Clinical efficacy of one-finger meditation massage on IBS-C based on the 'gut-brain axis' theory: study protocol for a randomized controlled trial

Autor: Xiayang Zeng, Jingjing He, Xiaoyu Li, Peng Chen, Jinhong Zuo, Xinlei Cai, Zhenyu Fan, Jianpeng Qu
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Complementary Medicine and Therapies, Vol 23, Iss 1, Pp 1-9 (2023)
Druh dokumentu: article
ISSN: 2662-7671
DOI: 10.1186/s12906-023-04019-3
Popis: Abstract Background 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. Discussion 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. Registration for Trial Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022. https://www.chictr.org.cn/bin/project/edit?pid=183461
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