Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial
Xin Wang,
Hui Zheng,
Zhigang Li,
Shu-Guang Yu,
Min Chen,
Da Li,
Jun Zhao,
Yu Hu,
Siyuan Liu,
Xiaowei Chen,
Kun Ye,
Suhua Shi,
Huixia Li,
Jianfang Wang,
Jinxia Ni,
Qingshuang Wei,
Jingwen Sun
Affiliations
Xin Wang
1the University of Manchester, AV Hill Building 5th Floor, Manchester, MAN M13 9PT, UK
Hui Zheng
College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China
Zhigang Li
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Shu-Guang Yu
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
Min Chen
Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, Sichuan, China
Da Li
1 Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Jun Zhao
4 School of Rehabilitation Medicine, Capital Medical University, Beijing, China
Yu Hu
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Siyuan Liu
Department of Cardiac & Thoracic Surgery, Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, China
Xiaowei Chen
Department of Spleen, Stomach, Liver and Gallbladder Diseases, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
Kun Ye
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
Suhua Shi
Department of Rehabilitation, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China
Huixia Li
Department of Gastroenterology, Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China
Jianfang Wang
Department of Spleen, Stomach, Liver and Gallbladder Diseases, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
Jinxia Ni
2 Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China
Qingshuang Wei
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Jingwen Sun
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Introduction Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder that presents with abdominal pain/discomfort and altered bowel patterns. IBS has multiple potential causes for which conventional medicines have had limited success, resulting in a significant number of patients who do not sensitively respond to pharmacotherapy for a period of 12 months and who develop a continuing symptom profile (described as refractory IBS) and seek help through (non)pharmacological treatments. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for refractory IBS on the basis of conventional treatments.Methods and analysis A total of 170 eligible patients who meet the Rome IV criteria for refractory IBS will be randomly allocated to receive acupuncture or sham acupuncture. Each patient will receive 12 sessions of acupuncture over 4 weeks and a 4-week follow-up. The primary outcome will be the IBS Symptom Severity Score. Secondary outcomes will include the proportion of participants experiencing adequate relief of global IBS symptoms, the weekly frequency of defecation, the stool properties assessed by the Bristol Grading Scale, the Work and Social Adjustment Scale, the IBS-Quality of Life score, and the Self-Rating Depression Scale and Self-Rating Anxiety Scale anxiety and depression scores. Outcome measures will be collected at baseline, 2 and 4 weeks of the intervention, and 6 and 8 weeks after the intervention. Categorical variables will be compared with Fisher’s exact test or the Wilcoxon rank-sum test, and continuous variables will be compared using Student’s t-test or the Wilcoxon rank-sum test.Ethics and dissemination The entire project has been approved by the ethics committees of Beijing University of Chinese Medicine (2020BZYLL0507) and Sichuan Province Regional Institution for Conducting Research on Traditional Chinese Medicine (2020KL-025). The outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration number NCT04276961.
