Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial

Abstract

IntroductionIrritable 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 analysisA 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 disseminationThe 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 numberNCT04276961.

Prevalence and impact of faecal incontinence among individuals with Rome IV irritable bowel syndrome

“…There are four domains: absenteeism (percentage of work hours missed because of IBS); presenteeism (percentage of impairment experienced at work because of IBS); overall work impairment (percentage of work productivity loss); or activity impairment (percentage impairment in activities of daily living). We also used the work and social adjustment scale (WSAS), 37 which has been used by others to measure impact of IBS on ability to work, manage at home, engage in social or private leisure activities, or maintain close relationships 38–41 . The five domains are scored on a 9‐point scale from “not at all” (score 0), through “definitely” (score 4), to “very severely” (score 8).…”

“…We also used the work and social adjustment scale (WSAS), 37 which has been used by others to measure impact of IBS on ability to work, manage at home, engage in social or private leisure activities, or maintain close relationships. [38][39][40][41] The five domains are scored on a 9-point scale from "not at all" (score 0), through "definitely" (score 4), to "very severely" (score 8). We dichotomised presence (score ≥4 ("definitely" impacting)) or absence (score <4) of an impact of IBS on home management activities, social or private leisure activities, or maintaining close relationships.…”

Suppression effect and safety of acupuncture on colonic spasm during colonoscopy: a randomized controlled trial

“…A study showed that acupuncture at Neiguan (PC 6) regulates the vagus nerve (26). A multicenter, large-sample, doubleblind randomized controlled study found that acupuncture at bilateral Tianshu (ST 25), Shangjuxu (ST 37), Neiguan (PC 6), and Zusanli (ST 36) was effective at relieving symptoms in chronic functional gastrointestinal disorder (27). Based on these previous studies, we chose the Hegu (LI 4) and Neiguan (PC 6) points to explore the efficacy of acupuncture in inhibiting colonic spasm during endoscopy.…”

Clinical evidence of acupuncture and moxibustion for irritable bowel syndrome: A systematic review and meta-analysis of randomized controlled trials

“…in the IBS population where high placebo responses are common (49). The ongoing randomized sham-controlled trials [NCT04276961 (50), ChiCTR2100044762] will clarify the efficacy of acupuncture compared with sham-acupuncture. And more shams, which are unlikely to have physiological effects, would be necessary for further research.…”