The efficacy of the traditional Korean herbal medicine Tongsayobang for the treatment of irritable bowel syndrome: A protocol for a systematic review and meta-analysis

BACKGROUND: Irritable bowel syndrome (IBS) is a functional bowel disorder with symptoms of recurrent abdominal pain associated with a change in stool frequency or appearance that decreases patient quality of life. Conventional Western medicine has limited efficacy in treating IBS. Tongsayobang (TSYB) is a traditional Korean medicine that has been used to treat lower intestinal problems. This study provides a procedure for conducting a systematic review of the efficacy and safety of TSYB for IBS. METHODS AND ANALYSIS: The main electronic databases will be searched up to May 2021 for randomized controlled trials and quasi-randomized controlled trials evaluating the effect of TSYB or modified TSYB on patients with IBS. The primary outcome will be the overall efficacy rate. The secondary outcome will be data such as IBS-related quality of life, global symptom scores, and adverse events. This study will adopt the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and will involve a meta-analysis, if possible. The methodological quality of the included studies will be assessed using the Risk of Bias tool from the Cochrane Handbook, version 6.1.0. ETHICS AND DISSEMINATION: Ethical approval is not required because this study does not include any participants’ personal information. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/M32BK (https://osf.io/m32bk)