• Jongwon Park, Seok-Jae Ko, Gajin Han, Keumji Kim, Hyejin Jun, and Jae-Woo Park.
• Department of Clinical Korean Medicine, Graduate School of Kyung Hee University, Seoul, Republic of Korea.
• Medicine (Baltimore). 2021 Jul 9; 100 (27): e26635e26635.

BackgroundIrritable bowel syndrome (IBS) is a chronic functional bowel disorder characterized by abdominal pain or discomfort, stool irregularities, and bloating. Owing to its atypical symptoms and various mechanisms, there is no standard treatment for IBS. Gwakhyangjeonggi-san (GJS), a traditional Korean herbal medicine, has been used to treat lower intestinal abnormalities in Asia. We will systematically review randomized controlled trials (RCTs) to evaluate the efficacy and safety of GJS as a complementary treatment for IBS.Methods And AnalysisFour English databases, namely, Medline (via PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database, will be searched for entries up to May, 2021. Additional databases will include 5 Korean databases, 1 Chinese database, and 1 Japanese database. RCTs and quasi-RCTs will be searched for to assess the effectiveness and safety of GJS. The primary outcome measure will be the overall efficacy rate, and the secondary outcome will include data such as global symptom scores, IBS Quality of Life measurements, and adverse events. Data analysis will be performed using Review Manager Version 5.3, and the risk of bias will be assessed using the Cochrane Collaboration's risk-of-bias tool. The quality of the results will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.ConclusionThis systematic review will provide evidence for the efficacy and safety of GJS for IBS.Osf Registration NumberDOI 10.17605/OSF.IO/V93JN (https://osf.io/v93jn).Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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