To assess the effective and safety of berberine hydrochloride in ulcerative colitis: A protocol for systematic review and meta-analysis

BACKGROUND: Ulcerative colitis (UC) is an inflammatory bowel disease characterized by a relapsing and remitting course, and the curative medical therapy of UC is not yet available with its precise etiology unknown. Berberine hydrochloride, one of the main alkaloids in rhizomes of Coptis chinensis, has been reported the efficacy in patients with UC. However, there is no systematic review related to berberine hydrochloride for UC published. In this work, we will systematically evaluate the effectiveness and safety of berberine hydrochloride for UC by a meta-analysis method to provide a substantial conclusion for clinical practice. METHODS AND ANALYSIS: In this study, we will search the Chinese and English databases by electronic and manual search to find the related literature of berberine hydrochloride in the treatment of UC published from the inception date of each predefined database up to October 2020. Databases include PubMed, Embase, MEDLINE, Cochrane Library Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI) database, Wanfang Data Knowledge Service Platform, the VIP information resource integration service platform (cqvip), China Biology Medicine Disc (Sino Med), the Chinese Clinical Trial Registry (ChiCTR), and ClinicalTrials.gov. The 2 professional trained authors will independently select the qualified studies for data extraction and assess the risk of bias in included studies. Then the synthesis and analyses of data will be carried out in RevMan 5.4. The heterogeneity of statistics will be assessed by a heterogeneity X(2) test and I(2) tests. Sensitivity analysis is used to evaluate whether the outcomes of systematic review or meta-analysis are robust and reliable. The funnel plot is the main method to evaluate the bias of reporting. Finally, we will use The Grading of Recommendations Assessment, Development and Evaluation to evaluate the quality of evidence. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: Whether berberine hydrochloride is an effectiveness and safety for patients with UC will be judged in the conclusion of this systematic review. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/X57U3.