5-Aminosalicylic acid for treatment of irritable bowel syndrome A protocol for a systematic review and meta-analysis

Background: The global prevalence of irritable bowel syndrome (IBS) is estimated to be as high as 15%, and it is estimated that IBS has a prevalence of approximately 10% to 20% in Western countries. Some trials showed mesalazine (5-aminosalicylic acid [5-ASA]) might be effective for IBS, but the results still need to be confirmed. Hence, this meta-analysis is designed to assess the efficacy and safety of mesalazine for IBS in adults and children. Methods: We conducted a comprehensive database search for randomized trials of mesalazine for IBS in PubMed, EMBASE, and the Cochrane Library. The search strategy was performed from inception to December 31, 2019, without restrictions on publication status and language. The reference lists of the included articles were also checked to identify additional studies for potential inclusion. Two reviewers will independently review all literature for inclusion and assess their risk of bias. Two reviewers will independently extract data from eligible studies based on a pre-designed standardized form. Any disagreements will be resolved by consensus. Stata SE 15.0 software will be used for data synthesis. Results: This is the first meta-analysis focusing on mesalazine for the treatment of IBS. We predict it will provide high-quality synthesis on existing evidence for IBS and a relatively comprehensive reference for clinical practice and development of clinical guidelines for IBS. Conclusion: This protocol outlined the significance and methodological details of a systematic review of mesalazine for IBS. This ongoing meta-analysis will provide high-quality synthesis on existing evidence for IBS.