Banxia Xiexin Decoction for patients with peptic ulcer or chronic gastritis infected with Helicobacter pylori

Objective: To compare the effectiveness and safety of Banxia Xiexin Decoction (BXD) as alternative therapy versus standard triple therapy or quadruple therapy for patients with peptic ulcer or chronic gastritis infected with Helicobacter pylori (H. pylori). Methods: Databases including China National Knowledge Infrastructure, Chongqing VIP, Wanfang Database, PubMed, the Cochrane Library and clinicaltrials.gov were searched in December 2018 for relevant randomized controlled trials (RCTs). Two authors independently screened and selected studies, extracted data and checked data extraction. Methodological quality was evaluated using the Cochrane Risk of Bias tool. Meta-analysis was performed by using RevMan 5.3.5 software. Results: Fourteen RCTs were included in our analysis involving 1300 patients. Thirteen RCTs compared the effects of BXD alone versus standard therapy, 11 involving triple therapy and 2 in quadruple therapy. The cure rate for both diseases were higher in the BXD alone group than in the standard therapy group (RR and 95% CI: 1.85 [1.07, 3.17] and 1.48 [1.24, 1.75], respectively). And also, the same result with effectiveness rate (RR and 95% CI: 1.18 [1.08, 1.29] and 1.14 [1.08, 1.20], respectively). However, there was no significant difference in the clearance of H. pylori one month after treatment, neither compared with quadruple therapy nor triple therapy (RR and 95% CI: 1.10 [1.00, 1.22] and 1.04 [0.97, 1.12], respectively). Adverse events appeared in 3 participants in the BXD group and 26 participants in the conventional therapy group. The quality of the trials included in this review was not very good. Conclusion: BXD has a superior effect to standard conventional therapy in improving clinical symptoms and repair of the mucosal lesion, and a similar effect to standard conventional therapy in clearing H. pylori. We still need good quality trials, especially placebo-controlled trials, in the future to confirm this result. Keywords: Banxia Xiexin Decoction, Randomized controlled trial, Meta-analysis, Helicobacter pylor