High-dose dual therapy versus bismuth-containing quadruple therapy for the treatment of helicobacter pylori infection: A meta-analysis of randomized controlled trials.

Background: Helicobacter pylori (H. pylori) infection is one of the most important public health issues, and bismuth-containing quadruple therapy (BQT) is the first-line therapeutic option. This study aimed to compare the efficacy and safety of high-dose dual therapy (HDDT) and BQT in eradicating H. pylori. Methods: Randomized controlled trials (RCTs) were retrieved from Pubmed, Embase, and Cochrane Library to evaluate the effects of HDDT and BQT on H. pylori infection from 2002 to August 31, 2022 (last 20 years). A meta-analysis was conducted using Review Manager 5.4 and dichotomous data were estimated by the risk ratio (RR) and the 100% confidence interval (CI). A heterogeneity test and publication bias adjustment were carried out using Stata 12.0. Results: 5604 participants from 14 RCTs were included in this meta-analysis. The eradication rates of H. pylori in the HDDT group and the BQT group were 87.46% and 85.70%, respectively. There was a bordered significant difference (RR = 1.02, 95% CI: 1.00 ~ 1.04, P = 0.03) in the intention-to-treat (ITT) analysis. Inconsistently, in per-protocol (PP) analysis, HDDT showed similar efficacy to BQT (89.97% vs 89.82%, RR = 1.00, 95% CI: 0.99 ~ 1.02, P = 0.67). HDDT showed fewer frequent adverse events than BQT (13.00% vs 31.05%, RR = 0.41, 95% CI: 0.33 ~0.50, P < 0.00001). After adjusting for publication bias, the tendency did not change (RR = 0.49, 95% CI: 0.44 ~ 0.55, P < 0.00001). The compliance of the HDDT group has no significant difference compared with the BQT group (95.88% vs 93.84%, RR = 1.01, 95% CI: 1.00 ~ 1.03, P = 0.14). Conclusion: HDDT achieved a non-inferiority eradication rate, fewer side effects, and similar compliance compared with BQT.