Background: The eradication rate of Helicobacter pylori infection with empirical therapy has decreased due to increased drug resistance. The latest guidelines recommend genotypic resistance-guided therapy, but its clinical efficacy remains unclear.
Objectives: The purpose of our study was to evaluate whether tailored therapy based on genotypic resistance is superior to empirical therapy for H. pylori infection.
Design: A systematic review and meta-analysis of randomized controlled trials (RCTs) comparing tailored therapy based on genotypic resistance with empirical therapy was performed.
Sources and methods: We retrieved relevant studies from PubMed, Embase, and the Cochrane Library. The primary outcome was H. pylori eradication rate and the adverse events (AEs) was the secondary outcome. A random-effect model was applied to compare pooled risk ratios (RRs) with related 95% confidence intervals (CIs).
Results: A total of 12 qualified RCTs containing 3940 patients were identified in our systematic review and meta-analysis. The pooled eradication rates of tailored therapy based on the detection of genotypic resistance were consistently higher than those in the empirical treatment group, with no statistical significance. In triple therapy, the eradication rate was significantly higher in the tailored group than in the empirical group by intention-to-treat analysis (ITT) and per-protocol analysis (PP) analysis (p < 0.0001, RR: 1.20; 95% CI: 1.12-1.29; p < 0.0001, RR: 1.20; 95% CI: 1.15-1.25). In quadruple therapy, the eradication rate was higher in the empirical group (p = 0.001, RR: 0.93; 95% CI: 0.89-0.97; p = 0.009, RR: 0.95; 95% CI: 0.92-0.99). And this result was true for both bismuth quadruple therapy (BQT) and non-BQT. Regarding total AEs, the pooled rate was 34% in the tailored group and 37% in the empirical group, and no difference between the two groups was found (p = 0.17, RR: 0.88; 95% CI: 0.74-1.06).
Conclusion: In conclusion, tailored therapy based on molecular methods may offer better efficacy than empirical triple therapy, but it may not be superior to empirical quadruple therapy in eradicating H. pylori infection. Larger and more individualized RCTs are needed to aid clinical decision-making.
Registration prospero: CRD42023408688.
Keywords: Helicobacter pylori; empirical; eradication; genotypic resistance; meta-analysis; tailored.
© The Author(s), 2023.