Background: Bismuth-containing quadruple therapy has been suggested as first-line and rescue alternative for Helicobacter pylori eradication. Our objective was to perform a meta-analysis evaluating the efficacy and safety of single capsule Pylera® (bismuth, metronidazole, and tetracycline) plus a proton-pump inhibitor (PPI) in any line of treatment.
Methods: Studies were selected up to October 2018. Outcomes were eradication and adverse events (AEs) rates pooled using the generic inverse variance method.
Results: In total, 30 studies (6482 patients) were included in the systematic review. The intention-to-treat (ITT) efficacy was 90% (95% CI: 87%-92%, 21 studies, I2 = 88%) in first-line therapy, 89% (95% CI: 86%-93%, 12 studies, I2 = 78%) in second-line and 82% (95% CI: 78%-87%, nine studies, I2 = 60%) in third-line; with no differences by the type or dosage of PPI used. For metronidazole-resistant infection, the ITT efficacy as first-line therapy was 93% (95% CI: 90%-96%, six studies, I2 = 0%). In second-line therapies where patients had been previously treated with clarithromycin, the ITT efficacy was 90% (95% CI: 87%-93%, 11 studies, I2 = 78%). The overall incidence of AEs was 43% (95% CI: 35%-50%, 24 studies, I2 = 92%) and they were mostly mild. In nearly 3% of the cases, treatment was interrupted due to AEs.
Conclusions: A 10-day treatment with Pylera® achieved an effective eradication rate of approximately 90% both in first- and second-line therapy. This applies regardless of the type and dose of the PPI, in patients with clarithromycin- or metronidazole-resistant strains, and in those previously treated with clarithromycin.
Keywords: Helicobacter pylori; Pylera®; bismuth; metronidazole; quadruple therapy; tetracycline.
© 2019 John Wiley & Sons Ltd.