Meta-analysis of three-in-one single capsule bismuth-containing quadruple therapy for the eradication of Helicobacter pylori

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 (6,482 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%, 9 studies, I2=60%) in third-line; with no differences by the type or dosage of PPI used. For clarithromycin or metronidazole resistant infection, the ITT efficacy as first-line therapy was 94% (95% CI=91-97%, 5 studies, I2=0%) and 93% (95% CI=90-96%, 6 studies, I2=0%) respectively. 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® represents a highly effective (≥ 90%) therapy against H. pylori infection, both as first- and second-line. 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.