10-Day versus 14-day bismuth quadruple therapy for first-line eradication of Helicobacter pylori infection: a randomised, open-label, non-inferiority trial

Abstract

Bismuth quadruple therapy is currently consensus recommendation for first-line Helicobacter pylori (H. pylori) treatment; however, the optimal duration is unknown. We compared the efficacy of 10-day bismuth quadruple therapy with that of 14-day bismuth quadruple therapy for first-line eradication. For our multicentre, parallel randomised, open-label, and non-inferiority study, we recruited H.pylori treatment-naïve patients from one medical centre and one teaching hospital in Taiwan. Patients were randomly assigned (1:1) to receive 10-day (PBMT-10) or 14-day (PBMT-14) bismuth quadruple therapy. The primary outcome was the eradication rate as determined by intention-to-treat (ITT) and per-protocol (PP) analyses. The eradication rates between the two groups were compared using a one-sided α value of 0.025 and a non-inferiority margin of 7%. The secondary outcomes were the rate of adverse effects. The trial is registered with ClincialTrials.gov (NCT04527055). From August 3, 2020 to April 28, 2023, 313H.pylori treatment-naïve patients (PBMT-10=157; PBMT-14=156) were enrolled. 35 patients were excluded from PP analyses. The eradication rates (95% CI) for PBMT-10 and PBMT-14 were respectively 92.4% (88.2%-96.5%) and 92.9% (88.9%-97.0%) by ITT analyses, and 97.9% (95.5%-100.0%) and 99.3% (97.8%-100.0%) by PP analyses. The eradication rates for PBMT-10 were non-inferior to those for PBMT-14 (absolute difference [lower boundary of the one-sided 97.5% CI]-0.6% [-6.7%], PNI=0.020 in ITT analyses,-1.4% [-5.8%], PNI=0.007 in PP analyses). The rates of overall adverse effects (54.1% versus 57.1%, P=0.604) were similar between the two groups; nevertheless, the rates of dizziness (18.5% versus 34.0%, P=0.003) and vomiting (4.5% versus 12.8%, P=0.008) were lower in PBMT-10 than in PBMT-14. The 10-day bismuth quadruple therapy was non-inferior to the 14-day therapy as a first-line treatment for eradicating H.pylori infection and had no different rates of overall adverse effects, but less serious adverse events in terms of dizziness and vomiting. The National Science and Technology Council and Ministry of Health and Welfare, Taiwan.