Ten‐day high‐dose proton pump inhibitor triple therapy versus sequential therapy for Helicobacter pylori eradication

Abstract

Background and AimEradication rates of Helicobacter pylori following standard triple therapy are declining worldwide, but high‐dose proton pump inhibitor‐based triple therapy (HD‐PPI‐TT) and sequential therapy (ST) have demonstrated higher cure rates. We aimed to compare the efficacy and tolerability of HD‐PPI‐TT and ST in H. pylori‐associated functional dyspepsia (FD).MethodsOne hundred and twenty H. pylori‐associated functional dyspepsia patients were randomized to receive 10‐day HD‐PPI‐TT (60 mg lansoprazole/500 mg clarithromycin/1 g amoxicillin, each administered twice daily for 10 days) or 10‐day ST (30 mg lansoprazole/1 g amoxicillin, each administered twice daily for 5 days followed by 30 mg lansoprazole/500 mg clarithromycin/400 mg metronidazole, each administered twice daily for 5 days). H. pylori status was determined in post‐treatment week 4 by 14C‐urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared.ResultsIntention‐to‐treat eradication rates were similar in the ST and HD‐PPI‐TT groups (85% vs. 80%; P = 0.47). However, the eradication rate was significantly higher following ST compared with HD‐PPI‐TT in per protocol analysis (94.4% vs. 81.4%; P = 0.035). ST achieved higher cure rates than HD‐PPI‐TT in clarithromycin‐resistant H. pylori strains (100% vs. 33.3%; P = 0.02). Treatment compliance was similar in the HD‐PPI‐TT and ST groups, although nausea and dizziness were more common in the ST group.ConclusionsSequential therapy achieved better H. pylori eradication than HD‐PPI‐TT in patients with FD. However, the eradication rate for ST fell from 94.4% in per protocol to 85% in intention‐to‐treat analysis. Adverse effects might result in poorer compliance and compromise actual ST efficacy (ClinicalTrials.gov: NCT01888237).