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

Abstract

Eradication 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). One hundred and twenty H.pylori-associated functional dyspepsia patients were randomized to receive 10-day HD-PPI-TT (60mg lansoprazole/500mg clarithromycin/1g amoxicillin, each administered twice daily for 10days) or 10-day ST (30mg lansoprazole/1g amoxicillin, each administered twice daily for 5days followed by 30mg lansoprazole/500mg clarithromycin/400mg metronidazole, each administered twice daily for 5days). H.pylori status was determined in post-treatment week 4 by 14 C-urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared. Intention-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. Sequential 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).