Randomiozed clinical trial: a comparative study of 10 day sequencial therapy with 7-day standard triple therapy for Helicobacter pylori infection in naive patients

Abstract

Background The eradication rates following standard triple therapy for Helicobacter pylori infection are declining worldwide. Recent studies have shown that sequential therapy for H. pylori infection yields high cure rates. Aim To compare the efficacy and tolerability of a sequential regimen as first-line treatment of H. pylori infection with a standard triple regimen. Methods A total of 348 naı ¨ ve H. pylori-infected patients from six hospitals in Korea were assigned randomly to standard triple or sequential therapy groups. Standard triple therapy consisted of 20 mg of rabeprazole, 1 g of amoxicil- lin and 500 mg of clarithromycin, twice daily for 7 days. Sequential therapy consisted of a 5-day dual therapy (20 mg of rabeprazole and 1 g of amoxi- cillin, twice daily) followed by a 5-day triple therapy (20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). Results The intention-to-treat (ITT) and per-protocol (PP) eradication rates were 62.2% (95% CI 54.8–69.6%) and 76.0% (95% CI 68.5–83.5%) in the stan- dard triple group, and 77.8% (95% CI 71.4–84.2%) and 87.9% (95% CI 82.3–93.5%) in the sequential group, respectively. The eradication rate was significantly higher in the sequential group compared with the standard tri- ple group in both the ITT and PP populations (P = 0.002 and P = 0.013 respectively), whereas the incidence of adverse events was similar. Conclusions Ten-day sequential therapy is more effective and equally tolerated for eradi- cation of H. pylori infection compared with standard triple therapy. Sequen- tial therapy may have a role as first-line treatment for H. pylori infection.