Clinical study of bismuth-based quadruple therapy as first-line therapy for the eradication of Helicobacter pylori.

Objective To evaluate the efficacy and safety of the 10-day bismuth-based quadruple therapy as first-line therapy for the eradication of Helicobacter pylori. Methods A total of 140 patients with H. pylori infection were enrolled and randomly assigned into triple therapy groups and quadruple therapy groups, each with 70 cases. Patients in the triple therapy group received esomeprazole 20 mg BID, clarithromycin 500 mg BID and amoxicillin 1.0 g BID for seven days. Patients in the quadruple therapy group received esomeprazole 20 mg BID, clarithromycin 500 mg BID, amoxicillin 1.0 g BID and pectin bismuth 150 mg TID for ten days. H. pylori eradication was assessed by 13C-urea breath test six weeks after cessation of therapy, and the safety was also evaluated. Results The per-protocol (PP) and intention-to-treat (ITT) eradication rates were 76.4% and 74.3% in the triple therapy group, and 92.5% and 88.6% in the quadruple therapy group, respectively. The eradication rate was significantly higher in the quadruple therapy group compared with the triple therapy group in both the PP and ITT populations (P=0.010 and P=0.030, respectively), whereas the incidence of adverse events was similar. No serious adverse reactions occurred in the two groups. Conclusion In the initial treatment of H. pylori infection, the 10-day bismuth-based quadruple therapy as first-line therapy can achieve a higher eradication rate than the 7-day standard triple therapy.