Bismuth, rabeprazole, amoxicillin, and doxycycline as first-line Helicobacter pylori therapy in clinical practice: A pilot study.

BACKGROUND

Bismuth-containing quadruple therapy (BQT) is a recommended alternative first-line therapy for Helicobacter pylori (H. pylori) infection. We aim to evaluate the efficacy and safety of a new BQT with amoxicillin and doxycycline as a first-line treatment for H. pylori infection in clinical practice.

METHODS

An open, prospective pilot clinical study including H. pylori-positive outpatients who had never received eradication treatment was carried out. An RADB regimen (10 mg rabeprazole, 1000 mg amoxicillin, 100 mg doxycycline, and 220 mg colloidal bismuth tartrate, all given bid for 14 days) was prescribed by gastroenterologists. H. pylori eradication was confirmed by a 13 C-urea breath test performed at least 6 weeks after the end of treatment. Regimen efficacy was evaluated by per-protocol (PP) and intention-to-treat (ITT) analyses.

RESULTS

One hundred eighteen patients were included in the study. The eradication rate of RADB was 93.8% (105/112; 95% CI 89.2%-98.3%) in PP analysis and 89.8% (106/118; 95% CI 84.3%-95.4%) in ITT analysis. The patient compliance rate was 97.5% (115/118). The adverse event rate was 6.8% (8/118). Adverse events included asthenia, loss of appetite, dry mouth, heartburn, diarrhea, and abdominal pain. All adverse events disappeared after completion of therapy.

CONCLUSION

Our results suggest that 14-day BQT with amoxicillin and doxycycline can be an effective and safe eradication regimen for first-line therapy against H. pylori infection in clinical practice.