Objective: Helicobacter pylori infection is found in at least 80% of people in developing countries. This randomized controlled trial was performed to evaluate the efficacy of 4 different H. pylori eradication regimens in Iranian patients.
Methods: We enrolled 428 patients referred to Razi hospital in Rasht city with dyspepsia. Patients were randomly assigned to four treatment groups of 107 patients (A-D). Group A received omeprazole, amoxicillin, metronidazole and bismuth, all given twice daily for 2 weeks. Group B received omeprazole, amoxicillin and clarithromycin, all given twice daily for 10 days. Group C patients were given omeprazole and amoxicillin, both twice daily for two weeks and ciprofloxacin twice a day for the first week. Group D received 10 days sequential treatment with omeprazole and amoxicillin for 5 days and omeprazole, clarithromycin and metronidazole all twice daily for the remaining 5 days. H. pylori status was rechecked by stool antigen test 8 weeks after treatment. H. pylori eradication rate (both "Intention to Treat" and "per Protocol") and adverse effects of the drugs were recorded after 8 weeks.
Results: Eradication rates in group A to D were, 84.1%, 90.7%, 65.4% and 80.4% respectively in "Intention to Treat" and 85.7%, 90.7%, 70%, and 81.1% respectively in "per Protocol" analyses. Patient compliance was significantly lower in Group C, whereas patient compliance in other groups was not significantly different.
Conclusion: Standard 10 days triple therapy had the highest success (p=0.0001) rate in our study while quadruple therapy was the second successful regimen. Sequential therapy was not found to be an acceptable treatment option.