A randomized trial comparing four Helicobacter pylori eradication regimens: standard triple therapy, ciprofloxacin based triple therapy, quadruple and sequential therapy.

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.