Comparison of two different eradication regimens for H. pylori: amoxicillin, metronidazole, bismuth and omeprazole (OMAB) versus the new regimen of penbactam, clarithromycin and omeprazole (OPC); a randomized clinical trial

Aim : The present study aimed to compare the eradication rate of H. pylori by traditional amoxicillin, metronidazole, bismuth, and omeprazole regimen, with a new one using clarithromycin, omeprazole and ampicillin/sulbactam (penbactam). Background : Due to the appearance of Amoxicillin-resistant H. pylori strains all over the world, the decreased efficacy of conventional Amoxicillin-containing treatment regimens has become a matter of concern. Patients and methods : A total of 332 dyspeptic patients whose H. pylori infection was confirmed by endoscopy and rapid urease test (RUT) were randomized into two groups: group A, comprising 162 patients who received the traditional quadruple treatment regimen for H. pylori (bismuth 240 mg, omeprazole 20 mg, amoxicillin 1gr, and metronidazole 500 mg twice daily) and  group B, containing 170 patients who received clarithromycin 500mg, penbactam (ampicillin 250 mg plus sulbactam 175 mg) and omeprazole 20 mg twice daily. Both groups were given the treatment for 2 weeks, and both underwent UBT 4 weeks after the end of treatment; UBT negative patients were considered responders and the rate of treatment response was compared by per-protocol and intention-to-treat analysis between two groups. Results : The eradication rate was 56.4% in group A and 87%in group B by per protocol analysis. The eradication rates were 48.8% and 81.7% according to intention-to-treat analysis in groups A and B respectively. The eradication rate was higher in group B patients taking penbactam, omeprazole and clarithromycin (P Conclusion : Our study showed that using ampicillin/sulbactam instead of amoxicillin, clarithromycin and omeprazole increased the eradication rate of H. pylori significantly.