Comparison of concomitant therapy versus standard triple-drug therapy for eradication of Helicobacter pylori infection: A prospective open-label randomized controlled trial.

Introduction: Resistance to commonly used antibiotics against Helicobacter pylori (H. pylori) is increasing rapidly leading to lower success of traditional triple therapy to eradicate H. pylori infection. So, search for a new regimen as the first-line therapy of H. pylori infection is needed.

Aim: In this study, we compared the efficacy of 14-day concomitant therapy and 14-day triple therapy for the eradication of H. pylori infection.

Method: In this open-labeled prospective trial, patients with H. pylori infection were randomized to concomitant therapy (pantoprazole 80 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and metronidazole 1000 mg daily in divided doses) and triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses). Duration of treatment was 14 days. Gastric biopsy was done 10-12 weeks after completion of therapy to confirm H. pylori eradication.

Result: The eradication rate achieved with the concomitant therapy was significantly greater than that obtained with the triple therapy. Per-protocol eradication rates of concomitant and triple therapy were 77% and 58.3% (p = 0.028), respectively. Intention-to-treat eradication rates of concomitant and triple therapy were 70.1% and 49.3% (p = 0.013), respectively. Both the treatment regimens were well tolerated.

Conclusion: Although the rate of eradication of H. pylori infection with  concomitant therapy was higher than that with triple therapy, the rate of concomitant therapy was still less than expected.