A Comparison between Hybrid and Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial

Abstract

Introduction: Helicobacter pylori infection is an important issue in global health, since almost half of the world's population is infected by the organism. Also, the infection is associated with peptic ulcer disease, gastric adenocarcinoma and lymphoma. Aims & Methods: Two hundred and fifty‐two patients with naïve H. pylori infection and peptic ulcer disease were randomly divided to receive either hybrid regimen (Pantoprazole 40 mg BID and Amoxicillin 1 gr BID for 14 days, accompanied by Clarithromycin 500 mg BID and Metronidazole 500 mg BID just during the last 7 days) or concomitant regimen (Pantoprazole 40 mg, Amoxicillin 1 gr, Clarithromycin 500 mg and Metronidazole 500 mg, all twice daily for 10 days). Eight weeks after therapy, 14C‐ Urease Breath test was performed to confirm eradication. Results: According to intention to treat analysis, the eradication rates were 87.3% (95% confidence interval=81.4 ‐ 93.1) and 80.9% (95% CI=74‐ 87.8) in hybrid and concomitant groups, respectively (p=0.38). Per‐protocol eradication rates were 89.3% (95% CI=83.8‐94.7) and 83.1% (95% CI=76.3‐89.8), respectively (p=0.19). The rates of severe side effects were not statistically different between the two groups (4% vs. 8.7%). Conclusion: Fourteen‐day hybrid therapy can be considered as a nearly acceptable regimen with few severe side effects in Iran. However, it seems that the efficacy of this therapy is decreasing as the resistance rates to antibiotics are increasing. We suggest further studies to assess the efficacy of a more prolonged concomitant therapy for H. pylori eradication in Iran.