EVALUATION OF TRIPLE an‎d QUADRUPLE REGIMENS IN ERADICATION OF HEUCOBACTER PYLORI INFECTION IN PEDIATRIC PATIENTS IN EMAM KHOMEINI HOSPITAL IN 2002-2003: A RANDOMIZED CLINICAL TRIAL

Background: Triple therapy with a proton pump inhibitor, clarithromycin and amoxicillin and quadruple therapy with a proton pump inhibitor, bismuth citrate, metronidazole and amoxicillin have been proposed in Maastricht 2000 as the optimal treatment of Helicobacter pylori infection. We aimed to compare these two regimens in Iranian pediatric patients. Methods: Arandomized clinical trial in Emam Khomeini Hospital between 1381 and 1382 was done. Patients with confirmed H. pylori infection by histology were divided in to two groups in a randomized 1:1 scheme. Triple regimen group: Clarithromycin 15mg/kg/d, Amoxicillin 50 mg/kg/d and Omeprazole 1mg/kg/day for 10 days. Quadruple regimen group: Omeprazole 1mg/kg/d, Amoxicillin 50 mg/kg/day, Metronidazole 20 mg/kg/day and Bismuthpitrate 8mg/kg for 10 days. The eradication was assessed by c-urea breath test 4 weeks after the end of treatment and by perprotocol analysis. Results: In our study, 100patients (50 in each group) were found and the eradication rates in the triple and quadruple group were 92% and 84% respectively (p=0.046). Conclusion: According to our results, we recommend triple therapy as first-line treatment in Iranian pediatric patients and quadruple therapy as a second line regimen.