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

 ABSTRACT 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: A randomized clinical trial in Em am Khomeini Hospital between 13 81 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 15 mg/kg/d, Amoxicillin 50 mglkg/d and Omeprazole 1 mg/kg/day for 10 days. Quadruple regimen group: Omeprazole 1 mg/kg/d, Amoxicillin 50 mglkg/day, Metronidazole 20 mglkg/day and Bismuth citrate 8 mglkg for 10 days. The eradication was assessed by c-urea breath test 4 weeks after the end of treatment and byperprotocol analysis. Results: In our study, 100 patients (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.