Abstract
BACKGROUND: Helicobacter pylori (H. pylori) infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. This study aimed to compare the efficacy, side effects, and influence of resistance of H. pylori strains between two different treatments. METHODS: This prospective, randomized blind study enrolled 112 symptomatic children infected with H. pylori (66 girls, mean age 11.1 years). Treatments, allocated randomly irrespective of the susceptibility of the strains, were either the standard omeprazole-amoxicillin-clarithromycin combination for 7 days (OAC7; group A) or omeprazole-amoxicillin with a higher dose of metronidazole (40 instead of 20 mg/kg/d) for 10 days (OAM10; group B). RESULTS: Before treatment, the resistance rates of H. pylori strains to metronidazole or clarithromycin were 37% and 13%, respectively, with 7% resistant to both antibiotics and neither to amoxicillin. Eradication rates obtained with OAM10 (80% by intention-to-treat [ITT] and 88% by per protocol [PP] analysis) were higher than with OAC7 (68% in ITT and 71% PP) and the differences (12% in ITT and 17% PP) were statistically significant (P=0.03). Successful treatments with OAM10 were obtained in metronidazole resistant strains and were more effective in children aged >10 years (P=0.02 by ITT and P=0.04 by PP). Only light or moderate side effects, mainly digestive, were observed. CONCLUSION: Because of its therapeutic efficacy, good tolerance and lower cost the OAM10 can be considered as an appropriate first-line therapeutic scheme in Algeria.