Comparative Study of H.pylori Eradication Rates of High and Frequent Dose of Omeprazole and Amoxicillin Dual Therapy versus Standard Triple Therapy in Children

Objectives and Study: With increasing prevalence of clarithromycin and metronidazole resistant H. pylori strains, eradication rates with triple therapy have fallen below 80% worldwide. Unlike that to clarithromycin or metronidazole, H.pylori resistance to amoxicillin(AMO) remains uncommon. High-dose dual therapy, of a proton pump inhibitor and AMO more than twice daily for 14 days, has been reported to have greater efficacy( over 90%) in adult .However, similar studies in the pediatric population remain limited. Therefore, we aimed to re- evaluate the efficacy and safety of high and frequent doses of PPI-AMO dual therapy for H. pylori eradication as a first- line therapy in children in Egypt where resistance rates for clarithromycin and metronidazole are relatively high.

Methods: One hundred and fifty six children with H pylori infection ,2-14 years ,( 80 boys ) were randomly assigned to one of two regimens: 1-dual therapy with amoxicillin (50mg/kg/day) and omeprazole (3mg/kg/day) three time daily for 2 weeks. 2- triple therapy with with amoxicillin(50mg/kg/day), metronidazole (20 mg/kg/day) and omeprazole (1mg/kg/day) twice daily for 2 weeks. Both groups are comparable as regard demographic , clinical and endoscopic data. H. pylori status was determined by rapid urease test and histopathology before treatment and by stool Ag 4 weeks after cessation of any medication.

Results: One hundred and forty three children completed the study. The eradication rate was 80.5% 58/72 in dual therapy group (intention-to-treat {ITT} analysis: 74.3%) vs. 84.7% 61/72 in triple therapy group ( ITT analysis 78.2%) these differences were not significant .Side effects ( diarrhea, nausea, abdominal discomfort and headache) , were more frequently recorded in triple therapy group 27/71( 38%) than dual therapy group 16/62 ( 25.8% )dual therapy group ( p< 0.05).None of the patients stopped taking medication because of the side effects.

Conclusions: High-dose PPI-amoxicillin dual therapy is comparable to the stander triple therapy for H. pylori eradication in children, however , it had fewer side effects . Dual therapy my provide an acceptable alternative first line therapy for H.pylori eradication in children in Egypt where high resistance rates to clarithromycin and metronidazole had been reported.