Comparative study of H.pylori eradication rates of high and frequent dose of Omeprazole and Amoxicillin dual therapy versus standard triple therapy in children. (Article)

Sana Barakat1, Saba Elgendi2, Amal Mahfouz1, Abeer Hassan1

Institute(s):

1Alexandria University, Faculty of Medicine, Pediatrics, Alexandria, Egypt, 2Alexandria University, Faculty of Medicine, Pathology, Alexandria, Egypt

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. AMO is also unique in that its bactericidal effect against H. pylori is time dependent (6-8 h after administration) and can be amplified by increasing the maximum intragastric pH(>6.5) using high-dose proton pump inhibitor( PPI) .we aimed to  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.

This study has been registered at Pan African Clinical Trials Registry ,Cochrane South Africa, under identifier PACTR201807134057681.

Posted by: sana Barakat, professor of Pediatrics, Alexandria University, Faculty of Medicine, Egypt (27-Aug-2019)
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