A multicenter prospective, double-blind RCT included 73 children (mean age 10.8 years) with dyspeptic symptoms. Patients were randomized to receive omeprazole + amoxicillin + chlarithromycin (OAC) or amoxicillin and clarithromycin (AC) for 7 days. H. pylori status was assessed before and 4 weeks after eradication treatment, by use of the carbon 13-labeled urea breath test. In intention-to-treat analysis (n = 63), eradication rates were 74.2% (95% CI 58.7 to 89.6) in the OAC group and 9.4% (95% CI 0 to 19.5) in the AC group. In per-protocol analysis (n = 53), the eradication rate increased to 80% (95% CI 64.3 to 95.7), remaining significantly higher than in AC group (10.7%; 95% CI 0 to 22.2).
A systematic review including 30 studies with a total of 870 subjects was abstracted in DARE. All study designs were eligible for inclusion provided they reported the following details: the number and children and their age; the type, total daily dose and duration of treatment; and eradication results. Some of the results appeared consistent; in particular, dual therapies with two antibiotics, or bismuth plus one antibiotic, seemed to be as effective as triple therapies if given for 2 weeks. Bismuth-based triple therapies were also more effective if given for 2 weeks, whereas proton-pump inhibitor-based triple therapies had a similar efficacy irrespective of the treatment duration. The authors conclude that the results need to be confirmed by randomised controlled trials, and no definite statement can be drawn at present.