Randomised controlled trial: sequential vs. standard triple therapy for Helicobacter pylori infection in Chinese children-a multicentre, open-labelled study

BackgroundStudies have showed that 10-day sequential treatment regimen achieved higher Helicobacter pylori eradication rate than standard triple therapies. AimTo compare a 10-day sequential therapy and standard triple therapy in Chinese children with H. pylori infection. MethodsA prospective, multicentre, open-label, randomised controlled trial was conducted in four tertiary medical centres in China. Children with H. pylori gastritis were randomly assigned to a 10-day sequential therapy consisting of omeprazole and amoxicillin for 5days followed by omeprazole, clarithromycin and metronidazole for the remaining 5days, or 7-day or 10-day standard triple therapy comprising of omeprazole, amoxicillin and clarithromycin. H. pylori eradication was assessed by H. pylori stool antigen test. ResultsA total of 360 patients were included. The eradication rate achieved with the 10-day sequential therapy was significantly higher than either the 7-day or 10-day standard triple treatment, either by the intention-to-treat analysis (81.4% vs. 61.9% or 67.7%, P<0.05) or per-protocol analysis (89.7% vs. 70.8% or 77.8%, P<0.05). ConclusionsThe 10-day sequential regimen was significantly more effective than standard 7-day or 10-day triple regimens in eradicating H. pylori infection in Chinese children.Gastroenterology & HepatologyPharmacology & PharmacySCI(E)2ARTICLE101230-12353