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Randomised controlled trial: sequential vs. standard triple therapy for Helicobacter pylori infection in Chinese children-a multicentre, open-labelled study.
BACKGROUND: Studies have showed that 10-day sequential treatment regimen achieved higher Helicobacter pylori eradication rate than standard triple therapies.
AIM: To compare a 10-day sequential therapy and standard triple therapy in Chinese children with H. pylori infection.
METHODS: A 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 5 days followed by omeprazole, clarithromycin and metronidazole for the remaining 5 days, 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.
RESULTS: A 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).
CONCLUSIONS: The 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.
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