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

Aliment Pharmacol Ther. 2013 Nov;38(10):1230-5. doi: 10.1111/apt.12516. Epub 2013 Oct 5.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Amoxicillin / administration & dosage
  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Asian People
  • Child
  • Child, Preschool
  • China
  • Clarithromycin / administration & dosage
  • Clarithromycin / therapeutic use
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Male
  • Metronidazole / administration & dosage
  • Metronidazole / therapeutic use
  • Omeprazole / administration & dosage
  • Omeprazole / therapeutic use
  • Prospective Studies
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / therapeutic use*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Proton Pump Inhibitors
  • Metronidazole
  • Amoxicillin
  • Clarithromycin
  • Omeprazole