Seven-day is more effective than 4-day ranitidine bismuth citrate-based triple therapy in eradication of Helicobacter pylori in children: a prospective randomized study

Abstract

Background: Helicobacter pylori infection is common in paediatric population. To date, there is still no universally accepted recommendation on the treatment of this infection in children. Ranitidine bismuth citrate-based triple therapy has been shown to be effective in H. pylori eradication in adults but its use has rarely been validated in children.

Aim: To investigate the efficacy of ranitidine bismuth citrate-based triple therapy in eradication of H. pylori in children and to determine the shortest duration of treatment required.

Patients and methods: We conducted a prospective randomized study comparing ranitidine bismuth citrate plus amoxicillin plus clarithromycin given for 4 days vs. 7 days in H. pylori-infected children diagnosed by (13)C-urea breath test. Eradication was evaluated by repeat (13)C-urea breath test at 6 weeks after treatment.

Results: A total of 206 children were recruited (median age 12 years, 97 boys and 109 girls). Ninety-eight (47.6%) and 108 (52.4%) children were randomized to receive 7-day and 4-day regimen respectively. The eradication rate of 4-day treatment arm was 77.8% (both intention-to-treat and per protocol) compared with 88.8% (intention-to-treat, P = 0.036) and 89.7% (per protocol, P = 0.022) of 7-day regimen. There was no statistical difference in terms of side effects between the two groups.

Conclusions: Seven-day ranitidine bismuth citrate-based triple therapy is an effective and well-tolerated treatment for eradication of H. pylori in children.