Sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children: a double-blind, randomized, controlled trial.

Author(s): Albrecht P, Kotowska M, Szajewska H

Affiliation(s): Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland.

Publication date & source: 2011-07, J Pediatr., 159(1):45-9. Epub 2011 Mar 3.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To determine the effectiveness of sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children. STUDY DESIGN: In 107 children with H pylori infection confirmed with 2 of 3 tests ((13)C-urea breath test, histopathology, rapid urease test), we conducted a double-blind, randomized, controlled trial comparing a sequential treatment (amoxicillin and omeprazole for 5 days followed by clarithromycin, tinidazole, and omeprazole for 5 days) to a 7-day standard triple eradication regimen (amoxicillin and clarithromycin plus omeprazole) followed by placebo for 3 days. RESULTS: In the experimental group (n=52) compared with the control group (n=51), there was a significant difference in the H pylori eradication rate at 6 to 8 weeks after the completion of treatment (primary outcome), as confirmed with negative results on (13)C-urea breath test (45/52 or 86.5% versus 35/51 or 68.6%; relative risk, 1.26; 95% CI, 1.02-1.60). Groups did not differ in any of the secondary outcomes (ie, adverse effects, the need for discontinuation of the H pylori therapy, compliance with therapy). CONCLUSIONS: In children with H pylori infection, sequential eradication therapy compared with standard triple therapy resulted in a higher eradication rate, although the difference was of borderline statistical significance. Copyright (c) 2011 Mosby, Inc. All rights reserved.