Sequential Therapy Compared with Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Double-Blind, Randomized, Controlled Trial

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 Hpylori infection confirmed with 2 of 3 tests (C-13-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 C-13-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. (J Pediatr 2011;159:45-9)