Triple therapy remains the recommended first line treatment for Helicobacter pylori infection. However, increased resistance to antibiotics used in the triple therapy is of concern, and this there has been interest in novel therapeutic strategies, one of which is sequential therapy—two-step, 10-day therapy consisting of administration of a proton pump inhibitor with amoxicillin for the first 5 days, followed by triple therapy that includes a proton pump inhibitor, clarithromycin, and tinidazole for another 5 days. Data on this regimen are limited. This RCT evaluated the effectiveness of sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children.

The study involved 107 children randomised to receive either sequential treatment (amoxicillin and omeprazole for 5 days followed by clarithromycin, tinidazole, and omeprazole for 5 days, n = 52) or a 7-day standard triple eradication regimen (amoxicillin and clarithromycin plus omeprazole) followed by placebo for 3 days (n= 51).

In the experimental group compared with the control group, there was a statistically (but marginal) significant difference in the H pylori eradication rate at 6 to 8 weeks after the completion of treatment (primary outcome) [45/52 (86.5%) vs. 35/51 (68.6%); relative risk, 1.26; 95% CI, 1.02 to 1.60). In addition, the groups did not differ in any of the secondary outcomes (i.e. adverse effects, need for discontinuation of H pylori therapy, compliance with therapy).

The researchers conclude from these findings that “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.” They add that this study adds to the growing body of evidence that sequential therapy may be beneficial, but they stress that it would be premature to suggest the routine use of sequential therapy for the management of children with H pylori infection. Further high-quality RCTs in other settings are needed, particularly in children for whom evidence is still limited.