Previously, we have shown in a meta-analysis that 10-day sequential therapy compared with standard triple therapy may be considered as an option for increasing the eradication rates in children with Helicobacter pylori (H. pylori) infection.
Recently, one of the randomized controlled trials (RCTs) included in our meta-analysis has been retracted by the editors of the Journal of Pediatric Gastroenterology and Nutrition ‘after finding issues related to the institutional review board approval of the project’, prompting us to re-evaluate the role of sequential therapy in children with H. pylori infection. For completeness, we re-searched databases (i.e. MEDLINE, EMBASE, and the Cochrane Library) from May 2012 (last search) to 30 January 2013 for any new trials published subsequent to our meta-analysis. The methods used are discussed in full detail in the original meta-analysis.
The updated meta-analysis included 9 RCTs involving 813 children aged 3–18 years compared with 10 RCTs (857 children aged 3–18 years). Of the 395 patients in the sequential therapy group, 303 (77%, 95%: CI 72–81) experienced eradication compared with 301 of the 418 patients (72%, 95% CI: 67–76) in the standard triple therapy group (RR 1.11, 95% CI: 1.03–1.20, number needed to treat 22; fixed-effects model) (Figure 1). Sequential therapy was superior to 7-day standard triple therapy (RR 1.17, 95% CI: 1.07–1.28), but it was not significantly better than 10-day or 14-day triple therapy (Figure 2). There were no significant differences between groups in the risk of adverse effects.
In conclusion, this update of our meta-analysis, which excludes data from 1 RCT by the investigators whose data have been questioned for ethical reasons, confirms that 10-day sequential therapy compared with standard triple therapy may be considered as an option for increasing the eradication rates of H. pylori infection in children. However, the difference between groups is of borderline statistical significance, and the eradication rate is still less than desired. Moreover, as before, the findings should be interpreted with caution due to the varied methodological quality of the included trials.