Commentary: something new to consider in the treatment of Helicobacter pylori infection? Authors' reply

Abstract

Dr Nseir and colleagues from Israel reported the results from their randomised, double-blinded comparison of simvastatin and placebo added to a triple regimen for Helicobacter pylori infection. Current approaches to the treatment of H. pylori infection are inadequate. This is borne out by Nseir et al. in the power calculation for their trial, as their expected cure rate with a 7-day course of a PPI, clarithromycin and amoxicillin was 65%. It is therefore reasonable to question why physicians in Israel do not treat for longer, or use alternative regimens. Nonetheless, the decision to study simvastatin as an adjunct was innovative and has produced potentially important findings. It is not immediately obvious how simvastatin might improve the performance of a standard triple therapy combination. As the authors point out, simvastatin may have anti-inflammatory effects, independent of its lipid-lowering properties. Although statins may improve histological gastritis caused by H. pylori, it is unclear whether this is through some direct effect on the bacterium or on the inflammatory response that it induces. On ITT analysis, the eradication rates were 86% for triple therapy with simvastatin, and 69% for triple therapy with placebo. It appears that the 95% confidence interval for this 17% difference is 1.9–32.1% and that the NNT is approximately 6. Given the generally excellent safety record of simvastatin, this strategy seems reasonable. Furthermore, reported adverse events for both treatment arms in this trial were infrequent, minor and comparable. However, before advocating widespread implementation, larger, confirmatory trials will be needed and a greater understanding of the mechanisms that may be behind this potentially useful effect is required.