Letter: the ethics of using inferior regimens in H. pylori randomised trials – editors’ reply

Alimentary Pharmacology & Therapeutics (AP&T) has published numerous randomised clinical trials that have compared regimens to eradicate infection with H. pylori, including three recently.1-3 Despite considerable research effort, there is still no regimen that can reliably eradicate 95% of H. pylori infections in an unselected compliant population. Current H. pylori eradication trials typically include a comparator arm (or ‘legacy regimen’) that fails to eradicate the infection in at least 20% of patients who are compliant, and may leave them with a residual disadvantage due to acquired bacterial resistance. The ethics of including such a comparator arm is under scrutiny in this issue.4 We would welcome readers’ comments on this controversy. In future, AP&T will apply high priority to the publication of the results of clinical trials assessing strategies that, in open non-blinded study, can produce extremely high per-protocol H. pylori eradication rates, with safety and cost as the other measures of success. Failed attempts of such strategies can be reported as a Letter to the Editors. Helicobacter pylori eradication is an objective end-point, but non-blinded studies require external audit, which should be detailed in the Methods of any report. Paradoxically, resumption of double-blind trials might only be reasonable if comparing two highly effective regimens, but it is unlikely that sufficient patients could be recruited to detect a significant difference in such a trial. Declaration of personal and funding interests: None.