WHAT ARE APPROPRIATE END-POINTS FOR HELICOBACTER-PYLORI ERADICATION IN THE TREATMENT OF DUODENAL-ULCER

The end-point of Helicobacter pylori eradication trials in peptic ulce r disease should be the presence or absence of continuing H. pylori in fection, and not ulcer healing or recurrence. This is not to suggest t hat ulcer healing or prevention of recurrence is not the desired clini cal end-point. It is to allow large trials to be conducted in a 'patie nt-friendly' manner and in a shorter time-scale, both of which reduce patient withdrawals, protocol violations and cost. For the same reason s, diagnosis of cure should be made by noninvasive means whenever poss ible. It is currently impossible to make anything other than generalis ations regarding the relative efficacies of modern eradication regimen s. As it seems unlikely that definitive head-to-head studies will be p erformed, the conduct and reporting of current trials needs to be impr oved and standardised, to allow meaningful comparisons. In particular, the course of each and every patient through the trial should be full y and clearly reported, especially withdrawals and dropouts. The prima ry efficacy analysis should be the intention-to-treat analysis, with p er protocol and modified intention-to-treat analyses also reported, wh ere appropriate.