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 ulcer disease should be the presence or absence of continuing H. pylori infection, and not ulcer healing or recurrence. This is not to suggest that ulcer healing or prevention of recurrence is not the desired clinical end-point. It is to allow large trials to be conducted in a 'patient-friendly' manner and in a shorter time-scale, both of which reduce patient withdrawals, protocol violations and cost. For the same reasons, diagnosis of cure should be made by noninvasive means whenever possible. It is currently impossible to make anything other than generalisations regarding the relative efficacies of modern eradication regiments. As it seems unlikely that definitive head-to-head studies will be performed, the conduct and reporting of current trials needs to be improved and standardised, to allow meaningful comparisons. In particular, the course of each and every patient through the trial should be fully and clearly reported, especially withdrawals and dropouts. The primary efficacy analysis should be the intention-to-treat analysis, with per protocol and modified intention-to-treat analyses also reported, where appropriate.
Royal Free Hospital School of Medicine, London, England.
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Williams
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D002986:Clinical Trials as Topic; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans