Abstract
There is controversy on the validity of binary end points used in irritable bowel syndrome (IBS) clinical trials. In a usual-care observational study, baseline severity influenced the response measured as satisfactory relief. This editorial reviews the observations from a non-pharmacological study to assess the effect of baseline severity on the performance of binary end points in large drug trials. The pivotal finding is that once the patients who reported adequate relief at baseline were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting adequate relief of IBS with treatment. As large drug trials enriched the study cohorts for at least moderate severity after a no-treatment, run-in period, it seems likely that the precaution of excluding mild disease de facto resolved the hypothetical weakness of the adequate relief end point. Given the high responsiveness and longitudinal construct validity demonstrated with adequate relief end point, it should be accepted as a trial end point.