Methodological problems in RCTson IBD

Abstract: Randomized controlled trials (RCTs) are the gold standard method for developing evidence-based medicine ininflammatory bowel disease (IBD).Methodological problems in RCTs in IBD concern different aspects such as the definition of the study population due tothe extreme variability of patients with IBD, the indices of disease activity, a clearly defined outcome, the environmentalrisk factors (i.e smoking behaviour) that may influence the randomization, the heterogeneous placebo rate of remissionand the different statistical methods used to analyze the results.It is important that trials are designed efficiently, done well and complement clinical practice with a careful subject selection,standardization of disease activity indices, and precise outcome measurement in order to continue the improvementof the IBD research process.