LOCF approach to handling missing data overestimates the pain score improvement of drop-outs.

摘要

The results of Shaibani et al's clinical trial comparing lacosamide to placebo in painful diabetic peripheral neuropathy (DPN) are potentially misleading as presented. The authors defined the primary endpoint as the "within-patient change in the mean daily pain score from baseline to the mean value over the last 4 weeks" of the maintenance period. In order to perform an intention-to-treat analysis incorporating all patients who took study medication, some method of incorporating patients with missing data must be used. The authors of this study used a last-observation-carried-forward (LOCF) method of handling missing data.