An unused multicenter paper compared treatments in children who were not eligible for the randomized RESCUE ESES trial.
The retrospective study included 72 children with developmental or epileptic encephalopathy with spike-wave activation in sleep. Twenty-four initially received corticosteroids and 48 clobazam. At six months, investigators judged daily functioning improved in 84% of the corticosteroid group and 51% of the clobazam group. The reported relative risk was 1.6, with a 95% confidence interval of 1.2–1.8.
The sleep EEG spike-wave index also improved more in the corticosteroid group. Daily functioning, EEG change, and formal cognitive test performance are different outcomes and should remain distinct.
Treatment allocation was observational, even though the analysis used an intention-to-treat framework based on initial treatment. That analytic choice does not create randomization. The primary functional judgment came from review of clinical records and could be affected by observer bias. Few children had suitable formal neuropsychological data.
The paper supports a comparative signal favoring corticosteroids in this selected population, while leaving potential treatment-selection differences. It does not establish that clobazam is ineffective for every child or that one child’s cognitive change was caused by a treatment. A case review should preserve baseline function, actual exposure, EEG timing, and the method used to judge improvement.
Original analysis of the supplied journal article, identified as PMC12927671.