Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial

Valentina Franco, M.P. Canevini, G. De Sarro, C. Fattore, G. Fedele, C. A. Galimberti, G. Gatti, A. La Neve, E. Rosati, L.M. Specchio, S. Striano, P. Tinuper, and E. Perucca, on behalf of the SOPHIE Study Group

Neurology® 2020;95:e239-e246. doi:10.1212/WNL.0000000000009880

Selezionato dal Lettore: Riccardo Meli - specializzando in Neurologia presso Università di Genova

MOTIVATION: In this study, Franco et al. want to determine  whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life (QoL) in patients with epilepsy.

This clinical problem has a long history and in the last decades different researchers tried to improve patients QoL and reduce the incidence of adverse effects related to AED. In patients with drug-resistant epilepsy, this question is even more important. A reduction on seizure rate, do not usually lead to an improve in QoL and the use of more drugs or a higher dose imply a higher risk of adverse events.

The idea of this study is quite simple, to collect clinical data of epileptic patients and give them a self-questionnaire at each visit. For the first group, data on adverse events were available to the clinician, for the other one, this was possible only at the end of the follow-up.

Results of this study are not in line with a previous one made in a single center (Gilliam et al) and shows lower improvement in the reduction of adverse events, but, even if results are not positive from a statistical point of view, it is important to better characterize an unsolved problem and a way to treat it that could be of little use. Conclusions show possible mistakes in this interpretation.