Outcomes for prednisolone = placebo in children with acute Bell's palsy (PREDICT)

Reference

Babl FE, Herd D, Borland M, et al, for the Paediatric Research in Emergency Departments International Collaborative (PREDICT). Efficacy of prednisolone for Bell palsy in children: a randomized, double-blind, placebo-controlled, multicenter trial. Neurology 2022;99(20):e2241-e2252.

Synopsis

In this multicenter trial, researchers randomized children (aged 6 months to 18 years) who presented to the emergency department with Bell's palsy to receive 10 days of prednisolone (1 mg/kg/d to a maximum of 50 mg; n = 94) or a similar tasting placebo (n = 93). Recovery was defined by a score of 1 point on the 6-point House-Brackmann scale. The authors found no difference in the rate of recovery of facial function at 1 month (49% vs 57%), at 3 months (90% vs 95%), and at 6 months (99% vs 93%). The study needed 270 children in each group to detect an absolute 12% difference in recovery, but the authors ran out of funding before they could reach this target. To illustrate the lack of power, the numbers needed to treat at each follow-up interval would have been 13, 20, and 17, all of which indicate modest effectiveness. Side effects were slightly more common in the children treated with prednisolone (33.0% vs 22.6%), although the authors don’t report discontinuation rates.