Does prednisolone improve outcomes in children with acute Bell's palsy?
In this underpowered study, prednisolone and placebo had comparable rates of recovery. Overall, most children with Bell's palsy improved without intervention.
Plan de l'etude:
Randomized controlled trial (double-blinded)
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.
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI