Efficacy of prednisolone for Bell palsy in children: a randomized, double-blind, placebo-controlled, multicenter trial

Franz E Babl*, David Herd, Meredith Borland, Amit Kochar, Ben Lawton, Jason Hort, Adam West, Shane George, Michael Zhang, Karthik Velusamy, Frank Sullivan, Ed Oakley, Andrew Davidson, Sandy M Hopper, John A Cheek, Robert Berkowitz, Stephen Hearps, Catherine L Wilson, Amanda Williams, Hannah ElboroughDonna Legg, B Pharm, Mark T Mackay, Katherine J Lee, Stuart R Dalziel, Paediatric Research in Emergency Departments International Collaborative (PREDICT)

*Corresponding author for this work

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Abstract

Background and Objective

Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell's palsy) in children, but their effectiveness is uncertain. We set out to determine if prednisolone improves the proportion of children with Bell's palsy with complete recovery at one month.


Methods

We conducted a double-blind, placebo-controlled, randomised trial of prednisolone in children presenting to emergency departments with Bell's palsy. Patients aged 6 months to less than 18 years, recruited within 72 hours after symptom onset, were randomly assigned to receive 10 days of treatment with oral prednisolone (approximately 1 mg/kg) or placebo. The primary outcome was complete recovery of facial function at 1 month rated on the House-Brackmann scale. Secondary outcomes included facial function, adverse events and pain up to 6 months. Target recruitment was n=540 (270 per group).


Results

Between 13 October 2015 to 23 August 2020, 187 children were randomised (94 to prednisolone and 93 to placebo) and included in the intention-to-treat analysis. At 1 month, the proportions of patients who had recovered facial function were 49% (n=43/87) in the prednisolone group compared with 57% (n=50/87) in the placebo group (risk difference -8.1%, 95% CI -22.8 to 6.7; adjusted odds ratio [aOR] 0.7, 95% CI 0.4 to 1.3). At 3 months these proportion were 90% (n=71/79) for the prednisolone group versus 85% (n=72/85) for the placebo group (risk difference 5.2%, 95%, CI -5.0 to 15.3; aOR 1.2, 95% CI 0.4 to 3.0) and at 6 months 99% (n=77/78) and 93% (n=76/82) respectively (risk difference 6.0%, 95% CI -0.1 to 12.2; aOR 3.0 95% CI 0.5 to 17.7) There were no serious adverse events and little evidence for group differences in secondary outcomes.


Discussion

In children with Bell's palsy the vast majority recover without treatment. The study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery.

Original languageEnglish
Article number201164
Pages (from-to)2241-2252
Number of pages12
JournalNeurology
Volume99
Issue number20
Early online date25 Aug 2022
DOIs
Publication statusPublished - 15 Nov 2022

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