Neurology: A randomized, double-blind, placebo-controlled, multicenter clinical study of prednisolone in the treatment of Bell's palsy in children

Corticosteroids are used to treat the early stages of idiopathic facial nerve palsy (Bell's palsy) in children, but their effectiveness is uncertain
.
A study published in Neurology seeks to determine whether prednisolone improves the rate of
children with Bell's palsy who fully recover within a month.

A double-blind, placebo-controlled, randomized trial
was conducted.
Patients recruited within 72 hours of symptom onset from 6 months to 18 years of age were randomly assigned to receive 10 days of oral prednisolone (approximately 1 mg/kg) or placebo
.
The primary result was complete restoration
of facial function at 1 month on the House-Brackmann scale.
Secondary outcomes included facial function, adverse events, and pain up to six months
.
The target number of recruits is 540 (270 in each group).

Between 13 October 2015 and 23 August 2020, 187 children were randomised (94 prednisolone and 93 placebo) and included in the intention-to-treat analysis
.
At 1 month, the proportion of patients with facial function recovery was 49% (n = 43/87) in the prednisolone group and 57% (n = 50/87) in the placebo group (risk difference -8.
1%, 95% CI -22.
8 to 6.
7; Correction ratio [aOR] 0.
7, 95% CI 0.
4 to 1.
3).

At 3 months, 90% (n = 71/79) was in the prednisolone group and 85% (n = 72/85) in 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 99% (n = 77/78) and 93% (n = 76/82) at six months (risk difference 6.
0%, 95% CI -0.
1 to 12.
2; aOR 3.
095% CI 0.
5 to 17.
7) had no serious adverse events and no evidence of between-group differences
in secondary outcomes.

The vast majority of children with Bell's palsy recover without treatment
.
This study, although under-energized, did not provide evidence that early treatment with prednisolone improved full recovery
.

This study provides Class I evidence that for children with Bell's palsy, prednisolone does not significantly alter the restoration of full facial function within one month
.
However, the study lacked precision in
excluding important harms or benefits of prednisolone.

Source: Babl FE, Herd D, Borland M, et al.
Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial [published online ahead of print, 2022 Aug 25].
Neurology.
2022; 10.
1212/WNL.
0000000000201164.
doi:10.
1212/WNL.
0000000000201164