Reader Response: Efficacy of Prednisolone for Bell Palsy in Children A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
Gerd FabianVolk, ENT surgeon and Head of the Facial-Nerv-Center Jena, Facial-Nerve-Center, Department of Otorhinolaryngology, Head and Neck Surgery, Center of Rare Diseases, Jena University Hospital
Michelle H.Cameron, Professor of Neurology, neurologist and physical therapist, Department of Neurology, Oregon Health & Science University, MS Center of Excellence-West, VA Portland Health Care System, Port
MyriamLoyo, Associate Professor, Co-director Facial Nerve Center, Facial Nerve Center, Department of Otolaryngology- Head and Neck Surgery, Oregon Health & Science University, Oregon, USA
Submitted December 24, 2022
While Babl et al.2 concluded that there is “no more than a marginal likelihood that prednisolone is beneficial” for Bell palsy in children, we are hesitant to recommend against corticosteroids in this circumstance. Pivotal trials have shown that corticosteroids improve outcomes in adults with Bell palsy leading to wide recommendation and adoption in both adults and children.2,3
There is risk of a type II error in Babl et al.’s study as they substantially under-recruited (187 instead of 540) and the House Brackman scale used to evaluate the primary outcome is limited by low precision and sensitivity.4 Not treating children with corticosteroids could not only limit recovery from weakness and but also leave some with lifelong synkinesis. The follow-up in the current trial does not allow for full evaluation of the risk of synkinesis because it develops months after recovery from flaccid paralysis and increases between 6 and 12 months after onset.5 Babl et al. did not require participants thought to have recovered from flaccid paralysis to attend subsequent outcome assessment visits.
In our opinion, while there are risks associated with corticosteroids, a short course of corticosteroids is reasonable to reduce the risk of lifelong facial movement difficulties.
References
1. Babl FE, Herd D, Borland, et al. Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Neurology. 2022;99(20):e2241-52. doi: 10.1212/WNL.00000000002011642
2. Sullivan F, Swan I, Donna P, et al. Early treatment with prednisolone or acyclovir in Bell’s palsy. N Eng J Med. 2007;357(16):1598-1607.
3 Engstr¨om M, Berg T, Stjernquist-Desatnik A, et al. Prednisolone and valaciclovir in Bell’s palsy: a randomised, double-blind, placebo-controlled, multicenter trial. Lancet Neurol. 2008;7(11):993-1000.
4 Fattah AY, Gurusinghe ADR, Gavilan J, Hadlock TA, et al. Sir Charles Bell Society. Facial nerve grading instruments: systematic review of the literature and suggestion for uniformity. Plastic and Reconstructive Surgery. 2015;135(2):569-79.
5 Bylund N, Jensson D, Enghag S, et al. Synkinesis in Bell's palsy in a randomised controlled trial. Clin Otolaryngol. 2017;42(3):673-80. doi: 10.1111/coa.12799.
Author disclosures are available upon request (journal@neurology.org)
While Babl et al.2 concluded that there is “no more than a marginal likelihood that prednisolone is beneficial” for Bell palsy in children, we are hesitant to recommend against corticosteroids in this circumstance. Pivotal trials have shown that corticosteroids improve outcomes in adults with Bell palsy leading to wide recommendation and adoption in both adults and children.2,3
There is risk of a type II error in Babl et al.’s study as they substantially under-recruited (187 instead of 540) and the House Brackman scale used to evaluate the primary outcome is limited by low precision and sensitivity.4 Not treating children with corticosteroids could not only limit recovery from weakness and but also leave some with lifelong synkinesis. The follow-up in the current trial does not allow for full evaluation of the risk of synkinesis because it develops months after recovery from flaccid paralysis and increases between 6 and 12 months after onset.5 Babl et al. did not require participants thought to have recovered from flaccid paralysis to attend subsequent outcome assessment visits.
In our opinion, while there are risks associated with corticosteroids, a short course of corticosteroids is reasonable to reduce the risk of lifelong facial movement difficulties.
References
1. Babl FE, Herd D, Borland, et al. Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Neurology. 2022;99(20):e2241-52. doi: 10.1212/WNL.00000000002011642
2. Sullivan F, Swan I, Donna P, et al. Early treatment with prednisolone or acyclovir in Bell’s palsy. N Eng J Med. 2007;357(16):1598-1607.
3 Engstr¨om M, Berg T, Stjernquist-Desatnik A, et al. Prednisolone and valaciclovir in Bell’s palsy: a randomised, double-blind, placebo-controlled, multicenter trial. Lancet Neurol. 2008;7(11):993-1000.
4 Fattah AY, Gurusinghe ADR, Gavilan J, Hadlock TA, et al. Sir Charles Bell Society. Facial nerve grading instruments: systematic review of the literature and suggestion for uniformity. Plastic and Reconstructive Surgery. 2015;135(2):569-79.
5 Bylund N, Jensson D, Enghag S, et al. Synkinesis in Bell's palsy in a randomised controlled trial. Clin Otolaryngol. 2017;42(3):673-80. doi: 10.1111/coa.12799.
Author disclosures are available upon request (journal@neurology.org)