Early treatment with prednisolone or acyclovir in Bell's palsy

Frank M. Sullivan, Iain R. C. Swan, Peter T. Donnan, Jillian M. Morrison, Blair Smith, Brian McKinstry, Richard J. Davenport, Luke D. Vale, Janet E. Clarkson, Victoria Hammersley, Sima Hayavi, Anne McAteer, Ken Stewart, Fergus Daly

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    Abstract

    Background

    Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis (i.e., Bell's palsy), but their effectiveness is uncertain.

    Methods

    We conducted a double-blind, placebo-controlled, randomized, factorial trial involving patients with Bell's palsy who were recruited within 72 hours after the onset of symptoms. Patients were randomly assigned to receive 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function, as rated on the House-Brackmann scale. Secondary outcomes included quality of life, appearance, and pain.

    Results

    Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83.0% in the prednisolone group as compared with 63.6% among patients who did not receive prednisolone (P<0.001) and 71.2% in the acyclovir group as compared with 75.7% among patients who did not receive acyclovir (adjusted P=0.50). After 9 months, these proportions were 94.4% for prednisolone and 81.6% for no prednisolone (P<0.001) and 85.4% for acyclovir and 90.8% for no acyclovir (adjusted P=0.10). For patients treated with both drugs, the proportions were 79.7% at 3 months (P<0.001) and 92.7% at 9 months (P<0.001). There were no clinically significant differences between the treatment groups in secondary outcomes. There were no serious adverse events in any group.

    Conclusions

    In patients with Bell's palsy, early treatment with prednisolone significantly improves the chances of complete recovery at 3 and 9 months. There is no evidence of a benefit of acyclovir given alone or an additional benefit of acyclovir in combination with prednisolone.

    Original languageEnglish
    Pages (from-to)1598-1607
    Number of pages10
    JournalNew England Journal of Medicine
    Volume357
    Issue number16
    DOIs
    Publication statusPublished - 18 Oct 2007

    Cite this

    Sullivan, F. M., Swan, I. R. C., Donnan, P. T., Morrison, J. M., Smith, B., McKinstry, B., Davenport, R. J., Vale, L. D., Clarkson, J. E., Hammersley, V., Hayavi, S., McAteer, A., Stewart, K., & Daly, F. (2007). Early treatment with prednisolone or acyclovir in Bell's palsy. New England Journal of Medicine, 357(16), 1598-1607. https://doi.org/10.1056/NEJMoa072006