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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. (Current Controlled Trials number, ISRCTN71548196
[controlled-trials.com]
.)
Source Information
From the Scottish School of Primary Care (F.M.S.), Community Health Sciences (P.T.D., F.D.), and Dental Health Services Research Unit (J.E.C.), University of Dundee, Dundee; the Department of Otolaryngology (I.R.C.S.) and the Division of Community Based Sciences (J.M.M., S.H.), University of Glasgow, Glasgow; the Department of General Practice and Primary Care (B.H.S., A.M.) and the Health Economics Research Unit (L.D.V.), University of Aberdeen, Aberdeen; Community Health Sciences (B.M., V.H.) and the Department of Clinical Neurosciences (R.J.D.), University of Edinburgh, Edinburgh; and St. John's Hospital, National Health Service Lothian, Livingston (K.S.) — all in the United Kingdom.
Address reprint requests to Dr. Sullivan at the Scottish School of Primary Care, Mackenzie Bldg., University of Dundee, Kirsty Semple Way, Dundee DD2 4BF, United Kingdom, or at f.m.sullivan{at}chs.dundee.ac.uk.
Related Letters:
Prednisolone or Acyclovir in Bell's Palsy
Beutner D., Leiner S., Korf E. S., Killestein J., Sullivan F., Swan I., Daly F.
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N Engl J Med 2008;
358:306-307, Jan 17, 2008.
Correspondence
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