Early treatment with prednisolone or acyclovir in Bell's palsy.
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].).
Sullivan
Frank M
FM
Scottish School of Primary Care, University of Dundee, Dundee, United Kingdom. f.m.sullivan@chs.dundee.ac.uk
Swan
Iain R C
IR
Donnan
Peter T
PT
Morrison
Jillian M
JM
Smith
Blair H
BH
McKinstry
Brian
B
Davenport
Richard J
RJ
Vale
Luke D
LD
Clarkson
Janet E
JE
Hammersley
Victoria
V
Hayavi
Sima
S
McAteer
Anne
A
Stewart
Ken
K
Daly
Fergus
F
D000212:Acyclovir / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D020330:Bell Palsy / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005154:Facial Nerve / Q000502:physiology; D005163:Factor Analysis, Statistical; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
D000998:Antiviral Agents; D005938:Glucocorticoids; D011239:Prednisolone; D000212:Acyclovir