Document Detail


Early treatment with prednisolone or acyclovir in Bell's palsy.
MedLine Citation:
PMID:  17942873     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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].).
Authors:
Frank M Sullivan; Iain R C Swan; Peter T Donnan; Jillian M Morrison; Blair H 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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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  357     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-18     Completed Date:  2007-10-25     Revised Date:  2008-04-07    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1598-607     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2007 Massachusetts Medical Society.
Affiliation:
Scottish School of Primary Care, University of Dundee, Dundee, United Kingdom. f.m.sullivan@chs.dundee.ac.uk
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN71548196
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MeSH Terms
Descriptor/Qualifier:
Acyclovir / adverse effects,  therapeutic use*
Adult
Antiviral Agents / adverse effects,  therapeutic use*
Bell Palsy / drug therapy*
Double-Blind Method
Drug Therapy, Combination
Facial Nerve / physiology
Factor Analysis, Statistical
Female
Glucocorticoids / adverse effects,  therapeutic use*
Humans
Male
Middle Aged
Pain / drug therapy
Prednisolone / adverse effects,  therapeutic use*
Quality of Life
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Glucocorticoids; 50-24-8/Prednisolone; 59277-89-3/Acyclovir
Comments/Corrections
Comment In:
N Engl J Med. 2007 Oct 18;357(16):1653-5   [PMID:  17942879 ]
N Engl J Med. 2008 Jan 17;358(3):306; author reply 307   [PMID:  18203331 ]
N Engl J Med. 2008 Jan 17;358(3):306-7; author reply 307   [PMID:  18203330 ]
N Engl J Med. 2008 Jan 17;358(3):306; author reply 307   [PMID:  18199872 ]
ACP J Club. 2008 Mar-Apr;148(2):29   [PMID:  18311859 ]
Evid Based Med. 2008 Apr;13(2):44   [PMID:  18375697 ]
J Fam Pract. 2008 Jan;57(1):22-5   [PMID:  18171565 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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