| Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. | |
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MedLine Citation:
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PMID: 18849193 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Previous trials of corticosteroid or antiviral treatments for Bell's palsy have been underpowered or have had insufficient follow-up. The aim of this study was to compare the short-term and long-term effects of prednisolone and valaciclovir in the recovery of the affected facial nerve in a large number of patients. METHODS: In this randomised, double-blind, placebo-controlled, multicentre trial, patients aged 18 to 75 years who sought care directly or were referred from emergency departments or general practitioners within 72 h of onset of acute, unilateral, peripheral facial palsy, between May, 2001, and September, 2006, were assessed. Patients were randomly assigned in permuted blocks of eight to receive placebo plus placebo; 60 mg prednisolone per day for 5 days then reduced by 10 mg per day (for a total treatment time of 10 days) plus placebo; 1000 mg valaciclovir three times per day for 7 days plus placebo; or prednisolone (10 days) plus valaciclovir (7 days). Follow-up was for 12 months. The primary outcome event was time to complete recovery of facial function, as assessed with a regional Sunnybrook scale score of 100 points. Analysis was by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00510263. FINDINGS: Of 839 patients who were randomly assigned, 829 were included in the modified intention-to-treat analysis: 206 received placebo plus placebo, 210 prednisolone plus placebo, 207 valaciclovir plus placebo, and 206 prednisolone plus valaciclovir. Time to recovery was significantly shorter in the 416 patients who received prednisolone compared with the 413 patients who did not (hazard ratio 1.40, 95% CI 1.18 to 1.64; p<0.0001). There was no difference in time to recovery between the 413 patients treated with valaciclovir and the 416 patients who did not receive valaciclovir (1.01, 0.85 to 1.19; p=0.90). The number of patients with adverse events was similar in all treatment arms. INTERPRETATION: Prednisolone shortened the time to complete recovery in patients with Bell's palsy, whereas valaciclovir did not affect facial recovery. |
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Authors:
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Mats Engström; Thomas Berg; Anna Stjernquist-Desatnik; Sara Axelsson; Anne Pitkäranta; Malou Hultcrantz; Mervi Kanerva; Per Hanner; Lars Jonsson |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-10-10 |
Journal Detail:
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Title: Lancet neurology Volume: 7 ISSN: 1474-4422 ISO Abbreviation: Lancet Neurol Publication Date: 2008 Nov |
Date Detail:
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Created Date: 2008-10-22 Completed Date: 2008-12-01 Revised Date: 2009-06-04 |
Medline Journal Info:
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Nlm Unique ID: 101139309 Medline TA: Lancet Neurol Country: England |
Other Details:
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Languages: eng Pagination: 993-1000 Citation Subset: IM |
Affiliation:
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Department of Otorhinolaryngology and Head and Neck Surgery, Uppsala University Hospital, Uppsala, Sweden. mats.engstrom@akademiska.se |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00510263 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acyclovir
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administration & dosage,
adverse effects,
analogs & derivatives* Adolescent Adult Aged Anti-Inflammatory Agents / administration & dosage, adverse effects Antiviral Agents / administration & dosage, adverse effects Bell Palsy / drug therapy*, physiopathology Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Female Herpes Simplex / complications Humans Male Middle Aged Placebos Prednisolone / administration & dosage*, adverse effects Recovery of Function / drug effects, physiology Time Factors Treatment Outcome Valine / administration & dosage, adverse effects, analogs & derivatives* Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents; 0/Antiviral Agents; 0/Placebos; 124832-27-5/valacyclovir; 50-24-8/Prednisolone; 59277-89-3/Acyclovir; 7004-03-7/Valine |
| Comments/Corrections | |
Comment In:
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Lancet Neurol. 2008 Nov;7(11):976-7
[PMID:
18849194
]
Nat Clin Pract Neurol. 2009 Feb;5(2):74-5 [PMID: 19139743 ] Ann Intern Med. 2009 Mar 17;150(6):JC3-12 [PMID: 19306494 ] Lancet Neurol. 2009 Jun;8(6):509; author reply 509-10 [PMID: 19446267 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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