Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial - PubMed (original) (raw)
Randomized Controlled Trial
. 2008 Nov;7(11):993-1000.
doi: 10.1016/S1474-4422(08)70221-7. Epub 2008 Oct 10.
Affiliations
- PMID: 18849193
- DOI: 10.1016/S1474-4422(08)70221-7
Randomized Controlled Trial
Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial
Mats Engström et al. Lancet Neurol. 2008 Nov.
Abstract
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.
Comment in
- Treatment of Bell's palsy--the pendulum has swung back to steroids alone.
Gilden D. Gilden D. Lancet Neurol. 2008 Nov;7(11):976-7. doi: 10.1016/S1474-4422(08)70222-9. Epub 2008 Oct 10. Lancet Neurol. 2008. PMID: 18849194 No abstract available. - Prednisolone--but not antiviral drugs--improves outcome in patients with Bell's palsy.
Tyler KL. Tyler KL. Nat Clin Pract Neurol. 2009 Feb;5(2):74-5. doi: 10.1038/ncpneuro1002. Epub 2009 Jan 13. Nat Clin Pract Neurol. 2009. PMID: 19139743 - ACP Journal Club. Prednisolone, but not valacyclovir, reduced time to complete recovery of facial-nerve function in Bell palsy.
Sommer DD, Banglawala S. Sommer DD, et al. Ann Intern Med. 2009 Mar 17;150(6):JC3-12. doi: 10.7326/0003-4819-150-6-200903170-02012. Ann Intern Med. 2009. PMID: 19306494 No abstract available. - Is antiviral medication for severe Bell's palsy still useful?
de Ru JA, van Benthem PP, Janssen LM. de Ru JA, et al. Lancet Neurol. 2009 Jun;8(6):509; author reply 509-10. doi: 10.1016/S1474-4422(09)70114-0. Lancet Neurol. 2009. PMID: 19446267 No abstract available.
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