Doron D. Sommer, MD, FRCSC; Sarfaraz Banglawala, MD
Does prednisolone or valacyclovir improve recovery of facial-nerve function in patients with Bell palsy?
Factorial, randomized, placebo-controlled trial (RCT).
Blinded (patients, study personnel, and data analysts).*
16 otorhinolaryngologic centers in Sweden and 1 in Finland.
839 patients 18 to 75 years of age who were referred from primary or emergency care settings or who sought care directly within 72 hours of onset of acute, unilateral, peripheral facial palsy. Exclusion criteria included use of systemic antiviral medications in the past 2 weeks or steroid medication, or current or past conditions that could be affected by the study medication or could affect study completion (e.g., breastfeeding; potential for pregnancy; neurologic, serious heart, renal, hepatic, or psychiatric disease; diabetes; uncontrolled hypertension; gastric or duodenal ulcer; otitis; recent head injury; glaucoma; tuberculosis; and immunodeficiency).
Prednisolone, 60 mg/d for 5 days, then reduced by 10 mg/d for 5 days, plus placebo (n = 213); valacyclovir, 1 g 3 times/d for 7 days, plus placebo (n = 207); prednisolone plus valacyclovir (n = 210); or both placebos (n = 209).
Included time to complete recovery of facial function (100 on Sunnybrook scale) and facial function at 12 months.
89% (99% [median age 40 y, 59% men] in modified intention-to-treat analysis).
Complete facial recovery rates at 12 months are shown in the Table. Time to complete recovery was shorter in the prednisolone than in the no-prednisolone groups (hazard ratio [HR] 1.4, 95% CI 1.2 to 1.6); the valacyclovir and no-valacyclovir groups did not differ (HR 1.01, CI 0.9 to 1.2).
Prednisolone, but not valacyclovir, reduced time to complete recovery of facial-nerve function in patients with Bell palsy.
Prednisolone or valacyclovir for Bell palsy‡
‡Abbreviations defined in Glossary. RBI, NNT, and CI calculated from data in article.
§Complete recovery = 100 on the Sunnybrook scale assessing facial function.
Doron D. Sommer, Sarfaraz Banglawala. Prednisolone, but not valacyclovir, reduced time to complete recovery of facial-nerve function in Bell palsy. Ann Intern Med. 2009;150:JC3–12. doi: 10.7326/0003-4819-150-6-200903170-02012
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Published: Ann Intern Med. 2009;150(6):JC3-12.
Infectious Disease, Neurology.
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