What Works for Bell's Palsy?
Abstract & Commentary
By Michael Rubin, MD, Professor of Clinical Neurology, Weill Medical College of Cornell University, NewYork-Presbyterian Hospital Dr. Rubin is on the speaker's bureau for Athena Diagnostics, and does research for Pfizer and Merck.
Synopsis: Prednisone treatment, with or without an antiviral drug, improves Bell's palsy outcome.
Source: Sullivan FM, et al. Early treatment with prednisolone or acyclovir in Bell's palsy. N Engl J Med 2007;357:1598-1607; Gilden DH, Tyler KL. Bell's palsy is glucocorticoid treatment enough? N Engl J Med 2007;357:1653-1655.
Are steroids, acyclovir, or surgical facial nerve decompression effective for Bell's palsy? According to an American Academy of Neurology Practice Parameter,1 benefit from these therapies "has not been definitively established", although evidence suggests "that steroids are probably effective, acyclovir combined with prednisone is possibly effective", and insufficient evidence was available regarding facial nerve decompression to make a recommendation. Well-designed studies were warranted. We now have the results of one such study addressing treatment with prednisolone and acyclovir.
Commissioned by the Health Technology Assessment Program of the National Institute for Health Research in Scotland to determine if prednisolone and/or acyclovir enhances recovery from Bell's palsy when used early in the course of disease, 17 Scottish centers conducted a randomized, double-blind, placebo-controlled, factorial trial. They enrolled 551 patients between June 2004 to June 2006 who had recent (72 hours) onset of Bell's palsy. Adults age 16 and older who had unilateral idiopathic facial weakness were divided into four groups and treated for 10 days with either: 1) prednisolone (50 mg qd), 2) acyclovir (2000 mg qd), 3) prednisolone and acyclovir, or 4) placebo. Exclusionary criteria included multiple sclerosis, pregnancy, uncontrolled diabetes, herpes zoster, sarcoidosis, breast-feeding, and systemic infection. Follow-up assessment occurred at three and nine months using a questionnaire and digital camera. Facial nerve function as graded by the House-Brackman system was the primary outcome measure; it was assessed by photographs in four poses: at rest, with forced smile, bared teeth, and buried eyelashes. Secondary outcome measures included health-related quality of life measured with Health Utilities Index Mark 3, facial appearance using the Derriford Appearance scale 59, and pain measured by the Brief Pain Inventory. Statistical analyses comprised the two-sided Fisher's exact test, t-tests, Mann-Whitney tests, and Wald tests, with p<0.05 considered statistically significant.
At three months, recovery rates were 83% versus 63.6%, respectively, for prednisolone versus non-prednisolone treated patients, and 71.2% versus 75.7%, respectively, for acyclovir versus non-acyclovir treated patients. At nine months, recovery rates increased to 94.4% versus 81.6% (p<0.001), respectively, for prednisolone versus non-prednisolone treated patients, and 85.4% versus 90.8% (p=0.10, non-significant), respectively, for acyclovir versus non-acyclovir treated patients. No significant additional benefit was accrued in the combined prednisolone and acyclovir treated patients, of whom 79.7% and 92.7%, respectively, improved at three and nine months. Adverse effects were not serious in any group. Treatment of Bell's palsy with prednisolone, within 72 hours of onset, significantly improves the likelihood of complete recovery at three and nine months. No benefit is accrued by using acyclovir, either alone or in combination with prednisolone.
Commentary
As noted in the accompanying editorial, unlike acyclovir, other antiviral agents may yet be beneficial when added to prednisone. Based on a multicenter, randomized, placebo-controlled trial, valacyclovir plus prednisone appeared to improve outcome compared to prednisone alone.2 Astonishingly, investigators in this study, who administered treatment and assessed outcome, were not blinded as to group assignment. In a randomized, controlled, prospective trial recently reported online, prednisone was compared to combined prednisone and famciclovir.3 Treatment was begun within one week of onset. Outcome measures, including clinical appearance, viral antibody titers, and electromyographic changes, were significantly improved in the combined therapy group compared to prednisone alone. Acyclovir is now the inglorious past for Bell's palsy, but the future remains bright for other anti-viral agents. Until further studies show otherwise, patients with Bell's palsy should receive a 10-day course of prednisone combined with valacyclovir or famciclovir.
References
1. Grogan PM, Gronseth GS. Neurology 2001;56:830-836.
2. Hato N, et al. Otol Neurotol 2007;28:408-413.
3. http://www.thieme-connect.com/ejournals/abstract/aktneu/doi/10.1055/s-2007-987564. Accessed on 11/20/07.
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