Corticosteroids Judged Superior for Bell's Palsy

October 17, 2007

DUNDEE, Scotland -- Early treatment of Bell's palsy with prednisolone significantly increases the chance of a full recovery by three to nine months from facial paralysis, investigators here reported.

DUNDEE, Scotland, Oct. 17 -- Early treatment of Bell's palsy with prednisolone significantly increases the chance of a full recovery by three to nine months from facial paralysis, investigators here reported.

But another treatment touted for Bell's palsy, acyclovir (Zovirax) was no better than placebo either as monotherapy or in combination with prednisolone, according to Frank M. Sullivan, Ph.D., of the Scottish School of Primary Care, and colleagues.

Although most patients with Bell's palsy will eventually recover without treatment, "our study showed that the administration of prednisolone can increase the probability of complete recovery at nine months, a finding that should help inform discussions about the use of corticosteroids," they wrote in the Oct. 18 issue of the New England Journal of Medicine.

Corticosteroids such as prednisolone or oral prednisone and the antiviral acyclovir are widely used for treatment of idiopathic facial palsies, but it's uncertain whether these therapies are effective, they said.

Prednisolone addresses the presumed vascular and inflammatory etiology of Bell's palsy, while acyclovir is designed to treat herpes infections that have been implicated as viral triggers of the disorder.

Their study, however, showed that "treatment with unesterified acyclovir at doses used in other trials either alone or with corticosteroids had no effect on the outcome," Dr. Sullivan and colleagues wrote. "Therefore, we cannot recommend acyclovir for use in the treatment of Bell's palsy,"

But a different antiviral agent, valacyclovir (Valtrex) might still offer benefit in early treatment of patients with severe or complete facial palsy, suggested Donald H. Gilden, M.D., and Kenneth L. Tyler, M.D., of the University of Colorado in Denver, in an accompanying editorial.

They noted that a prospective study by Nahito Hato, M.D., of Ehimi University in Ehime, Japan, and colleagues, published in the April 2007 issue of Otology & Neurotology, showed a benefit for a valacyclovir added to prednisolone over prednisolone monotherapy in patients with Bell's palsy.

In that study "a complete recovery was seen in 96.5% of 114 patients who received valacyclovir and prednisolone, as compared with 89.7% of 107 patients who received placebo and prednisolone (an absolute risk reduction of 6.8%)," Dr. Gilden and Dr. Tyler noted. "More striking was the report of the full recovery of 90.1% of patients with complete facial palsy who were treated with valacyclovir and prednisolone, as compared with 75.0% of those treated with placebo and prednisolone."

That study, however, also suffered from methodological flaws, noted both the editorialists and Dr. Sullivan, and a larger trial will be needed before a definitive answer about a possible therapeutic benefit of acyclovir in Bell's palsy can be found, they said.

Dr. Sullivan and colleagues conducted a double-blind, placebo-controlled, randomized, factorial trial pitting prednisolone against acyclovir and placebo, and a combination of the agents against placebo.

They recruited patients within 72 hours of the onset of symptoms, and randomly assigned them to into one of four groups, each of whom received 10 days of treatment with two preparations--prednisolone at 25 mg twice plus lactose placebo, acyclovir at 400 mg five times daily plus placebo, prednisolone plus acyclovir, or two placebo capsule.

The primary outcome was recovery of facial function, measured by the House-Brackmann scale. Patient quality of life, appearance, and pain were secondary outcomes.

Of the 551 patients who were randomized, 496 were available for final outcome assessments.

They found that at three months, 83.0% of patients in the prednisolone group recovered facial function, compared with 63.6% among patients who did not receive it (P

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