Acyclovir plus steroid vs steroid alone in the treatment of Bell's palsy. Bell's palsy treatment with acyclovir and prednisone compared with prednisone alone: a double-blind, randomized, controlled trial. Reactivation of herpes simplex virus type 1 and varicella-zoster virus and therapeutic effects of combination therapy with prednisolone and valacyclovir in patients with Bell's palsy. Valacyclovir and prednisolone treatment for Bell's palsy: a multicenter, randomized, placebo-controlled study. Early treatment with prednisolone or acyclovir in Bell's palsy. Corticosteroid treatment of childhood Bell's palsy.
The pathogenetic mechanism of Bell's palsy is thought to involve herpes simplex virus reactivation within the geniculate ganglion, followed by inflammation and entrapment of the nerve at the meatal foramen. We therefore compared the therapeutic effect of acyclovir plus steroid vs steroid alone, in combination with physical therapy, in patients with Bell's palsy.
                In a double-blind, randomized, prospective trial, 91 patients were randomized to treatment with acyclovir and prednisone (44 patients) or prednisone alone (47 patients). All patients underwent physical therapy. The follow-up period was greater than 6 months or encompassed the period of complete recovery from paralysis. House-Brackmann grade was evaluated 2 and 6 months after onset, with complete and satisfactory recovery defined as House-Brackmann grades I and II, respectively.
                The overall recovery rate of patients treated with steroid and acyclovir (93.1%) was greater than that of patients treated with steroid alone (85.1%), but the difference was not statistically significant.
                The benefit of acyclovir in Bell's palsy has not been definitively established. In a double-blind study, we compared the final outcome of 99 Bell's palsy patients treated with either acyclovir-prednisone (53 patients) or placebo-prednisone (46 patients). For patients receiving acyclovir, the dosage was 2,000 mg (400 mg 5 times daily) for 10 days. Electrical tests included electroneurography and the maximal stimulation test. Univariate comparisons of outcome and electrical tests between the two groups were made with chi 2 analysis, Fisher's exact test, and t-tests. The outcome in acyclovir-prednisone-treated patients was superior to that in placebo-prednisone-treated patients. Treatment with acyclovir-prednisone was statistically more effective in returning volitional muscle motion (recovery profile of 10; p = .02) and in preventing partial nerve degeneration (p = .05) than placebo-prednisone treatment. The t-tests indicated that the recovery profile and index means were significantly better for the acyclovir-treated group (recovery profile t = 1.99, p = .051; recovery index t = 2.10, p = .040). We conclude that acyclovir-prednisone is superior to prednisone alone in treating Bell's palsy patients and suggest that herpes simplex is the probable cause of Bell's palsy. To determine whether reactivation of herpes simplex virus (HSV) type 1 or varicella-zoster virus (VZV) is the main cause of Bell's palsy and whether antiviral drugs bring about recovery from Bell's palsy.
                Randomized, multicenter, controlled study.
                One hundred fifty patients with Bell's palsy were enrolled in this study. The patients were randomly assigned to a prednisolone group or a prednisolone-valacyclovir group, in whom virologic examinations for HSV-1 and VZV were performed by simple randomization scheme in sealed envelopes. The recovery rates among various groups were analyzed using the Kaplan-Meier method and the Cox proportional hazards model.
                Reactivation of HSV-1, VZV, and both viruses was detected in 15.3%, 14.7%, and 4.0% of patients, respectively. There was no significant difference in recovery rates between the prednisolone group and the prednisolone-valacyclovir group, although recovery in the patients with HSV-1 reactivation tended to be higher in the prednisolone-valacyclovir group than in the prednisolone group. There was a significant difference in recovery among age groups and between individuals with complete and incomplete paralysis.
                Reactivation of HSV-1 or VZV was observed in 34% of the patients with Bell's palsy. The effect of combination therapy with prednisolone and valacyclovir on recovery was not significantly higher than that with prednisolone alone. To investigate the effects of valacyclovir and prednisolone in comparison with those of placebo and prednisolone for the treatment of Bell's palsy, excluding zoster sine herpete.
                Prospective, multicenter, randomized placebo-controlled study.
                Six academic tertiary referral centers.
                Ultimately, 221 patients with Bell's palsy who were treated within 7 days of the onset. Serological and polymerase chain reaction examinations were performed to distinguish Bell's palsy from zoster sine herpete.
                The patients were treated with either valacyclovir (dosage, 1,000 mg/d for 5 days) plus prednisolone (VP [n = 114]) or placebo plus prednisolone (PP [n = 107]) administered orally.
                Recovery from the palsy was defined as a score higher than 36 using Yanagihara 40-point scoring system without facial contracture or synkinesis. The patients were followed up until complete recovery occurred or for more than 6 months in cases with a poor prognosis.
                The overall rate of patient recovery among those treated with VP (96.5%) was significantly better (p < 0.05) than the rate among those treated with PP (89.7%). The rate of patient recovery was also analyzed by classifying the initial severity of facial palsy. In cases of complete or severe palsy, the rates of patients treated with VP and PP who recovered were 95.7% (n = 92) and 86.6% (n = 82), respectively; the recovery rate for treatment with VP was significantly better than that with PP (p < 0.05).
                The valacyclovir and prednisolone therapy was more effective in treating Bell's palsy, excluding zoster sine herpete, than the conventional prednisolone therapy. To our knowledge, this is the first controlled study of an antiviral agent in the treatment of a sufficient number of Bell's palsy cases based on an etiologic background. Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis (i.e., Bell's palsy), but their effectiveness is uncertain.
                We conducted a double-blind, placebo-controlled, randomized, factorial trial involving patients with Bell's palsy who were recruited within 72 hours after the onset of symptoms. Patients were randomly assigned to receive 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function, as rated on the House-Brackmann scale. Secondary outcomes included quality of life, appearance, and pain.
                Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83.0% in the prednisolone group as compared with 63.6% among patients who did not receive prednisolone (P<0.001) and 71.2% in the acyclovir group as compared with 75.7% among patients who did not receive acyclovir (adjusted P=0.50). After 9 months, these proportions were 94.4% for prednisolone and 81.6% for no prednisolone (P<0.001) and 85.4% for acyclovir and 90.8% for no acyclovir (adjusted P=0.10). For patients treated with both drugs, the proportions were 79.7% at 3 months (P<0.001) and 92.7% at 9 months (P<0.001). There were no clinically significant differences between the treatment groups in secondary outcomes. There were no serious adverse events in any group.
                In patients with Bell's palsy, early treatment with prednisolone significantly improves the chances of complete recovery at 3 and 9 months. There is no evidence of a benefit of acyclovir given alone or an additional benefit of acyclovir in combination with prednisolone. (Current Controlled Trials number, ISRCTN71548196 [controlled-trials.com].).
                Copyright 2007 Massachusetts Medical Society. The therapeutic effect of corticosteroids in acute idiopathic peripheral nerve paralysis (Bell's palsy) in children is controversial. The authors evaluated the effect of steroids on the early and late outcome of children with Bell's palsy in a prospective randomized controlled setting. Forty-two patients (21 females, 21 males) with complete paralysis were enrolled in the study. Group 1 (n = 21) received methylprednisolone (1 mg/kg daily for 10 days orally); Group 2 (n = 21) did not. All patients were observed in the first 3 days of the disease and at 4, 6, and 12 months of follow-up. The mean age of Group 1 was 52.4 +/- 4.3 months, not significantly different from that of Group 2. In Group 1, 86% and 100% exhibited normal nerve function at 4 and 6 months of follow-up, respectively; in Group 2, 72% and 86% demonstrated complete recovery at 4 and 6 months, respectively, with improvement in all patients by 12 months. The improvement rates between the treated and untreated groups did not differ significantly. No side effects necessitated steroid withdrawal. The results of this study indicate that steroid therapy initiated at an early stage of childhood Bell's palsy does not significantly improve the outcome.
High quality evidence showed no significant benefit from anti-herpes simplex antivirals compared with placebo in producing complete recovery from Bell's palsy. Moderate quality evidence showed that antivirals were significantly less likely than corticosteroids to produce complete recovery.