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Authors Lee HY , Byun JY , Park MS , Yeo SG
Journal The American journal of medicine
Year 2013
BACKGROUND: The extent of facial nerve damage is expected to be more severe in higher grades of facial palsy, and the outcome after applying different treatment methods may reveal obvious differences between severe Bell's palsy and mild to moderate palsy. This study aimed to systematically evaluate the effects of different treatment methods and related prognostic factors in severe to complete Bell's palsy. METHODS: This randomized, prospective study was performed in patients with severe to complete Bell's palsy. Patients were assigned randomly to treatment with a steroid or a combination of a steroid and an antiviral agent. We collected data about recovery and other prognostic factors. RESULTS: The steroid treatment group (S group) comprised 107 patients, and the combination treatment group (S+A group) comprised 99 patients. There were no significant intergroup differences in age, sex, accompanying disease, period from onset to treatment, or results of an electrophysiology test (P >.05). There was a significant difference in complete recovery between the 2 groups. The recovery (grades I and II) of the S group was 66.4% and that of the S+A group was 82.8% (P=.010). The S+A group showed a 2.6-times higher possibility of complete recovery than the S group, and patients with favorable electromyography showed a 2.2-times higher possibility of complete recovery. CONCLUSIONS: Combined treatment with a steroid and an antiviral agent is more effective in treating severe to complete Bell's palsy than steroid treatment alone.

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Journal Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery
Year 2012
OBJECTIVES: To evaluate the treatment effect of prednisolone and/or valaciclovir in Bell's palsy patients with different baseline severity of palsy. DESIGN: Patient data were collected from the Scandinavian Bell's Palsy Study, a prospective, randomised, double-blind, placebo-controlled, multi-centre trial. SETTING: Sixteen otorhinolaryngological centres in Sweden and one in Finland. PARTICIPANTS: Altogether, 829 patients aged 18-75 years were treated within 72 h of palsy onset. Patients were randomly assigned to treatment with prednisolone plus placebo (n = 210), valaciclovir plus placebo (n = 207), prednisolone plus valaciclovir (n = 206), placebo plus placebo (n = 206). Follow-up was 12 months. MAIN OUTCOME MEASURES: Facial function was assessed using the Sunnybrook grading scale at baseline and at 12 months. Complete recovery was defined as Sunnybrook score = 100. RESULTS: All patients, regardless of baseline severity, showed significantly higher complete recovery rates if treated with prednisolone compared with no prednisolone. In patients with severe palsy, recovery at 12 months was 51% with prednisolone treatment versus 31% without prednisolone (P = 0.02). Corresponding results were 68%versus 51% (P = 0.004) for moderate, and 83%versus 73% (P = 0.02) for mild palsy. In patient groups with moderate and mild palsy at baseline, significantly fewer prednisolone-treated patients had synkinesis at 12 months (P = 0.04 and P < 0.0001, respectively). For patients with severe palsy at baseline, prednisolone versus no prednisolone made no significant difference regarding synkinesis at 12 months. Valaciclovir did not add any significant effect to prednisolone regarding recovery rate or synkinesis at 12 months. CONCLUSION: Prednisolone treatment resulted in higher complete recovery rates, regardless of severity at baseline. Prednisolone treatment should be considered in all patients irrespective of degree of palsy.

Primary study

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Journal Archives of otolaryngology--head & neck surgery
Year 2012
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OBJECTIVE: To study whether prednisolone reduces sequelae in Bell's palsy. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter trial with 12 months of follow-up. SETTING: Seventeen referral centers. PATIENTS: In all, 829 patients aged 18 to 75 years. INTERVENTIONS: Randomization within 72 hours in a factorial fashion to placebo plus placebo (n = 206); prednisolone, 60 mg/d for 5 days, with the dosage then tapered for 5 days, plus placebo (n = 210); valacyclovir hydrochloride, 1000 mg 3 times daily for 7 days, plus placebo (n = 207); or prednisolone plus valacyclovir (n = 206). MAIN OUTCOME MEASURES: Facial function at 12 months assessed with the Sunnybrook and House-Brackmann grading systems. RESULTS: In 184 of the 829 patients, the Sunnybrook score was less than 90 at 12 months; 71 had been treated with prednisolone and 113 had not (P < .001). In 98 patients, the Sunnybrook score was less than 70; 33 had received prednisolone and 65 had not (P < .001). The difference between patients who received prednisolone and who did not in House-Brackmann gradings higher than I and higher than II was also significant (P < .001 and P = .01, respectively). No significant difference was found between patients who received prednisolone and those who did not in Sunnybrook scores less than 50 (P = .10) or House-Brackmann grades higher than III (P = .80). Synkinesis was assessed with the Sunnybrook score in 743 patients. Ninety-six patients had a synkinesis score more than 2, of whom 33 had received prednisolone and 63 had not (P = .001). Sixty patients had a synkinesis score more than 4, of whom 22 had received prednisolone and 38 had not (P = .005). CONCLUSION: Prednisolone significantly reduces mild and moderate sequelae in Bell's palsy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00510263.

Primary study

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Journal Mymensingh medical journal : MMJ
Year 2011
The antiviral drug acyclovir or its analogue, valacyclovir, has been applied in various trials on Bell's palsy with inconsistent results. We compared the therapeutic effect of famciclovir plus prednisolone with prednisolone alone, in patients with Bell's palsy. In a randomized, prospective trial, 68 patients were randomized to treatment with famciclovir and prednisolone (34 patients) or prednisolone alone (34 patients). All patients underwent supportive therapy. Severity of Bell's palsy was evaluated using the House-Brackmann scale (HBS). Follow-up was done after 1 week, 1 month and 3 months, with complete recovery defined as House-Brackmann grade I. The analysis revealed that recovery rates at month 1 and 3 were significantly higher in combination group than that of prednisolone only group (94.1% vs. 61.8% and 97.1% vs. 74.5% respectively). Again recovery from mild to moderate (HBS-II, III, IV) Bell's palsy occurred completely at month 3 and that of severe (HBS-V, VI) Bell's palsy was two-third of the patients. Again in severe Bell's palsy combination treatment increased the chance of complete recovery more than 10-fold than that of steroid only. The study results suggest that better outcome for Bell's palsy patients occurred if they were treated with prednisolone and famciclovir combination instead of prednisolone alone. In fact a considerable number of patients were benefited from additional antiviral therapy with famciclovir.

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Authors Tang IP , Lee SC , Shashinder S , Raman R
Journal The Medical journal of Malaysia
Year 2009
This is a retrospective study. The objective of this study is to review the factors influencing the outcome of treatment for the patients presented with idiopathic facial nerve paralysis. The demographic data, clinical presentation and management of 84 patients with idiopathic facial nerve paralysis (Bell's palsy) were collected from the medical record office, reviewed and analyzed from 2000 to 2005. Thirty-four (72.3%) out of 47 patients who were treated with oral prednisolone alone, fully recovered from Bell's palsy meanwhile 36 (97%) out of 37 patients who were treated with combination of oral prednisolone and acyclovir fully recovered. The difference was statistically significant. 42 (93.3%) out of 45 patients who presented within three days to our clinic, fully recovered while 28 (71.8%) out of 39 patients presented later then three days had full recovery from Bell's palsy. The difference was statistically significant. The outcome of full recovery is better with the patients treated with combined acyclovir and prednisolone compared with prednisolone alone. The patients who were treated after three days of clinical presentation, who were more than 50 years of age, who had concurrent chronic medical illness and facial nerve paralysis HB Grade IV to VI during initial presentation have reduced chance of full recovery of facial nerve paralysis.

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Journal Revista Médica del Uruguay
Year 2008
INTRODUCTION: Bell's palsy is a common condition. Incomplete recovery occurs in 15% of cases. In recent years evidence of a possible role of herpes simplex virus type 1 in its etiology has accumulated. OBJECTIVES: To compare the efficacy of valacyclovir and prednisone versus prednisone placebo in Bell's palsy. MATERIAL AND METHODS: We conducted a prospective, randomized and placebo controlled study. Of 41 patients enrolled, 21 were treated with 2 g valacyclovir qd for seven days and prednisone (PV) and 19 with prednisone plus placebo (PP) administered orally. Clinical controls were carried out at 2, 4, 8 and 12 weeks, patients with incomplete recovery were followed for six months. Recovery was defined as satisfactory with a score higher than 90 on a composite score of facial paralysis (FGS). RESULTS: There were no significant differences between groups in the score of facial paralysis. Recovery at six months was 86.4% in the PV group and 89.5% in the PP group (p = 0.86). The average recovery was 70.2 and 71.1 days, respectively (p = 0.88). CONCLUSIONS: Our results do not show an additional benefit of valacyclovir in the treatment of Bell's palsy. According to current evidence, there is no consensus regarding the routine use of antivirals in all cases of Bell's palsy

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Journal Journal of neurology
Year 2008
There is insufficient evidence concerning the efficacy of antiviral treatment of Bell's palsy (BP). We therefore compared the efficacy of prednisone and famciclovir to prednisone treatment alone in BP. A total of 167 consecutive patients with untreated acute BP were included. Severity of BP was evaluated using the House-Brackmann scale (HBS) and virus antibody tests (herpes simplex virus, varicella zoster virus) were performed. Patients admitted on even dates were treated with prednisone ("P group") and patients admitted on odd dates were treated with prednisone and famciclovir ("P+F group"). 117 patients completed the follow-up after 3 months or later (67 P/51 P+F). While most patients showed at least partial recovery with both treatment types, improvement of at least 4 grades in the HBS was more common in the "P+F group" (29.4 % vs. 11.9 %), whereas smaller changes of less than 3 grades were more common in the "P group" (29.9 % vs. 17.6 %; Chi-square test, p = 0.02). Patients with complete BP (HBS grade of 5 or 6) had significantly better chances of reaching normal function if treated with famciclovir additionally instead with prednisone alone (73.7 % vs. 47.1 %; Cochran-Armitage trend test, p = 0.03). These results suggest that the combined treatment of famciclovir and prednisolone should be considered (at least) in patients with severe BP.

Primary study

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Journal Lancet neurology
Year 2008
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; 1000mg 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 NCT00S10263. 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, 207valaciclovir 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 &lt; 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, where as valaciclovir did not affect facial recovery. Funding: Uppsala University; GlaxoSmithKline (Sweden); Pfizer AB (Sweden); Acta Otolaryngologica Foundation; Rosa and Emanuel Nachmanssons Foundation; Stig and Ragna Gorthon Foundation; Torsten Birger Segerfalk Foundation; Margit Arstrups Foundation; County Council of Skåne; Helsinki University Central Hospital Research Funds. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Primary study

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Authors Yeo SG , Lee YC , Park DC , Cha CI
Journal American journal of otolaryngology
Year 2008
PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: The benefit of acyclovir in Bell's palsy has not been definitively established.

Primary study

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Journal The Laryngoscope
Year 2007
OBJECTIVES: 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. STUDY DESIGN: Randomized, multicenter, controlled study. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.