Sara Axelsson

Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial

BACKGROUND Previous trials of corticosteroid or antiviral treatments for Bells 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; 1000 mg 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 NCT00510263. 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, 207 valaciclovir 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<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 Bells palsy, whereas valaciclovir did not affect facial recovery.

Outcome of treatment with valacyclovir and prednisone in patients with Bell's palsy.

Idiopathic facial paralysis, or Bells palsy, shows a nonepidemic pattern that might indicate reactivation of a latent microorganism such as herpes simplex type I as a causative agent. Thirty percent of patients with Bells palsy given no treatment will not recover completely, and 5% will have severe sequelae. The aim of this study was to find out whether treatment with an antiviral drug in combination with corticosteroids is more effective than no medical treatment at all in patients with Bells palsy. Fifty-six consecutive adult patients attending the otorhinolaryngology department of the University Hospital of Lund from 1997 to 1999 were treated with 1 g of valacyclovir hydrochloride 3 times per day for 7 days and 50 mg of prednisone daily for 5 days, with the dose being reduced by 10 mg daily for the next 5 days. Fifty-six adult patients with Bells palsy attending the same department between 1995 and 1996 who were given no medical treatment were studied retrospectively and used as the control group. Forty-nine patients (87.5%) in the treatment group recovered completely, as compared with 38 patients (68%) in the control group (p <.05). One patient (1.8%) in the treatment group displayed severe sequelae, defined as a House-Brackmann score of IV or worse, as compared with 10 of 56 patients (18%) in the control group (p <.01). Among patients over 60 years old, 10 of 10 in the treatment group had complete recovery, as compared with 5 of 12 patients in the control group (p <.01). The present study showed a significantly better outcome in patients with Bells palsy treated with valacyclovir and prednisone as compared with patients given no medical treatment. This difference in outcome was especially pronounced among elderly patients.

Bell's palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.

Clin. Otolaryngol. 2012, 37, 283–290

Prednisolone in Bell's Palsy Related to Treatment Start and Age.

Objective: To evaluate if treatment start and age are related to the outcome in Bells palsy patients treated with prednisolone. Study Design: Prospective, randomized, double-blind, placebo-controlled, multicenter trial. Setting: Sixteen otorhinolaryngologic centers in Sweden and 1 in Finland. Patients Data were collected from the Scandinavian Bells palsy study. A total of 829 patients were treated within 72 hours of onset of palsy. Follow-up was 12 months. Intervention: Patients were randomly assigned to treatment with placebo plus placebo (n = 206), prednisolone plus placebo (n = 210), valacyclovir plus placebo (n = 207), or prednisolone plus valacyclovir (n = 206). Main Outcome Measures: Facial function was assessed with the Sunnybrook grading system, and complete recovery was defined as Sunnybrook = 100. Time from onset of palsy to treatment start was registered. Results: Patients treated with prednisolone within 24 hours and 25 to 48 hours had significantly higher complete recovery rates, 66% (103/156) and 76% (128/168), than patients given no prednisolone, 51% (77/152) and 58% (102/177) (p = 0.008 and p = 0.0003, respectively). For patients treated within 49 to 72 hours of palsy onset, there were no significant differences. Patients aged 40 years or older had significantly higher complete recovery rates if treated with prednisolone, whereas patients aged younger than 40 years did not differ with respect to prednisolone treatment. However, synkinesis was significantly less in patients younger than 40 years given prednisolone (p = 0.002). Conclusion: Treatment with prednisolone within 48 hours of onset of palsy resulted in significantly higher complete recovery rates and less synkinesis compared with no prednisolone.

Sunnybrook and House-Brackmann Systems in 5397 Facial Gradings

Objectives. To study the correlation between Sunnybrook and House-Brackmann facial grading systems at different time points during the course of peripheral facial palsy. Study Design. Prospective multicenter trial. Setting. Seventeen otorhinolaryngological centers. Subjects and Methods. Data are part of the Scandinavian Bell’s palsy study. The facial function of 1920 patients with peripheral facial palsy was assessed 5397 times with both Sunnybrook and House-Brackmann (H-B) facial grading systems. Grading was done at initial visit, at days 11 to 17 of palsy onset, and at 1 month, 2 months, 3 months, 6 months, and 12 months. Statistical evaluation was by Spearman correlation coefficient and box plot analysis. Results. Spearman correlation coefficient varied from −0.81 to −0.96, with the weakest correlation found at initial visit. Box plot analysis for all assessments revealed that Sunnybrook scores were widely spread over different H-B grades. With 50% of the results closest to the median, Sunnybrook composite scores varied in H-B grades as follows: H-B I, 100; H-B II, 71 to 90; H-B III, 43 to 62; H-B IV, 26 to 43; H-B V, 13 to 25; and H-B VI, 5 to 14. Conclusion. Gradings correlated better in follow-up assessments than at initial visit. As shown by the wide overlap of the grading results, subjective grading systems are only approximate. However, a conversion table for Sunnybrook and H-B gradings was obtained and is included in the article. It can be used for further development of facial grading systems.

The Course of Pain in Bell's Palsy: Treatment With Prednisolone and Valacyclovir.

Objective: To evaluate the effect of prednisolone and valacyclovir on ipsilateral pain around the ear and in the face or neck in Bells palsy. The incidence and intensity of pain during the first 2 months of palsy and its prognostic value were also assessed. Study Design: Prospective, randomized, double-blind, placebo-controlled, multicenter trial. Setting: Sixteen tertiary referral centers in Sweden and 1 in Finland. Patients: Data are part of the Scandinavian Bells palsy study; 829 patients aged 18 to 75 years with onset of palsy within 72 hours were included. Follow-up time was 12 months. Intervention: Patients were assigned to 1 of 4 treatment arms in a factorial fashion: placebo plus placebo; prednisolone 60 mg daily for 5 days, then tapering for 5 days, plus placebo; valacyclovir 1,000 mg 3 times daily for 7 days plus placebo; or prednisolone plus valacyclovir. Main Outcome Measures: Pain was registered on a visual analog scale within 72 hours, at Days 11 to 17, 1 month, and 2 months. Facial function was assessed with the Sunnybrook and House-Brackmann systems. Results: Prednisolone and/or valacyclovir did not significantly affect the incidence or intensity of pain during the first 2 months. Pain was registered in 542 (65%) of 829 patients. At 2 months, 53 (8%) of 637 patients still reported pain. Subjects with pain at Days 11 to 17 had lower facial recovery rates at 12 months than those with no pain (p < 0.0001). Conclusion: Prednisolone and/or valacyclovir did not affect the incidence or intensity of ipsilateral pain in Bells palsy. The incidence of pain was similar during the first 2 weeks and then decreased. Presence of pain at Days 11 to 17 indicated a worse prognosis for facial recovery.