OBJECTIVE: To evaluate if treatment start and age are related to the outcome in Bell's palsy patients treated withprednisolone. 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 Bell's 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.
RCT Entities:
OBJECTIVE: To evaluate if treatment start and age are related to the outcome in Bell's palsypatients 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 Bell's 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.
Authors: John R de Almeida; Gordon H Guyatt; Sachin Sud; Joanne Dorion; Michael D Hill; Michael R Kolber; Jane Lea; Sylvia Loong Reg; Balvinder K Somogyi; Brian D Westerberg; Chris White; Joseph M Chen Journal: CMAJ Date: 2014-06-16 Impact factor: 8.262