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 prednisoloneand 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.
RCT Entities:
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.
Authors: Deniz Demir; Sena Genç; Mehmet Güven; Mahmut Sinan Yılmaz; Ahmet Kara; Ünal Erkorkmaz Journal: J Int Adv Otol Date: 2020-04 Impact factor: 1.017