The effect of prednisolone on sequelae in Bell's palsy.
OBJECTIVE
To study whether prednisolone reduces sequelae in Bell's palsy.


METHODS
Prospective, randomized, double-blind, placebo-controlled, multicenter trial with 12 months of follow-up.


METHODS
Seventeen referral centers.


METHODS
In all, 829 patients aged 18 to 75 years.


METHODS
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).


METHODS
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).


CONCLUSIONS
Prednisolone significantly reduces mild and moderate sequelae in Bell's palsy.


BACKGROUND
clinicaltrials.gov Identifier: NCT00510263.
Department of Plastic and Reconstructive Surgery and the Institute for Surgical Research, Oslo University Hospital Rikshospitalet, Oslo, Norway. thomas.berg@lycos.com
Thomas
T
Berg
Nina
N
Bylund
Elin
E
Marsk
Lars
L
Jonsson
Mervi
M
Kanerva
Malou
M
Hultcrantz
Mats
M
Engström
D000212:Acyclovir / Q000031:analogs & derivatives / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D020330:Bell Palsy / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005387:Finland; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011239:Prednisolone / Q000627:therapeutic use*; D011446:Prospective Studies; D013548:Sweden; D016896:Treatment Outcome; D000077483:Valacyclovir; D014633:Valine / Q000031:analogs & derivatives / Q000627:therapeutic use
D000998:Antiviral Agents; D005938:Glucocorticoids; D010919:Placebos; D011239:Prednisolone; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir