Prednisolone may reduce mild, moderate sequelae in Bell's palsy

Treatment with prednisolone may reduce mild and moderate sequelae of Bell's palsy, according to a new study.

Researchers used data from a randomized, double-blind, placebo-controlled, multicenter trial with 12-month follow-up to compare four regimens for treatment of Bell's palsy. Eight hundred twenty-nine patients 18 to 75 years of age from 17 referral centers were randomly assigned to receive placebo plus placebo (206 patients); prednisolone, 60 mg/d for five days and a tapered dosage for five additional days, plus placebo (210 patients); valacyclovir hydrochloride, 1,000 mg three times daily for seven days, plus placebo (207 patients); or prednisolone plus valacyclovir (206 patients).

Patients were assigned to treatment within 72 hours of palsy onset. The study's main outcome measure was facial function after 12 months as determined by the Sunnybrook and House-Brackmann grading systems. The Sunnybrook system scores facial function on a scale of 0 (complete paralysis) to 100 (normal function), while the House-Brackmann system grades facial function on a scale of I (normal function) to VI (complete paralysis). The synkinesis portion of the Sunnybrook score, which ranges from 1 (mildest) to 15 (most severe), was also evaluated separately.

Overall, 184 of 829 patients had a Sunnybrook score below 90 at 12 months. Of these, 71 had received prednisolone and 113 had not (P<0.001). Ninety-eight patients had a Sunnybrook score less than 70, and of these 33 had received prednisolone and 65 had not (P<0.001). Patients who had received prednisolone and those who did not also had a statistically significant difference in House-Brackmann grades higher than I (P<0.001) and higher than II (P=0.01), but Sunnybrook scores less than 50 and House-Brackmann grades above III did not differ significantly according to prednisolone therapy (P=0.10 and P=0.80, respectively). In the 743 patients whose Sunnybrook score for synkinesis was evaluated separately, 96 had a score above 2 and 60 had a score above 4. In the former group, 33 patients had received prednisolone and 63 had not (P=0.001); in the latter group, 22 patients had received prednisolone and 38 had not (P=0.005).

The authors noted that they did not distinguish between complete and incomplete palsy at baseline and that their statistical comparisons may have been affected by the relatively small number of patients in the subgroup analyses. However, they concluded that treatment with prednisolone significantly reduced mild and moderate sequelae in patients with Bell's palsy at 12 months, although it did not affect the number of patients who developed severe sequelae. In addition, they noted, sequelae severity was not affected by valacyclovir alone, and prednisolone plus valacyclovir did not decrease the number of patients who developed sequelae when compared with prednisolone alone. The study results appeared in the May Archives of Otolaryngology—Head & Neck Surgery.