Prednisolone Reduces Mild, Moderate Bell's Palsy Sequelae

Larry Hand

May 24, 2012

May 24, 2012 — The anti-inflammatory drug prednisolone significantly reduces mild and moderate aftereffects of Bell's palsy, but does not have the same benefit for patients with more severe sequelae, according to a study published in the May issue of the Archives of Otolaryngology–Head & Neck Surgery.

Thomas Berg, MD, PhD, from the Department of Plastic and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Norway, and colleagues analyzed data from the Swedish and Finnish Scandinavian Bell's Palsy Study, a prospective, randomized, placebo-controlled, multicenter trial. Primary endpoint data from this large study were first published in 2008. The current study evaluates secondary outcomes.

Patients aged 18 to 75 years old who had onset of Bell's palsy within 72 hours were enrolled between May 1, 2001, and September 30, 2006, and with follow-up 12 months later. The patients were randomly assigned to 1 of 4 treatment groups: placebo plus placebo, prednisolone plus placebo, valacyclovir plus placebo, or prednisolone plus valacyclovir.

To lower the risk for bias, the researchers used 2 grading systems to assess facial function. The Sunnybrook system evaluates voluntary and associated movements on a scale of 0 to 100, with 100 equaling complete recovery. The House-Brackmann system grades facial function on a scale of I to VI, with I equaling complete recovery. In addition, the researchers assessed synkinesis on a scale of 1 (mildest) to 15 (most severe).

Of the 829 total patients in the study, the Sunnybrook score was less than 90 at 12 months' follow-up for 184 patients, less than 40 for 32 patients, and in-between for the remainder. For those with a score less than 90 (correlating to mild Bell’s palsy), 71, or 17.1% (95% confidence interval [CI], 13.4% - 20.7%), had been treated with prednisolone, whereas 113, or 27.4% (95% CI, 23.0% - 31.7%), had not. This difference of −10.3% (95% CI, −15.9% to −4.7%) was significant (P < .001).

For those with a score less than 70 (representing moderate Bell’s palsy), 33 (7.9%; 95% CI, 5.3% - 10.5%) had been treated with prednisolone, whereas 65 (15.7%; 95% CI, 12.2% - 19.3%) had not; this difference of −7.8% (95% CI, −12.1% to −3.4%) was also significant (P < .001). However, for those with scores lower than 40 or severe Bell’s palsy, the difference between treatment with vs treatment without prednisolone was not significant (P = .29).

The House-Brackman grade was greater than I (mild) for 239 patients, 92 (22.1%) treated with prednisolone and 147 (35.6%) not treated with prednisolone, for a difference of −13.5% (P < .001). In the 18 patients with House-Brackman scores greater than IV (corresponding with severe Bell’s palsy), 12 (2.9%) had been treated with prednisolone and 6 (1.5%) had not, resulting in a nonsignificant difference of 1.4% (P = .23).

"Treatment with prednisolone for Bell's palsy within 72 hours significantly reduced the number of patients with mild to moderate severity of palsy at 12 months when we assessed the condition of patients with the Sunnybrook scale and the House-Brackmann grading system," the researchers write. They found the same effect for patients with synkinesis.

The cause of Bell's palsy is unknown. Although about 70% of patients with this condition recover within 6 months without treatment, about 30% develop functional, psychosocial, or esthetic aftereffects. Previous research had found that treatment with prednisolone improves recovery rates, but no prior large, controlled studies had looked into whether prednisolone reduces the severity of sequelae, the researchers write.

"We found that prednisolone significantly reduced the proportion of patients who would be classified as having mild or moderate sequelae (Sunnybrook score <90 to <50) at 12 months," the researchers write. "The number of patients with more severe sequelae, however, was not reduced by treatment with this drug."

"Valacyclovir alone did not affect the severity of sequelae. The combination of prednisolone plus valacyclovir did not reduce the number of patients with sequelae compared with prednisolone alone," the authors add in their conclusion.

This study was supported by the Uppsala University and Acta Otolaryngologica Foundation. The authors have disclosed no relevant financial relationships.

Arch Otolaryngol Head Neck Surg. 2012;138:445-449. Full text