The course of pain in Bell's palsy: treatment with prednisolone and valacyclovir.

OBJECTIVE

To evaluate the effect of prednisolone and valacyclovir on ipsilateral pain around the ear and in the face or neck in Bell's palsy. The incidence and intensity of pain during the first 2 months of palsy and its prognostic value were also assessed.

STUDY DESIGN

Prospective, randomized, double-blind, placebo-controlled, multicenter trial.

SETTING

Sixteen tertiary referral centers in Sweden and 1 in Finland.

PATIENTS

Data are part of the Scandinavian Bell's palsy study; 829 patients aged 18 to 75 years with onset of palsy within 72 hours were included. Follow-up time was 12 months.

INTERVENTION

Patients were assigned to 1 of 4 treatment arms in a factorial fashion: placebo plus placebo; prednisolone 60 mg daily for 5 days, then tapering for 5 days, plus placebo; valacyclovir 1,000 mg 3 times daily for 7 days plus placebo; or prednisolone plus valacyclovir.

MAIN OUTCOME MEASURES

Pain was registered on a visual analog scale within 72 hours, at Days 11 to 17, 1 month, and 2 months. Facial function was assessed with the Sunnybrook and House-Brackmann systems.

RESULTS

Prednisolone and/or valacyclovir did not significantly affect the incidence or intensity of pain during the first 2 months. Pain was registered in 542 (65%) of 829 patients. At 2 months, 53 (8%) of 637 patients still reported pain. Subjects with pain at Days 11 to 17 had lower facial recovery rates at 12 months than those with no pain (p < 0.0001).

CONCLUSION

Prednisolone and/or valacyclovir did not affect the incidence or intensity of ipsilateral pain in Bell's palsy. The incidence of pain was similar during the first 2 weeks and then decreased. Presence of pain at Days 11 to 17 indicated a worse prognosis for facial recovery.