Objective: To investigate adjuvant effect and safety of intratympanic steroid for the treatment of Bell's palsy.
Study design: Prospective, investigator blinded, randomized study.
Setting: Tertiary referral center.
Patients: Patients who received treatment for Bell's palsy from December 2007 to March 2011 were randomly divided into two groups. The control group (n = 17) was treated with systemic steroid plus antiviral agent, and intratympanic steroid injection group (IT group, n = 14) received intratympanic steroid injection combined with medications. Facial functions were evaluated on a regular basis up to 6 months.
Intervention: Intratympanic steroid injection.
Main outcome measures: Facial nerve functions of initial presentation and follow-up were evaluated with House-Brackmann (H-B) system. Primary outcome was complete recovery rate of 6 months. Secondary outcomes included improvement of H-B grade within 3 weeks, time of first improvement in facial function, and cumulative recovery rate. In addition, subgroup analysis of H-B grade over than IV was performed.
Results: Complete recovery rate was not different between groups. Time of first improvement was shorter in IT group (p = 0.043). And IT group had a better cumulative recovery rate (p = 0.041) and showed the significant improvement in H-B grade within 3 weeks compared with control group (p = 0.045). In severe facial palsy, complete recovery rate of IT group and control group were 80% and 50% (p = 0.16), and IT groups showed the significant facial improvement within 3 weeks (p = 0.025). And there were no major adverse effects of intratympanic injection.
Conclusion: Intratympanic steroid injection might be a safe and useful adjuvant treatment modality for Bell's palsy.