Objective: To compare the effect of Prednisolone and placebo on recovery of unilateral Idiopathic Sudden Sensorineural Hearing Loss.
Study design: Prospective, randomized, triple-blind placebo-controlled multicentre trial.
Setting: Four tertiary and ten secondary referral centers.
Patients: Of 103 patients randomly assigned, 93 included in the modified intention-to treat analysis. The patients were aged 18–80 years seeking care between Jan 2006–Sept 2010 within one week after onset of acute unilateral sensorineural hearing loss with a PTA of ≥30dB in the three contiguous frequencies most affected.
Intervention: Patients were randomly assigned in permuted blocks of ten to receive Prednisolone or placebo in tapering doses from 60 mg for 3 days, and thereafter 50, 40, 30, 20, 10 mg each day until day 8. If complete recovery, no more medication given, otherwise medication continued at 10 mg per day until day 30. Final follow-up was after 3 months with audiogram. 47 patients received Prednisolone and 46 placebo.
Main outcome measure: Primary endpoint was efficacy of treatment on recovery at day 8 and day 90. Analysis was by modified Intention-To Treat and Per Protocol. The secondary endpoints were prognostic factors for hearing recovery.
Results: The hearing improvement for 47 patients treated with Prednisolone was 25.5 ± 27.1 dB compared to 46 patients treated with placebo 26.4 ± 26.2 dB at day eight and 39 ± 20.1 dB vs. 35.1 ± 38.3 dB after three months. (ns). Presence of vertigo had significant negative effect on hearing improvement in both groups. Inflammatory signs in laboratory work-up had a positive prognostic effect, irrespective of treatment.
Conclusion: Prednisolone in customary dosage does not seem to influence recovery of idiopathic sudden sensorineural hearing loss.
¨Idiopathic Sudden Sensorineural Hearing Loss, Sudden Deafness, Prednisolone, Randomized, Triple-blind trial