Objective: To determine if the addition of an antiviral medication to systemic steroids improves recovery in the treatment of idiopathic sudden sensorineural hearing loss.
Study design: Randomized, double-blind, placebo-controlled prospective multicenter clinical trial.
Setting: The study was administrated from a tertiary care center and clinical research institute; patients were enrolled by otolaryngologists in academic and private practice outpatient settings.
Patients: Inclusion criteria included 1) loss of at least 30 dB in 3 contiguous frequencies over <3 days in patients with previous audiometry, 2) marked loss of hearing in patients with prior subjectively normal hearing and no previous audiometry, with contralateral hearing taken as baseline, and 3) patients seen within 10 days of onset of hearing loss. Pretreatment evaluation included audiometry and complete blood cell count, complete blood chemistry, and fluorescent treponemal antibody absorption test. Auditory brainstem-evoked response or magnetic resonance imaging was recommended.
Intervention: Patients received prednisone (80 mg/d for 4 d, then tapered over 8 d) with placebo or prednisone with valacyclovir (1 g, 3 times a day for 10 days).
Main outcome measure: 1) Audiometric assessment at presentation, Week 2, and Week 6; 2) Hearing Screening Inventory questionnaire twice weekly for 6 weeks; and 3) acute Short Form-12 questionnaire at presentation and Week 2.
Results: Of 105 subjects enrolled in the study, 84 subjects were evaluable. There were no significant differences between placebo and valacyclovir treatment groups in terms of hearing recovery or symptom recovery on the basis of the Hearing Screening Inventory or Short Form-12 questionnaires. No adverse events were related to the use of valacyclovir.
Conclusion: Within the paradigm used in the current study, an antiviral medication did not provide more benefit than steroid alone in the treatment of idiopathic sudden sensorineural hearing loss.