Treatment of sudden sensorineural hearing loss with systemic steroids and valacyclovir.
OBJECTIVE
To determine if the addition of an antiviral medication to systemic steroids improves recovery in the treatment of idiopathic sudden sensorineural hearing loss.


METHODS
Randomized, double-blind, placebo-controlled prospective multicenter clinical trial.


METHODS
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.


METHODS
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.


METHODS
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).


METHODS
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.


CONCLUSIONS
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.
Tucci
Debara L
DL
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA. tucci001@duke.edu
Farmer
Joseph C
JC
Kitch
Russell D
RD
Witsell
David L
DL
D000212:Acyclovir / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006309:Hearing; D003639:Hearing Loss, Sudden / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D017211:Treatment Failure; D000077483:Valacyclovir; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D000998:Antiviral Agents; D005938:Glucocorticoids; D014633:Valine; D000077483:Valacyclovir; D011241:Prednisone; D000212:Acyclovir