The treatment of idiopathic sudden sensorineural hearing loss using pulse therapy: a prospective, randomized, double-blind clinical trial.
OBJECTIVE
The etiology and treatment of idiopathic sudden sensorineural hearing loss (ISSHL) is still unclear. The anti-inflammatory effect of corticosteroids is thought to play an important part in the recovery from ISSHL. We aimed to determine whether a more powerful anti-inflammatory technique using pulse therapy is effective in the treatment of ISSHL.


METHODS
In a randomized, prospective, double-blind, multicenter clinical trial, we recruited 81 patients with ISSHL. Patients were randomly allocated to pulse therapy (300 mg dexamethasone for 3 consecutive days followed by 4 days of placebo) or control treatment (prednisone 70 mg per day tapered in steps of 10 mg per day to 0 mg). The primary outcome was hearing recovery as measured by pure-tone audiometry and speech audiometry after 12 months. Secondary outcomes were subjective parameters such as hearing recovery, tinnitus, vertigo, and a pressure sensation in the ear.


RESULTS
The overall improvement in pure-tone thresholds and speech discrimination scores was not significantly better in patients who were given dexamethasone than those who were given standard prednisone. Hearing improved from 71 dB HL to 36 dB HL in the dexamethasone group and from 75 dB HL to 42 dB HL in the prednisone group. Speech discrimination scores of 100% were achieved by 64% of dexamethasone-treated patients and by 57% of the prednisone group.


CONCLUSIONS
Pulse therapy is equally effective and safe as standard-dose prednisone. Pulse therapy suppresses both humoral and cellular immune responses and therefore has a wider anti-inflammatory effect.
Westerlaken
Boris O
BO
Department of Otorhinolaryngology, University Medical Center Groningen, The Netherlands. b.o.westerlaken@kno.umcg.nl
de Kleine
Emile
E
van der Laan
Bernard
B
Albers
Frans
F
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001301:Audiometry, Pure-Tone; D001302:Audiometry, Speech; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D020551:Pulse Therapy, Drug / Q000379:methods; D020127:Recovery of Function; D012720:Severity of Illness Index; D013063:Speech Discrimination Tests; D013067:Speech Perception; D014012:Tinnitus / Q000175:diagnosis / Q000453:epidemiology; D014717:Vertigo / Q000175:diagnosis / Q000453:epidemiology
D000893:Anti-Inflammatory Agents; D003907:Dexamethasone; D011241:Prednisone