title: Intratympanic steroid therapy in moderate sudden hearing loss: a randomized, triple-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To investigate the efficacy of an intratympanic steroid as a first-line therapy in patients affected by moderate idiopathic sudden sensorineural hearing loss (ISSNHL).
  
  
  METHODS
  Prospective, randomized, triple-blind, placebo-controlled trial.
  
  
  METHODS
  Fifty patients presenting with moderate idiopathic sudden sensorineural hearing loss involving all frequencies from 250 Hz to 8,000 Hz (a flat audiogram) were enrolled. Patients were randomized into two groups of 25 each. The first group (intratympanic steroid) underwent a daily intratympanic administration of prednisolone for 3 consecutive days. Subjects in the second group (control) received a daily intratympanic injection of a saline solution for 3 consecutive days. Audiometric tests were performed at day 7 after the beginning of therapy (T1), and then 10 and 30 days after T1. The patients in both groups who did not show a complete recovery at T1 were treated with oral prednisone at a tapering dose.
  
  
  RESULTS
  In the intratympanic steroid group, 19 out of 25 patients presented at T1 complete recovery (76%), whereas in the control group the number patients who recovered completely at T1 was five out of 25 (20%). The mean pure-tone average (PTA) recorded at T1 shows a statistically significant improvement in the hearing threshold of the first group compared to the control group (P < .01).
  
  
  CONCLUSIONS
  The mean PTA recorded after the first-line approach (T1) demonstrated a significant therapeutic action of the short-duration intratympanic steroid therapy on moderate ISSNHL, with a flat audiogram shape, compared to the natural course of the disease and the placebo effect at that time point.
authors: Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
authors: Roberto
authors: R
authors: Filipo
authors: Giuseppe
authors: G
authors: Attanasio
authors: Francesca Y
authors: FY
authors: Russo
authors: Marika
authors: M
authors: Viccaro
authors: Patrizia
authors: P
authors: Mancini
authors: Edoardo
authors: E
authors: Covelli
mesh_terms: D000328:Adult; D001301:Audiometry, Pure-Tone; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy*; D003639:Hearing Loss, Sudden / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone