title: Effect of transtympanic low-pressure therapy in patients with unilateral Menière's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial.
abstract: OBJECTIVE
  To determine the effect of the Meniett low-pressure generator on the subjective symptoms and audiovestibular disease markers of patients with unilateral Menière's disease unresponsive to betahistine treatment.
  
  
  METHODS
  Randomised, placebo-controlled, double-blinded, clinical trial at a tertiary referral centre. After ventilation tube placement, patients were randomised to the active treatment or placebo group. Monitoring comprised audiometry and air caloric testing and a vertigo diary (enabling calculation of vertigo and activity scores, and the number of vertigo days, vertigo-free days and sick days).
  
  
  RESULTS
  Sixty-eight patients completed the study. For the active treatment versus placebo group, the following pre- and post-treatment values, and significances for treatment effect comparisons, were respectively seen: cumulative vertigo scores, 22.47 and 15.97 vs 20.42 and 19.23 (p = 0.048); vertigo days, 6.5 and 4.08 vs 5.94 and 5.52 (p = 0.102); sick days, 3.08 and 0.78 vs 2.87 and 3.45 (p = 0.041); vertigo-free days, 14.47 and 17.61 vs 15.48 and 17.58 (p = 0.362); activity score, 23.61 and 13.42 vs 24.68 and 20.23 (p = 0.078); low-tone hearing threshold, 49.15 and 53.18 dB nHL vs 41.66 and 46.10 dB nHL (p > 0.05); and slow phase velocity in response to caloric stimulation, 18.86 and 18.72 °/second vs 14.97 and 15.95 °/second, (p > 0.05).
  
  
  CONCLUSIONS
  Use of the Meniett low-pressure generator improved patients' vertigo but not their hearing or vestibular function. This safe, minimally invasive treatment is recommended as second-line treatment for unilateral Menière's disease.
authors.affiliation: Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Ludwig Maximilians University of Munich, Germany. Robert.Guerkov@med.uni-muenchen.de
authors.forename: R
authors.initials: R
authors.lastname: Gürkov
authors.forename: L B
authors.initials: LB
authors.lastname: Filipe Mingas
authors.forename: T
authors.initials: T
authors.lastname: Rader
authors.forename: J
authors.initials: J
authors.lastname: Louza
authors.forename: B
authors.initials: B
authors.lastname: Olzowy
authors.forename: E
authors.initials: E
authors.lastname: Krause
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001301:Audiometry, Pure-Tone; D001621:Betahistine / Q000627:therapeutic use; D002150:Caloric Tests; D004311:Double-Blind Method; D004424:Ear Canal; D004867:Equipment Design; D005260:Female; D017442:Histamine Agonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008499:Medical Records; D008575:Meniere Disease / Q000503:physiopathology / Q000628:therapy*; D008875:Middle Aged; D010036:Otolaryngology / Q000295:instrumentation / Q000379:methods*; D010919:Placebos; D011312:Pressure; D012665:Semicircular Canals / Q000503:physiopathology; D012720:Severity of Illness Index; D017211:Treatment Failure; D016896:Treatment Outcome; D014717:Vertigo / Q000503:physiopathology / Q000628:therapy*; D055815:Young Adult
chemical_list: D017442:Histamine Agonists; D010919:Placebos; D001621:Betahistine