title: Intratympanic dexamethasone versus high dosage of betahistine in the treatment of intractable unilateral Meniere disease.
abstract: OBJECTIVE
  The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD).
  
  
  METHODS
  Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory.
  
  
  RESULTS
  Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients.
  
  
  CONCLUSIONS
  Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation.
authors.affiliation: Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania; Ro-Neuro Clinic Cluj-Napoca, Romania. Electronic address: silviualbu63@gmail.com.
authors.forename: Silviu
authors.initials: S
authors.lastname: Albu
authors.affiliation: Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania.
authors.forename: Felician
authors.initials: F
authors.lastname: Chirtes
authors.affiliation: Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania.
authors.forename: Veronica
authors.initials: V
authors.lastname: Trombitas
authors.affiliation: Ro-Neuro Clinic Cluj-Napoca, Romania.
authors.forename: Alina
authors.initials: A
authors.lastname: Nagy
authors.affiliation: University of Medicine and Pharmacy Brasov, Romania.
authors.forename: Luigi
authors.initials: L
authors.lastname: Marceanu
authors.affiliation: Operative Unit of Otolaryngology and Otosurgery, Padua University, Padua, Italy.
authors.forename: Gregorio
authors.initials: G
authors.lastname: Babighian
authors.affiliation: Operative Unit of Otolaryngology and Otosurgery, Padua University, Padua, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Trabalzini
mesh_terms: D000328:Adult; D000368:Aged; D001621:Betahistine / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D007558:Italy; D008297:Male; D008575:Meniere Disease / Q000175:diagnosis* / Q000188:drug therapy*; D008875:Middle Aged; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000187:drug effects*
chemical_list: D003907:Dexamethasone; D001621:Betahistine