title: Treatment of Meniere's disease with intratympanic dexamethazone plus high dosage of betahistine.
abstract: OBJECTIVE
  The aim of the present study was to assess if the combined therapy of intratympanic dexamethasone (ITD) and high dosage of betahistine (HDBH) is able to provide increased vertigo control compared to ITD alone in patients suffering from definite unilateral Meniere's disease (MD).
  
  
  METHODS
  Consecutive MD patients were enrolled and randomly divided in two groups, each comprising 33 cases. Group A received a combination of ITD and identical-appearing placebo pills while Group B received a combination of ITD and HDBH. ITD protocol consisted of three consecutive daily injections. HDBH comprised 144mg/day (48mg tid). The main outcome measures were: 1) vertigo class, pure tone average (PTA), speech discrimination score (SDS) and Functional Level Score (FLS) according to the American Academy of Otolaryngology-Head and Neck Surgery criteria; 2) complete and substantial vertigo control according to the Kaplan-Meier survival method.
  
  
  RESULTS
  Sixty two patients completed the 24-month follow-up. A complete vertigo control was achieved in 14 patients (44%) from Group A and in 22 patients (73.3%) from Group B, statistically significant (p=0.01). Complete vertigo relief is also significant according to the Kaplan-Meier method: p=0.027, log rank test. Substantial vertigo control was obtained in 21 patients (65.6%) in Group A and 27 patients (90%) in Group B. The difference is statistically significant, p=0.02. The difference is significant according to the Kaplan-Meier method: p=0.035, log rank test. No significant differences between hearing levels and tinnitus scores were demonstrated between the groups.
  
  
  CONCLUSIONS
  Our preliminary results demonstrate that complete and substantial vertigo control is significantly higher in patients treated with a combination of HDBH and ITD.
authors.affiliation: II-nd Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca Cluj-Napoca, Romania; RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania. Electronic address: silviualbu63@gmail.com.
authors.forename: Silviu
authors.initials: S
authors.lastname: Albu
authors.affiliation: RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania.
authors.forename: Alina
authors.initials: A
authors.lastname: Nagy
authors.affiliation: Department of Otolaryngology, Victor Babes University of Medicine and Pharmacy Timisoara, Timisoara, Romania.
authors.forename: Caius
authors.initials: C
authors.lastname: Doros
authors.affiliation: Transilvania University Brasov, Brasov, Romania.
authors.forename: Luigi
authors.initials: L
authors.lastname: Marceanu
authors.affiliation: Department of Otolaryngology, Grigore T. Popa University of Medicine and Pharmacy Iasi, Iasi, Romania.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Cozma
authors.affiliation: Department of Otolaryngology, Sf. Maria Hospital Bucuresti, Romania.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Musat
authors.affiliation: Otology and Skull Base Surgery Unit, Siena University Hospital, Siena, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Trabalzini
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001621:Betahistine / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D017442:Histamine Agonists / Q000627:therapeutic use*; D006801:Humans; D000069555:Injection, Intratympanic; D008297:Male; D008575:Meniere Disease / Q000150:complications / Q000178:diet therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D014717:Vertigo / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000893:Anti-Inflammatory Agents; D017442:Histamine Agonists; D003907:Dexamethasone; D001621:Betahistine