Res Vestib Sci.  2016 Jun;15(2):44-50. 10.0000/rvs.2016.15.2.44.

Multicenter Randomized Study on the Efficacy of Isosorbide in Patients with Mèniére's Disease

Affiliations
  • 1Department of Otorhinolaryngology, Sungkyunkwan University, Samsung Seoul Hospital, Seoul, Korea. whchung@skku.edu
  • 2Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.
  • 3Department of Otorhinolaryngology, Inha University Hospital, Incheon, Korea.
  • 4Department of Otolaryngology, Asan Medical center, Seoul, Korea.
  • 5Department of Otorhinolaryngology, Korea University Guro Hospital, Seoul, Korea.
  • 6Department of Otorhinolaryngology, Seoul National University Bundang Hospital, Bungdang, Korea.
  • 7Department of Otorhinolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.
  • 8Department of Otorhinolaryngology, Pusan National University Hospital, Busan, Korea.
  • 9Departments of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Gachon University of Medicine and Science, Incheon, Korea.

Abstract


OBJECTIVES
Mèniére's disease is one of the most common causes of episodic vestibular syndrome that shows symptom complexes of recurrent vertigo, hearing loss, tinnitus and ear fullness. Isosorbide (Isobide) is a osmotic diuretics which has been used for Meniere's disease to reduce the endolymphatic pressure. The purpose of this study was to evaluate the efficacy of isosorbide in the treatment of Mèniére's disease by comparing the combined therapy of isosorbide and betahistine (Meniace) to betahistine only.
METHODS
Among 220 patients enrolled with Mèniére's disease from 9 centers, 187 patients completed this clinical study. Patients were randomly subjected either to betahistine alone therapy at dose of 6 mg three times a day (n=97) or to combined therapy with isosorbide (dose of 30 mL three times a day) and betahistine (n=90) for 12 weeks. Two groups were compared at 4 and 12 weeks after treatment on frequency of vertigo, hearing level (pure tone audiometry, speech audiometry), electocochleography (ECoG), tinnitus (Tinnitus Handicap Inventory, THI) and quality of life (Korean functional level scale, Korean dizziness handicap inventory).
RESULTS
During first 4 weeks after treatment, the frequency of vertigo was not reduced in either betahistine alone therapy group or combined therapy group. However, between 8 and 12 weeks, the frequency of vertigo was significantly reduced in either group, and in the combined group frequency of vertigo was more significantly reduced than in the betahistine alone therapy group (p=0.041). The hearing level, ECoG, tinnitus and quality of life was not significantly different between two groups.
CONCLUSION
Isosorbide and betahistine combined therapy were more effective for vertigo control than betahistine alone therapy. Isosorbide is an effective diuretic in vertigo control in definite Mèniére's disease.

Keyword

Meniere disease; Vertigo; Betahistine; Isosorbide
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