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Research in Vestibular Science > Volume 15(2); 2016 > Article
Research in Vestibular Science 2016;15(2): 44-50.
메니에르병 환자의 치료에서 Isosorbide의 유용성 평가를 위한 다기관 무작위 연구
박현우1, 정원호1, 김성헌2, 김규성3, 정종우4, 채성원5, 구자원6, 김보경7, 고의경8, 한규철9
1삼성서울병원 이비인후과
2연세대학교 의과대학 세브란스병원 이비인후과
3인하대병원 이비인후과
4서울아산병원 이비인후과
5고려대학교 구로병원 이비인후과
6분당서울대학교병원 이비인후과
7순천향대학교 부천병원 이비인후과
8부산대학교병원 이비인후과
9가천대 길병원 이비인후과
Multicenter Randomized Study on the Efficacy of Isosorbide in Patients with Mèniére's Disease
Hyun Woo Park1, Won Ho Chung1, Sung Huhn Kim2, Kyu Sung Kim3, Jong Woo Chung4, Sung Won Chae5, Ja Won Koo6, Bo Gyung Kim7, Eui Kyung Goh8, Gyu Cheol Han9
1Department of Otorhinolaryngology, Sungkyunkwan University, Samsung Seoul Hospital, Seoul, Korea
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.
Correspondence  Won Ho Chung ,Tel: +82-2-3410-3571, Fax: +82-2-3410-3879, Email: whchung@skku.edu
Received: March 18, 2016; Revised: May 21, 2016   Accepted: May 26, 2016.  Published online: June 15, 2016.
Objective:   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.
Method:   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.
Keywords: Meniere disease; Vertigo; Betahistine; Isosorbide
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