Effects of Endolymphatic Sac Drainage With Steroids for Intractable Ménière's Disease: A Long-Term Follow-Up and Randomized Controlled Study
Article first published online: 2 JAN 2009
Copyright © 2008 The Triological Society
Volume 118, Issue 5, pages 854–861, May 2008
How to Cite
Kitahara, T., Kubo, T., Okumura, S.-i. and Kitahara, M. (2008), Effects of Endolymphatic Sac Drainage With Steroids for Intractable Ménière's Disease: A Long-Term Follow-Up and Randomized Controlled Study. The Laryngoscope, 118: 854–861. doi: 10.1097/MLG.0b013e3181651c4a
- Issue published online: 2 JAN 2009
- Article first published online: 2 JAN 2009
- Manuscript Accepted: 12 DEC 2007
- Ménière's disease;
- endolymphatic sac drainage;
Objective: Ménière's disease is a common inner ear disease with an incidence of 15 to 50 per 100,000 population. Since Ménière's disease is thought to be triggered by an immune insult to the inner ear, we examined intraendolymphatic sac application of steroids as a new therapeutic strategy for intractable Ménière's disease.
Study Design: Prospective randomized controlled study.
Methods: Between 1996 and 2005, we enrolled and assigned 197 intractable Ménière's patients to three groups in a randomized controlled trial: Group I (G-I)— patients who underwent endolymphatic sac drainage and steroid-instillation; Group II (G-II)—those who underwent endolymphatic sac drainage without steroid-instillation; and Group III (G-III)—those who declined endolymphatic sac drainage. Definitive spells and hearing in all three groups were determined for 2 to 7 years after treatment.
Results: According to the 1995 American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) criteria, 2-year results demonstrated that vertigo was completely controlled in 88.0% of patients in G-I (n = 100), 85.1% of patients in G-II (n = 47), and 8.0% in G-III (n = 50). Statistically, G-I = G-II>G-III. Hearing was improved in 49.0% of patients in G-I, 31.9% in G-II, and 6.0% in G-III (G-I>G-II>G-III). Results after 7 years showed that vertigo was completely controlled in 78.8% of patients in G-I, 79.2% in G-II, and 25.0% in G-III (G-I = G-II>G-III). Hearing improved in 36.5% of patients in G-I, 8.3% in G-II, and 0.0% in G-III (G-I>G-II = G-III).
Conclusions: From non-surgical observation in G-III for at least 7 years after treatment, steroids instilled into endolymphatic sac in G-I patients significantly improved hearing in intractable Ménière's patients, more so than endolymphatic sac drainage without steroids in G-II patients.