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Effects of Endolymphatic Sac Drainage With Steroids for Intractable Ménière's Disease: A Long‐Term Follow‐Up and Randomized Controlled Study
Author(s) -
Kitahara Tadashi,
Kubo Takeshi,
Okumura Shinichi,
Kitahara Masaaki
Publication year - 2008
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1097/mlg.0b013e3181651c4a
Subject(s) - meniere's disease , endolymphatic sac , medicine , vertigo , otorhinolaryngology , meniere disease , surgery , randomized controlled trial , population , hearing loss , inner ear , anatomy , audiology , environmental health
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.