Effects of endolymphatic sac drainage with steroids for intractable Meniere's disease: a long-term follow-up and randomized controlled study.
OBJECTIVE
Meniere's disease is a common inner ear disease with an incidence of 15 to 50 per 100,000 population. Since Meniere'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 Meniere's disease.


METHODS
Prospective randomized controlled study.


METHODS
Between 1996 and 2005, we enrolled and assigned 197 intractable Meniere'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 Meniere's patients, more so than endolymphatic sac drainage without steroids in G-II patients.
Kitahara
Tadashi
T
Department of Otolaryngology, Osaka University, School of Medicine, Osaka, Japan. tkitahara@ent.med.osaka-u.ac.jp
Kubo
Takeshi
T
Okumura
Shin-ichi
S
Kitahara
Masaaki
M
D000893:Anti-Inflammatory Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D003907:Dexamethasone / Q000494:pharmacology* / Q000627:therapeutic use*; D003975:Diazepam / Q000494:pharmacology* / Q000627:therapeutic use*; D004111:Dimenhydrinate / Q000494:pharmacology* / Q000627:therapeutic use*; D004232:Diuretics / Q000494:pharmacology* / Q000627:therapeutic use*; D004712:Endolymphatic Sac / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008575:Meniere Disease / Q000188:drug therapy*; D008875:Middle Aged; D010880:Piperidines / Q000494:pharmacology* / Q000627:therapeutic use*; D011446:Prospective Studies
D000893:Anti-Inflammatory Agents; D000928:Antidepressive Agents; D004232:Diuretics; D006634:Histamine H1 Antagonists; D010880:Piperidines; D003907:Dexamethasone; D004111:Dimenhydrinate; C004858:diphenidol; D003975:Diazepam