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EFFECTS OF INTRA-ENDOLYMPHATIC SAC APPLICATION OF LARGE DOSES OF STEROIDS FOR INTRACTABLE MENIERE'S DISEASE: A RANDOMIZED CONTROLLED TRIAL

Tadashi Kitahara1, Shin-ichi Okumura2, Takeshi Kubo1, Masaaki Kitahara3

1Department of Otolaryngology, Osaka University, Suita-city, Japan/2Department of Otolaryngology, Osaka Rosai Hospital, Sakai-city, Japan/3Sosei Neurotologic Medical Center, Kyoto-city, Japan

OBJECTIVES: Meniere's disease is a common inner ear disease and has an incidence of 15-50 per 100,000 population. Some of Meniere's patients suffer from frequent episodic vertigo with fluctuating and progressive sensorineural hearing loss in spite of various kinds of medication. Since immune-mediated responses in the inner ear are supposed to be one of the main causes, systemic administration and/or local perfusion in the middle ear of corticosteroids have/has been adopted for intractable Meniere's patients. However, even good results in some cases especially in hearing could not last so long. In the present study, we examined the intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

METHODS: We enrolled and assigned 197 intractable Meniere’s patients to three groups as a randomized control trial: Group-I (G-I) - patients who took endolymphatic sac drainage and steroid-instillation, Group-II (G-II) - those who took endolymphatic sac drainage without steroid-instillation and Group-III (G-III) - those who declined endolymphatic sac drainage. Definitive spells and hearing in G-I and GII were determined for 10 years and G-III for 7 years after treatment.

RESULTS: According to the criteria in 1995 AAO-HNS, twoyear- results demonstrated that vertigo was completely controlled in 88.0% in G-I (n=100), 85.1% 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% in G-I, 31.9% in G-II and 6.0% in G-III (statistically G-I>G-II>G-III). Sevenyear- results showed that vertigo was completely controlled in 78.8% in G-I, 79.2% in G-II and 25.0% in G-III (statistically G-I=G-II>G-III). Hearing was improved in 36.5% in G-I, 8.3% in G-II and 0.0% in GIII (statistically G-I>G-II=G-III). Eight-to-ten-year-results showed that vertigo was completely controlled in 75.0% in G-I and 82.9% in G-II (statistically G-I=G-II). Hearing was improved in 31.6% in G-I and 11.4% in G-II (statistically G-I>G-II).

CONCLUSIONS: High concentration of intra-endolymphatic sac steroids in G-I could make additional effects to G-II especially on hearing. Improvement of inner ear function is not always necessary for suppressing vertigo attack, but indispensable for hearing recovery in Meniere's treatment. The intra-endolymphatic sac application of large doses of steroids might have power for it at least for 8-10 years after the treatment.