Meniere's disease
Conditions
Interventions
control group:intratympanic hormone therapy
intervention group:intratympanic gentamicin therapy
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years old (including 18 and 60 years old), and with no gender limitation; 2. be diagnosed with unilateral Meniere's disease in accord with the Clinical Practice Guidelines for Meniere's Disease issued by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in 2020, with PTA >= 50dB; 3. with frequency of veitigo attack >= 2 in 6 months; 4. having received conventional therapy (lifestyle intervention and drug treatment) in 6 months with poor results; 5. be willing to accept random grouping assignment, to sign informed consent and to cooperate with follow up.
Exclusion criteria
Exclusion criteria: 1. With other neuro-otogenic diseases that may be similar to Meniere's disease, such as VM, vertebrobasilar transient ischemic attack, acoustic neuroma, etc.; complicated middle ear lesions that may interfere with tympanic treatment; with a family history of deafness of unknown genetic cause; 2. having an intratympanic injection of gentamicin, or systemic or intra-tympanic hormone therapy within 3 months before enrollment; 3. with past adverse reactions to steroids or gentamicin (aminoglycoside antibiotics) or hormones; 4. with renal function insufficiency; 5. with severe disabilities (e.g., neurological, orthopedic, cardiovascular) or serious complications that may interfere with treatment or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of dizziness attacks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dizziness handicap inventory;Pure tone audiometry;Word recognition score;Vestibular function test;Aural fullness; | — |
Countries
China
Contacts
Public ContactLi Huawei
Eye & ENT Hospital of Fudan University
Outcome results
None listed