Tinnitus
Conditions
Keywords
tinnitus, donepezil
Brief summary
This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.
Detailed description
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
Interventions
DRUGDonepezil group
Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months
DRUGPlacebo group
35 Pacients with tinnitus received for 3 months placebo medication
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with chronic sensorineural tinnitus type
Exclusion criteria
* pregnancy, arrhythmia, donepezil allergy, yelow dye allergy, otitis or any ear inflamatory diseases, patients taking any medication for dementia, convulsive diseases, asthma, patients taking any of these medications: carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole, quinidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tinnitus improvement | 3 months | Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS). |
Countries
Brazil
Outcome results
None listed