Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
age > 18 years at the start of the trial.
≥ 4 vertigo attacks over the last 6 months.
willing to adhere to daily trial medications and the follow-up assessments.
bilateral MD
severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
otitis media with effusion based on tympanogram results.
Parallel
Methylprednisolon
DrugIntratympanal injection with Methylprednisolon 62.5 mg/ ml
Placebo
DrugIntratympanal injection with saline, natriumchloride 0.9%
Vertigo spells
A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Futhermore, at baseline after 6 and 12 months, caloric testing and a video-head impusle test are performend. Additionally the dizziness handicap inventory will be taken.
Hearing loss
Hearing loss will be measured at baseline, 6 and 12 months after injection. Pure tone audimetry and extended fletcher index including the speech discrimination score will be tested.
Tinnitus
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-5D
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-VAS, this will be a scale from 0 to 100 in which 0 means the worst health you can imagine and 100 means the best health you can imagine
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Gelre Hospitals
Collaborator
Maasstad Hospital
Collaborator
Maastricht University Medical Center
Collaborator
Medisch Spectrum Twente
Collaborator
HagaZiekenhuis
Collaborator
