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.
Meniere's disease is an inner ear disease characterized by recurrent episodes of vertigo, hearing loss, tinnitus and aural fullness. It is estimated that 15000 patients in de Netherlands suffer from this disease. Endolymfactic hydrops is thought to be the underlying pathophysiology of the symptoms. Salt restriction, oral medication (diuretics and betahistine), intratympanic gentamicin and steroids, ablative surgery, and endolymphatic sac surgery are some of the current therapy options. A probable effectiveness of the treatment with intratympanic gentamicin is found but this treatment is ototoxic and carries a risk of hearing loss. Methylprednisolone injections have been shown to be safer, however there is insufficient data to support the efficacy of this treatment. Therefore in this double-blinded, randomized, placebo-controlled trial, effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease is compared. The investigators aim to include 74 patients in each arm, based on a statistical power of 80 percent. Patients will be randomly randomized to one of the two treatment arms, receiving either a placebo injection or a methylprednisolone sodium succinate injection at a dose of 62.5 mg/ml. After 14 days, this injection will be given once more. A follow-up visit will be scheduled after six and twelve months and telephone follow-up calls will be scheduled after three and nine months. The primary objective will be the control of vertigo, with secondary outcomes including hearing loss, tinnitus, the frequency of escape interventions, quality of life, adverse events and cost effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
148
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Intratympanal injection with saline, natriumchloride 0.9%
Leiden University Medical Centre
Leiden, South Holland, Netherlands
RECRUITINGVertigo 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.
Time frame: Daily, change from baseline to one year
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.
Time frame: At baseline, 6 months and 12 months
Tinnitus
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
Time frame: At baseline, 6 months 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
Time frame: At baseline, 6 months 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-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
Time frame: At baseline, 6 months and 12 months
Escape medication
The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
Time frame: At baseline, 3 months, 6 months, 9 months, 12 months
Adverse events
At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
Time frame: Daily, change from baseline to one year
Cost-effectiveness
Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
Time frame: At baseline, 6 months and 12 months
Co-interventions
The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
Time frame: Daily, change from baseline to one year
Overall function
The functional level scale will be measured with the questionnaire: Functional level scale: a scale from 1-6 in which 1 means: my dizziness has no effect on my activities and 6 means: I have been disabled for one year or longer and/or I received compensation (money) because of y dizziness or balance problem.
Time frame: At baseline, 6 months and 12 months
Impact of Dizziness
The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
Time frame: Change from baseline to 6 months to 12 months
Tinnitus severity
The tinnitus severety will be measured with the questionnaire: Tinnitus functional index
Time frame: At baseline, 6 months and 12 months
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