Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days). Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.

Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects. Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing. Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days). Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months. Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.

Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo

Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo

Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg

Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function

Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function

measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological

Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures

Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo

Patients often experience troubled sleep when treated with corticosteroids. How much has not been assessed. The patients will assess their sleep the previous night according to a Liknert scale (1=good nights sleep, 10=hardly slept at all)

Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness

Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut

measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological

Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures

Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures

Inclusion Criteria: definite unilateral vestibulopathy no pathological HINTS (examination criteria in acute vestibular syndrome) capable of making their own decisions Exclusion Criteria: tinnitus or hearing loss with same debut as vertigo history of bleeding peptic ulcer glaucoma pregnancy or non-acceptance to use anticonception measures during 13 days after debut high blood pressure >180 systolic, 105, diastolic ketoacidosis with a Base Excess >=2 psychic disorder (not including mild depression) serious infection (neutropenia, tuberculosis) chronic otitis history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV

Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;(5):CD008607. doi: 10.1002/14651858.CD008607.pub2.

Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. doi: 10.1056/NEJMoa033280.