Vestibular Diseases Clinical Trial
Official title:
Prednisone Treatment for Vestibular Neuronitis
The purpose of the study is to investigate the value of steroids in the treatment of vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the clinical response, self-perceived handicap and laboratory parameters.
Vestibular neuronitis is the second most common cause of peripheral vestibulopathy (the
first being benign paroxysmal positional vertigo) with incidence of about 3.5/100000.
Currently vestibular neuronitis is explained by a viral pathogenesis.
Vestibular neuronitis is considered to have a benign course. The static rotatory vertigo and
disequilibrium, present even when the patient is completely at rest, subside in most cases
within a few days, and a gradual return to daily activities is the rule. However, it has
been shown that there is generally incomplete restoration of peripheral function, and
clinical recovery is achieved by proprioceptive and visual substitution for the unilateral
vestibular deficit, combined with central vestibular compensation of the imbalance in
vestibular tone. Although vestibular neuronitis is usually restricted to one attack, several
studies have reported continuous or episodic vertigo or unsteadiness in 43% -53% of
patients. The main residua include impaired vision and disequilibrium during walking and
especially during head movement toward the affected ear. The rate of positive finding on
vestibular evaluation may reach 60%. However, vestibular impairment as reflected by positive
bedside testing and vestibular laboratory evaluation is not necessarily accompanied by
subjective complaints and does not always reflect the level of incapacity.
The assumed HSV-1 etiology of vestibular neuronitis and the reported benefit of the
combination of steroids and acyclovir in Bell's palsy suggest similar advantage in the
treatment of vestibular neuronitis. Also, glucocorticoid receptors activation was reported
to enhance vestibular compensation after acute peripheral vestibular insults in various
animal models. A recent study investigated the effect of prednisolone versus valacyclovir
and placebo on canal paresis in vestibular neuronitis patients. It was found that steroid
treatment significantly improved peripheral vestibular function to the extent reflected by
the caloric testing. However, bedside findings, patients' complaints and daily handicap were
not evaluated. The relevance of the EOG caloric test results to clinical improvement could
be argued in light of a previous report showing no correlation between EOG findings and
residual symptoms in a long-term follow-up of vestibular neuronitis patients, and the
finding that corticosteroid therapy had no effect on symptoms despite significant recovery
of the caloric-test results.
The purpose of the study:
Prospective controlled longitudinal 12-month evaluation of the value of steroids in the
treatment of vestibular neuronitis. The potential benefits of steroid therapy would be
analyzed by the clinical response, self-perceived handicap and EOG laboratory parameters.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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