The Efficacy of Steroid Therapy in Vestibular Neuritis

Study Overview
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Brief Summary
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The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

Detailed Description
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This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Official Title
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The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study

Conditions
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Vestibular Neuritis

Intervention / Treatment
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* Drug: Ginkgo biloba & Methylprednisolone
* Drug: Ginkgo biloba


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages over 18 years Acute vertigo that occurred within 7 days The spontaneous nystagmus should be detected Caloric weakness over 20% Exclusion Criteria: Suspicious or verified a central nervous system lesion If the patient has denied. Other otologic disease (acute/chronic otitis media, otosclerosis, etc) The patient with history of otologic surgery The patient with history of brain surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: : Ginkgo biloba & methylprednisolone<br>Patients receive Ginkgo biloba & methylprednisolone per oral. | Drug: Ginkgo biloba & Methylprednisolone<br>* Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days.<br>* Other names: Methylprednisolone;|
| Placebo Comparator: Ginkgo biloba<br>Patients receive Ginkgo biloba per oral. | Drug: Ginkgo biloba<br>* Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.<br>* Other names: Ginexin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in vestibular function test (caloric & videop HIT) after treatment | The effectiveness of steroid therapy was determined by comparing the improvement of vestibular function (the degree of canal paresis by caloric test; gain and presence of refixation-saccade by video HIT test). | The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in dizziness handicap inventory after treatment | The effectiveness of steroid therapy was determined by comparing improvement of subjective symptoms (symptom score by DHI) in each group. | The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular neuritis, Vertigo, Head impulse test, Steroid