One hundred thirteen patients suffering from vertigo and/or dizziness due to Meniere's disease, benign paroxismal positional vertigo (BPPV), cerebrovascular disorder, etc, were evaluated on their treatment effects with bifemerane hydrochloride (Celeport ®) in the otorhinolaryngological departments of 18 hospitals in Japan.
A dose of 150 mg/day was given for three to six months to each patient in the open trial.
In order to elucidate the antivertiginous effectsof the bifemerane, clinical subjective and objective evaluations of their treatment effects on the vertiginous diseases were made by using the AAO-HNS evaluation (1985).
The subjective symptoms were evaluated every one month for the charactor, intensity, duration and frequency of the vertiginous spells (numeric vertigo score), for tinnitus, and for the disability of daily and bussiness lives.Moreover, the objective symptoms were also evaluated every month for the neurotological examinations, especially included such equilibrium findings as spontaneous and gaze nystagmus, positional nystagmus, caloric nystagmus responses, standing and stepping test results.
From these clinical observations, it could be evaluated that the global judgment of the drug effects was indicated as 39.8% marked improvement, 26.5% moderate improvement, and 26.5% slight improvement from the view point of the global evaluation criteria.Only 4 patients (0.35%) complained of side effects such as constipation, head heaviness, stomachache, diarrhea and loss of appetite.
Therefore, from these clinical results, it is coucluded that the bifemerane (Celeport ®) is useful for the treatment of vertiginous diseases originating from not only the peripheral vestibular system but also the central nervous system.
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