Abstract
A multi-center open clinical study was carried out to evaluate the therapeutic effect of kallikrein tablets in daily doses of 6 or 9 tablets in the treatment of patients with peripheral vestibular vertigo (mainly Meniere's disease). A total of 172 patients in 12 hospitals were treated with kallikrein in daily doses of either 6 or 9 tablets for two weeks or more. The therapeutic effectiveness was evaluated by experienced physicians who analysed the subjective symptoms (mainly vertigo) and the objective findings (balance tests, auditory tests, etc.). Twenty-four patients were excluded from the analysis.
1) Overall improvement was evaluated on the basis of subjective symptoms and objective findings combined. The percentage of patients rated as slightly or markedly improved was high in both groups, 76% of the 6-tablet group and 79% of the 9-tablet group. In contrast, the percentage of markedly improved and of moderately to markedly improved patients was 4% and 25% in the 6-tablet group and 13% and 42% in the 9-tablet group, respectively. The latter figure is significant (p<0.05).
2) Adverse reactions were noted in three patients: edema of the hands and headache+increased feeling of left-ear obstruction in two patients in the 6-tablet group and rash on both forearms in one patient in the 9-tablet group. There was no significant difference in the incidence of adverse reactions between the two groups.
3) The evaluation of usefulness on the basis of overall improvement plus overall safety was rated extremely useful and moderately to markedly useful in 4% and 27% of the 6-tablet group and 15% and 44% of the 9-tablet group, respectively. The latter figure is significant (p<0.05).
