Effects of Lisuride Hydrogen Maleate on EEG in Patients with Cerebral Vascular Impairments and Mild Senile Dementia

Multi-center Double Blind Study

Abstract

The effects of Lisuride hydrogen maleate (Eunal®, hereinafter called Lisuride) on EEG in patients with cerebral vascular impairments and mild senile dementia were studied by double blind technique using placebo as reference. The duration of treatment was at least 12 weeks or 16 weeks as far as possible. This study was conducted at 15 hospitals throughout Japan. All the EEG were read by EEG specialists. Cinnarizine was given to both groups as a basic drug.
1) Patients whose EEG was subjected to statistical analysis in Lisuride group (hereinafter called E group) and placebo group (hereinafter called P group) numbered 62 and 63, respectively. These patients demonstrated no significant difference in terms of background factors and EEG findings before treatment.
2) The global improvement rates of EEG at 12 weeks were 51% in E group and 39 % in P group, and aggravation rates were 12 % and 28 % respectively. Thus E group tended to be superior to P group.The improvement rates in local wave at 8 weeks were significantly (P<0.05) better in E group.
3) In E group, localized θ wave significantly (P<0.01) decreased at 8 weeks, α wave tended to be increased (P<0.10) at 12 weeks and dominant wave (α wave) was significantly larger than that in P group at 12 weeks.
4) With cerebral arteriosclerosis and cerebral infarction cumulated as ischemic cerebral disease, the improvement rates of EEG in E group was significantly (P<0.05) better at 12 weeks and the improvement rates of local wave also showed significant difference from that of P group.
5) In E group, the cases of a relatively long period of affection being more than 2 years and of the symptoms being stabilized showed good results in respects to global EEG improvement rates, improvement rates of local wave, etc. at 8, 12 and 16 weeks.
6) No significant correlation was observed between improvement of dementia test and EEG improvements.
7) By stochastically examining the various EEG factors which are associated with EEG improvements, the effects on the evaluation of the various factors which could be collectively considered unconsciously upon reading of EEG could be mathematically pointed out.
8) Incidence of side effects was 8.8 % in E group and 8.5% in P group.The side effects observed were all mild. The various clinical laboratory tests determined were within the normal range.
It is concluded from the above results that Lisuride is a useful and safe drug which enables to improve EEG in patients with cerebral vascular impairments and mild senile dementia.