CHOTO-SAN IN THE TREATMENT OF VASCULAR DEMENTIA - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

In an earlier placebo-controlled study, we demonstrated that a kampo ( Japanese herbal) medicine called Choto-san (Diao-Teng-San in Chinese) was effective in treating vascular dementia. To evaluate its efficacy using more objective criteria, we carried out a multi-center, double-b lind study of Choto-san extract (7.5 g/day) and a placebo, each given three times a day for 12 weeks to patients suffering from this conditi on. The study enrolled and analyzed 139 patients, 50 males and 89 fema les, with a mean age of 76.6 years. Choto-san was statistically superi or to the placebo in global improvement rating, utility rating, global improvement rating of subjective symptoms, global improvement rating of psychiatric symptoms and global improvement rating of disturbance i n daily living activities. Such items as spontaneity of conversation, lack of facial expression, decline in simple mathematical ability, glo bal intellectual ability, nocturnal delirium, sleep disturbance, hallu cination or delusion, and putting on and taking off clothes were signi ficantly improved at one or more evaluation points in those taking Cho to-san compared to those taking the placebo. Furthermore, the change i n revised version of Hasegawa's dementia scale from the beginning poin t in Choto-san group was tended to be higher than that in placebo grou p with no statistical significance. These results suggest that Choto-s an is effective in the treatment of vascular dementia.