Journal Article

A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia

Asada, Takashi, Yamaguchi, Kiyoshi, Okada, Masakatsu, Toba, Kenji, Odawara, Toshinari, Iwakiri, Masahiko, Suzuki, Tatsuya, Kotoku, Hayato, Omori, Koji, Kudo, Sumio, Nakamura, Youichi, Sonohara, Kazuki, Hanyu, Haruo, Miyamura, Toshihiro, Kinoshita, Toru, Tanaka, Katsuaki, Kawasaki, Yosuke, Mizukami, Katsuyoshi, Nakai, Ryuhei, Shiozaki, Kazumasa, Kanaya, Kiyoshi, Kurita, Hirofumi, Takao, Tetsuya, Yamada, Shizuru

2009

Overview

The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.

• Publisher: Cambridge University Press,Oxford University Press
• Subject: Activities of daily living / Aged / Aged, 80 and over / Behavioral Symptoms - drug therapy / Behavioral Symptoms - etiology / Behavioral Symptoms - psychology / Bias / Cross-Over Studies / Dementia / Dementia - complications / Dementia - psychology / Drug Evaluation / Drugs, Chinese Herbal - therapeutic use / Female / Humans / Japan - epidemiology / Male / Medicine, Chinese Traditional / Mental Status Schedule / Middle Aged / Neuropsychological Tests / Statistics, Nonparametric