A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia.
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.
Mizukami
Katsuyoshi
K
Department of Psychiatry, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan. mizukami@md.tsukuba.ac.jp
Asada
Takashi
T
Kinoshita
Toru
T
Tanaka
Katsuaki
K
Sonohara
Kazuki
K
Nakai
Ryuhei
R
Yamaguchi
Kiyoshi
K
Hanyu
Haruo
H
Kanaya
Kiyoshi
K
Takao
Tetsuya
T
Okada
Masakatsu
M
Kudo
Sumio
S
Kotoku
Hayato
H
Iwakiri
Masahiko
M
Kurita
Hirofumi
H
Miyamura
Toshihiro
T
Kawasaki
Yosuke
Y
Omori
Koji
K
Shiozaki
Kazumasa
K
Odawara
Toshinari
T
Suzuki
Tatsuya
T
Yamada
Shizuru
S
Nakamura
Youichi
Y
Toba
Kenji
K
D000368:Aged; D000369:Aged, 80 and over; D001526:Behavioral Symptoms / Q000188:drug therapy / Q000209:etiology / Q000523:psychology; D015982:Bias; D018592:Cross-Over Studies; D003704:Dementia / Q000150:complications* / Q000523:psychology*; D004341:Drug Evaluation; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008516:Medicine, Chinese Traditional; D008609:Mental Status Schedule; D008875:Middle Aged; D009483:Neuropsychological Tests; D018709:Statistics, Nonparametric
D004365:Drugs, Chinese Herbal; C524644:Yi-Gan San