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...

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Bibliographic Details
Published in:The international journal of neuropsychopharmacology 2009-03, Vol.12 (2), p.191-199
Main Authors: Mizukami, Katsuyoshi, Asada, Takashi, Kinoshita, Toru, Tanaka, Katsuaki, Sonohara, Kazuki, Nakai, Ryuhei, Yamaguchi, Kiyoshi, Hanyu, Haruo, Kanaya, Kiyoshi, Takao, Tetsuya, Okada, Masakatsu, Kudo, Sumio, Kotoku, Hayato, Iwakiri, Masahiko, Kurita, Hirofumi, Miyamura, Toshihiro, Kawasaki, Yosuke, Omori, Koji, Shiozaki, Kazumasa, Odawara, Toshinari, Suzuki, Tatsuya, Yamada, Shizuru, Nakamura, Youichi, Toba, Kenji
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Behavioral Symptoms - drug therapy
Behavioral Symptoms - etiology
Behavioral Symptoms - psychology
Bias
Cross-Over Studies
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
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Summary: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.
ISSN:1461-1457
1469-5111
DOI:10.1017/S146114570800970X