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


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


The International Journal Of Neuropsychopharmacology / Official Scientific Journal Of The Collegium Internationale Neuropsychopharmacologicum (CINP), Volume: 12, No.: 2, Pages.: 191-199

Year of Publication



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.;

Bibtex Citation

@article{Mizukami_2008, doi = {10.1017/s146114570800970x}, url = {}, year = 2008, month = {dec}, publisher = {Oxford University Press ({OUP})}, volume = {12}, number = {02}, pages = {191}, author = {Katsuyoshi Mizukami and Takashi Asada and Toru Kinoshita and Katsuaki Tanaka and Kazuki Sonohara and Ryuhei Nakai and Kiyoshi Yamaguchi and Haruo Hanyu and Kiyoshi Kanaya and Tetsuya Takao and Masakatsu Okada and Sumio Kudo and Hayato Kotoku and Masahiko Iwakiri and Hirofumi Kurita and Toshihiro Miyamura and Yosuke Kawasaki and Koji Omori and Kazumasa Shiozaki and Toshinari Odawara and Tatsuya Suzuki and Shizuru Yamada and Youichi Nakamura and Kenji Toba}, title = {A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia}, journal = {The International Journal of Neuropsychopharmacology} }


aged, aged, 80 and over, behavioral symptoms, bias epidemiology, complications, dementia, drug evaluation, drug therapy, drugs chinese herbal, epidemiology, etiology, female, humans, japan, kampo, male, medicine chinese traditional, mental status schedule, middle aged, neuropsychological tests, psychology, statistics nonparametric, therapeutic use, yokukansan

Countries of Study


Types of Dementia

Dementia (general / unspecified)

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Herbal remedies, vitamins, dietary supplements