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  • The International Journal of Neuropsychopharmacology, Volume 12, Issue 2
  • March 2009, pp. 191-199

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

  • Katsuyoshi Mizukami (a1), Takashi Asada (a1), Toru Kinoshita (a2), Katsuaki Tanaka (a3), Kazuki Sonohara (a3), Ryuhei Nakai (a4), Kiyoshi Yamaguchi (a5), Haruo Hanyu (a6), Kiyoshi Kanaya (a7), Tetsuya Takao (a8), Masakatsu Okada (a9), Sumio Kudo (a10), Hayato Kotoku (a11), Masahiko Iwakiri (a12), Hirofumi Kurita (a13), Toshihiro Miyamura (a14), Yosuke Kawasaki (a15), Koji Omori (a16), Kazumasa Shiozaki (a17), Toshinari Odawara (a17), Tatsuya Suzuki (a18), Shizuru Yamada (a19), Youichi Nakamura (a20) and Kenji Toba (a3)
  • DOI:
  • Published online: 11 December 2008

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.

Corresponding author
Address for correspondence: K. Mizukami, M.D., Ph.D., Department of Psychiatry, Institute of Clinical Medicine, University of Tsukuba, 1-1-1, Tennodai Tsukuba City, Ibaraki, 305-8575, Japan. Tel.: +81-29-853-3182Fax: +81-29-853-3182Email:
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The International Journal of Neuropsychopharmacology
  • ISSN: 1461-1457
  • EISSN: 1469-5111
  • URL: /core/journals/the-international-journal-of-neuropsychopharmacology
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