The International Journal of Neuropsychopharmacology

Research Article

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

Katsuyoshi Mizukamia1 c1, Takashi Asadaa1, Toru Kinoshitaa2, Katsuaki Tanakaa3, Kazuki Sonoharaa3, Ryuhei Nakaia4, Kiyoshi Yamaguchia5, Haruo Hanyua6, Kiyoshi Kanayaa7, Tetsuya Takaoa8, Masakatsu Okadaa9, Sumio Kudoa10, Hayato Kotokua11, Masahiko Iwakiria12, Hirofumi Kuritaa13, Toshihiro Miyamuraa14, Yosuke Kawasakia15, Koji Omoria16, Kazumasa Shiozakia17, Toshinari Odawaraa17, Tatsuya Suzukia18, Shizuru Yamadaa19, Youichi Nakamuraa20 and Kenji Tobaa3

a1 Department of Psychiatry, Institute of Clinical Medicine, University of Tsukuba, Japan

a2 Kodama Clinic, Japan

a3 Department of Geriatric Medicine, Kyorin University, School of Medicine, Japan

a4 Kikyogahara Hospital, Japan

a5 Department of Geriatric Medicine, Graduate School of Medicine, the University of Tokyo, Japan

a6 Department of Geriatric Medicine, Tokyo Medical University, Japan

a7 Geriatric Medicine, Hachioji Medical Center of Tokyo Medical University, Japan

a8 Hospital Bando, Japan

a9 Hitachi Umegaoka Hospital, Japan

a10 Hitachi Sakura Clinic, Japan

a11 Luria-mental Clinic, Japan

a12 Ishizaki Hospital, Japan

a13 Kurita Hospital, Japan

a14 Health Care Center, University of Yamanashi, Japan

a15 Kyosai Hospital, Japan

a16 Gunma Prefectural Psychiatric Medical Center, Japan

a17 Psychiatric Center, Yokohama City University Medical Center, Japan

a18 Division of Geriatric Medicine, Nippon Medical School, Japan

a19 Geriatric Facilities Mahoroba-no-sato, Japan

a20 Nakamura Clinic, Japan

Abstract

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.

(Received March 13 2008)

(Reviewed June 13 2008)

(Revised September 24 2008)

(Accepted November 03 2008)

(Online publication December 11 2008)

Correspondence:

c1 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.: +81-29-853-3182 Fax: +81-29-853-3182 Email: mizukami@md.tsukuba.ac.jp

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