PMID- 19079814
OWN - NLM
STAT- MEDLINE
DCOM- 20090616
LR  - 20220408
IS  - 1469-5111 (Electronic)
IS  - 1461-1457 (Linking)
VI  - 12
IP  - 2
DP  - 2009 Mar
TI  - A randomized cross-over study of a traditional Japanese medicine (kampo), 
      yokukansan, in the treatment of the behavioural and psychological symptoms of 
      dementia.
PG  - 191-9
LID - 10.1017/S146114570800970X [doi]
AB  - 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.
FAU - Mizukami, Katsuyoshi
AU  - Mizukami K
AD  - Department of Psychiatry, Institute of Clinical Medicine, University of Tsukuba, 
      Ibaraki, Japan. mizukami@md.tsukuba.ac.jp
FAU - Asada, Takashi
AU  - Asada T
FAU - Kinoshita, Toru
AU  - Kinoshita T
FAU - Tanaka, Katsuaki
AU  - Tanaka K
FAU - Sonohara, Kazuki
AU  - Sonohara K
FAU - Nakai, Ryuhei
AU  - Nakai R
FAU - Yamaguchi, Kiyoshi
AU  - Yamaguchi K
FAU - Hanyu, Haruo
AU  - Hanyu H
FAU - Kanaya, Kiyoshi
AU  - Kanaya K
FAU - Takao, Tetsuya
AU  - Takao T
FAU - Okada, Masakatsu
AU  - Okada M
FAU - Kudo, Sumio
AU  - Kudo S
FAU - Kotoku, Hayato
AU  - Kotoku H
FAU - Iwakiri, Masahiko
AU  - Iwakiri M
FAU - Kurita, Hirofumi
AU  - Kurita H
FAU - Miyamura, Toshihiro
AU  - Miyamura T
FAU - Kawasaki, Yosuke
AU  - Kawasaki Y
FAU - Omori, Koji
AU  - Omori K
FAU - Shiozaki, Kazumasa
AU  - Shiozaki K
FAU - Odawara, Toshinari
AU  - Odawara T
FAU - Suzuki, Tatsuya
AU  - Suzuki T
FAU - Yamada, Shizuru
AU  - Yamada S
FAU - Nakamura, Youichi
AU  - Nakamura Y
FAU - Toba, Kenji
AU  - Toba K
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20081211
PL  - England
TA  - Int J Neuropsychopharmacol
JT  - The international journal of neuropsychopharmacology
JID - 9815893
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Yi-Gan San)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Behavioral Symptoms/drug therapy/etiology/psychology
MH  - Bias
MH  - Cross-Over Studies
MH  - Dementia/*complications/*psychology
MH  - Drug Evaluation
MH  - Drugs, Chinese Herbal/*therapeutic use
MH  - Female
MH  - Humans
MH  - Japan/epidemiology
MH  - Male
MH  - *Medicine, Chinese Traditional
MH  - Mental Status Schedule
MH  - Middle Aged
MH  - Neuropsychological Tests
MH  - Statistics, Nonparametric
EDAT- 2008/12/17 09:00
MHDA- 2009/06/17 09:00
CRDT- 2008/12/17 09:00
PHST- 2008/12/17 09:00 [entrez]
PHST- 2008/12/17 09:00 [pubmed]
PHST- 2009/06/17 09:00 [medline]
AID - S146114570800970X [pii]
AID - 10.1017/S146114570800970X [doi]
PST - ppublish
SO  - Int J Neuropsychopharmacol. 2009 Mar;12(2):191-9. doi: 10.1017/S146114570800970X. 
      Epub 2008 Dec 11.