A randomized, double-blind, placebo-controlled clinical trial of the Chinese herbal medicine "ba wei di huang wan" in the treatment of dementia.
OBJECTIVE
To evaluate whether a traditional Chinese herbal medicine, ba wei di huang wan (BDW), improves cognitive and physical functioning in dementia patients.


METHODS
An 8-week randomized, double-blind, placebo-controlled trial.


METHODS
Long-term-care facility in Japan.


METHODS
Thirty-three patients with mild to severe dementia (7 men and 26 women; mean age +/- standard deviation=84.4 +/- 7.8) were recruited and enrolled from May 2002 through September 2002.


METHODS
Participants were randomly assigned to the active drug (BDW) group (n=16) or the placebo group (n=17) and treated for 8 weeks.


METHODS
Cognitive function and activities of daily living (ADLs); palsatility index.


RESULTS
After the trial, cognitive function as assessed using the Mini-Mental State Examination (MMSE) significantly improved from 13.5 +/- 8.5 to 16.3 +/- 7.7 (P<.01, 95% confidence interval (CI)=-4.1 to -1.4) in the BDW group. The ADL score in the Barthel Index also significantly changed, from 61.8 +/- 34.6 to 78.9 +/- 21.1 (P<.01, 95% CI=-26.2 to -7.9). In contrast, MMSE and Barthel Index scores of the placebo group showed no significant change. Eight weeks after the end of the administration, MMSE and Barthel Index scores of the BDW group declined to the baseline level. The pulsatility index in the internal carotid artery as measured using Doppler sonography significantly decreased in the BDW group (2.5 +/- 1.7 to 1.9 +/- 0.5, P<.05) but not in the placebo group.


CONCLUSIONS
These results argue the benefits of BDW in the treatment of dementia.
Iwasaki
Koh
K
Department of Geriatric and Complementary Medicine (Advanced Research Center for Asian Traditional Medicine), Tohoku University, School of Medicine, Sendai, Japan. QFG03604@nifty.ni.jp
Kobayashi
Seiichi
S
Chimura
Yuri
Y
Taguchi
Mayumi
M
Inoue
Kazumi
K
Cho
Shigehumi
S
Akiba
Tetsuo
T
Arai
Hiroyuki
H
Cyong
Jong-Chol
JC
Sasaki
Hidetada
H
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001794:Blood Pressure / Q000187:drug effects; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging / Q000187:drug effects / Q000503:physiopathology; D003071:Cognition / Q000187:drug effects; D003704:Dementia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008516:Medicine, Chinese Traditional; D008609:Mental Status Schedule; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011673:Pulsatile Flow / Q000187:drug effects; D018401:Sample Size; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler
D004365:Drugs, Chinese Herbal; C054591:hachimijiogan