A Randomized, Observer-Blind, Controlled Trial of the Traditional Chinese Medicine Yi-Gan San for Improvement of Behavioral and Psychological Symptoms and Activities of Daily Living in Dementia Patients
J Clin Psychiatry 2005;66(2):248-252
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: This randomized, observer-blind,
controlled trial examined the efficacy and safety of the
traditional Chinese herbal medicine Yi-Gan San (YGS, Yokukan-San in Japanese) in the improvement of behavioral and psychological
symptoms of dementia (BPSD) and activities of daily living (ADL).
Method: Fifty-two patients with mild-to-severe
dementia (24 men and 28 women, mean ± SD age = 80.3 ± 9.0
years) according to DSM-IV criteria were investigated.
Participants were randomly assigned to the YGS group (N = 27) or
control (drug-free) group (N = 25) and treated for 4 weeks. The
Neuropsychiatric Inventory (NPI) for the assessment of BPSD, the
Mini-Mental State Examination (MMSE) for cognitive function, and
the Barthel Index for ADL were administered at baseline and the
end of the treatment. The frequency of extrapyramidal symptoms
(EPS) and other adverse events was recorded. If patients showed
insufficient response to treatment after 1 week, tiapride
hydrochloride, a dopamine D1 selective neuroleptic,
was added to the regimen. Data were collected from January 2004
to March 2004.
Results: All participants in both groups
completed the trial. In the control group, 11 patients required
treatment with tiapride hydrochloride. Significant improvements
in mean ± SD NPI (from 37.9 ± 16.1 to 19.5 ± 15.6) and Barthel
Index (from 56.4 ± 34.2 to 62.9 ± 35.2) scores were observed in
the YGS group, but not in the control group. MMSE results were
unchanged in both groups. EPS were not observed in either group,
but dizziness and impaired postural sway were observed in 6
patients treated with tiapride hydrochloride.
Conclusion: Yi-Gan San improves BPSD and
ADL. Follow-up studies using a double-blinded, placebo-controlled
design are recommended.