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.
| Project/Area Number |
17590592
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
General internal medicine (including Psychosomatic medicine)
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| Research Institution | Tohoku University |
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Principal Investigator |
IWASAKI Koh Tohoku university Graduate School of medicine, Associate Professor, 大学院医学系研究科, 助教授 (90396432)
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| Co-Investigator(Kenkyū-buntansha) |
ARAI Hiroyuki Tohoku University, Graduate School of medicine, Professor, 大学院医学系研究科, 教授 (30261613)
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| Project Period (FY) |
2005 – 2006
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| Project Status |
Completed (Fiscal Year 2006)
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| Budget Amount *help |
¥2,700,000 (Direct Cost: ¥2,700,000)
Fiscal Year 2006: ¥1,000,000 (Direct Cost: ¥1,000,000)
Fiscal Year 2005: ¥1,700,000 (Direct Cost: ¥1,700,000)
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| Keywords | Senile dementia / behavioral and psychological symptoms of dementia (BPSD) / activities of daily living (ADL) / Traditional Chinese medicine / Yi-Gan San / アルツハイマー病 / 日常生活動作 / 認知機能 / 漢方薬 / 副作用 |
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| Research Abstract |
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 treatment of behavioral and psychological symptoms of dementia (BPSD). The influence of YGS on cognitive function and activities of daily living (ADL) were also investigated.
Method : 52 patients with mild-to-severe dementia (18 men and 34 women; age 80.3 ± 9.0 [mean ± SD] years) admitted to long-term care facilities 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) test was used for the assessment of BPSD, the Mini-Mental State Examination (MMSE) for cognitive function, and the Barthel Index for ADL. The frequency of extrapyramidal symptoms (EPS) and other adverse events were recorded.
Results : All participants of both groups completed the trial. In the control group, 11 patients needed to be treated with tiapride hydrochloride.
Significant improvements in NPI scores (from 37.9 ± 16.1 to 19.5±15.6, mean±SD) and Barthel index scores (from 56.4±34.2 to 62.9±35.2) were observed in the YGS group, but not in the control group. MMSE was unchanged in both groups. EPS was not observed in either group, but dizziness and impaired postural sway were observed in 6 patients treated with tiapride hydrochloride.
Conclusion : A Traditional Chinese medicine, Yi-Gan San, improves BPSD and ADL without affecting cognitive function.
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Report
(3 results)
Research Products
(10 results)
