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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.

Research Project

Project/Area Number 17590592
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field General internal medicine (including Psychosomatic medicine)
Research InstitutionTohoku University

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)

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)
Project Period (FY) 2005 – 2006
Project Status Completed (Fiscal Year 2006)
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)
KeywordsSenile 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
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.

Report

(3 results)
  • 2006 Annual Research Report   Final Research Report Summary
  • 2005 Annual Research Report
  • Research Products

    (10 results)

All 2007 2006 2005

All Journal Article (9 results) Book (1 results)

  • [Journal Article] Uncaria rhynchophylla, a Chinese medicinal herb, has potent anti-aggregation effects on Alzheimer's beta-amyloidproteins2006

    • Author(s)
      Fujiwara H, Iwasaki K 他
    • Journal Title

      J Neuroscience Research 84

      Pages: 427-433

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Annual Research Report 2006 Final Research Report Summary
  • [Journal Article] Uncaria rhynchophylla, a Chinese medicinal herb, has potent anti-aggregation effects on Alzheimer's beta-amyloidproteins2006

    • Author(s)
      Fujiwara H, Iwasaki K et al.
    • Journal Title

      J Neurosci Res. 84

      Pages: 427-433

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Benefits of combining donepezil plus traditional Japanese herbal medicine on cognition and brain perfusion in Alzheimer's disease : A 12-week observer-blind, donepezil monotherapy-controlled trial.2006

    • Author(s)
      Maruyama M, Tomita N, Iwasaki K 他
    • Journal Title

      J American Geriatrics Society 54(5):

      Pages: 869-71

    • Related Report
      2006 Annual Research Report
  • [Journal Article] A randomized, observer-blind, controlled trial of the traditional Chinese medicine Yi-Gan San for improvement of behavioral and psychological symptoms and artivities of daily living in dementia patients2005

    • Author(s)
      Iwasaki K, Satoh-Nakagawa T他
    • Journal Title

      J Clin Psychiatry. 66(2)

      Pages: 248-252

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Effects of the Traditional Chinese Herbal Medicine for Cholinesterase inhibitor-Resistant Visual Hallucinations and Neuropsychiatric Symptoms in patients with Dementia with Lewy Bodies.2005

    • Author(s)
      Iwasaki K, Maruyama M他
    • Journal Title

      J Clin Psychiatry 66:12

      Pages: 1612-1613

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Effects of the Traditional Chinese Herbal Medicine for Cholinesterase inhibitor-Resistant Visual Hallucinations and Neuropsychiatric Symptoms in patients with Dementia with Lewy Bodies2005

    • Author(s)
      Iwasaki K, Maruyama M, Tomita N et al.
    • Journal Title

      J of Clin Psychiatry 66:12

      Pages: 1612-1613

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] 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.2005

    • Author(s)
      Iwasaki K, Satoh-Nakagawa T, Maruyama M
    • Journal Title

      J Clin Psychiatry 66(2)

      Pages: 248-252

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] 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.2005

    • Author(s)
      Iwasaki K, Arai H et al.
    • Journal Title

      J Clin Psychiatry 66(2)

      Pages: 248-252

    • Related Report
      2005 Annual Research Report
  • [Journal Article] Dementia caregiver's burdens and use off public service.2005

    • Author(s)
      Tanji H, Iwasaki K, Arai H et al.
    • Journal Title

      Geriatrics and Gerontology International 5(2)

      Pages: 94-98

    • Related Report
      2005 Annual Research Report
  • [Book] EBM神経疾患の治療2007

    • Author(s)
      岡本幸市他(共著)
    • Total Pages
      534
    • Publisher
      中外医学社
    • Related Report
      2006 Annual Research Report

URL: 

Published: 2005-04-01   Modified: 2016-04-21  

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