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.

一项随机、观察者盲法对照试验，研究中药益肝散改善痴呆患者的行为和心理症状以及日常生活活动。

• 批准号: 17590592
• 负责人: IWASAKI Koh
• 金额: $ 1.73万
• 依托单位: Tohoku University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2005
• 资助国家: 日本
• 起止时间: 2005 至 2006
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-17590592/
• 关键词: 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

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.

目的：本研究采用随机、双盲、对照试验的方法，探讨中药益肝散（YGS，Yokukan San）治疗痴呆的行为和心理症状（BPSD）的有效性和安全性。方法：对52例（男18例，女34例;年龄80.3 ± 9.0（mean ± SD）岁）长期住院的轻度至重度痴呆患者进行调查。参与者被随机分配到YGS组（n = 27）或对照组（无药物）（n = 25），并治疗4周。采用神经精神量表（NPI）评定BPSD，简易精神状态检查量表（MMSE）评定认知功能，Barthel指数评定日常生活活动能力。结果：两组患者均完成了试验。YGS组NPI评分（37.9 ± 16.1）和Barthel指数评分（56.4±34.2）均较对照组（19.5±15.6）和Barthel指数评分（62.9±35.2）显著改善，而对照组无明显改善。MMSE在两组中均无变化。结论：益肝散能改善BPSD和ADL，且不影响认知功能。

项目成果

EBM神経疾患の治療

EBM 神经系统疾病治疗

• 发表时间: 2007
• 作者: Ohashi T;Eto Y.;衛藤 義勝;Eto Y;Eto Y;衛藤義勝;衛藤義勝;衛藤義勝;Eto Y;衛藤義勝;Eto Y;衛藤義勝;衛藤義勝;衛藤 義勝;衛藤義勝;衛藤義勝;衛藤義勝;衛藤 義勝;衛藤義勝;衛藤 義勝;衛藤義勝
• 通讯作者: 衛藤義勝

Dementia caregiver's burdens and use off public service.

痴呆症护理人员的负担和使用公共服务。

• 发表时间: 2005
• 期刊: Geriatrics and Gerontology International 5(2)
• 作者: Tanji H;Iwasaki K;Arai H et al.
• 通讯作者: Arai H et al.

Effects of the Traditional Chinese Herbal Medicine for Cholinesterase inhibitor-Resistant Visual Hallucinations and Neuropsychiatric Symptoms in patients with Dementia with Lewy Bodies.

中草药对路易体痴呆患者抗胆碱酯酶抑制剂幻视和神经精神症状的影响。

• 发表时间: 2005
• 期刊: J Clin Psychiatry 66:12
• 作者: Iwasaki K;Maruyama M他
• 通讯作者: Maruyama M他

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

• DOI: 10.4088/jcp.v66n0214
• 发表时间: 2005-02-01
• 期刊: JOURNAL OF CLINICAL PSYCHIATRY
• 影响因子: 5.3
• 作者: Iwasaki, K;Satoh-Nakagawa, T;Sasaki, H
• 通讯作者: Sasaki, H

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 patients

中药益肝散改善痴呆患者行为心理症状和日常生活能力的随机、观察者盲法对照试验

• 发表时间: 2005
• 期刊: J Clin Psychiatry. 66(2)
• 作者: Iwasaki K;Satoh-Nakagawa T他
• 通讯作者: Satoh-Nakagawa T他