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.

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。

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.