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：观察中药益肝散治疗痴呆(BPSD)行为和心理症状的疗效和安全性。方法：对长期护理机构收治的52例轻、重度痴呆患者(男18例，女34例；平均年龄80.3±9.0岁)进行调查。将受试者随机分为益气活血组(n=27)和对照组(n=25)，治疗4周。神经精神病学问卷(NPI)用于评估BPSD，简易精神状态检查(MMSE)用于认知功能，Barthel指数用于ADL。记录锥体外系症状(EPS)及其他不良事件的发生频率。结果：两组受试者均完成试验。对照组11例需应用盐酸硫必利治疗，治疗组NPI评分(由37.9±16.1分改善至19.5±15.6分)和Barthel指数评分(由56.4±34.2分至62.9±35.2分)均有显著改善，而对照组无明显改善。两组MMSE均无变化。两组均未观察到EPS，但有6例患者出现头晕和姿势摆动障碍。结论：益肝散能改善BPSD和ADL，而不影响认知功能。

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.