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
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
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DOI：
10.4088/jcp.v66n0214
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发表时间：
2005-02-01
影响因子：
5.3
通讯作者：
Sasaki, H
中科院分区：
文献类型：
--
作者：
Iwasaki, K;Satoh-Nakagawa, T;Sasaki, H
目的：本研究采用随机、双盲、对照试验的方法，对中药益肝散的有效性和安全性进行了研究（YGS，日本Yokukan-San）在改善痴呆的行为和心理症状（BPSD）和日常生活活动（ADL）方面的作用。根据DSM-IV标准，研究了52例轻度至重度痴呆患者（24例男性和28例女性，平均± SD年龄= 80.3 ± 9.0岁）。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。在基线和治疗结束时采用神经精神量表（NPI）评估BPSD，简易精神状态检查量表（MMSE）评估认知功能，Barthel指数评估ADL。记录锥体外系症状（EPS）和其他不良事件的发生率。如果患者在1周后对治疗反应不足，则将盐酸硫必利（一种多巴胺D，选择性Deuroleptic）添加到方案中。数据收集时间为2004年1月至2004年3月。结果：两组均完成试验。在对照组中，11例患者需要盐酸硫必利治疗。在YGS组中观察到平均SD NPI（从37.9 +/- 16.1到19.5 +/- 15.6）和Barthel指数（从56.4 +/- 34.2到62.9 +/- 35.2）评分的显著改善，但在对照组中没有观察到。两组MMSE结果均无变化。结论：益肝散能改善BPSD和ADL，改善BPSD和ADL。建议采用双盲、安慰剂对照设计进行随访研究。
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 improvement of behavioral and psychological symptoms of dementia (BPSD) and activities of daily living (ADL).Method: Fifty-two patients with mild-to-severe dementia (24 men and 28 women, mean +/- SD age = 80.3 +/- 9.0 years) according to DSM-IV criteria 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) for the assessment of BPSD, the Mini-Mental State Examination (MMSE) for cognitive function, and the Barthel Index for ADL were administered at baseline and the end of the treatment. The frequency of extrapyramidal symptoms (EPS) and other adverse events was recorded. If patients showed insufficient response to treatment after 1 week, tiapride hydrochloride, a dopamine D, selective Deuroleptic, was added to the regimen. Data were collected from January 2004 to March 2004.Results: All participants in both groups completed the trial. In the control group, 11 patients required treatment with tiapride hydrochloride. Significant improvements in mean SD NPI (from 37.9 +/- 16.1 to 19.5 +/- 15.6) and Barthel Index (from 56.4 +/- 34.2 to 62.9 +/- 35.2) scores were observed in the YGS group, but not in the control group. MMSE results were unchanged in both groups. EPS were not observed in either group, but dizziness and impaired postural sway were observed in 6 patients treated with tiapride hydrochloride.Conclusion: Yi-Gan San improves BPSD and ADL. Follow-up studies using a double-blinded, placebo-controlled design are recommended.