Choto-san in the treatment of vascular dementia: A double-blind, placebo-controlled study

Choto-san in the treatment of vascular dementia: A double-blind, placebo-controlled study
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DOI:
10.1016/s0944-7113(97)80022-0
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发表时间:
1997-03-01
期刊:
影响因子:
7.9
通讯作者:
Takaori, S
Takaori, S
中科院分区:
医学1区
文献类型:
--
作者:
Terasawa, K;Shimada, Y;Takaori, S

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在早期的一项安慰剂对照研究中,我们证明了一种名为Choto-San(日本草药)的药物在治疗血管性痴呆方面有效。为了使用更客观的标准来评估其疗效,我们进行了一项多中心、双盲研究,分别给予患有这种疾病的患者每天三次,每次7.5克/天,并服用安慰剂。这项研究招募并分析了139名患者,其中50名男性和89名女性,平均年龄为76.6岁。在总体改善等级、效用等级、主观症状总体改善等级、精神症状总体改善等级和日常生活活动障碍的整体改善等级方面,Choto-San在统计学上均优于安慰剂。与服用安慰剂的人相比,服用Choto-San的人在一个或多个评估点上显著改善了诸如交谈的自发性、缺乏面部表情、简单数学能力下降、整体智力下降、夜间妄想、睡眠障碍、幻觉或妄想以及穿脱衣服等项目。此外,长谷川痴呆量表修订版的变化在Choto-San组有高于安慰剂组的趋势,但无统计学意义。上述结果提示,中成药对治疗血管性痴呆有一定疗效。
In an earlier placebo-controlled study, we demonstrated that a kampo (Japanese herbal) medicine called Choto-san (Diao-Teng-San in Chinese) was effective in treating vascular dementia. To evaluate its efficacy using more objective criteria, we carried out a multi-center, double-blind study of Choto-san extract (7.5 g/day) and a placebo, each given three times a day for 12 weeks to patients suffering from this condition. The study enrolled and analyzed 139 patients, 50 males and 89 females, with a mean age of 76.6 years. Choto-san was statistically superior to the placebo in global improvement rating, utility rating, global improvement rating of subjective symptoms, global improvement rating of psychiatric symptoms and global improvement rating of disturbance in daily living activities. Such items as spontaneity of conversation, lack of facial expression, decline in simple mathematical ability, global intellectual ability, nocturnal delirium, sleep disturbance, hallucination or delusion, and putting on and taking off clothes were significantly improved at one or more evaluation points in those taking Choto-san compared to those taking the placebo. Furthermore, the change in revised version of Hasegawa's dementia scale from the beginning point in Choto-san group was tended to be higher than that in placebo group with no statistical significance. These results suggest that Choto-san is effective in the treatment of vascular dementia.