Salvia officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease:: a double blind, randomized and placebo-controlled trial
Salvia officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease:: a double blind, randomized and placebo-controlled trial
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DOI：
10.1046/j.1365-2710.2003.00463.x
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发表时间：
2003-02-01
影响因子：
2
通讯作者：
Khani, M
中科院分区：
文献类型：
--
作者：
Akhondzadeh, S;Noroozian, M;Khani, M
背景：阿尔茨海默病的特征是认知功能和行为缓慢、进行性下降。乙酰胆碱酯酶抑制剂是食品和药物管理局批准用于治疗阿尔茨海默病的唯一药物。所有其他用于治疗阿尔茨海默病的药物都是在标签外使用的。目前对新药的研究集中在预防、减缓和/或阻止疾病进程的药物上。Savia officinalis已被用于草药许多世纪。在传统医学的基础上，它的体外胆碱能结合特性和对人类情绪和认知能力的调节已经表明，鼠尾草可能为阿尔茨海默病提供一种新的天然治疗方法。本研究的目的是评估鼠尾草提取物使用固定剂量（60滴/天）的疗效和安全性，在轻度至中度阿尔茨海默氏病患者，在4个月periods.Methods：这是一个4个月，平行组，安慰剂对照试验在三个中心在德黑兰，伊朗进行。年龄在65 - 80岁之间的轻度至中度阿尔茨海默病患者（n = 42，18名女性），阿尔茨海默病评估量表（ADAS-cog）的认知子量表评分大于或等于12，临床痴呆评分（CDR）小于或等于2，随机接受安慰剂或固定剂量的S。药用浸膏在16周内，主要疗效指标为ADAS-cog和CDR-Box总和评分与基线相比的变化。此外，在整个研究过程中使用检查表系统地记录副作用。与安慰剂相比，药用植物提取物对认知功能产生了显著更好的结果（ADAS-cog：F = 4.77，d. f. = 1，P = 0.03）（CDR-SB：F = 10.84，d. f. = 1，P < 0.003）。除安慰剂组中出现更频繁的激越外（P = 0.09），两组在观察到的副作用方面没有显著差异。在轻度至中度阿尔茨海默病的管理中的药用植物提取物。此外，S.中药可能很好地减少病人的激动，但这需要得到证实。
Background: Alzheimer's disease is characterized by a slow, progressive decline in cognitive function and behaviour. Acetylcholine esterase inhibitors are the only agents approved by the Food and Drug Administration for the treatment of Alzheimer's disease. All other agents prescribed for the treatment of Alzheimer's disease are used on an off-label basis. Current research into new drugs is focused on agents that will prevent, slow down and/or halt the progress of the disease process. Savia officinalis has been used in herbal medicine for many centuries. It has been suggested, on the basis of traditional medicine, its in vitro cholinergic binding properties and modulation of mood and cognitive performance in humans, that Salvia officinalis might potentially provide a novel natural treatment for Alzheimer's disease. The objective of this study was to assess the efficacy and safety of Salvia officinalis extract using a fixed dose (60 drops/day), in patients with mild to moderate Alzheimer's disease, over a 4-month period.Methods: This was a 4-month, parallel group, placebo-controlled trial undertaken in three centres in Tehran, Iran. Patients with mild to moderate Alzheimer's disease aged between 65 and 80 years (n = 42, 18 women) with a score of greater than or equal to12 on the cognitive subscale of Alzheimer's Disease Assessment Scale (ADAS-cog) and less than or equal to2 on the Clinical Dementia Rating (CDR) were randomized to placebo or fixed dose of S. officinalis extract. Over the 16 weeks, the main efficacy measures were the change in the ADAS-cog and CDR-Sum of Boxes scores compared with baseline. In addition, side-effects were systematically recorded throughout the study using a checklist.Results: At 4 months, S. officinalis extract produced a significant better outcome on cognitive functions than placebo (ADAS-cog: F = 4.77, d.f. = 1, P = 0.03) (CDR-SB: F = 10.84, d.f. = 1, P < 0.003). There were no significant differences in the two groups in terms of observed side-effects except agitation that appears to be more frequent in the placebo group (P = 0.09).Conclusions: The results of this study indicate the efficacy of S. officinalis extract in the management of mild to moderate Alzheimer's disease. Moreover, S. officinalis may well reduce agitation of patients but this needs to be confirmed.