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一项随机双盲安慰剂对照的初步试验,研究鼠尾草、迷迭香和香蜂草的混合提取物(三种传统草药)对正常健康受试者记忆力的增强作用,包括年龄的影响。

A randomised double-blind placebo-controlled pilot trial of a combined extract of sage, rosemary and melissa, traditional herbal medicines, on the enhancement of memory in normal healthy subjects, including influence of age.

机构信息

Dilston Physic Garden, Corbridge, Northumberland, UK.

The Body Works Centre, 4 Eastgate, Hexham, UK.

出版信息

Phytomedicine. 2018 Jan 15;39:42-48. doi: 10.1016/j.phymed.2017.08.015. Epub 2017 Aug 18.

Abstract

OBJECTIVE

To evaluate for the first time the effects of a combination of sage, rosemary and melissa (Salvia officinalis L., Rosmarinus officinalis L. and Melissa officinalis L.; SRM), traditional European medicines, on verbal recall in normal healthy subjects. To devise a suitable study design for assessing the clinical efficacy of traditional herbal medicines for memory and brain function.

METHODS

Forty-four normal healthy subjects (mean age 61 ± 9.26y SD; m/f 6/38) participated in this study. A double-blind, randomised, placebo-controlled pilot study was performed with subjects randomised into an active and placebo group. The study consisted of a single 2-week term ethanol extract of SRM that was chemically-characterised using high resolution LC-UV-MS/MS analysis. Immediate and delayed word recall were used to assess memory after taking SRM or placebo (ethanol extract of Myrrhis odorata (L.) Scop.). In addition analysis was performed with subjects divided into younger and older subgroups (≤ 62 years mean age n = 26: SRM n = 10, Placebo n = 16; ≥ 63 years n = 19: SRM n = 13, Placebo n = 6).

RESULTS

Overall there were no significant differences between treatment and placebo change from baseline for immediate or delayed word recall. However subgroup analysis showed significant improvements to delayed word recall in the under 63 year age group (p < 0.0123) with Cohen's effect size d = 0.92. No adverse effects were observed.

CONCLUSION

This pilot study indicates that an oral preparation of SRM at the selected dose and for the period of administration is more effective than a placebo in supported verbal episodic memory in healthy subjects under 63 years of age. Short- and long- term supplementation with SRM extract merits more robust investigation as an adjunctive treatment for patients with Alzheimer's disease and in the general ageing population. The study design proved a simple cost effective trial protocol to test the efficacy of herbal medicines on verbal episodic memory, with future studies including broader cognitive assessment.

摘要

目的

首次评估迷迭香、鼠尾草和香蜂草(唇形科鼠尾草、迷迭香和香蜂草;SRM)这一欧洲传统草药组合对正常健康受试者言语回忆的影响。设计一种合适的研究方案,以评估传统草药治疗记忆力和大脑功能的临床疗效。

方法

44 名正常健康受试者(平均年龄 61±9.26 岁;男女比例 6/38)参与了这项研究。采用双盲、随机、安慰剂对照的初步研究,将受试者随机分为活性药物组和安慰剂组。该研究包括为期 2 周的 SRM 乙醇提取物,采用高分辨率 LC-UV-MS/MS 分析进行化学表征。服用 SRM 或安慰剂(Myrrhis odorata(L.)Scop.乙醇提取物)后,采用即时和延迟单词回忆来评估记忆。此外,还根据年龄将受试者分为年轻组(≤62 岁,平均年龄 n=26:SRM n=10,安慰剂 n=16)和老年组(≥63 岁,n=19:SRM n=13,安慰剂 n=6)进行分析。

结果

总体而言,与安慰剂相比,SRM 治疗组在即时和延迟单词回忆方面的变化无显著差异。然而,亚组分析显示,在 63 岁以下年龄组中,延迟单词回忆有显著改善(p<0.0123,Cohen's 效应大小 d=0.92)。未观察到不良反应。

结论

这项初步研究表明,在 63 岁以下健康受试者中,与安慰剂相比,选定剂量和治疗时间的 SRM 口服制剂在支持言语情景记忆方面更有效。SRM 提取物的短期和长期补充值得更深入的研究,作为阿尔茨海默病患者的辅助治疗方法以及在一般老龄化人群中。该研究设计证明了一种简单、经济有效的试验方案,可用于测试草药对言语情景记忆的疗效,未来的研究将包括更广泛的认知评估。

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