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一种适应原提取物对轻度认知障碍老年受试者脑电活动的影响:一项随机、双盲、安慰剂对照、双臂交叉研究。

Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Two-Armed Cross-Over Study.

作者信息

Dimpfel Wilfried, Schombert Leonie, Keplinger-Dimpfel Ingrid K, Panossian Alexander

机构信息

Justus-Liebig-University Giessen, Giessen, c/o NeuroCode AG, D-35578 Wetzlar, Germany.

NeuroCode AG, D-35578 Wetzlar, Germany.

出版信息

Pharmaceuticals (Basel). 2020 Mar 14;13(3):45. doi: 10.3390/ph13030045.

Abstract

BACKGROUND

The current and potential uses of adaptogens are mainly related to treatment of stress-induced fatigue, impaired cognitive function, mental illness, and behavioral- and age-related disorders. However, clinical evidence regarding the efficacy of adaptogens is limited. The primary aim of this study is to determine whether a combination of adaptogenic plant extracts from and (Adaptra Forte) could be used as effective and safe treatment for impaired cognitive, memory, or learning ability functions and sleep disorders.

METHODS

The changes in electroencephalogram (EEG) frequency ranges in 17 different brain regions, psychometric tests of cognitive performance, as well as standard questionnaires of assessment of mood and sleep were measured after single and repeated administration of Adaptra or placebo for four weeks and after a two-week treatment-free follow-up period within a randomized, double-blind, placebo-controlled two-armed cross-over study.

RESULTS

Adaptra Forte significantly improved cognitive performance in the d2-Test for attention and the concentration performance test after four weeks' treatment, and was positively correlated with increases in δ and θ power in the quantitative EEG compared with placebo during cognitive challenges.

CONCLUSION

The results of this study suggest that Adaptra Forte exhibits a calming and anxiolytic effect without sedation, and is associated with overall stress-protective activity.

摘要

背景

适应原目前的及潜在的用途主要与治疗应激性疲劳、认知功能受损、精神疾病以及行为和年龄相关疾病有关。然而,关于适应原功效的临床证据有限。本研究的主要目的是确定来自[两种植物名称未给出]的适应原植物提取物组合(Adaptra Forte)是否可作为治疗认知、记忆或学习能力受损以及睡眠障碍的有效且安全的疗法。

方法

在一项随机、双盲、安慰剂对照的双臂交叉研究中,单次及重复服用Adaptra或安慰剂四周后,以及在为期两周的无治疗随访期后,测量17个不同脑区的脑电图(EEG)频率范围变化、认知表现的心理测量测试以及情绪和睡眠评估的标准问卷。

结果

治疗四周后,Adaptra Forte在注意力的d2测试和注意力集中表现测试中显著改善了认知表现,并且与认知挑战期间与安慰剂相比定量脑电图中δ和θ波功率增加呈正相关。

结论

本研究结果表明,Adaptra Forte具有镇静和抗焦虑作用而无镇静作用,并且与整体应激保护活性相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba40/7151715/47fae876870a/pharmaceuticals-13-00045-g001.jpg

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