Tolerability and efficacy of valerian/lemon balm in healthy volunteers (a double-blind, placebo-controlled, multicentre study)
Tolerability and efficacy of valerian/lemon balm in healthy volunteers (a double-blind, placebo-controlled, multicentre study)
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DOI：
10.1016/s0367-326x(99)00018-0
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发表时间：
1999-06-01
期刊：
影响因子：
3.4
通讯作者：
Schmid, K
中科院分区：
文献类型：
--
作者：
Cerny, A;Schmid, K
这项临床研究的目的是评估一种新的草药助眠剂盖伦制剂的耐受性和疗效，一种缬/柠檬香膏组合，用于治疗轻微的睡眠障碍。本研究采用随机、安慰剂对照、双盲、平行组、多中心设计，在健康志愿者中进行。主要参数是总体耐受性和不良事件发生率的评估。次要参数包括实验室检查、体格检查以及健康和睡眠质量评估。大多数受试者对该制剂的耐受性良好（缬/柠檬香膏组93%的受试者和安慰剂组91%的受试者）。两个治疗组之间的不良事件频率无统计学显著差异（瓦勒里安/柠檬香膏29%，安慰剂28%），未报告严重不良事件，实验室检查、体格检查和健康评级未观察到显著变化。相比之下，缬/柠檬香膏组的睡眠质量（33%）显著高于安慰剂组（9%），P值= 0.04。总之，这些结果表明，该缬草/柠檬香蜂草制剂耐受性良好。(C)1999 Elsevier Science B. V.保留所有权利。
This clinical study was conducted to evaluate the tolerability and efficacy of a new galenic formulation of a herbal sleeping aid, a valerian/lemon balm combination, to treat minor sleep disorders. The study was performed according to a randomised, placebo-controlled, double-blind, parallel group, multicentre design with healthy volunteers. Primary parameters were the assessment of the overall tolerability and the incidence of adverse events. Secondary parameters included laboratory tests, physical examination and assessments of well-being and sleep quality. The preparation proved to be well tolerated by most subjects (93% of the participants in the valerian/lemon balm group and 91% in the placebo group). There was no statistically significant difference concerning the frequency of adverse events between the two treatment groups (vaierian/lemon balm 29%, placebo 28%) and no serious adverse events were reported, No significant changes were seen in regard to laboratory tests, physical examination and rating of well-being. In contrast, the valerian/lemon balm group revealed a significantly higher quality of sleep (33%) compared to the placebo group (9%), P-value = 0.04. In conclusion, these results indicate that this valerian/lemon balm formulation is well tolerated. (C) 1999 Elsevier Science B.V. All rights reserved.