Vonderheid-Guth B, Todorova A, Brattström A, Dimpfel W
Pro Science Private Research Clinic GmbH, med. Forschung und Entwicklung , Kurt-Schumacher-Str. 9, D-35440 Linden, Germany.
Eur J Med Res. 2000 Apr 19;5(4):139-44.
The aim of this investigation was to objectify the pharmacodynamic effects of different dosages of a commercially available plant extract mixture of valerian and hops by means of the quantitative topographical EEG (qEEG) in healthy young adults in comparison to placebo. Two different dosages were applied in two single-blind, cross-over designed observation trials in 12 healthy volunteers (1st dosage: 500 mg valerian and 120 mg hops, versus placebo, first clinical trial; 2nd dosage: 1500 mg valerian and 360 mg hops, versus placebo, second clinical trial). QEEG was recorded bipolarly from 17 surface electrodes according to the 10:20 system and analysed using the Fast Fourier Transformation prior to, 1, 2 and 4 hours after drug intake in the recording conditions eyes open, eyes closed and under mental demand. The EEG-spectra were cut into six frequency bands. Both resting conditions (eyes open and eyes closed) were analysed together. After application of the low dosage qEEG power changes remained more or less within placebo range following the normal circadian rhythmics, except for a tendentious reduction of alpha- and beta1-power 4 h after drug intake. The high dosage led to power increases in delta, decreases in alpha and a weak decrease in beta-power. Under mental performance only weak differences to placebo were seen which are not discussed here. In the CPT (completion of complicated additions and subtractions) the concentration and performance capability were hardly influenced. However, a minimal increase of mean answer time and mean OK time (time for correct answers) was observed 4 hours after intake of 2 dragees and 1 hour after 6 dragees of valerian and hops mixture with more pronounced changes after the low dosage than the high one. In summary, the quantitative topographical EEG was able to show slight, but clear visible effects on the CNS especially after intake of the high dosage of valerian-hops mixture Ze 91019 indicating reproducible pharmacodynamic responses of the target organ.
本研究的目的是，通过定量地形图脑电图（qEEG），在健康的年轻成年人中，与安慰剂相比，客观地评估不同剂量的市售缬草和啤酒花植物提取物混合物的药效学作用。在两项单盲、交叉设计的观察试验中，对12名健康志愿者施用了两种不同剂量（第一次剂量：500毫克缬草和120毫克啤酒花，与安慰剂对比，第一次临床试验；第二次剂量：1500毫克缬草和360毫克啤酒花，与安慰剂对比，第二次临床试验）。根据10:20系统，从17个表面电极双极记录qEEG，并在药物摄入前、摄入后1、2和4小时，在睁眼、闭眼和精神需求状态下的记录条件下，使用快速傅里叶变换进行分析。脑电图频谱被划分为六个频段。对两种静息状态（睁眼和闭眼）一起进行分析。施用低剂量后，qEEG功率变化除了在药物摄入后4小时α和β1功率有下降趋势外，大致保持在安慰剂范围内，并遵循正常的昼夜节律。高剂量导致δ功率增加、α功率降低以及β功率微弱下降。在精神表现方面，与安慰剂仅有微弱差异，在此不作讨论。在连续减法和加法任务（CPT）中，注意力集中程度和执行能力几乎未受影响。然而，在摄入2片缬草和啤酒花混合物糖衣丸后4小时以及6片后1小时，观察到平均答题时间和平均正确答题时间（正确答案的时间）略有增加，低剂量组的变化比高剂量组更明显。总之，定量地形图脑电图能够显示出对中枢神经系统有轻微但明显的影响，尤其是在摄入高剂量的缬草 - 啤酒花混合物Ze 91019后，表明靶器官有可重复的药效学反应。
