Pharmacodynamic effects of valerian and hops extract combination (Ze 91019) on the quantitative-topographical EEG in healthy volunteers.
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.
Vonderheid-Guth
B
B
Pro Science Private Research Clinic GmbH, med. Forschung und Entwicklung , Kurt-Schumacher-Str. 9, D-35440 Linden, Germany.
Todorova
A
A
Brattström
A
A
Dimpfel
W
W
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001931:Brain Mapping; D002540:Cerebral Cortex / Q000187:drug effects; D002940:Circadian Rhythm; D018592:Cross-Over Studies; D004569:Electroencephalography / Q000187:drug effects*; D006801:Humans; D008297:Male; D010936:Plant Extracts / Q000008:administration & dosage*; D010946:Plants, Medicinal; D011597:Psychomotor Performance / Q000187:drug effects; D012146:Rest; D016037:Single-Blind Method; D014632:Valerian
D010936:Plant Extracts