The influence of valerian treatment on "reaction time, alertness and concentration" in volunteers.
A randomised, controlled, double-blind trial was performed on 102 male and female volunteers to determine whether reaction time, alertness and concentration might be impaired by treatment with a native valerian root extract (VRE). The effect was first examined the morning after a single evening dose of VRE (600 mg LI 156) vs. flunitrazepam (FNZ) (1 mg) and placebo (PL) (trial section A), and then after two weeks of evening administration of VRE (600 mg LI 156) vs. PL (trial section B). 99 volunteers were analysed in section A and 91 in section B. The primary criterion was the median of reaction time (MRT) measured with the Vienna Determination Test. Secondary criteria were cognitrones (alertness test), tracking test (two-handed co-ordination), sleep quality (VIS-A, Vis-M), further VDT parameters, and safety criteria. The single administration of LI 156 did not impair the reaction abilities, concentration and co-ordination. After 14 days of treatment, the equivalence of VRE and PL was proven by confirmative analysis concerning the improvement of MRT (p = 0.4481). Evaluation of the secondary criteria were consistent with the results of the primary criterion. It is concluded that neither single nor repeated evening administrations of 600 mg of VRE have a relevant negative impact on reaction time, alertness and concentration the morning after intake.
Kuhlmann
J
J
Lichtwer Pharma AG, Berlin, Germany. jkuhlmann@csi.com
Berger
W
W
Podzuweit
H
H
Schmidt
U
U
D000328:Adult; D014151:Anti-Anxiety Agents / Q000494:pharmacology; D001288:Attention / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005445:Flunitrazepam / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010946:Plants, Medicinal; D011594:Psychometrics; D011597:Psychomotor Performance / Q000187:drug effects; D011930:Reaction Time / Q000187:drug effects*; D012890:Sleep / Q000187:drug effects; D014632:Valerian / Q000009:adverse effects*
D014151:Anti-Anxiety Agents; D005445:Flunitrazepam