J. Kuhlmann et al., The influence of valerian treatment on "Reaction time, alertness and concentration" in volunteers, PHARMACOPS, 32(6), 1999, pp. 235-241
A randomised, controlled, double-blind trial was performed on 102 male and
female volunteers to determine whether reaction time, alertness and concent
ration 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) (tr
ial 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 sec
tion A and 91 in section B. The primary criterion was the median of reactio
n time (MRT) measured with the Vienna Determination Test. Secondary criteri
a were cognitrones (alertness test), tracking test (two-handed co-ordinatio
n), sleep quality (VIS-A, Vis-M), further VDT parameters, and safety criter
ia. The single administration of LI 156 did not impair the reaction abiliti
es, concentration and co-ordination. After 14 days of treatment, the equiva
lence of VRE and PL was proven by confirmative analysis concerning the impr
ovement of MRT (p=0.4481). Evaluation of the secondary criteria were consis
tent with the results of the primary criterion. It is concluded that neithe
r single nor repeated evening administrations of 600 mg of VRE have a relev
ant negative impact on reaction time, alertness and concentration the morni
ng after intake.