Proof of Effectiveness of PASCOFLAIR® in Subjects Suffering from Examination Anxiety Using Quantitative EEG in Combination with Eye-Tracking (EnkephaloVision). A Double-Blind, Randomized, Placebo Controlled, 2-Armed, Phase IV Study in Parallel Design

Abstract

The pharmaco-dynamic action of plant-derived drugs still remains a big challenge in the field of pharmacology. This applies especially for the discovering of the possible mechanism of action. With respect to the brain, surrogate parameters may be very helpful. Non-invasive pharmaco-EEG has been proven to provide valid information on drug effects in general. Fast dynamic EEG recording with epoch length of 364 ms has now been achieved in combination with Eye-Tracking in order to elucidate single scenes during cognitive and emotional challenges (EnkephaloVision). The present investigation deals with the psychophysiological characterization of the effect of a plant-derived preparation marketed in Germany under the name of PASCOFLAIR® containing 425 mg of passionflower extract in subjects suffering from examination anxiety. Forty healthy volunteer subjects (17 men and 23 woman), with ages varying between 18 and 40 years (26 ± 6.726 for men and 25 ± 5.397 for women) were included into the study when having a score higher than 60 in the PAF (Pr&#220fungsangstfragebogen). Spectral power analysis of pre-drug data with respect to beta waves revealed a significant correlation to the score of the PAF. Increases of delta, theta and beta waves as induced by 4 cognitive and 4 emotional challenges were attenuated in the presence of 2 tablets of PASCOFLAIR® already 45 minutes after intake in a statistically significant manner in comparison to placebo. Regarding attenuation of beta1 and beta2 spectral power, effects on glutamatergic and GABAergic neurotransmission, respectively, can be suspected according to our knowledge of frequency—transmitter relations. Accordingly, this attenuation must be interpreted as ability to counteract examination induced stress symptoms. Results confirm and extend earlier experimental data showing a calming action of PASCOFLAIR®.