TITLE:
Psychophysiological Effectiveness of Calmvalera Hevert Tablets as Measured by EnkephaloVision in Anxious Subjects during Audio-Visual Cognitive and Emotional Challenges: A Double-Blind, Randomized, Placebo-Controlled, 2-Armed, Phase IV Study in Parallel Design
AUTHORS:
Wilfried Dimpfel, Sieglinde Tausend, Samir Suliman, Gwladys N. Chiegoua Dipah
KEYWORDS:
EEG Source Density, Spectral Power, Calmvalera Hevert Tablets, Cognition, Psychophysiology, CATEEM®, Neurocode-Tracking, Eye-Tracking, EnkephaloVision
JOURNAL NAME:
Journal of Behavioral and Brain Science,
Vol.6 No.10,
September
30,
2016
ABSTRACT: Subjects suffering from anxiety during examinations
often take drugs with considerable side effects. As alternative, homeopathic preparations virtually lack side effects
in general. However, clinical efficacy has to be demonstrated. This
experimental series was initiated to provide evidence, that Calmvalera Hevert tablets, marketed for treatment of nervous
restlessness and better coping with stress, have an influence on brain electric activity. In order to test this, a
new clinical design was used: “EnkephaloVision”. It consists of the combination
of quantitative EEG recording with time epochs of 364 ms (Neurocode-Tracking)
with conventional Eye-Tracking. Seventeen channels of EEG and one channel EOG
were recorded. After frequency analysis (FFT) current source density was
calculated. Recording was performed in the presence of a video clip, which
contained several different cognitive and emotional challenges in series.
Twenty-four male and female subjects having a score >60 in an anxiety
questionnaire (Prüfungsangstfragebogen PAF-S) were recruited to participate. A
correlation between the Hamilton
anxiety score and spectral alpha1 power during the recording condition “eyes
open” before drug intake was detected. Spectral power was averaged including Cz,
F3 and F4 electrode positions. Audiovisual challenges
induced spectral changes with respect to delta, theta and beta power, not in
the alpha ranges, to a different but statistically significant degree. Intake
of Calmvalera Hevert tablets resulted in statistically significant increases of
alpha1 and alpha2 spectral power during most of the recording conditions within
the left hemisphere. Increases of alpha activity have been related to
relaxation and calmness as reported in the literature. Discriminant analysis of
the whole data set revealed a clear difference between verum and placebo and a
projection of the data into the vicinity of other plant-derived calming preparations. Performance of
psychometric tasks was not disturbed. Efficacy of Calmvalera Hevert tablets points
to active molecules contained due to low triturations (D2 - D8).