| Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PARALLEL-GROUP TRIAL (PHASE I) WAS PERFORMED TO EVALUATE THE CENTRAL PHARMACODYNAMIC EFFECTS OF TWO HYPERICUM EXTRACTS WITH DIFFERENT CONTENTS OF HYPERFORIN (0.5% AND 5.0%) BUT IDENTICAL HYPERICIN
CONTENT. THREE GROUPS OF 18 VOLUNTEERS BETWEEN 18 AND 35 YEARS OF AGE PARTICIPATED IN THE TRIAL. THE VOLUNTEERS RECEIVING VERUM TOOK 900 MG OF THE EXTRACT ONCE A DAY FOR 8 CONSECUTIVE DAYS. THE PRIMARY AIM OF THIS STUDY WAS TO OBSERVE THE
FREQUENCY BANDS, I.E., DELTA (1.25-4.5 HZ), THETA (4.75-6.75 HZ), ALPHA-1 (7.0-9.5 HZ), ALPHA-2 (9.5-12.5 HZ), BETA-1 (12.75-18.5 HX), AND BETA-2 (18.75-35 HZ). THIS WAS THE FIRST STUDY OF ITS KIND TESTING HYPERICUM CONTROLLED ON THE BASIS OF IT
HYPERFORIN CONTENTS. A QUANTITATIVE TOPOGRAPHIC EEG (QEEG) WAS PERFORMED ON DAYS 1 AND 8 AS AN INDICATOR OF DRUG-INDUCED PHARMACOLOGICAL ACTION. THE VOLUNTEER'S ELECTROPHYSIOLOGICAL DATA WERE OBTAINED PRIOR TO APPLICATION AND 2,4,6,8, AND 10
HOURS POST ADMINSTRATION. THE QEEG RESULTS OF THE PLACEBO GROUP ON DAYS 1 AND 8 SHOWED NO SIGNIFICANT CHANGES WITH REGARD TO THEIR PHYSICOLOGICAL DAILY RHYTHM. IN BOTH VERUM GROUP (0.5% AND 5.0% HYPERFORIN CONTENT), REPRODUCIBLE CENTRAL
PHARAMCODYNAMIC EFFECTS WERE APPARENT IN COMPARISON TO PLACEBO, IN PARTICULAR WITH THE EXTRACT CONTAINING 5.0% OF HYEPRFORIN. A PEAK PHARMACODYNAMIC EFFICACY WAS OBERVED BETWEEN 4 AND 8 HOURS POST ADMINISTRATION. THESE RESULTS WERE CONFIRMED
ON DAY 8 OF TRIAL. THE EXTRACT CONTAINING 5.0% HYPERFORIN SHOWED A MARKED TENDENCY TO PRODUCE HIGHER INCREASES IN QEEG BASELINE POWER PERFORMANCES THAN THE ONE CONTAINING 0.5% HYPERFORIN. THESE HIGHTER BASELINE OUTPUTS ON DAY 8 WERE SEEN AT THE
DELTA, THETA, AND ALPHA-1 FREQENCY VALUES EXCLUSIVELY FOR THE EXTRACT CONTAINING 5.0% HYPERFORIN. THE THETA AND ALPHA-1 FREQUENCY VALUES SHOWED A NOTICEABLE TENDENCY MORE EMPHASIZED ON DAY 8 THAN ON DAY 1. PRECLINICAL TRIALS IN RAT HAVE BEEN
OBSERVED WITH SIMILAR CHANGES IN THE FREQUENCY BANDS MENTIONED ABOVE, ESPECIALLY IN THE CHOLINERGIC (DELTA), NORADRENERGIC (THETA) AND SEROTONERGIC (ALPHA) NEUROTRANSMITTER SYSTEMS. |