| Disease | PATIENTS ATTENDING ONE OF 15 STUDY CENTRES (PRACTITIONERS) AS A RESULT OF AN ACUTE COMMON COLD WERE RANDOMISED TO THE DOUBLE-BLIND PLACEBO-CONTROLLED STUDY. 3 TABLETS OF STUDY MEDICATION WERE APPLIED FOR 7 TO 9 DAYS. PATIENTS DAILY DOCUMENTED
THE INTENSITY OF 18 COLD SYMPTOMS. AS WELL AS THE COLD OVERALL, USING A 10-POINT SCALE AND ESTIMATED THEIR GENERAL WELL-BEING USING THE WELZEL-KOHNEN COLOUR SCALES. ADDITIONALLY, THE SEVERITY OF ILLNESS WAS ASSESSED BY THE PHYSICIAN ON DAYS 4
AND 8(CGI-1). THE MAIN AND CONFIRMATORY OUTCOME MEASURE WAS EXPRESSED AS A TOTAL EFFICACY VALUE. THIS WAS GAUGED FROM THE Z-STANDARDISED AUC VALUES OF THE PRIMARY ENDOPOINTS(RHINITIS SCORE, BRONCHITIS SCORE. CGI-I AND GENERAL WELL-BEING).
ADVERSE ENENTS, OVERALL TOLERABILITY, VITAL SIGNS AND LABORATORY PARAMETERS WERE DOCUMENTED. 263 PATIENTS WERE INCLUDED. FOR SAFETY ANALYSIS, ALL PATIENTS WERE USED. 259 PATIENTS WERE EVALUABLE FOR PRIMARY EFFICACY ANALYSIS(ITT). RESULTS WERE
CONFIRMED ANALYSING ONLY THE 238 VALID CASES(VCS). THE PRIMARY EFFICACY PARAMETERS SHOWED THE SUPERIORITY OF THE HERBAL REMEDY OVER PLACEBO (P<0.05). EFFECT SIZE WAS 20.6% OF THE STANDARD DEVIATION (90% CI: 0.04-42.1%; ITT) AND 23.1% (1.7-44%
VC). IN RELATION TO THE GENERAL WELL-BEING, THE EFFECT SIZE WAS 33.9% OF THE STANDARD DEVIATION (12.5-55.3%; VC). PATIENTS WHO SUFFERED FROM AT LEAST MODERATE SYMPTOM INTENSITY AT BASELINE SHOWED RESPONSE RATES (AT LEAST 50% IMPROVEMENT OF THE
GLOBAL SCORE, DAY 5) OF 55.3% IN THE HERBAL REMEDY GROUP AND 27.3% IN THE PLACEBO GROUP (P=0.017; NNT=3.5). IN THE SUBGROUP OF PATIENTS WHO STARTED THERAPY AT AN EARLY PHASE OF THEIR COLD, THE EFFICACY OF THE HERBAL REMEDY WAS MOST PROMINENT (P
=0.014 FOR THE PRIMARY EFFICACY PARAMETER). THE THERAPEUTIC BENEFIT OF THE HERBAL REMEDY HAD ALREADY OCCURRED ON DAY 2 AND REACHED SIGNIFICANCE (P<0.05) ON DAY 4, AND CONTINUED UNTIL THE END OF THE TREATMENT IN THE TOTAL SCORE OF SYMPTOMS,
BRONCHITIS SCORE AND RHINITIS SCORE, AS WELL AS IN THE PATIENTS' OVERALL RATING OF THE COLD INTENSITY. AT THAT TIME, EQUAL LEVELS OF IMPROVEMENT WERE REACHED 3 DAYS EARLIER IN THE VERUM GROUP THAN IN THE PLACEBO GROUP. IN 26 PATIENTS RECEIVING
THE HERBAL REMEDY AND 23 PATIENTS RECEIVING PLACEBO, ADVERSE EVENTS WERE REPORTED. ADVERSE DRUG REACTIONS WERE SUSPECTED IN 2 PATIENTS IN THE VERUM GROUP AND IN 4 PATIENTS IN THE PLACEBO GROUP. SERIOUS ADVERSE EVENTS DID NOT OCCUR. THIS STUDY
SHOWS THAT THE HERBAL REMEDY IS EFFECTIVE AND SAFE. THE THERAPEUTIC BENEFIT CONSISTS OF A RAPID ONSET OF IMPROVEMENT OF COLD SYMPTOMS. IF PATIENTS WITH COLDS ARE ABLE TO START THE APPLICATION OF THE HERBAL REMEDY AS SOON AS PRACTICAL AFTER THE
OCCURRENCE OF THE INITIAL SYMPTOMS, THE BENEFIT WOULD BE EXPECTED TO INCREASE(E.G.SELF-MEDICATION).
A COMMERCIAL PRODUCT, ESBERITOX, WAS USED. |