| Disease | SEVENTY-EIGHT MALE AND FEMALE PATIENTS BETWEEN THE AGES OF 45 AND 73, WHOWERE AFFECTED BY CHRONIC HEART FAILURE DEFINED AS NYHA FUNCTIONAL CLASSII, WERE TREATED EITHER WITH CRATAEGUS EXTRACT OR WITH A PLACEBOPREPARATION. THE EXTRACT LI 132
WAS ADMINISTERED TO THE PATIENTS IN THE FORM OF 3 DRAGEES A DAY (VERUMPREPARATION) CORRESPONDING TO A DAILY DOSE OF 600 MG. TREATMENT WASCONTINUED OVER A PERIOD OF 8 WEEKS, WITH A WASH-OUT PHASE OF ONE WEEK. THECONFIRMATORY PARAMETER USED TO
ASSESS THE EFFICACY OF THE PREPARATION WAS THE PATIENTS' WORKINGCAPACITY WHICH WAS MEASURED USING AN ERGOMETER BICYCLE. BEFORE THE STARTOF THE STUDY, AN INCREASE IN THE PATIENTS' WORKING CAPACITY OF AT LEASTHALF AN EXERCISE STEP ON THE
ERGOMETER BICYCLE (12.5 WATT) WAS DETERMINED TO BE CLINICALLY RELEVANT.APART FROM THE COMPATIBILITY OF THE PREPARATION, A SCORE SYSTEM WAS USEDTO ASSESS THE SEVERITY LEVEL OF THE TYPICAL SYMPTOMS. FROM DAY 0 TO DAY 56OF THE TRIAL, THE MEDIAN
VALUES OBTAINED FOR THE WORKING CAPACITY OF THE PATIENTS TREATED WITH THEVERUM PREPARATION WERE FOUND TO HAVE INCREASED BY 28 WATT, WHILE THEINCREASE IN THE WORKING CAPACITY OF THE PLACEBO PATIENTS WAS AS LITTLE AS5 WATT. THE DIFFERENCE WAS
STATISTICALLY SIGNIFICANT (P<0.001). APART FROM THAT, A SIGNIFICANT REDUCTION OF THE SYSTOLIC BLOOD PRESSURE, OF THE HEART RATE AND OF THE PRESSURE/RATE PRODUCT WAS OBSERVED FOR THE PATIENTS TREATED WITH THE VERUMPREPARATION, COMPARED TO THE
PATIENTS TREATED WITH THE PLACEBO PREPARATION. ALSO, THE CLINICALSYMPTOMS(SCORE SYSTEM) WERE FOUND TO HAVE IMPROVED SIGNIFICANTLY. THEREWERE NO SEVERE SIDE EFFECTS OBSERVED. |