| Disease | A MONOCENTER RANDOMIZED, PLACEBO-CONTROLLED DOUBLE-BLIND STUDY WITH PARALLEL-GROUP COMPARISON WAS CARRIED OUT IN ORDER TO DEMONSTRATE THE EFFICACY OF GINKGO BILOBA SPECIAL EXTRACT EGB 761 ON OBJECTIVE AND SUBJECTIVE PARAMETERS OF WALKING
PERFORMANCE IN TRAINED PATIENTS SUFFERING FROM PERIPHEAL ARTERIAL OCCLUSIVE DISEASE IN FONTAINE STAGE IIB. IN TOTAL 60 PATIENTS WERE RECRUITED WITH ANGIOGRAPHICALLY PROVEN PERIPHERAL ARTERIAL OCCLUSIVE DISEASE OF THE LOWER EXTREMITIES AND AN
INTERMITTENT CLAUDICATION EXISTING FOR AT LEAST 6 MONTHS. NO IMPROVEMENT HAD BEEN SHOWN DESPITE CONSISTENT WALKING TRAINING AND A MAXIMUM PAIN-FREE WALKING DISTANCE ON THE TREADMILL OF LESS THAN 15 M WAS RECORDED AT THE BEGINNING OF THE STUDY.
THE THERAPEUTIC GROUPS WERE TREATED WITH EITHER GINKGO BILOBA SPECIAL EXTRACT ECB 761 AT A DOSE OF 1 FILM-COATED TABLET OF 40 MG 3 TIMES PER DAY BY ORAL ROUTE OR PLACEBO OVER A DURATION OF 24 WEEKS FOLLOWING A TWO-WEEK PLACEBO RUN-IN PHASE. THE
MAIN OUTCOME MEASURE WAS THE DIFFERENCE OF THE WALKING DISTANCE BETWEEN THE START OF TREATMENT AND AFTER 8,16 AND 24 WEEKS OF TREATMENT AS MEASURED ON THE TREADMILL(WALKING SPEED 3KM/H AND SLOPE OF 12%). AS SECONDARY PARAMETERS THE CORRESPONDING
DIFFERENCES FOR THE MAXIMUM WALKING DISTANCE, THE RELATIVE INCREASE OF THE PAIN-FREE WALKING DISTANCE, THE DOPPLER INDEX AND THE SUBJECTIVE EVALUATION OF THE PATIENTS WERE ANALYZED. THE ABSOLUTE CHANGES IN THE PAIN-FREE WALKING DISTANCE IN
TREATMENT WEEKS 8, 16 AND 24 AS OPPOSED TO THE BEGINNING OF TREATMENT LED TO THE FOLLOWING VALUES OF THE PATIENTS TREATED WITH GINKGO BILOBA SPECIAL EXTRACT EGB 761: 19 M(14,33), 34 M(18,50) AND 41 M(26,64). THE CORRESPONDING VALUES IN THE PLACEBO
GROUP WERE AS FOLLOWS: 7 M(-4,12), 12 M(5,22) AND 8 M(-1,21). THE ADVANTAGE OF THE EGB 761-TREATED GROUP AS COMPARED TO THE PLACEBO GROUP COULD BE VERIFIED STATISTICALLY AT THE 3 TIME POINTS WITH P<0.0001,P=0.0003 AND P<0.0001. THE TEST FOR THE
PRESENCE OF A CLINICALLY RELEVANT DIFFERENCE OF 20% BETWEEN EGB 761 AND PLACEBO ALSO PRODUCED A STATISTICALLY SIGNIFICANT RESULT(P=0.008). A CORRESPONDING STATISTICALLY SIGNIFICANT ADVANTAGE FOR THE EGB 761 GROUP WAS OBSERVED ON A DESCRIPTIVE
LEVEL FOR THE OTHER PARAMETERS TESTED. THE RESULTS OF THIS PLACEBO-CONTROLLED STUDY SHOW THAT TREATMENT WITH GINKGO BILOBA SPECIAL EXTRACT EG6 761 PRODUCED A STATISTICALLY HIGHLY SIGNIFICANT AND CLINICALLY REVELANT IMPROVEMENT OF THE WALKING
PERFORMANCE IN TRAINED PATIENTS SUFFERING FROM INTERMITTENT CLAUDICATION WITH VERY GOOD TOLERANCE OF THE STUDY PREPARATION.
A COMMERCIAL PRODUCT, EGB-761, WAS USED. |