PLACEBO-CONTROLLED DOUBLE-BLIND-STUDY ON THE EFFICACY OF GINGKO BILOBA EXTRACT EGB-761 IN TRAINED PATIENTS SUFFERING FROM INTERMITTENT CLAUDICATION

This monocenter, randomized, placebo-controlled double-blind study wit h parallel-group comparison was carried out in order to demonstrate th e efficacy of Ginkgo biloba special extract EGb 761 on objective and s ubjective parameters of the walking performance in trained patients su ffering from peripheral arterial occlusive disease in Fontaine stage I Ib. In total 60 patients were recruited (42 men; aged 47-82 years) wit h angiographically proven peripheral arterial occlusive disease of the lower extremities and an intermittent claudication existing for at le ast 6 months. No improvement had been shown despite consistent walking training and a maximum pain-free walking distance on the treadmill of less than 150 m was recorded at the beginning of the study. The thera peutic groups were treated with either Ginkgo biloba special extract E Gb 761 at a dose of 3 times 1 film-coated tablet of 40 mg per day by o ral 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 t he walking distance between the start of treatment and after 8, 16 and 24 weeks of treatment as measured on the treadmill (walking speed 3 k m/h and slope of 12%). As secondary parameters the corresponding diffe rences for the maximum walking distance, the relative increase of the pain-free walking distance, the Doppler index and the subjective evalu ation of the patients were analyzed. The absolute changes in the pain- free walking distance in treatment weeks 8, 16 and 24 as against the t reatment beginning (median values with 95% confidence interval) led to the following values for the patients treated with Ginkgo biloba spec ial extract EGb 761: 19 m (14, 33), 34 m (18, 50) and 41 m (26, 64). T he 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-trea ted group as compared to the placebo group could be verified statistic ally 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% b etween EGb 761 and placebo also produced a statistically significant r esult (p = 0.008). The Doppler index remained unchanged in both therap eutic groups: A corresponding statistically significant advantage for the EGb 761 group was observed on a descriptive level for the other pa rameters tested. The tolerance of the treatment was very good. The res ults of this placebo-controlled study show that treatment with Ginkgo biloba special extract EGb 761 produces a statistically highly signifi cant and clinically relevant improvement of the walking performance in trained patients suffering from intermittent claudication with very g ood tolerance of the study preparation.