Increase in circulating endothelial cells in patients with primary chronicvenous insufficiency: Protective effect of Ginkor Fort in a randomized double-blind, placebo-controlled clinical trial

One possible mechanism that accounts for the alterations observed in varico se veins is the activation of endothelial cells by ischemia occurring in th e leg veins during blood stasis and the cascade of reactions that follows. Because in vitro data suggest that endothelium alteration is a key event in the development of the pathology, it was important to confirm this hypothe sis in patients. We used the number of circulating endothelial cells detach ed from the vascular wall as a criterion of the endothelium injury. We firs t compared the number of circulating endothelial cells (CECs) in patients w ith chronic venous insufficiency (CVI) with those of a control population. A twofold increase in the CEC count (1,001 +/- 127 CEC/ml of plasma compare d with 514 +/- 82 CECs/ml) was observed in CVI patients, which indeed sugge sts an alteration of the endothelium in this disease. Second, the protectiv e effect of a venotropic drug, Ginkgo biloba extract, troxerutine, and hept aminol (Ginkor Fort), was tested by a randomized double-blind, placebo-cont rolled clinical trial. In the active-treatment group, the mean values of th e CEC count decreased by 14.5% after a 4-week treatment, whereas in the pla cebo group, the decrease was less (8.4%). The decrease from week 0 to the e nd of treatment was significantly higher in the active-treatment group than in the placebo group. These results confirm the important role of the endo thelium alterations in the development of varicose veins and suggest a pote ntial beneficial action of a venotropic drug on the venous wall.