Pharmacodynamic effects of ruscus extract (Cyclo 3 Fort (R)) on superficial and deep veins in patients with primary varicose veins - Assessment by duplexsonography

Objective: To assess, using duplexsonography, the pharmacodynamic effects o f a venotropic substance [ruscus extract (Cyclo 3 Fort(R))] on superficial primary varicose veins and deep veins in patients with primary Varicose vei n disease. Patients and Methods: This trial was an open, non-placebo-controlled phase IV study that included 12 male patients (mean age 49.6 +/- 12.9 years) with primary varicosity of the greater saphenous vein. Three patients had no ev idence of chronic venous insufficiency (Widmer classification), six had ven ous insufficiency grade I, and three patients had venous insufficiency grad e II. All patients were administered three capsules of ruscus extract per d ay for 7 +/- 1 days. Using a duplex scanner (duplexsonography), venous diam eter and parameters of venous flow (peak velocity, mean velocity and flow v olume) were measured in the supine and standing positions at baseline, 2 ho urs after intake of three capsules of ruscus extract on the first day of th e study, and at the end of the 7-day study period. The veins assessed were the common femoral vein, the popliteal vein and the greater saphenous vein. Results: Mean venous diameter measured in the popliteal vein in standing pa tients was significantly lower 2 hours after treatment with ruscus extract than at baseline (1.17 +/- 0.22 vs 1.21 +/- 0.24cm, respectively; p = 0.009 ). Similarly, mean venous diameter measured in the common femoral vein in s tanding patients was significantly lower after 1 week's treatment with rusc us extract than at baseline (1.72 +/- 0.19 vs 1.75 +/- 0.21cm, respectively ; p = 0.02). Nonstatistically significant decreases in greater saphenous ve in (p = 0.06) and common femoral vein (p = 0.08) diameters, compared with b aseline, were measured in the standing position at the 2-hour assessment. V enous diameter did not change with treatment in any vein segment measured i n the supine position. Mean velocity of venous flow in the popliteal vein w as significantly greater in the standing position at the 2-hour visit (0.95 +/- 0.79 vs 0.7 +/- 0.54 cm/sec at baseline; p = 0.05). In the greater sap henous vein, parameters of venous flow (mean velocity, flow volume) measure d in the standing position were non-significantly lower than baseline at th e 2-hour and 1-week assessments. No adverse effects of ruscus extract treat ment were observed. Conclusions: Drug effects can be quantitatively measured by duplexsonograph y although assessment of veins should be conducted with the patient in the standing position. A significant decrease in the venous diameter of deep ve ins, together with a significant increase in flow parameters in those veins and a nonsignificant decrease in flow parameters in superficial veins, was found when patients with primary varicose vein disease treated with ruscus extract were assessed in the standing position. A large, double-blind, pla cebo-controlled study is needed to confirm the postulated venoconstrictive effect of ruscus extract.