Pharmacodynamic effects of ruscus extract (Cycle 3 Fort®) on superficial and deep veins in patients with primary varicose veins. Assessment by duplexsonography

Objective: To assess, using duplexsonography, the pharmacodynamic effects of a venotropic substance [ruscus extract (Cycle 3 Fort®)] on superficial primary varicose veins and deep veins in patients with primary varicose vein 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 evidence of chronic venous insufficiency (Widmer classification), six had venous insufficiency grade I, and three patients had venous insufficiency grade II. All patients were administered three capsules of ruscus extract per day for 7 ± 1 days. Using a duplex scanner (duplexsonography), venous diameter and parameters of venous flow (peak velocity, mean velocity and flow volume) were measured in the supine and standing positions at baseline, 2 hours after intake of three capsules of ruscus extract on the first day of the 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 patients was significantly lower 2 hours after treatment with ruscus extract than at baseline (1.17 ±: 0.22 vs 1.21 ± 0.24 cm, respectively; p = 0.009). Similarly, mean venous diameter measured in the common femoral vein in standing patients was significantly lower after 1 week's treatment with ruscus extract than at baseline (1.72 ± 0.19 vs 1.75 ± 0.21 cm, respectively; p = 0.02). Nonstatistically significant decreases in greater saphenous vein (p = 0.06) and common femoral vein (p = 0.08) diameters, compared with baseline, were measured in the standing position at the 2-hour assessment. Venous diameter did not change with treatment in any vein segment measured in the supine position. Mean velocity of venous flow in the popliteal vein was 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 saphenous vein, parameters of venous flow (mean velocity, flow volume) measured in the standing position were non-significantly lower than baseline at the 2-hour and 1-week assessments. No adverse effects of ruscus extract treatment were observed.