Double-Blind Trial of the Efficacy of Troxerutin in Chronic Venous Insufficiency

Abstract

Objective: To evaluate the efficacy of troxerutin in chronic venous insufficiency. Design: Randomized, double-blind, multicentre, prospective controlled trial. Setting: Hôtel Dieu Hospital and Notre Dame de Bon Secours Hospital, Paris, France. Patients: Sixty-nine patients with truncal varicose veins. Intervention: After a single-blind 15-day placebo run-in period, one group ( n = 34) received troxerutin 3500 mg daily for 2 months. The other group ( n = 35) received a placebo. Main outcome measures: Subjective symptoms, ankle circumference, venous refilling time with photoplethysmography, erythrocyte aggregation using the SEFAM aggregameter and fibrinogen level. Results: Leg aching ( p < 0.001) and venous function score ( p < 0.001) improvements were significantly higher in the troxerutin group (83% and −3.7) compared with the placebo group (23% and −0.7). A significant difference in favour of troxerutin was found for erythrocyte aggregation kinetic indexes ( p < 0.001) and dissociation threshold ( p < 0.01). Conclusions: This study confirmed the dual action of the drug: a parietal effect and a rheological effect.