EVALUATION OF A NEW VENOACTIVE MICRONIZED FLAVONOID FRACTION (S-5682)IN SYMPTOMATIC DISTURBANCES OF THE VENOLYMPHATIC CIRCULATION OF THE LOWER-LIMB - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective: To determine the effect of a new venoactive flavonoid fract ion (S 5682) in the treatment of symptomatic disturbances of the venol ymphatic system.Design: Double-blind, randomized, placebo-controlled, parallel group trial conducted in two centres. Setting: Department of Internal Medicine, La Palmosa Hospital, Menton, France. and Department of Vascular Surgery, Kremlin-Bicetre University Hospital, Le Kremlin- Bicetre, France. Patients: One hundred and sixty patients with symptom atic disturbances of the venolymphatic system, including chronic venou s insufficiency, were included in the study. Interventions: Treatment lasted 8 weeks and consisted of the daily administration of two tablet s of either S 5682 (n = 80) or placebo (n = 80). Main outcome measures : The primary end-point was the evolution of eight symptoms of disturb ance of the venolymphatic system over the 2-month observation period. The secondary end-point was the change of circumference of each affect ed leg over the same observation period. Results: When compared with p lacebo, S 5682 led to a significant improvement in four symptoms (func tional discomfort, sensation of heaviness, nocturnal cramps, sensation of swelling) at week 4 and in two additional symptoms (pain and sensa tion of heat or burning) at week 8. Similarly, S 5682 was associated w ith a significant decrease in calf muscle and supramalleolar circumfer ences at week 4 (p<0.001) and week 8 (p<0.001) reflecting a reduction of oedema. The decrease of the supramalleolar circumference correlated well with the improvement of the swelling sensation (r<0.56; p<0.001) . The clinical and biological acceptability of S 5682 was good. Conclu sions: These results indicate that S 5682 shows early and prolonged ef ficacy in the treatment of symptomatic disturbances of the venolymphat ic system, including chronic venous insufficiency, without significant side-effects.