Objective: To determine the effect of a new venoactive flavonoid fraction (S 5682) in the treatment of symptomatic disturbances of the venolymphatic 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 symptomatic disturbances of the venolymphatic system, including chronic venous insufficiency, were included in the study. Interventions: Treatment lasted 8 weeks and consisted of the daily administration of two tablets of either S 5682 (n = 80) or placebo (n = 80). Main outcome measures: The primary end-point was the evolution of eight symptoms of disturbance of the venolymphatic system over the 2-month observation period. The secondary end-point was the change of circumference of each affected leg over the same observation period. Results: When compared with placebo, S 5682 led to a significant improvement in four symptoms (functional discomfort, sensation of heaviness, nocturnal cramps, sensation of swelling) at week 4 and in two additional symptoms (pain and sensation of heat or burning) at week 8. Similarly, S 5682 was associated with a significant decrease in calf muscle and supramalleolar circumferences 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. Conclusions: These results indicate that S 5682 shows early and prolonged efficacy in the treatment of symptomatic disturbances of the venolymphatic system, including chronic venous insufficiency, without significant side-effects.
