Abstract
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-Bicêtre University Hospital, Le Kremlin-Bicêtre, 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.
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