Article révisé par les pairs
Résumé : An open, observational clinical study to investigate the onset of action of the extract of the red vine-leaf AS195 has been conducted in 39 patients suffering from Chronic Venous Insufficiency [CVI; grade I or II according to the Widmer classification (grade 2 to 4 of the international CEAP classification)]. Symptoms of CVI in the patients included oedema and subjective clinical complaints. The patients received 180 mg of extract twice daily (360 mg in total) during six weeks. The parameters investigated were objective measurements (lower leg volume by water plethysmography and the circumference of the leg at a fixed height), as well as subjective criteria such as heaviness and pain in the leg, measured using visual analogue scales (VAS). A clear and significant effect was already observed after two weeks of treatment. This effect was still present and increased slightly after four and six weeks in all objective and subjective parameters tested in this study. The decrease of the calf volume was statistically significant after 2, 4 and 6 weeks. The calf volume decreased on average by 26.3 ml after 2 weeks (t=-5.37 p<0.001), 29.8 ml after 4 weeks (t=-6.44 p<0.001) and 32.7 ml after 6 weeks (t=-7.67<0.001). The intensity of the sensation of heaviness and pain decreased also statistically significantly after 2, 4 and 6 weeks. The measured intensity on the VAS decreased on the average by 2.2 points after 2 weeks (t=-8.21 p<0.001), 2.6 points after 4 weeks (t=-10.93 p<0.001) and 2.6 points after 6 weeks (t=-10.75 p<0.001). In general, the treatments were well tolerated. Three patients prematurely stopped the trial for reasons not linked to the treatment or to the disease. This study has shown a fast onset of action and an excellent efficacy of the vitis viniferae Folia AS 195 extract in Chronic Venous Insufficiency. © 2006 by Verlag Hans Huber, Hogrefe AG.