DOUBLE-BLIND RANDOMIZED TRIAL OF NICERGOL IN AND NAFTIDROFURYL ON QUALITY-OF-LIFE IN OBLITERATIVE ARTERIAL-DISEASE OF THE LOWER-LIMBS WITH INTERMITTENT CLAUDICATION

The functional limitation of patients with obliterative arterial disea se, and with intermittent claudication, damages their quality of life. The purpose of this trial was to compare the effects of nicergolin an d naftidrofuryl on the quality of life and the functional discomfort o f the 131 patients with claudication. It was a multicentre, randomised , double-blind trial with parallel groups. The patients were asked to complete a quality of life questionnaire and a Visual Analogue Scale, and to evaluate the number of steps on flat ground before the pain beg an. After 6 months of treatment, we observed, For all treatments combi ned, a significant improvement (p = 0.0001) in the quality of life and in the functional discomfort. Three variables favoured nicergoline: t he estimated time before the onset of the pain (p = 0.003), the functi onal discomfort quantified by the Visual Analogue Scale (p < 0.05), th e distance covered on flat ground (p = 0.013). The other variables, an d especially the total score on the self-questionnaire, confirmed this impression, without reaching significance (p = 0.136). The data sugge st that in terms of quality of life nicergoline is superior. The clini cal tolerance is good and comparable between the two treatments.