[Double-blind randomized comparative study of nicergoline naftidrofuryl on the quality of life in chronic obliterative arteriopathy of lower limbs with intermittent claudication].
The functional limitation of patients with obliterative arterial disease, and with intermittent claudication, damages their quality of life. The purpose of this trial was to compare the effects of nicergoline and naftidrofuryl on the quality of life and the functional discomfort of 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 began. After 6 months of treatment, we observed, for all treatments combined, a significant improvement (p = 0.0001) in the quality of life and in the functional discomfort. Three variables favoured nicergoline: the estimated time before the onset of the pain (p = 0.003), the functional discomfort quantified by the Visual Analogue Scale (p < 0.05), the distance covered on flat ground (p = 0.013). The other variables, and especially the total score on the self-questionnaire, confirmed this impression, without reaching significance (p = 0.136). The data suggest that in terms of quality of life nicergoline is superior. The clinical tolerance is good and comparable between the two treatments.
Meilhac
B
B
Laboratories Rhône-Poulenc Rorer, Département Cardiovasculaire, Montrouge, France.
Montestruc
F
F
Aubin
F
F
Djian
F
F
Rouffy
J
J
D000328:Adult; D000368:Aged; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000188:drug therapy*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology*; D007866:Leg; D008297:Male; D008875:Middle Aged; D009257:Nafronyl / Q000627:therapeutic use*; D009530:Nicergoline / Q000627:therapeutic use*; D011788:Quality of Life; D014665:Vasodilator Agents / Q000627:therapeutic use*
D014665:Vasodilator Agents; D009257:Nafronyl; D009530:Nicergoline