[Action of Buflomedil on the cutaneous microcirculation studies by a cold provocation test. Multicenter, double-blind, placebo controlled trial].
The aim of this multicentre trial involving 136 cardiologists was to evaluate, in double-blind versus placebo design, the vasoactive effect of Buflomedil in out-patients with a very simple cooling-test from a practical standpoint and previously described (1). The authors have selected patients having a basal pulpar temperature below 30 degrees C by cutaneous thermometer and falling after immersion of the contralateral hand in water at 4 degrees C, with out complete recovery during 10 minutes following withdrawal. This study carried out 408 eligible patients with 398 finally included in double-blind period (200 in the Buflomedil group, 198 in the placebo group). After a run-in period of 7 days with placebo in single blind, to evaluate the stability of measures, the patients were then treated with either Buflomedil 600 mg a day or placebo at the same dosage, for 14 days. The patients in both groups had a Raynaud's phenomenon and were heavy smokers (> or = 20 packs/year), having either acrocyanosis or lower limbs arterial occlusive disease. The results have shown, after 14 days of oral treatment an increase of basal temperature of 2.01 degrees C in Buflomedil group, versus only 0.82 degrees C in placebo group. This warming-up give evidence of microcirculatory blood flux increasing. This significant difference between the both groups was the same each measurement time after immersion during the recovery phase. There also was a good parallelism between the cutaneous temperature and the global clinical improvement by visual analogic scale filled out by the investigator (p < or = 0.0001) and the patients (p < or = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)
Maurel
A
A
Laboratoire d'Etude clinique de la Microcirculation, Policlinique du Pr. Portos, CHU Henri-Mondor, Créteil.
Betrancourt
J C
JC
Van Frenkel
R
R
Thuillez
C
C
D000328:Adult; D000368:Aged; D003080:Cold Temperature; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008833:Microcirculation / Q000187:drug effects; D008875:Middle Aged; D010147:Pain Measurement; D010919:Placebos; D011759:Pyrrolidines / Q000494:pharmacology*; D012867:Skin / Q000098:blood supply*; D012881:Skin Temperature; D014665:Vasodilator Agents / Q000494:pharmacology*
D010919:Placebos; D011759:Pyrrolidines; D014665:Vasodilator Agents; C010651:buflomedil
Action du Buflomédil sur la microcirculation cutanée étudiée par un test de provocation au froid. Etude multicentrique, double aveugle versus placebo.