Effects of short-term treatment with vitamin E in systemic sclerosis: a double blind, randomized, controlled clinical trial of efficacy based on urinary isoprostane measurement.
This double blind randomized controlled trial was designed to investigate whether short-term vitamin E treatment at doses of 500 and 1000 mg/day, compared to placebo, decreased urinary F(2)-isoprostanes and improved the microvascular perfusion after cold exposure in patients suffering from SSc. Thirty-three eligible patients were randomly assigned in a 1.3:1:1 ratio to receive placebo, vitamin E 500 mg, or vitamin E 1000 mg daily for 3 weeks. Clinical examination, analysis of plasma vitamin E, urinary F(2)-isoprostane levels and a whole body cooling test were performed at baseline and after a 3-week period of treatment. Urinary 15-F(2t)-IsoP levels and cutaneous blood flow variation in response to cold did not significantly differ before versus after treatment in any group. Furthermore, no difference was found between groups after 3 weeks of treatment. We show that 3-week vitamin E treatment at doses of 500 or 1000 mg/day neither decreases the basal rate of lipid peroxidation nor improves microvascular perfusion after cold exposure. These data does not support the need for phase III clinical trials to test efficacy of vitamin E in SSc.
Cracowski
Jean-Luc
JL
Clinical Research Center INSERM 003, Grenoble University Hospital, Cedex 09 Grenoble 38043, France. Jean-Luc.Cracowski@ujf-grenoble.fr
Girolet
Stéphanie
S
Imbert
Bernard
B
Seinturier
Christophe
C
Stanke-Labesque
Françoise
F
Bessard
Janine
J
Boignard
Aude
A
Bessard
Germain
G
Carpentier
Patrick H
PH
D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D001783:Blood Flow Velocity; D004311:Double-Blind Method; D028441:F2-Isoprostanes / Q000652:urine*; D005260:Female; D006801:Humans; D015227:Lipid Peroxidation / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012595:Scleroderma, Systemic / Q000188:drug therapy* / Q000652:urine; D013997:Time Factors; D016896:Treatment Outcome; D014810:Vitamin E / Q000627:therapeutic use*
D000975:Antioxidants; D028441:F2-Isoprostanes; D010919:Placebos; D014810:Vitamin E