A double-blind study of the effectiveness of cyclosporine in amyotrophic lateral sclerosis.
In a double-blind placebo-controlled trial of cyclosporine in amyotrophic lateral sclerosis, no differences were observed in the monthly rate of progression or the relative risk of progression in comparing 38 patients randomized to the placebo group and 36 patients randomized to the cyclosporine group. In comparing three subgroups of patients, cyclosporine appeared to benefit men who entered the study within 18 months of the onset of first symptoms, whereas it was of no value to women or to men who entered later than 18 months. For the men with recent onset of disease, the relative risk of progression was 0.403; the monthly rate of progression was 5.2 +/- 1.1 points with placebo and 3.5 +/- 0.7 points with cyclosporine. These provocative results support the need for a full study of cyclosporine in men with recent onset of disease.
Appel
S H
SH
Department of Neurology, Baylor College of Medicine, Houston, TX 77030.
Stewart
S S
SS
Appel
V
V
Harati
Y
Y
Mietlowski
W
W
Weiss
W
W
Belendiuk
G W
GW
D000690:Amyotrophic Lateral Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002986:Clinical Trials as Topic; D003524:Cyclosporins / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D010919:Placebos; D011897:Random Allocation; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors
D003524:Cyclosporins; D010919:Placebos