Bg. Weinshenker et al., A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease, ANN NEUROL, 46(6), 1999, pp. 878-886
There are no established treatments for patients with acute, severe neurolo
gical deficits caused by multiple sclerosis or other inflammatory demyelina
ting diseases of the central nervous system who fail to recover after treat
ment with high-dose corticosteroids. We conducted a randomized, sham-contro
lled, double-masked study of plasma exchange without concomitant immunosupp
ressive treatment in patients with recently acquired, severe neurological d
eficits resulting from attacks of inflammatory demyelinating disease, who f
ailed to recover after treatment with intravenous corticosteroids. Patients
who did not achieve moderate or greater improvement after the first treatm
ent phase crossed over to the opposite treatment. Moderate or greater impro
vement in neurological disability occurred during 8 of 19 (42.1%) courses o
f active treatment compared with 1 of 17 (5.9%) courses of sham treatment.
The primary analysis was positive. Improvement occurred early in the course
of treatment, and was sustained on follow-up. However, 4 of the patients w
ho responded to the active treatment experienced new attacks of demyelinati
ng disease during 6 months of follow-up. Moderate or greater improvement oc
curred during follow-up in only 2 of 13 patients who failed to improve duri
ng the treatment phase. Plasma exchange leads to functionally important neu
rological recovery in an important proportion of severely disabled patients
with acute attacks of idiopathic inflammatory demyelinating disease.