A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease

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.