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To find out whether non-specific immunosuppression is beneficial in multiple sclerosis(MS)a randomised,placebo-controlled,single-masked trial was carried out in nine university centres.168 patients with clinically or laboratory-supported definite MS in progressive phase(deterioration by at least 1-0 on the expanded disability status scale[EDSS]in the previous year)were randomised to receive intravenous cyclophosphamide and oral prednisone(n=55);daily oral cyclophosphamide,alternate day prednisone(22 weeks),and weekly plasma exchange(20 weeks)(n=57);or placebo medications and sham plasma exchange(n=56).All patients were followed for at least 12 months(mean 3-4 months)by a monitoring neurologist,who was aware of treatment allocation,and an evaluating neurologist,who was not.The primary analysis was a comparison of rates of treatment failure(worsening of evaluating neurologist's assessment of EDSS by 1-0 or more on two consecutive 6-monthly assessments).There were no significant differences among the groups in this primary analysis(19[35%]treatment failures with cyclophosphamide;18[32%]with plasma exchange;16[29%]with placebo).Nor were there any differences in the proportions improved,stabilised,or worsened at each 6 month assessment or in the mean change in the EDSS at the final assessment(0-81 cyclophosphamide;0-69 plasma exchange;0-69 placebo).A slight trend favouring the plasma exchange group at 12-24 months of follow-up was not sustained at the final assessment.This study fails to confirm previous reports that immunosuppressive treatments result in stabilisation or improvement in progressive MS. |
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cyclophosphamide
immunosuppressive agents
multiple sclerosis
multiple sclerosis,chronic progressive
multiple sclerosis,treatment of
plasmapheresis
treatment of neurologic disorder
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