Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS.
OBJECTIVE
There is only limited evidence from adequately controlled clinical trials to support high-dose methylprednisolone therapy for attacks of multiple sclerosis (MS) and none supporting oral administration. We assessed the effect of oral high-dose methylprednisolone therapy in attacks of MS.


METHODS
Twenty-five patients with an attack of MS lasting less than 4 weeks were randomized to placebo treatment. Twenty-six patients received oral methylprednisolone (500 mg once a day for 5 days with a 10-day tapering period). The patients received scores on the Scripps Neurological Rating Scale (NRS) and Kurtzke Expanded Disability Status Scale. The symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks of treatment. Primary efficacy measures were NRS and VAS scores in the first 3 weeks and changes in NRS score and answers to an efficacy questionnaire administered after 8 weeks of treatment.


RESULTS
Changes in NRS scores among methylprednisolone- and placebo-treated patients differed significantly in the first 3 weeks and after 8 weeks (p = 0.005 and p = 0.0007). VAS scores the first 3 weeks and treatment efficacy after 8 weeks also favored a beneficial effect of methylprednisolone treatment (p = 0.02 and p = 0.05). After 1, 3, and 8 weeks, 4%, 24%, and 32% in the placebo group and 31%, 54%, and 65% in the methylprednisolone group had improved one point on the Expanded Disability Status Scale score (all p < 0.05). No serious adverse events were seen.


CONCLUSIONS
Oral high-dose methylprednisolone is recommended for managing attacks of MS.
Department of Neurology, Glostrup Hospital, University of Copenhagen, Glostrup Copenhagen, Denmark.
F
F
Sellebjerg
J L
JL
Frederiksen
P M
PM
Nielsen
J
J
Olesen
D000284:Administration, Oral; D000328:Adult; D003363:Cost Control; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000191:economics / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000191:economics; D018696:Neuroprotective Agents / Q000191:economics / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018696:Neuroprotective Agents; D008775:Methylprednisolone