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Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS
F Sellebjerg1, J L Frederiksen, P M Nielsen
1Department of Neurology, Glostrup Hospital, University of Copenhagen, Glostrup Copenhagen, Denmark.
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.
Conclusion:
Oral high-dose methylprednisolone is recommended for managing attacks of MS.
Insights
High-dose oral methylprednisolone effectively treats multiple sclerosis (MS) attacks, improving neurological function and disability status. This study recommends its use for managing MS relapses.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Limited evidence supports high-dose methylprednisolone for multiple sclerosis (MS) attacks.
- No prior studies confirmed efficacy of oral administration for MS relapses.
Purpose of the Study:
- To assess the efficacy of oral high-dose methylprednisolone in managing acute attacks of multiple sclerosis (MS).
Main Methods:
- Randomized controlled trial comparing oral methylprednisolone (500 mg/day) with placebo in 51 MS patients.
- Evaluated Scripps Neurological Rating Scale (NRS), Kurtzke Expanded Disability Status Scale, and visual analog scale (VAS) scores.
- Primary outcomes included NRS and VAS scores at 3 weeks and efficacy at 8 weeks.
Main Results:
- Methylprednisolone significantly improved NRS scores at 3 and 8 weeks (p=0.005, p=0.0007).
- Oral methylprednisolone showed beneficial effects on VAS scores and treatment efficacy (p=0.02, p=0.05).
- Higher disability improvement rates observed in the methylprednisolone group (31-65%) versus placebo (4-32%) at 8 weeks.
Conclusions:
- Oral high-dose methylprednisolone is a safe and effective treatment for multiple sclerosis attacks.
- The study recommends oral methylprednisolone for managing MS relapses.
- No serious adverse events were reported, supporting its safety profile.