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Double-blind, placebo-controlled, randomized, crossover trial of high-dose methylprednisolone in patients with
G Cazzato1, T Mesiano, R Antonello
1Department of Neurology, University of Trieste, Cattinara Hospital, Italy.
Abstract:
A double-blind, placebo-controlled, randomized crossover trial of high-dose methylprednisolone (MP) was performed in 35 patients with a primarily chronic progressive form of multiple sclerosis as defined clinically according to Poser's criteria. At time 0 of every course of treatment (1 g MP administered i.v. daily for 5 days followed by oral prednisone tapering over 4 days, or placebo) and at 10, 30 and 90 days thereafter, each patient underwent psychometric tests and was clinically tested according to Kurtzke's Expanded Disability Status Scale (EDSS). The disability pattern of most patients who were treated with placebo either worsened or did not change. A statistically significant improvement (p < 0.001) of EDSS in MP-treated patients was recorded. The improvement mainly concerned the pyramidal, cerebellar and sensitive disorders; it was already evident at the first clinical follow-up and lasted for 3 months from the beginning of the treatment. No frequent and/or important side effects were detected throughout the trial.
Insights
High-dose methylprednisolone (MP) significantly improved disability in patients with chronic progressive multiple sclerosis (MS). This treatment showed benefits in motor and sensory functions lasting three months with no significant side effects.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Multiple sclerosis (MS) is a chronic, progressive neurological disease.
- Current treatments for progressive MS have limited efficacy.
Purpose of the Study:
- To evaluate the efficacy and safety of high-dose methylprednisolone (MP) in patients with chronic progressive multiple sclerosis (MS).
Main Methods:
- A double-blind, placebo-controlled, randomized crossover trial was conducted.
- 35 patients with chronic progressive MS received either 1g IV MP daily for 5 days followed by oral prednisone or placebo.
- Clinical assessments using Kurtzke's Expanded Disability Status Scale (EDSS) and psychometric tests were performed at baseline and at 10, 30, and 90 days.
Main Results:
- MP treatment resulted in a statistically significant improvement in EDSS scores (p < 0.001).
- Improvements were observed in pyramidal, cerebellar, and sensory functions.
- The beneficial effects of MP lasted for at least 3 months post-treatment.
- No frequent or significant side effects were reported.
Conclusions:
- High-dose methylprednisolone (MP) offers a significant, albeit temporary, therapeutic benefit for patients with chronic progressive multiple sclerosis (MS).
- MP demonstrates a favorable safety profile in this patient population.