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Double-blind, placebo-controlled, randomized, crossover trial of high-dose methylprednisolone in patients with chronic progressive form of multiple sclerosis. 1995

G Cazzato, and T Mesiano, and R Antonello, and F Monti, and N Carraro, and P Torre, and A Bosco, and D Cargnelutti
Department of Neurology, University of Trieste, Cattinara Hospital, Italy.

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.

UI MeSH Term Description Entries
D008297 Male Males
D008775 Methylprednisolone A PREDNISOLONE derivative with similar anti-inflammatory action. 6-Methylprednisolone,Medrol,Metipred,Urbason,6 Methylprednisolone
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009103 Multiple Sclerosis An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903) MS (Multiple Sclerosis),Multiple Sclerosis, Acute Fulminating,Sclerosis, Disseminated,Disseminated Sclerosis,Sclerosis, Multiple
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002908 Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). Chronic Condition,Chronic Illness,Chronically Ill,Chronic Conditions,Chronic Diseases,Chronic Illnesses,Condition, Chronic,Disease, Chronic,Illness, Chronic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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