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Methylprednisolone and other confounders to spinal cord injury clinical trials

Nature Clinical Practice Neurology volume 2, pages 402–403 (2006)Cite this article

A number of diverse neuroprotective regimens are in, or progressing towards, clinical trials for spinal cord injury (SCI). Various obstacles might jeopardize these translational research efforts, however, including the concurrent use of methylprednisolone, a lack of sensitive outcome measures, inconsistencies in clinical management, and the low incidence of SCI within the general population. In this Viewpoint, we examine the status of translational research in patients post SCI, focusing specifically on the use of methylprednisolone. We also discuss other potential confounders and suggest possible solutions.

For the past 15 years, pharmacological treatment of acute SCI has mainly relied on the use of steroids. Administration of high-dose methylprednisolone to patients with acute non-penetrating SCI became widespread in many countries since a post-hoc subgroup analysis of the second National Acute SCI Study showed evidence of neurological gain with this treatment.1 Subsequent studies, however, have reported extensive complications with minimal neurological gain,2 and there is also the question of whether methylprednisolone use might result in steroid myopathy.3

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Authors and Affiliations

  1. Professor and Director of Neuroscience Research in the Department of Physical Medicine and Rehabilitation at the University of Alabama, Birmingham, AL

    Marca L Sipski & Damien D Pearse

  2. Assistant Professor in the Department of Neurologic Surgery and The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA

    Marca L Sipski & Damien D Pearse

Authors
  1. Marca L Sipski
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  2. Damien D Pearse
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Correspondence to Marca L Sipski.

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Competing interests

Dr Sipski is a consultant to ProNeuron Biotechnologies Inc (Los Angeles, CA). Dr Pearse has received research support from Biogen-Idec Inc (Cambridge, MA) and GlaxoSmithKline (Research Triangle Park, NC).

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Sipski, M., Pearse, D. Methylprednisolone and other confounders to spinal cord injury clinical trials. Nat Rev Neurol 2, 402–403 (2006). https://doi.org/10.1038/ncpneuro0221

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