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The Role of Methylprednisolone in Acute Spinal Cord Injury

Summary Statement: The Use of Methylprednisolone in Acute Spinal Cord Injury

Fehlings, Michael G. the Spine Focus Panel

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Methylprednisolone has become widely used in the management of acute spinal cord injury and is considered by many to represent a “standard of care.” This is largely based on the results of the NASCIS-2 randomized clinical trial and the subsequent NASCIS-3 study. 1–4 However, these trials have resulted in considerable controversy. Some clinicians have called into question whether the results of NASCIS-2 and NASCIS-3 provide convincing evidence to support the use of methylprednisolone in acute spinal cord injury and have raised concerns regarding potential risks of this intervention. 5–8 The articles in this section by Drs. Bracken and Hurlbert reflect the spectrum of opinion regarding the use of steroids in acute spinal cord injury.

Members of the Spine Focus Panel extensively discussed the role of methylprednisolone in acute spinal cord injury but could not reach agreement on key points. While it was acknowledged that the NASCIS trials represent landmark clinical studies, no clear consensus could be reached on the appropriate use of steroids in acute spinal cord injury. Many members of the Spinal Focus Panel acknowledged that although methylprednisolone is only modestly neuroprotective, this drug is clearly indicated in acute spinal cord injury because of its favorable risk/benefit profile and the lack of alternative therapies. However, a significant minority was of the opinion that the evidence supporting the use of steroids in spinal cord injury was weak and did not justify the use of this medication.

The Spine Focus Panel did agree that given the devastating impact of spinal cord injury and the modest efficacy of methylprednisolone, clinical trials of other therapeutic interventions are urgently required. Many panel members also felt that a reanalysis of the NASCIS data might help to resolve the controversies surrounding the use of steroids in acute spinal cord injury. Of note, Dr. Bracken has agreed to release the data of the NASCIS trials for “protocol-driven research by qualified investigators.” This willingness to share the NASCIS data is to be applauded and may lead to further insights into the most appropriate clinical indications for methylprednisolone in acute spinal cord injury.

An editorial, which reflects the opinion of the Spinal Focus Panel Chair, regarding the use of steroids in acute spinal cord injury follows this summary statement and serves as a potential guide for clinicians.

References

1. Bracken MB, Shepard MJ, Collins WF Jr, et al. Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data: results of the Second National Acute Spinal Cord Injury Study. J Neurosurg 1992; 76: 23–31.
2. Bracken MB, Shepard MJ, Collins WF, et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of the Second National Acute Spinal Cord Injury Study. N Engl J Med 1990; 322: 1405–11.
3. Bracken MB, Shepard MJ, Holford TR, et al. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury: results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA 1997; 277: 1597–604.
4. Bracken MB, Shepard MJ, Holford TR, et al. Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. J Neurosurg 1998; 89: 699–706.
5. Coleman WP, Benzel D, Cahill DW, et al. A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury. J Spinal Disord 2000; 13: 185–99.
6. Hurlbert RJ. Methylprednisolone for acute spinal cord injury: an inappropriate standard of care. J Neurosurg 2000; 93: 1–7.
7. Nesathurai S. Steroids and spinal cord injury: revisiting the NASCIS 2 and NASCIS 3 trials. J Trauma 1998; 45: 1088–93.
8. Short DJ, El Masry WS, Jones PW. High dose methylprednisolone in the management of acute spinal cord injury: a systematic review from a clinical perspective. Spinal Cord 2000; 38; 273–86.
© 2001 Lippincott Williams & Wilkins, Inc.