R J Hurlbert1. 1. University of Calgary Spine Program, Foothills Hospital and Medical Centre, Alberta, Canada. jhurlber@ucalgary.ca
Abstract
OBJECT: Since publication in 1990, results from the National Acute Spinal Cord Injury Study II (NASCIS II) trial have changed the way patients suffering an acute spinal cord injury (SCI) are treated. More recently, recommendations from NASCIS III are being adopted by institutions around the world. The purpose of this paper is to reevaluate carefully the results and conclusions of these studies to determine the role they should play in influencing decisions about care of the acutely spinal cord-injured patient. METHODS: Published results from NASCIS II and III were reviewed in the context of the original study design, including primary outcomes compared with post-hoc comparisons. Data were retroconverted from tabular form back to raw form to allow direct inspection of changes in treatment groups. These findings were further analyzed with respect to justification of practice standards. Although well-designed and well-executed, both NASCIS II and III failed to demonstrate improvement in primary outcome measures as a result of the administration of methylprednisolone. Post-hoc comparisons, although interesting, did not provide compelling data to establish a new standard of care in the treatment of patients with acute SCI. CONCLUSIONS: The use of methylprednisolone administration in the treatment of acute SCI is not proven as a standard of care, nor can it be considered a recommended treatment. Evidence of the drug's efficacy and impact is weak and may only represent random events. In the strictest sense, 24-hour administration of methylprednisolone must still be considered experimental for use in clinical SCI. Forty-eight-hour therapy is not recommended. These conclusions are important to consider in the design of future trials and in the medicolegal arena.
OBJECT: Since publication in 1990, results from the National Acute Spinal Cord Injury Study II (NASCIS II) trial have changed the way patients suffering an acute spinal cord injury (SCI) are treated. More recently, recommendations from NASCIS III are being adopted by institutions around the world. The purpose of this paper is to reevaluate carefully the results and conclusions of these studies to determine the role they should play in influencing decisions about care of the acutely spinal cord-injured patient. METHODS: Published results from NASCIS II and III were reviewed in the context of the original study design, including primary outcomes compared with post-hoc comparisons. Data were retroconverted from tabular form back to raw form to allow direct inspection of changes in treatment groups. These findings were further analyzed with respect to justification of practice standards. Although well-designed and well-executed, both NASCIS II and III failed to demonstrate improvement in primary outcome measures as a result of the administration of methylprednisolone. Post-hoc comparisons, although interesting, did not provide compelling data to establish a new standard of care in the treatment of patients with acute SCI. CONCLUSIONS: The use of methylprednisolone administration in the treatment of acute SCI is not proven as a standard of care, nor can it be considered a recommended treatment. Evidence of the drug's efficacy and impact is weak and may only represent random events. In the strictest sense, 24-hour administration of methylprednisolone must still be considered experimental for use in clinical SCI. Forty-eight-hour therapy is not recommended. These conclusions are important to consider in the design of future trials and in the medicolegal arena.