Study design: The authors review the evidence supporting the role of glucocorticosteroids in spinal cord injury, critique published studies, and provide recommendations for steroid use in this complex and difficult problem.
Objectives: The authors detail the evolution of the use of glucocorticosteroids for acute spinal cord injury and objectively assess the results of NASCIS I and II.
Summary of background data: Glucocorticosteroids were first used in patients with acute spinal cord injury in the 1960s. An initial randomized clinical trial (NASCIS I) did not demonstrate a difference in outcome between the low- and high-dose steroid therapy. A subsequent study (NASCIS II) demonstrated that a treatment could enhance neurologic recovery.
Methods: The authors critically review the preclinical studies of glucocorticosteroids, NASCIS I and NASCIS II: The majority of the critique focuses on NASCIS II and independent analysis of the data generated by that trial.
Results: NASCIS II suggests clinical benefit from high-dose intravenous methylprednisolone therapy. The true benefit of steroid therapy is unclear because of the difference in outcome of the two placebo groups who entered the protocol before and after 8 hours. The initial promising results may be negated by the better recovery of the delayed treatment and/or untreated group of patients in the greater than 8-hour placebo group. However, until the raw patient data from NASCIS II is made available for independent review, the actual benefit of intensive steroid therapy will remain elusive.
Conclusions: Even with the controversies and unresolved issues, we advocate initiation of intensive glucocorticosteroid therapy as soon as possible after acute spinal cord injury, and not beyond the first 8 hours. There is too much data available to arrive at any other conclusion.