Spinal cord injury. Role of steroid therapy.

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.