NASCIS II

NASCIS II Trial Summary

Objective

The NASCIS II (National Acute Spinal Cord Injury Study II) trial aimed to evaluate the efficacy of high-dose methylprednisolone and naloxone in improving neurological recovery in patients with acute spinal cord injury.

Methods

• Design: Multicenter, double-blind, randomized controlled trial.
• Participants: 487 patients with acute spinal cord injury were randomized to receive either high-dose methylprednisolone, naloxone, or placebo.
• Outcome Measures: Neurological recovery of motor function and sensory function (pinprick and light touch sensation) was assessed six weeks and six months post-injury. Morbidity and mortality were also analyzed.

Results

• Neurological Recovery: Patients treated with high-dose methylprednisolone showed significant improvement in motor function and pinprick sensation at six months compared to the placebo group. Naloxone treatment did not show a significant difference in neurological recovery compared to placebo.
• Adverse Events: The rate of complications did not differ significantly between the groups, although there was a trend towards higher wound infection rates in the methylprednisolone group.

Conclusion

The NASCIS II trial demonstrated that high-dose methylprednisolone significantly improves neurological recovery in patients with acute spinal cord injury if administered within eight hours of injury. Naloxone did not show similar benefits. These findings support the use of high-dose methylprednisolone as a standard treatment for acute spinal cord injury.

Reference

Bracken MB, Shepard MJ, Collins WF, et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. N Engl J Med 1990; 322: 1405-1411.