NASCIS I
NASCIS I Trial Summary
Objective
The NASCIS I (National Acute Spinal Cord Injury Study I) trial aimed to evaluate the efficacy of high-dose versus standard-dose methylprednisolone in improving neurological recovery in patients with acute spinal cord injury.
Methods
- Design: Multicenter, double-blind, randomized controlled trial.
- Participants: 330 patients with acute spinal cord injury were randomized to receive either a high dose (1,000 mg bolus followed by daily doses for ten days) or a standard dose (100 mg bolus followed by daily doses for ten days) of methylprednisolone.
- Outcome Measures: Neurological recovery of motor function, pinprick, and light touch sensation was assessed six weeks and six months post-injury. Morbidity and mortality were also analyzed.
Results
- Neurological Recovery: No significant difference was observed in the neurological recovery of motor function, pinprick, or light touch sensation between the high-dose and standard-dose groups at six weeks and six months post-injury.
- Adverse Events: Early case fatality was higher in the high-dose group (relative risk of 3.1 within 14 days and 1.9 within 15-28 days post-injury) but not statistically significant from 29 to 210 days post-injury. Wound infections were more prevalent in the high-dose group (relative risk of 3.6).
Conclusion
The NASCIS I trial found no significant difference in neurological recovery between high-dose and standard-dose methylprednisolone treatments in patients with acute spinal cord injury. However, the high-dose regimen was associated with higher early mortality and increased wound infection rates. These findings suggest that the standard-dose regimen may be preferable due to a better safety profile.
Reference
Bracken MB, Collins WF, Freeman DF, et al. Efficacy of methylprednisolone in acute spinal cord injury. JAMA 1984; 251: 45-52. File:NASICS1.pdf