From the Guidelines
It is not recommended to administer steroids early on to improve the neurological prognosis after spinal cord injury. The current evidence, as outlined in the French recommendations for the management of patients with spinal cord injury or at risk of spinal cord injury 1, suggests that early administration of steroids does not improve post-traumatic neurological outcomes.
The rationale behind this recommendation is based on several randomised controlled trials, including the NACSIS 1, NACSIS 2, and NACSIS 3 trials, which investigated the role of methylprednisolone in patients with traumatic spinal cord injury 1. These trials found no significant difference in terms of neurologic improvement between patients treated with steroids and those who were not. Furthermore, the trials reported a higher rate of infectious complications in patients treated with steroids.
Key points to consider include:
- The NACSIS 1 trial compared two doses of steroids and found no difference in neurologic improvement, but a higher rate of infectious complications in the low-dose group 1.
- The NACSIS 2 trial found a modest improvement of motor scores at 6 months in patients treated with steroids within the first 8 hours, but also reported more infections in the steroid group 1.
- The NACSIS 3 trial found no better motor improvement in patients treated with a 48-hour administration of steroids, but a higher rate of infectious complications 1.
- A recent propensity score analysis of a large Canadian cohort found no beneficial effect of steroids on one-year motor function and more infectious pulmonary and urinary complications in patients treated with steroids 1.
Given the lack of evidence supporting the use of steroids in improving neurological outcomes after spinal cord injury, and the potential for increased infectious complications, the use of steroids is not recommended as part of the standard treatment regimen. Instead, treatment should focus on other evidence-based interventions that prioritize reducing morbidity, mortality, and improving quality of life.
From the FDA Drug Label
When high dose therapy is desired, the recommended dose of methylprednisolone sodium succinate for injection is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.
The steroid regimen for spinal cord injury is 30 mg/kg of methylprednisolone administered intravenously over at least 30 minutes, which may be repeated every 4 to 6 hours for 48 hours 2.
From the Research
Steroid Regimen for Spinal Cord Injury
The steroid regimen for spinal cord injury typically involves the administration of methylprednisolone sodium succinate. The recommended dose regimen is:
- Bolus 30mg/kg administered over 15 minutes
- Maintenance infusion of 5.4 mg/kg per hour infused for 23 hours 3, 4, 5
Extension of Methylprednisolone Therapy
Some studies suggest that extending the maintenance dose from 24 to 48 hours may provide additional benefit if treatment cannot be started until between 3 to 8 hours after injury 3, 4, 5, 6. However, one study found that there is insufficient evidence to support extending methylprednisolone infusion beyond 23 hours 7.
Key Points
- Methylprednisolone sodium succinate is the only pharmacological therapy shown to have efficacy in a Phase Three randomized trial when administered within 8 hours of injury 3, 4, 5
- High-dose methylprednisolone steroid therapy is the standard therapy in many countries 5
- The risk of bias was low in the largest methylprednisolone trials, and there was no evidence of significantly increased complications or mortality from the 23 or 48 hour therapy 4