Clear guidance needed on methylprednisolone indications for partial SCI

NEW ORLEANS — Methylprednisolone for incomplete spinal cord injury remains controversial based on a debate session held at the Congress of Neurological Surgeons Annual Meeting, here.

During the debate, R. John Hurlbert, MD, PhD, FRCSC, said surgeons need to ensure the drug’s use meets the larger clinical criteria of any intervention and the need for more level 1 studies for evidence to support its use. Michael G. Fehlings, MD, PhD, FRCSC, FACS, FRSC, said to let the surgeon referee use of the drug in challenging cases and its continued availability as a treatment option.

Hurlbert said the steroid is often contraindicated in incomplete spinal cord injury (SCI) cases. He discussed some weaknesses in results of the NASCIS II study by Bracken and colleagues, a multicenter, prospective, double-blind study in which 487 patients were randomized to receive one of three treatments. For the motor score results, where 0 is quadriplegia and 70 is normal, at the 12-month follow-up, the NASCIS II investigators did not provide data, but simply said, “the results were not statistically significant for 161 methylprednisolone patients and 170 placebo,” according to Hurlbert.

“How do we propose this as a treatment? The primary outcome measures are preplanned and intuitive, and they are all negative,” he said.

In addition, pinprick sensation test results were barely different between patients who received methylprednisolone and patients who received placebo by 12 months. He finished by saying of all the patients represented in the NASCIS II study, only 12 patients with incomplete SCI showed improvement.

“What is important to me is then, if you step back and look at the entire population setting, that is where we find our harmful side effects — significant in four of the class 1 randomized controlled studies on their entire population data set, including wound infection, hyperglycemia requiring insulin, GI hemorrhage and death.”

Fehlings said methylprednisolone is helpful in many instances, such as in the absence of polytrauma, cervical spine injuries and cases of incomplete injury.

“We need some options for treating our patient,” he said, noting the need for early decompression and stabilization in these patients cannot be underestimated.

Fehlings said a consensus meeting held in Toronto last month resulted in a key recommendation that makes sense for patients who sustain these devastating injuries.

“When started within 8 hours of injury we – the group – suggest that a 24-hour infusion of a high-dose level of methylprednisolone be offered to all patients with acute spinal cord injury as a treatment, as an option.”

There is bit of a trend toward gastrointestinal bleeds and other adverse events with the drug, but none are significant when the surgeon focuses on his or her patient, according to Fehlings.

“I think physicians and surgeons should have the option of when to use it and not to use it, but there is no consistent evidence that recommends against its use as a treatment option. Decisions around this should be left in your hands,” he said. – by Susan M. Rapp

Reference:

Controversy: Methylprednisolone in incomplete spinal cord injury: Contraindicated or helpful? Hurlbert RJ. Contraindicated. Fehlings MG. Helpful. Presented at: Congress of Neurological Surgeons Annual Meeting; Sept. 26-30, 2015; New Orleans.

Disclosures: Fehlings and Hurlbert report no relevant financial disclosures.