The jury is finally in — all the way in — on the early use of steroids for treating spinal cord injury.
New evidence-based recommendations from two neurological associations for treating acute spine and spinal cord injuries in adults state unequivocally that methylprednisolone is not recommended. The document from the American Association of Neurological Surgeons and the Congress of Neurological Surgeons goes on to add that high-dose steroids are associated with harmful side effects, including death. (Neurosurgery 2013;72:93.)
These conclusions probably won't surprise many neurosurgeons or many emergency physicians, for that matter, and certainly not most of those who work in hospitals with trauma centers. A literature search for “methylprednisolone” and “spinal cord injury” quickly yields papers that call the drug “an inappropriate standard of care,” label its usefulness as a “myth,” and point out its “failure” to improve outcome.
NASCIS II initially appeared to find benefit in early use of methylprednisolone, but the unusual way in which the results were originally released in 1992 led to two decades of controversy, confusion, and defensive medicine, said Mark N. Hadley, MD, a contributor to the NASCIS studies and a lead author of the 2002 version of the guidelines, which were far more equivocal on steroids and spinal cord injury.
“Back when we first completed the NASCIS II trial, we thought it was the greatest thing since sliced bread,” he said. “At first we believed, oh, my gosh, we have a treatment.”
NASCIS II's findings initially went out in faxes and announcements from the National Institutes of Health to emergency physicians and the public via the news media before the final data were in, an unusual departure from scientific reporting practice. “No medical discovery has ever been brought forward like that,” said Dr. Hadley. “The public, hospitals, and CEOs just assumed this all to be fact. But as we looked at the data from a statistical analysis and medical evidence standpoint, there was no proof of benefit related to the use of steroids.”
Indeed, the primary analysis of NASCIS II was negative, and positive results were only found in a post hoc analysis of a small subgroup of patients. But the ball had already started rolling downhill. It was an era of defensive medicine, and emergency physicians, neurosurgeons, and others involved in caring for acute spinal cord injuries feared being sued if they didn't give steroids.
Michael T. Fitch, MD, PhD, an associate professor of emergency medicine at Wake Forest School of Medicine in North Carolina, recalled doubt and debate on using steroids from his early days in practice.
“I can remember patients being transferred to my facility from smaller institutions, and the referring physician calling me and saying, ‘I know it probably doesn't work, but I guess I need to start steroids, right?’ Everyone knew the data didn't support it very strongly, but we felt we had to,” said Dr. Fitch, who has lectured about the controversy and appeared in Audio-Digest Emergency Medicine. “It was very frustrating. It came down to the perception of medicolegal risk. With something like spinal cord injury that has devastating outcomes for a lot of patients and not many great treatments that can be started in the acute phase, it felt like the only thing we had.”
That was likely part of the reason the authors of the 2002 version of the AANS/CNS guidelines, Dr. Hadley included, used some of the squishiest language ever used by professional medical societies in addressing the practice. “There is insufficient evidence to support treatment standards. Methylprednisolone for either 24 or 48 hours is recommended as an option in the treatment of patients with acute spinal cord injuries that should be undertaken only with the knowledge that the evidence suggesting harmful side effects is more consistent than any suggestion of clinical benefit,” that document noted.
“I felt like I knew what was meant by that,” Dr. Fitch said, chuckling. “To me, that was a very clear statement. I can only imagine the spirited discussions and arguments that led to that language.”
The body of evidence suggesting that harm outweighed benefit continued to accumulate. Most recently, Japanese researchers showed that patients receiving high-dose methylprednisolone after spinal cord injury had a significantly increased risk of major complications — gastrointestinal ulcer and bleeding, in particular — although they had no increased mortality. (Emerg Med J 2013 Feb 28. [Epub ahead of print].)
Still, Dr. Fitch noted that the belief persisted that there might be some small clinical benefit in certain populations. “One of my trauma colleagues suggested the situation of a patient with, say, a high cervical injury, where a tiny improvement in the injury level might have a large benefit to the patient. Yes, there are risks involved with high-dose steroids, but in such cases might the risk be worth it where a small chance of recovery could be clinically meaningful? But we didn't have any evidence or guidance for the selection of patients.”
Indeed, even today, Dr. Hadley said, some in neurosurgery circles still argue that using steroids in acute spinal cord injuries has a beneficial effect, at least among some subsets of patients. He said he hoped the new guidelines would mitigate that practice.
“The accumulated evidence shows us that there is no proven benefit in any age group at any time,” he said. “In the acute setting for spinal cord injury, what is most important is to immobilize the patient, get blood pressure up if it's marginal or low, and proceed rapidly through evaluation and triage in order to get the patient prompt medical attention at a facility best able to manage these injuries. You don't need to stop and give them steroids.”
The new guidelines will alleviate the pressure to take that step in institutions where it still lingers, Dr. Fitch said. “Time has passed. We have had more experience. People now see that others aren't doing this. Now that we have some new guidelines that are much clearer in terms of how to put that original data in context, it sends a much clearer message, and it will be a much easier conversation when it does come up, which I suspect will be less and less often.”
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