For the first time ever, experts are recommending against the use of steroids early after an acute spinal cord injury.
The new recommendation is among 112 evidence-based recommendations contained in an updated document on the management of acute cervical spine and spinal cord injuries, released by the Congress of Neurological Surgeons (CNS) and the American Association of Neurological Surgeons (AANS).
The previous recommendation on steroid use had been a "marvelous waffle" in that it recommended the use of these agents as long as practitioners realized that the chance of causing harm was greater than the chance of causing good, Daniel K. Resnick, MD, professor, neurological surgery, University of Wisconsin School of Medicine and Public Health, Madison, and president-elect of the CNS, told Medscape Medical News.
"The way I look at it is that we're going back to the original data to basically correct something" that was done incorrectly in the past, said Dr. Resnick, who headed the review committee for the new guidelines.
The recommendations, which incorporate the newest available studies as well as scrutinize older studies, are published as a supplement to the March issue of Neurosurgery.
Mitchell S. Berger, MD, president of the AANS, and chairman of the Department of Neurological Surgery and Kathleen M. Plant Distinguished Professor at the University of California, San Francisco, said the new document was a joint effort between the AANS and CNS through the Joint Section on Trauma, under the auspices of their Washington Committee.
"We're very proud of the fact that this was a joint effort, done with members of both organizations to come up with these guidelines, which serve as really good, potentially useful tools for us to help patients," Dr. Berger told Medscape Medical News.
Still, he said, "I think it's also important to point out that we believe physicians must have autonomy and flexibility in how they pursue the optimal care for the patient."
Lack of Medical Evidence
The guidelines are an updated version of the original set of only 76 recommendations that was published in 2002. The new version has 19 level I recommendations, each supported by class I medical evidence. There are also 16 level II recommendations based on class II medical evidence and 77 level III recommendations based on class III medical evidence.
But because of the lack of relevant evidence, the new guidelines do not include recommendations on the use of hypothermia in the care of the patient with spinal cord injury (SCI) or on other areas of the management and treatment of these injuries.
In contrast to the old guidelines, a recommendation in the chapter "Pharmacological Therapy for Acute Spinal Cord Injury" is that methylprednisolone (MP) not be used for the treatment of acute SCI within the first 24 to 48 hours. The standard was revised because of the lack of medical evidence supporting the benefits of these drugs in the clinical setting. In fact, the report includes strong evidence that high-dose steroids are associated with harmful adverse effects.
In 2002, the initial recommendation from the writing committee was very similar to the current guidelines, but what actually appeared after review by the boards of the 2 parent organizations was much less clear, said Dr. Resnick, who authored the original document. It was a recommendation at an option level, or at a low level of confidence, he said.
"Now we're saying don't use steroids and are issuing that recommendation with a much higher level of confidence. "
Steroid use in this population has been associated with higher incidence of infections, sepsis, longer stays in the intensive care unit, increased complications, and sometimes death.
Dr. Berger also pointed to this new recommendation as one of the most significant in the new document. "I think this is a bit of a paradigm shift from where we were, thinking that high-dose steroids in the acute setting were very beneficial. We actually know that that's not the case; that steroids really didn't show the benefit we'd hoped in the long-term," he said.
This new recommendation appears to provide clear direction to practicing neurosurgeons. A member of the review committee, Langston Holly, MD, University of California at Los Angeles Medical Center,said that it will help provide "an immediate and beneficial impact on patient care."
"The present day usage of methylprednisolone is fueled by both a desire to do everything humanly possible for these tragically injured patients, as well as medicolegal concerns, which can be quite significant in some communities," said Dr. Holly. "The 2012 guidelines clearly state that methylprednisolone is not recommended in the management of acute SCI, and that there is no class I or II evidence to support its use. In stark contrast, there is class I to III evidence that this treatment is associated with harmful side effects."
Another substantial change to the guidelines relates to vertebral artery injury. The new document recommends screening imaging in most patients with significant spinal injuries whereas the old recommendations did not, said Dr. Resnick.
This presents a bit of a problem because doctors aren't sure what to do with these injured patients, he said. "The vast majority of them are asymptomatic, so while it does seem that imaging will demonstrate a lot of these injuries, there's not a lot of guidance on exactly what to do about them."
In addition, the new document includes other recommendations pertaining to the assessment of functional outcomes, the assessment of pain after SCI, radiographic assessment, diagnosis of Atlanto-occipital dislocation, and pediatric spinal injuries, among other areas.
Dr. Berger noted there are also recommendations about how best to transport patients and preferred imaging protocols with which to look for severe spinal cord injuries that may not be associated with a fracture.
"Many of us might imagine that for severe spinal cord injury to occur, you would have to see some kind of radiographic abnormality, like a fracture, but it turns out that there clearly are situations where there are no radiographic abnormalities, but there is severe spinal cord injury," Dr. Berger said. "One of the things that's changed is it points out there has to be attention to the entire axis of the spine, from the neck all the way down to the tailbone, to rule out any potential instability, even though there's not a fracture."
The 250-plus page document includes an easy-to-use summary table that illustrates the differences between the old and new guidelines. Readers can see at a glance whether a recommendation has changed and where a recommendation is introduced for the first time.
For surgeons who have a lot of information coming at them all the time, "having a table that sort of succinctly says 'here's what's new' is useful," said Dr. Resnick.
A key change is in the nomenclature. For example, "standards" has been replaced by "level I," "guidelines" has been replaced by "level II," and "options" is now known as "level III."
As mentioned previously, there are some topics that the updated guidelines don't broach simply because definitive medical evidence in the literature is insufficient. For example, the guidelines do not address the use of hypothermia or the timing of surgery after acute traumatic cervical spinal injury.
"It might have been a bit of an oversight not to at least have commented on them," said Dr. Resnick, adding that the spine section of his organization does have a position statement on hypothermia. "If there was a guideline, it would have been that there's not enough evidence to support a recommendation."
As for timing of surgery, "it's thus far been impossible to prove that earlier surgery improves outcomes even though we all believe it," said Dr. Resnick.
He pointed to a recent study, the Surgical Trial in Acute Spinal Cord Injury Study (STASCIS), published online in PlosONE February 2012, that found patients with cervical spine injuries were twice as likely to have major neurologic recovery when surgery was done within 24 hours, but this could have more to do with the fact that these patients had fewer complications than with timing of surgery. An important issue with timing cutoffs is that studies variably use 24 hours, 48 hours, or 72 hours, said Dr. Resnick.
There is also no guideline on the use of electrophysiologic monitoring during surgery for SCI. This area is a bit of a "sticky wicket," said Dr. Resnick, because there is so little literature related to trauma. "There would be a series of 1000 patients and of these, maybe 100 had trauma, so trying to figure out how to interpret the data with regard to the trauma patients was very difficult."
The revised guidelines got accolades from practicing neurosurgeons who were part of the review process and submitted commentaries that appear with the document. For example, Dr. Holly said the authors should be congratulated for their excellent work. "This was an arduous and challenging task that was completed in an elegant and outstanding fashion."
Jeffrey W. Cozzens, MD, professor and chair, Division of Neurosurgery, Southern Illinois University School of Medicine, Springfield,called the document "an outstanding achievement" even though some recommendations (eg, those on the management of acute traumatic central cord syndrome) are repeated.
"Overall, the methodology is sound and the results are solid," he told Medscape Medical News. "I congratulate the authors for not being tempted to comment on popular but yet inadequately studied topics, such as hypothermic treatment of acute spinal cord injury, just because this topic appears in the newspapers."
However, Dr. Cozzens questioned the recommendation that patients with acute cervical spine injury or SCI be transported when possible to specialized acute SCI treatment centers. "What makes an institution a 'specialized acute spinal cord injury treatment center'? Are these centers designated by a governmental agency/regulatory body, or are they self-designated?"
Dr. Resnick explained that the reason the recommendation does not stipulate level 1 trauma center is that lots of centers around the country are level 2 centers and are "perfectly capable" of taking care of patients with SCI. "We just wanted to get message across that there should be expertise to manage these patients."
And for J. Adair Prall, MD, South Denver Neurosurgery, Littleton, Colorado, the new guidelines are "very tightly tied" to the available evidence in the literature.
"Features such as a summary of changes between the 2 sets of guidelines, and evidence tables that are easy to cross-reference with text and recommendations, make this edition more accessible than ever before."
Neurosurgery. 2013;72:1-259. Full text
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Cite this: New CNS/AANS Guidelines Discourage Steroids in Spinal Injury - Medscape - Mar 28, 2013.