Failure to administer methylprednisolone for acute traumatic spinal cord injury—a prospective audit of 100 patients from a regional spinal injuries unit
Introduction
Evidence based medicine was defined by Sackett et al. [1] as being the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” The randomised controlled trial usually provides the best quality evidence. Because small volume surgical specialities do not lend themselves to randomised controlled trials there are only a few areas in which Evidence Based Medicine can be practiced. One notable exception is the use of methylprednisolone in spinal cord injury [2], [3]. Methylprednisolone is thought to improve extracellular calcium ion recovery and therefore produce a local vasodilation response in the contused spinal cord [4]. Methylprednisolone also inhibits lipid peroxidation and hydrolysis at the injured region of the spinal cord [5]. The breakdown of the membranes at the injured site begins and peaks within the first 8 h [6], [7] and this coincides with the treatment window defined by the NASCIS. The value of methylprednisolone is currently being evaluated for head injuries in the CRASH study [8].
The NASCIS that were published in 1990 [2] and 1997 [3], respectively, reported improved neurological outcome in patients treated with high dose methylprednisolone following acute traumatic spinal cord injury. The NASCIS II concluded that methylprednisolone should be given if a spinal cord injured patient was seen less than 8 h after their injury. Initially, a bolus dose of 30 mg/kg body weight should be administered followed by an infusion of 5.4 mg/kg for 23 h. No benefit was seen in patients treated after 8 h. The NASCIS III went a step further. It stated that, if a patient was seen within 3 h of their injury they should be treated according to the NASCIS II protocol but if they were seen between 3 and 8 h the 5.4 mg/kg infusion of methylprednisolone should be continued for 48 h. Despite the findings of the NASCIS, management of acute traumatic spinal cord injury in the United Kingdom often falls short of the recommendations outlined by Bracken et al [2], [3]. In the US, a physician who fails to implement the methylprednisolone protocol runs the risk of medicolegal action [9].
The NASCIS are the only two randomised double blind controlled trials that we have to date in the treatment of traumatic acute spinal cord injury with methylprednisolone. These studies, however, have been criticised on a number of accounts. Before their findings were published, the National Institute for Health in the United States released the results of the study and outlined the protocol for administration of methylprednisolone. Abbreviated versions of the results also found their way into the popular press. These studies are unlikely to be repeated in the US because of medicolegal constraints. Further, placebo controlled trials would be difficult to undertake because of the documented beneficial therapeutic effect of methylprednisolone apparently demonstrated by the NASCIS.
Despite the criticisms of the studies, if we are to practice evidence based medicine in the treatment of the spinal cord injured patient [10], it seems reasonable to assume that virtually all of these patients in the UK should receive methylprednisolone following an acute traumatic spinal cord injury. To test this hypothesis, we undertook a prospective analysis of patients admitted to the Royal National Orthopaedic Hospital (Regional Spinal Injuries Unit) over a 2 years period after the publication of the NASCIS III.
Section snippets
Methods
Patient data, including sex, age, date and time of injury, date of referral and admission to the Royal National Orthopaedic Hospital, the referring hospital, the admission Frankel grade (A–D) and ASIA neurological classification [11] were all recorded prospectively onto a database. One hundred consecutive patients with incomplete and complete spinal cord injuries over a 2 years period were included in the study. We adhered to the exclusion criteria in the NASCIS. The medical management of all
Results
There were 28 females and 72 males in our study. The average age of the patients was 39 years (95% confidence intervals 38–41 years). Ninety-two percent of the patients were referred by Orthopaedic surgeons and the remaining 8% by Neurosurgeons. The 46 of the 100 patients had cervical cord injuries, and 54 had thoracolumbar injuries. Out of 100 patients, five in the study had documented head injuries that hindered neurological testing. Only 25% of the patients in our study were given
Discussion
Traumatic spinal cord injury is a devastating event and every attempt should be made to restore the patient to their best possible functional ability. The findings of both the NASCIS [2], [3] and the Cochrane review [10] on pharmacological interventions for acute spinal cord injury advocate the use of methylprednisolone in the early management in order to reduce the extent of neurological disability.
A number of recent papers [12], [13], [14] however, have strongly criticised the NASCIS. A
Conclusion
ATLS and the Cochrane review state that methylprednisolone should be administered to patients with an acute traumatic spinal cord injury. These guidelines are not being implemented. If we do not believe the efficacy of the NASCIS then we have to repeat the studies or re-evaluate our guidelines.
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