Writing in Emergency Medicine Journal, Hirotaka Chikuda (Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, Tokyo, Japan) and others report that administration of high-dose methylprednisolone in patients with acute spinal cord injury is associated with a significant increase in major complications—in particular, gastrointestinal bleeding. However, the drug is not associated with an increase in mortality.
Chikuda et al note that many hospitals across the globe adopted the practice of administering high-dose methylprednisolone in patients with an acute spinal cord injury after the National Acute Spinal Cord Injury Studies (NASCIS) indicated that the drug was associated with greater neurological improvement in these patients. However, the authors add that subsequent studies have indicated that high-dose methylprednisolone increases the risk of complications (possibly even death) and have raised doubts about the efficacy of this treatment. The authors comment: “Despite widespread use of this treatment, information from high-level evidence about the risks associated with high-dose methylprednisolone is lacking.” They therefore conducted a retrospective observational study to examine the risks of using high-dose methylprednisolone in patients with acute cervical spinal cord injury.
Using data from the (Japanese) Diagnosis Procedure Combination Database, Chikuda et al identified 812 matched pairs of patients with an acute cervical spinal cord injury who received ≥500mg high-dose methylprednisolone starting on the day of admission patients and control patients who did not receive high-dose methylprednisolone (including those who received
Patients who received high-dose methylprednisolone did not have a significantly increased rate of death compared with the control group—2.8% vs. 3%, respectively; p=0.884. However, the high-dose methylprednisolone group did have significantly more major complications (17.7% vs. 11.8%; p=0.001), including gastrointestinal bleeding (8.4% vs. 3.8%; p=0.001). The authors note: “After adjustment for the measure confounders, the high-dose methylprednisolone group was significantly more likely to have major complications than the control group (odds ratio 1.66; p=0.001).”
According to Chikuda et al, because of their findings and those of others, a “strong case” exists for a randomised placebo-controlled trial to re-examine the potential benefit of high-dose methylprednisolone in patients with acute spinal cord injury. They add that a problem with the NASCIS results is that the benefit that was observed with high-dose methylprednisolone was only seen in a post-hoc subanalysis rather than in the primary comparison. Concluding, Chikuda et al write: “We believe that the findings of our study provides critical information on the risks associated with high-dose methylprednisolone administration in patients with spinal cord injury and thus, may help physicians make a more informed decision on the use of this highly controversial treatment.”
Chikuda told Spinal News International: “Although the effect of high-dose methylprednisolone may not be as dramatic as previously thought, I am still looking forward to further confirmatory trials with modern design, given that this relatively low-cost treatment is readily available around the world.
Last year, in a joint guideline, the Congress of Neurological Surgeons and the American Association of Neurological Surgeons said that they no longer recommended high-dose methylprednisolone in acute spinal cord injury because of the lack of medical evidence supporting its use in this area.