By Matthew E. Fink, MD
Louis and Gertrude Feil Professor and Chair, Department of Neurology, Associate Dean for Clinical Affairs, New York Presbyterian/Weill Cornell Medical College
SOURCE: Miah IP, Holl DC, Blaaux J, et al. Dexamethasone versus surgery for chronic subdural hematoma. N Engl J Med 2023;388:2230-2240.
Chronic subdural hematomas are common disorders and may occur after minor trauma or no trauma. They are increasing in frequency with increasing use of antithrombotic medications. Our aging population has an increased risk of slips and falls, and this also has resulted in more frequent diagnoses of chronic subdural hematoma. Standard treatment for subdural hematomas has been evacuation of the hematoma by a burr hole craniotomy, with placement of subdural drains. However, there frequently are recurrent hematomas that result in the need for craniotomy, and there is risk of infection and death. For decades, nonsurgical therapies have been tried and proposed, including the use of corticosteroids. Various case series and nonrandomized trials of treatment with corticosteroids have been reported to show benefit, but efficacy of steroid therapy has been uncertain.
The current investigators designed a multicenter, open-label, controlled, noninferiority trial with random assignment of symptomatic patients with chronic subdural hematomas in a 1:1 ratio to either burr hole drainage or a 19-day tapering course of dexamethasone. The primary outcome was functional outcome three months after randomization as assessed by the modified Rankin Scale. Noninferiority was defined as the lower limit of the 95% confidence interval (CI) with an odds ratio for better functional outcome with dexamethasone compared to surgery at 0.9 or more.
A total of 252 patients were enrolled, with 127 patients assigned to the dexamethasone group and 125 patients to the surgery group. The mean age of the patients was 74 years and 77% were men. Although the planned sample size was 420, the trial was terminated earlier by the data and safety monitoring board because of concerns regarding safety and outcome in the dexamethasone group. The odds ratio for a better score on the modified Rankin Scale at three months with dexamethasone compared to surgery was 0.55 (95% CI, 0.34-0.90), which failed to show noninferiority of dexamethasone. Complications occurred in 59% of the patients in the dexamethasone group and 32% of the patients in the surgery group. Additional surgery had to be performed in 55% of the dexamethasone group.
The trial was stopped early and dexamethasone treatment was not found to be noninferior to burr hole drainage with respect to both functional outcomes as well as complications and greater likelihood of later surgery. In conclusion, treatment of chronic subdural hematoma with dexamethasone is not recommended.
