Abstract
Background:
Chronic subdural hematoma is a common neurological disorder, especially prevalent among older people. The effect of dexamethasone on the outcome of patients with chronic subdural hematoma has not been well studied.
Methods:
From 2015 through 2019 we randomly assigned adult patients in the U.K. with symptomatic chronic subdural hematoma in a 1:1 ratio to receive a two-week tapering course of oral dexamethasone starting at 8 mg orally twice daily, or placebo. The decision to surgically evacuate the hematoma was made by treating clinicians. The primary outcome was the difference between the two groups in the modified Rankin Scale dichotomized as a score of 0 to 3, representing favorable outcome (mRS, range 0 [no symptoms at all] to 6 [death]) at 6 months.
Results:
A total of 748 patients were included in the trial, 375 assigned to receive dexamethasone and 373 to receive placebo. The mean age of patients was 74 years and 94% had surgical treatment of their hematomas; 60% in both groups had mRS 1-3 on admission. In a modified intention to treat analysis, favorable outcome of mRS 0-3 occurred in 286/341 (83.9%) of patients receiving dexamethasone compared to 306/339 (90.3%) receiving placebo (difference, 6.4 percentage points favoring placebo; 95% confidence interval [CI] -11.4% to -1.4%; P=0.01). Repeat surgery for recurrence of the hematoma occurred in 25/350 (7.1%) in the placebo arm versus 6/349 (1.7%) in the dexamethasone arm, for whom data were available. The dexamethasone group had more adverse events.
Conclusions:
In adults with symptomatic chronic subdural hematoma, most of whom had surgical treatment of the hematoma, dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo but fewer repeat surgeries at 6 months.
Chronic subdural hematoma is a common neurological disorder, especially prevalent among older people. The effect of dexamethasone on the outcome of patients with chronic subdural hematoma has not been well studied.
Methods:
From 2015 through 2019 we randomly assigned adult patients in the U.K. with symptomatic chronic subdural hematoma in a 1:1 ratio to receive a two-week tapering course of oral dexamethasone starting at 8 mg orally twice daily, or placebo. The decision to surgically evacuate the hematoma was made by treating clinicians. The primary outcome was the difference between the two groups in the modified Rankin Scale dichotomized as a score of 0 to 3, representing favorable outcome (mRS, range 0 [no symptoms at all] to 6 [death]) at 6 months.
Results:
A total of 748 patients were included in the trial, 375 assigned to receive dexamethasone and 373 to receive placebo. The mean age of patients was 74 years and 94% had surgical treatment of their hematomas; 60% in both groups had mRS 1-3 on admission. In a modified intention to treat analysis, favorable outcome of mRS 0-3 occurred in 286/341 (83.9%) of patients receiving dexamethasone compared to 306/339 (90.3%) receiving placebo (difference, 6.4 percentage points favoring placebo; 95% confidence interval [CI] -11.4% to -1.4%; P=0.01). Repeat surgery for recurrence of the hematoma occurred in 25/350 (7.1%) in the placebo arm versus 6/349 (1.7%) in the dexamethasone arm, for whom data were available. The dexamethasone group had more adverse events.
Conclusions:
In adults with symptomatic chronic subdural hematoma, most of whom had surgical treatment of the hematoma, dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo but fewer repeat surgeries at 6 months.
| Original language | English |
|---|---|
| Pages (from-to) | 2616-2627 |
| Number of pages | 12 |
| Journal | The New England Journal of Medicine |
| Volume | 383 |
| Early online date | 16 Dec 2020 |
| DOIs | |
| Publication status | Published - 31 Dec 2020 |
Keywords
- Neurology
- neurosurgery
- brain injuries
- intracranial hematoma
- randomized controlled trial