Dexamethasone treatment was not noninferior with respect to functional outcomes and was associated with more complications
By Elana Gotkine HealthDay Reporter
THURSDAY, June 15, 2023 (HealthDay News) — For patients with chronic subdural hematoma, a 19-day tapering course of dexamethasone therapy is not noninferior to surgery with respect to functional outcomes at three months, according to a study published in the June 15 issue of the New England Journal of Medicine.
Ishita P. Miah, M.D., Ph.D., from Amphia Hospital in Breda, Netherlands, and colleagues enrolled 252 symptomatic patients with chronic subdural hematoma who were randomly assigned to a 19-day tapering course of dexamethasone or burr-hole drainage (127 and 125 patients, respectively). Due to safety and outcome concerns in the dexamethasone group, the trial was terminated early by the data and safety monitoring board.
The researchers found that the adjusted common odds ratio for a lower (better) score on the modified Rankin scale at three months was 0.55 for dexamethasone versus surgery, which failed to demonstrate noninferiority of dexamethasone. The scores on the Markwalder Grading Scale and Extended Glasgow Outcome Scale were generally supportive of these results. Complications occurred in 59 and 32 percent of patients in the dexamethasone and surgery groups, respectively; additional surgery was performed in 55 and 6 percent, respectively.
“Dexamethasone therapy was not found to be noninferior to surgery by burr-hole drainage,” the authors write. “Patients who received dexamethasone more frequently underwent additional surgery and had more adverse events than patients who initially had surgical drainage.”
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