Reuters Health – 16/12/2020 – Treating chronic subdural hematoma with dexamethasone may do more harm than good, producing less favorable outcomes and more side effects than placebo, according to a new U.K. study that randomized 748 patients.
Whether the treatment is useful “has been an unanswered question for decades,” chief author Dr. Peter Hutchinson of the University of Cambridge told Reuters Health by phone.
“I would hope and anticipate that doctors will stop using it. This has certainly changed our practice in Cambridge,” he said.
Nearly all of the participants had surgery to remove the hematoma during the index hospitalization. Glucocorticoid therapy did significantly lower the need for repeat operations, but the recurrence rate was low — 7.1% with placebo versus 1.7% among the dexamethasone recipients.
Dr. Hutchinson’s team assessed the treatment based on a primary outcome of 0 to 3 on the 7-point modified Rankin Scale, where a score of 6 indicated death.
Before randomization, 60% of patients had a score of 1, 2, or 3 with symptoms that included headache, confusion, weakness and memory loss.
Among the patients who could be evaluated, 83.9% of dexamethasone patients met the primary outcome after 6 months versus 90.3% of placebo recipients (P=0.01).
The rates of serious adverse events during the first 30 days were 16.0% with the glucocorticoid compared with 6.4% in the placebo group (P<0.001).
“Although the trial answers an important question that has lingered for 50 years by showing no benefit from glucocorticoids with respect to the disability outcome, it is perhaps less certain on the issue of whether glucocorticoids shrink the subdural collection and reduce the need for reoperations. The results of this trial reduce the enthusiasm for treating chronic subdural hematomas with glucocorticoids,” writes Dr. Allan Ropper in an editorial in the New England Journal of Medicine, where the study appears.
“The lower percentage of patients who had a favorable disability outcome and the occurrence of more adverse events in the dexamethasone group tip the scale against using the drug,” adds Dr. Ropper, a deputy editor at the journal.
The 30-day rate of death with dexamethasone treatment was 2.1%, significantly higher than the 0.5% with placebo; at six months, it was 8.8% versus 5.0%, respectively, a difference that fell just short of significance.
Doctors can now focus on other potential treatments and not be distracted by the dexamethasone debate, said Dr. Hutchinson. That’s important because “this pathology is going to become increasingly prevalent as the global population ages.”
The trial, conducted at 23 neurosurgical units, was funded by the U.K.’s National Institute for Health Research.
SOURCES: https://bit.ly/2WbduN0 and https://bit.ly/3gOfOmI The New England Journal of Medicine, online December 16, 2020.
By Gene Emery
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