番茄社区

Dexamethasone treatment failed to demonstrate noninferiority to surgery for chronic subdural hematoma and was associated with more complications and a greater risk of later surgery, according to results of a randomized study terminated early due to safety and outcome concerns.

In the trial, the odds ratio of a better functional outcome score with dexamethasone versus burr-hole drainage landed at 0.55 (95% CI 0.34-0.90), with the lower CI bound needing to avoid dipping below 0.90 for noninferiority.

Complications occurred in 59% of the patients in the dexamethasone group and 32% of the surgery group. Additional surgery was performed in 55% and 6%, respectively, reported researchers led by Ishita Miah, MD, PhD, of Amphia Hospital in Breda, the Netherlands.

"The trial was not designed to test the superiority of either approach, but most results numerically favored surgery," the team wrote in the .

Subdural hematoma often is treated with surgical evacuation but the procedure can be risky and may lead to death, the authors noted. Some have proposed glucocorticoid therapy as an alternative to surgery.

Dexamethasone has the potential to block inflammatory changes in the subdural space. It is administered in some institutions as an adjunct to surgery, but whether it could replace initial surgery as a stand-alone treatment was unclear, Miah and colleagues noted.

A found that patients who had mostly undergone initial operations for chronic subdural hematoma had fewer favorable outcomes and more adverse events with dexamethasone than placebo, but fewer repeat operations for hematoma recurrence were performed in the dexamethasone group. A found worse outcomes with the use of dexamethasone compared with surgery.

The search goes on "for effective agents to combat angiogenesis, inflammation, and fibrinolysis that are present in chronic subdural hematomas," wrote Ossama Al-Mefty, MD, of Brigham and Women's Hospital and Harvard School of Medicine in Boston, in an .

"The matter is not likely to be cleanly settled by clinical trials, regardless of the level of evidence," partly because "what we uncritically call chronic subdural hematoma arises from several entities," each with its own particular circumstances and potentially modifying treatments, Al-Mefty noted.

"Simply stated, the treatment of chronic subdural hematomas needs to be individualized according to the patient's condition and the cause of the hematoma, and this type of care beats algorithms," he concluded.

The DECSA trial ran from 2016 to 2021 and included 252 patients with symptomatic chronic subdural hematoma. It randomized 127 people to a 19-day tapering course of dexamethasone and 125 people to burr-hole drainage. Mean age was 74 and 77.4% were male. Overall, 75.4% had known head trauma before chronic subdural hematoma developed.

Burr-hole drainage was performed a median of 2 days after randomization for the surgery group. The primary outcome was the functional outcome at 3 months after randomization, measured by modified Rankin scale scores.

Secondary outcomes generally supported the primary analysis, including 3-month scores on the Markwalder Grading Scale and the Extended Glasgow Outcome Scale.

Mean hematoma thickness at 2 weeks was 15.7 mm (left side) and 17.1 mm (right side) for the dexamethasone group and 17.1 mm and 12.5 mm for the surgery group. Additional therapy after the index treatment was received by 60.6% of the dexamethasone group and 16.8% of the surgery group.

In the dexamethasone group, 144 adverse events occurred, versus 89 in the surgery group. Serious adverse events were 102 and 65, respectively. Infection was reported in 22.8% and 19.2% of patients in the respective groups. The mean length of hospital stay was 12 days and 6.8 days.

Limitations included a smaller than expected number of patients enrolled, the researchers noted. Open-label study design and local practices may have influenced the timing and decision to perform surgery on patients after dexamethasone treatment.

Most participants had slight-to-moderate focal neurologic deficits and the findings apply mainly to that group. Also, patients randomized to dexamethasone had higher functional impairment at admission than the surgery group, though this was adjusted for in the analyses.

Comment