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Published on: February 27, 2018
Corticosteroids as an Adjuvant Treatment to Surgery in Chronic Subdural Hematomas: A Multi-Center Double-Blind
Sam Ng1, Julien Boetto1, Héléna Huguet2,3
1Department of Neurosurgery, Gui de Chauliac Hospital, Montpellier University Medical Center, Montpellier, France.
Insights
Corticosteroids like prednisone may reduce early radiological recurrence of chronic subdural hematoma (CSDH) after surgery. However, clinical benefits and reoperation rates were not significantly different, with increased sleep disorders observed.
Area of Science:
- Neurosurgery
- Clinical Trials
- Pharmacology
Background:
- Chronic subdural hematoma (CSDH) frequently recurs after surgical treatment, impacting patient outcomes.
- Adjuvant therapies are being investigated to improve surgical success rates for CSDH.
Purpose of the Study:
- To evaluate the efficacy of corticosteroids (prednisone) as an adjuvant treatment to surgery for reducing CSDH recurrence.
- To assess the impact of prednisone on radiological resolution, reoperation rates, safety, and quality of life in CSDH patients.
Main Methods:
- Prospective, randomized, double-blind, placebo-controlled, multi-centric HEMACORT trial (NCT01380028).
- Participants received either oral prednisone (1mg/kg/day with tapering) or placebo post-surgery.
- Primary outcome: CSDH recurrence (reoperation or radiological progression) at 6 months.
Main Results:
- No significant difference in clinicoradiological recurrence between prednisone and placebo groups in intention-to-treat analysis (21.8% vs. 35.1%, p=0.06).
- Post hoc analysis suggested statistical significance (p=0.02). Earlier radiological resolution observed with prednisone.
- No difference in reoperation rates or functional outcomes at 6 months; increased sleep disorders in the prednisone group.
Conclusions:
- Prednisone may reduce early radiological recurrence of CSDH post-surgery, but clinical benefits remain unclear.
- Further trials are needed to assess shorter treatment durations for safety and efficacy.
- Adjuvant corticosteroid therapy requires careful consideration of risk-benefit profile in CSDH management.
Abstract:
Chronic subdural hematoma (CSDH) is a common condition necessitating surgery; however, recurrence occurs in 15-25% of cases despite surgical management. The HEMACORT trial was a prospective randomized, double-blind, placebo-controlled, multi-centric study (NCT01380028). The aim of this trial was to determine the effect of corticosteroids as an adjuvant treatment to surgery on CSDH recurrence at 6 months. After surgery, participants were assigned by block-randomization to receive either placebo or oral prednisone at a dose of 1 mg/kg/day followed by weekly stepwise tapering in steps of 10 mg/day. The primary outcome was CSDH recurrence, defined by the need for reoperation and/or radiological progression of CSDH. Secondary outcomes were one-year death, radiological changes, safety, neurological status, and quality of life. The trial was discontinued at midpoint of expected inclusions: 78 participants received prednisone and 77 received placebo controls. In an intention-to-treat analysis, CSDH clinicoradiological recurrence was not different between prednisone and placebo groups (21.8% vs. 35.1%, respectively; hazard ratio 0.56; 95% confidence interval 0.30-1.02; p = 0.06), although post hoc analyses concluded to statistical significance (p = 0.02). Earlier radiological resolution was observed after prednisone administration, but reoperation rates (reaching 5.8% overall) and functional outcomes were not different at 6 months. Among adverse events, sleep disorders occurred more often in the prednisone group (26.1% vs. 9.1%, p = 0.02). The HEMACORT trial data suggest that prednisone, as an adjuvant treatment to surgery, may reduce early radiological recurrence of CSDH, although clinical benefits are unclear. In view of these findings, the authors suggest that shorter treatment duration should be assessed for safety and efficacy in future trials.
