Dear colleagues, it is an honour and a pleasure to have the opportunity to present the results of our trial on chronic subdural hematomas and corticosteroids. We will try to give as much information as possible, but considering the short time frame, some aspects of this work will be addressed once published. Chronic subdural hematoma is a very common pathology, which strongly relies on inflammatory cascades after an initial traumatic event. Considering this, neurosurgeons have proposed the use of corticosteroids as an alternative to surgery. However, despite interesting preclinical data, there is a lack of high-level studies reporting their efficacy. In that context, we designed a trial to assess the effect of methylprednisolone on chronic subdural hematomas. For that purpose, we designed a multicentric, randomized, double-blinded, placebo-controlled trial. The inclusion criteria were as follows. An age higher than 18. The presence of a chronic or subacute subdural hematoma diagnosed on a CT scan. And the absence of clinical or radiological signs of severity. Apart from the signs of severity, the non-inclusion criteria included the presence of diabetes, contraindications for methylprednisolone, a previously treated subdural hematoma within the last six months, pre-existing dementia, and long-term steroid treatment. All patients gave signed informed consent, and the trial was approved by an ethics committee. After a baseline assessment, patients were randomized between a placebo arm and a treatment of 1 mg per kg per day of methylprednisolone during three weeks. Dietetic advice was provided for all patients. Biological assessment was performed every week during the first month, with additional cortisol dosage at one month. Follow-up was performed at one, three, and six months, including clinical evaluation, cranial CT scan, as well as quality of life, functional, and cognitive assessments. The primary endpoint was the occurrence of surgery at one month follow-up. Secondary endpoints included the occurrence of surgery at three and six months, overall survival, quality of life, functional and cognitive evaluation, radiological improvement, biological tolerance, and adverse events monitoring. An intention to treat statistical analysis was performed. 202 patients were included. Some were lost to follow-up. Some stopped to follow-up or discontinued the treatment. Major deviations were found for four patients. Ninety-nine patients in each arm were eligible for final analysis. The general characteristics are shown on the right panel. All were well balanced between the two groups. The primary endpoint analysis showed a statistically significant difference between the two arms at one month, with four events in the steroid group compared to 12 in the placebo group. At six months follow-up, a difference still persists, even if less significant. The overall survival, not shown in this presentation, was not impacted by the treatment arm, with two deaths in the MP group and one in the placebo group. One major finding is that 82% of placebo patients did not require surgery. The analysis of quality of life performed through the SF12 score showed no difference between the two arms in the physical and mental scores. There was a significant increase over time in both groups in a comparable way. The functional outcome, assessed by IADL and MRS, was not influenced by methylprednisolone administration, but significantly improved over time in both groups. Superficial cognitive assessment, by the MMSE, was identical between the two groups, but also significantly increased over time. The radiological assessment showed similar improvement rates at one month and six months between the two groups, even if there was a trend toward faster improvement in the methylprednisolone group. Further analysis will be performed to find potential risk factors for conservative treatment failure. Data on biological tolerance showed that even if plasmatic sodium and potassium significantly decreased in the methylprednisolone group, the variations remained low and had no clinical consequences. Glycemia did not increase with methylprednisolone and even showed a trend to be lower. No related symptoms were noted. The analysis of general side effects showed significantly more neuropsychic side effects, mostly composed of transitory confusion and agitation. Endocrine disorders were also more frequent, mostly transitory glucocorticoid deficiency. However, three cases of long-term insufficiency requiring substitution happened in the methylprednisolone group. Gastrointestinal and musculoskeletal side effects related to methylprednisolone remained mostly benign. As a conclusion, this study showed that the use of methylprednisolone decreases the recourse to surgery for non-severe chronic subdural hematomas. However, the most striking finding is that the natural history of these hematomas yields a spontaneous healing rate of 82%. Considering that methylprednisolone had significant side effects, the risk-benefit balance has to be closely adapted to each patient. Subgroup analysis will be performed and might provide further insights. Thank you very much for your attention.

chronic subdural hematoma

corticosteroids

trial results

methylprednisolone

surgery