The Role of Dexamethasone in the Era of “Dex-CSDH” Randomized Controlled Trial. A Multicenter, Prospective Study on Specific Subset of Patients with Chronic Subdural Hematoma (CSDH) Treated with Dexamethasone Alone or Surgery

Abstract

Background:The efficacy of Dexamethasone as a method of conservative management for CSDH to avoid surgery remains inconclusive even after "Dex-CSDH" randomized controlled trial as almost all patients underwent an initial operation to remove the hematoma. Current study aims to determine the efficacy and safety of Dexamethasone alone therapy in comparison with the surgical drain of CSDH. Methods:A multicenter, prospective study on mild to moderately symptomatic adult patients with CSDH were performed from January 2019 to December 2020. The patients were enrolled in a 1:1 ratio to receive a 3-weeks tapering course of oral Dexamethasone, starting at 4 mg thrice daily, or surgical drain of CSDH. The patient was assigned to a particular therapy based on their preference. The primary outcome was functional outcome in each group at 6 months determined by mRS, and cure rate (symptomatic relief and radiological resolution of CSDH).Results: Twenty eights patients were assigned to Dexamethasone group and 30 patients to surgical group. The mean age of the patient was about 62 years in both groups with male predominance (>60%). A favorable outcome determined by mRS scale of 1 to 3 at 6 months follow-up was 25/28 (89.2%) in Dexamethasone group compared to 28/30 (93.3%) in surgical group (difference, -4.1 [95% CI, -6.8 to -2.2], p=0.12). The cure rate was 23/28 (82.1%) in Dexamethasone group compared to 28/30 (93.3%) in the surgical group during index admission (difference, [95% CI,] in favor of the surgical group, p=0.005). Recurrence rate for CSDH was 2/28 (7.1%) in Dexamethasone group compared to surgical group 4/30 (13.3%) which was statistically significant (p=0.01). Morbidity related to medical therapy was not statistically higher compared to surgical group. Conclusion:Current study exhibits superiority of surgery over Dexamethasone therapy for resolution of symptomatic CSDH. The recurrence rate of CSDH is lower in patients with corticotherapy compared to surgical drain. Patients in Dexamethasone group did not have functional outcome at 6 months or morbidity significantly higher than surgical group. This study strongly puts forward the utility of Dexamethasone as an effective and safe alternative to surgery for CSDH.

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population

“…Dexamethasone has also been shown to reduce the occurrence of repeat surgery after BC for CSDH in randomized control trials; however, not only was it not associated with improved outcomes on the modified Rankin scale at 6 months postsurgery, but it was instead associated with deterioratation. 9,10 It has also been suggested that the adverse effects of dexamethasone has a negative effect on outcomes. 9,10 Atorvastatin has also been reported to be an effective nonsurgical treatment for CSDH 11,12 ; however, there are concerns about the side effects of administering large doses of atorvastatin to the elderly, who typically have reduced hepatic and renal function.…”

“…9,10 It has also been suggested that the adverse effects of dexamethasone has a negative effect on outcomes. 9,10 Atorvastatin has also been reported to be an effective nonsurgical treatment for CSDH 11,12 ; however, there are concerns about the side effects of administering large doses of atorvastatin to the elderly, who typically have reduced hepatic and renal function. Interaction between atorvastatin and CYP 4A3 is also a concern.…”

“…39,40 Variables Data were extracted from the claims data for each patient during the 12-month lookback period. Confounders were identified in recent studies [1][2][3][4][5][6][7][8][9][10][11][12] and used as covariates. The covariates were as follows: age; sex; bilateral lesion; calendar year; hypertension; diabetes; liver cirrhosis or failure; coagulation disorder; cerebrovascular disease; malignant tumors; alcohol-related disease; a drug history of angiotensin-converting enzyme inhibitors (ACEIs), antiplatelet agents, anticoagulant agents, statins, or steroids; and unilateral and bilateral lesions.…”

“…For example, recent clinical trials on the effect of atorvastatin and dexamethasone for CSDH did not restrict the use of these drugs. 9,10,12…”

“…Dexamethasone, 9,10 statins, 11,12 tranexamic acid (TXA), 13-16 angiotensin-converting enzyme inhibitors, 17 and some Chinese herbal medicines (CHMs) 18,19 have been reported as nonsurgical treatments for CSDH. However, it is unknown which of these drugs are safe and suitable for the elderly, given their high incidence of frailty and their tendency to be prescribed with multiple medications.…”