A Prospective Randomized Study on the Preventive Effect of Japanese Herbal Kampo Medicine Goreisan for Recurrence of Chronic Subdural Hematoma

Abstract

Although the recurrence of chronic subdural hematoma (CSDH) after surgical treatment significantly affects the patients’ quality of life, the recurrence rate has not improved in decades. Goreisan, a Japanese herbal Kampo medicine, promotes the hydragogue effect and has been empirically used in the treatment of CSDH in Japan. We conducted a prospective randomized study to investigate whether Goreisan treatment decreases the recurrence rate of CSDH. Between March 2013 and December 2018, a total of 224 patients who underwent initial burr hole surgery for CSDH were randomly assigned to receive Goreisan for 3 months (Group G) or no medication (Group N). The primary endpoint was symptomatic recurrence within 3 months postoperatively, and the secondary endpoint was complications, including the adverse effects of Goreisan. Of 224 randomized patients, 208 were included in the final analysis (104 in Group G and 104 in Group N). The overall recurrence rate was 9.1% (19/208). The recurrence rate of Group G was lower than that of Group N (5.8% vs 12.5%, P = 0.09), but the difference was not statistically significant. However, a significant preventive effect of Goreisan was found in 145 patients with high-risk computed tomography (CT) features, namely, homogeneous and separated types (5.6% vs 17.6%, P = 0.04). Although the present study did not prove the beneficial effect of Goreisan treatment, it suggested the importance of selecting patients with an increased risk of recurrence. A subset of patients whose hematoma showed homogeneous and separated patterns on CT image might benefit from Goreisan treatment.

Pharmacological Treatment in the Management of Chronic Subdural Hematoma

“…The database search yielded 873 articles. Finally, 12 controlled trials were deemed eligible for inclusion in the Bayesian meta-analysis (Poulsen et al, 2014 ; Chan et al, 2015 ; Prud'homme et al, 2016 ; Jiang et al, 2018 ; Katayama et al, 2018 ; Workewych et al, 2018 ; Hutchinson et al, 2020 ; Mebberson et al, 2020 ; Wan et al, 2020 ; Yamada and Natori, 2020 ; Yang et al, 2020 ; Fujisawa et al, 2021 ). The PRISMA flow chart showing the publication selection process and a list of studies with reasons for exclusion are provided in Figure 1 .…”

“…The eligible trials were published from 2014 to 2021, with population sizes ranging from 20 to 748 participants. One trial assessed perindopril (Poulsen et al, 2014 ); two trial assessed atorvastatin (Jiang et al, 2018 ; Yang et al, 2020 ); two trials assessed goreisan (Katayama et al, 2018 ; Fujisawa et al, 2021 ); three trials assessed tranexamic acid (Workewych et al, 2018 ; Wan et al, 2020 ; Yamada and Natori, 2020 ); and four trials assessed dexamethasone (Chan et al, 2015 ; Prud'homme et al, 2016 ; Hutchinson et al, 2020 ; Mebberson et al, 2020 ). One of the included randomized clinical trials (RCTs) was a three-arm trial (Yamada and Natori, 2020 ).…”

The Efficacy of Japanese Herbal Kampo Medicine as an Acute and Prophylactic Medication to Treat Chronic Daily Headache and Medication Overuse Headache:-Single Arm Retrospective Study

“…Daikenchuto prevents postoperative ileus after abdominal surgery [ 35 ]. Goreisan prevents postoperative recurrence of some types of chronic subdural hematomas [ 36 ]. Like these clinical trials, a large prospective study for headache treatment using Kampo medicine is needed.…”

Goreisan alleviates cerebral oedema by inhibiting aquaporin 4 function: In vivo study using an established mouse model of cerebral oedema

“…Goreisan (GRS), traditionally known as a diuretic, is an approved Kampo medicine in Japan with indications for headache, oedema, and diarrhoea [21]. It is clinically effective in treating headaches and chronic subdural haematoma [22][23][24][25]. GRS suppresses chronic cerebral oedema and increases AQP4 expression in a rodent model of acute cerebral ischaemia [26,27].…”