The Effect of Goreisan on the Prevention of Chronic Subdural Hematoma Recurrence: Multi-Center Randomized Controlled Study

Abstract

The relatively high rate of post-operative recurrence in the treatment of chronic subdural hematoma (CSDH) is a significant problem. Goreisan is an herbal medicine that exhibits a hydragogue effect by inhibiting the expression of aquaporins, and its efficacy in preventing post-operative CSDH recurrence has been suggested by several case trials. This multi-center prospective randomized controlled trial was performed to investigate the preventative effect of goreisan on post-operative CSDH recurrence. Patients with symptomatic CSDH over 60 years old undergoing burr hole surgery were enrolled in this study. The patients were randomly allocated to the control group or the goreisan group, in which oral administration of goreisan (7.5 g daily) was continued for 12 weeks. The primary end-point was the post-operative recurrence rate at 12 weeks and the secondary end-point was hematoma volume reduction rates on computed tomography scan at 12 weeks. The analyses were performed not only on patients of all ages older than 60 years, but also on patients divided into those over or under 75 years old. One hundred and eighty patients were followed and analyzed (the control group, n = 88; the goreisan group, n = 92). The recurrence rates considering patients of all ages and patients under 75 years old were relatively low in the goreisan group but without a significant difference. The hematoma volume reduction rates showed no significant difference. Based on the results of the present study, a larger-scale study including more cases is necessary in future to confirm the efficacy of goreisan.

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

“…For example, a study by Katayama et al found that Goreisan had a favorable effect in patients aged 60-74 years while no beneficial effect was observed in patients aged ≥75 years. 37) Our data also showed a similar tendency in patients aged <70 years. We conducted additional analysis to seek the relevance of CT findings because some previous studies demonstrated the association between the radiological features on CT image and recurrence rate of CSDH.…”

“…controlled studies including the present study have been conducted on the effect of Goreisan to prevent recurrence, but none of those could prove the benefit of Goreisan treatment. 27,37) Although some previous studies have discussed the surgical strategy might affect the recurrence rate, 12,48) it would have little impact on those negative results because the recurrence rates of control patients in two previous studies were 9.8% and 12.5%; it was quite comparable to the result of our study (Group N, 12.5%).…”

“…30) Although several small case series mostly from Japan showed the clinical effect of Goreisan to replace or enhance the effect of surgical treatment, [30][31][32][33][34][35][36] the reliable data collected in a prospective and randomized fashion are scarce. Recently, Katayama et al 37) conducted a prospective randomized trial for patients aged >60 years and evaluated whether Goreisan treatment lowers the recurrence rate. Although no beneficial effect for overall participants was observed, their subanalysis revealed that the recurrence rate was successfully lowered by Goreisan treatment in patients aged 60-74 years, indicating its potential benefit to relatively younger patients.…”

Endoscopically Observed Outer Membrane Color of Chronic Subdural Hematoma and Histopathological Staging: White as a Risk Factor for Recurrence

“…All of the patients took the Japanese herbal kampo medicine goreisan postoperatively, which acts as a hydragogue by inhibiting aquaporin expression and could prevent CSDH recurrence. 7) We performed 119 operations for the first CSDH and another seven for recurrence and two for re-recurrent CSDH. Of the 119 patients, one patient died of pneumonia, while two others were moved to other clinical facilities due to their main diseases, preventing follow-up of CSDH recurrence.…”

Oryeongsan (Goreisan) Ameliorates Experimental Autoimmune Encephalomyelitis

“…Goreisan is used as an aquaretic drug to adjust the water balance of the body. Therefore, Goreisan is prescribed for patients with oral dryness and decreased urine volume, such as in edema, nephrosis, alcoholic hangover, acute gastrointestinal catarrh, diarrhea, nausea, vomiting, dizziness, water retention in the stomach, headache, uremia, heat-stroke, and diabetes mellitus (3).…”