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

Naoaki Fujisawa, Soichi Oya, Shinsuke Yoshida, Tsukasa Tsuchiya, Takumi Nakamura, Masahiro Indo, Toru Matsui, Naoaki Fujisawa, Soichi Oya, Shinsuke Yoshida, Tsukasa Tsuchiya, Takumi Nakamura, Masahiro Indo, Toru Matsui

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.

Keywords: Goreisan; chronic subdural hematoma; prospective randomized trial; recurrence.

Conflict of interest statement

Conflict of Interest Disclosure

The authors have no conflict of interest to declare.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram for patient screening and randomization.
Fig. 2
Fig. 2
(A) Subtypes of CT scan finding used in this study according to Nakaguchi classification. (B) Bar graphs showing the recurrence rates according to CT classifications of hematoma. There was no significant difference in recurrence rate between each CT classification (P = 0.27). Note that recurrence occurs at ≥10% for homogenous- and separated-type hematomas, while the risks of recurrence are sufficiently low for laminar- and trabecular-type hematomas. (C) Bar graphs demonstrating the preventive effect of Goreisan for chronic subdural hematoma recurrence in patients with homogeneous and separated types (5.6% vs 17.6%, P = 0.04). CT: computed tomography.

References

    1. Miranda LB, Braxton E, Hobbs J, Quigley MR: Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg 114: 72–76, 2011
    1. Uno M, Toi H, Hirai S: Chronic subdural hematoma in elderly patients: is this disease benign? Neurol Med Chir (Tokyo) 57: 402–409, 2017
    1. Karibe H, Kameyama M, Kawase M, Hirano T, Kawaguchi T, Tominaga T: Epidemiology of chronic subdural hematomas. No Shinkei Geka 39: 1149–1153, 2011. (Japanese)
    1. Kudo H, Kuwamura K, Izawa I, Sawa H, Tamaki N: Chronic subdural hematoma in elderly people: present status on Awaji Island and epidemiological prospect. Neurol Med Chir (Tokyo) 32: 207–209, 1992
    1. Andersen-Ranberg NC, Debrabant B, Poulsen FR, Bergholt B, Hundsholt T, Fugleholm K: The Danish chronic subdural hematoma study-predicting recurrence of chronic subdural hematoma. Acta Neurochir (Wien) 161: 885–894, 2019
    1. Han MH, Ryu JI, Kim CH, Kim JM, Cheong JH, Yi HJ: Predictive factors for recurrence and clinical outcomes in patients with chronic subdural hematoma. J Neurosurg 127: 1117–1125, 2017
    1. Kim J, Moon J, Kim T, et al. : Risk factor analysis for the recurrence of chronic subdural hematoma: a review of 368 consecutive surgical cases. Korean J Neurotrauma 11: 63–69, 2015
    1. Motiei-Langroudi R, Stippler M, Shi S, et al. : Factors predicting reoperation of chronic subdural hematoma following primary surgical evacuation. J Neurosurg 129: 1143–1150, 2018
    1. Motoie R, Karashima S, Otsuji R, et al. : Recurrence in 787 patients with chronic subdural hematoma: retrospective cohort investigation of associated factors including direct oral anticoagulant use. World Neurosurg 118: e87–e91, 2018
    1. Ridwan S, Bohrer AM, Grote A, Simon M: Surgical treatment of chronic subdural hematoma: predicting recurrence and cure. World Neurosurg 128: e1010–e1023, 2019
    1. Santarius T, Qureshi HU, Sivakumaran R, Kirkpatrick PJ, Kirollos RW, Hutchinson PJ: The role of external drains and peritoneal conduits in the treatment of recurrent chronic subdural hematoma. World Neurosurg 73: 747–750, 2010
    1. Santarius T, Kirkpatrick PJ, Ganesan D, et al. : Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. The Lancet 374: 1067–1073, 2009
    1. Santos RGD, Xander PAW, Rodrigues LHDS, Costa GHFD, Veiga JCE, Aguiar GB: Analysis of predisposing factors for chronic subdural hematoma recurrence. Rev Assoc Med Bras (1992) 65: 834–838, 2019
    1. Stavrinou P, Katsigiannis S, Lee JH, et al. : Risk factors for chronic subdural hematoma recurrence identified using quantitative computed tomography analysis of hematoma volume and density. World Neurosurge 99: 465–470, 2017
    1. Torihashi K, Sadamasa N, Yoshida K, Narumi O, Chin M, Yamagata S: Independent predictors for recurrence of chronic subdural hematoma: a review of 343 consecutive surgical cases. Neurosurgery 63: 1125–1129; discussion 1129, 2008
    1. You W, Zhu Y, Wang Y, et al. : Prevalence of and risk factors for recurrence of chronic subdural hematoma. Acta Neurochir (Wien) 160: 893–899, 2018
    1. Berghauser Pont LME, Dammers R, Schouten JW, Lingsma HF, Dirven CMF: Clinical factors associated with outcome in chronic subdural hematoma: a retrospective cohort study of patients on preoperative corticosteroid therapy. Neurosurgery 70: 873–880; discussion 880, 2012
    1. Holl DC, Volovici V, Dirven CMF, et al. : Corticosteroid treatment compared with surgery in chronic subdural hematoma: a systematic review and meta-analysis. Acta Neurochir (Wien) 161: 1231–1242, 2019
    1. Tang R, Shi J, Li X, et al. : Effects of atorvastatin on surgical treatments of chronic subdural hematoma. World Neurosurg 117: e425–e429, 2018
    1. Xu M, Chen P, Zhu X, Wang C, Shi X, Yu B: Effects of atorvastatin on conservative and surgical treatments of chronic subdural hematoma in patients. World Neurosurg 91: 23–28, 2016
    1. Kageyama H, Toyooka T, Tsuzuki N, Oka K: Nonsurgical treatment of chronic subdural hematoma with tranexamic acid. J Neurosurg 119: 332–337, 2013
    1. Hirashima Y, Kurimoto M, Nagai S, Hori E, Origasa H, Endo S: Effect of platelet-activating factor receptor antagonist, etizolam, on resolution of chronic subdural hematoma – a prospective study to investigate use as conservative therapy. Neurol Med Chir (Tokyo) 45: 621–626; discussion 626, 2005
    1. Weigel R, Schmiedek P, Krauss JK: Outcome of contemporary surgery for chronic subdural haematoma: evidence based review. J Neurol Neurosurg Psychiatr 74: 937–943, 2003
    1. Bartek J, Sjåvik K, Schaible S, et al. : The role of angiotensin-converting enzyme inhibitors in patients with chronic subdural hematoma: a scandinavian population-based multicenter study. World Neurosurg 113: e555–e560, 2018
    1. Mebberson K, Colditz M, Marshman LAG, Thomas PAW, Mitchell PS, Robertson K: Prospective randomized placebo-controlled double-blind clinical study of adjuvant dexamethasone with surgery for chronic subdural haematoma with post-operative subdural drainage: interim analysis. J Clin Neurosci 71: 153–157, 2020
    1. Poulsen FR, Munthe S, Søe M, Halle B: Perindopril and residual chronic subdural hematoma volumes six weeks after burr hole surgery: a randomized trial. Clin Neurol Neurosurg 123: 4–8, 2014
    1. Yamada T, Natori Y: Prospective study on the efficacy of orally administered tranexamic acid and goreisan for the prevention of recurrence after chronic subdural hematoma burr hole surgery. World Neurosurg 134: e549–e553, 2020
    1. Gardner JW: Traumatic subdural hematoma with particular reference to the latent interval. Arch Neurol Psychiatry 1932: 847–858, 1932
    1. Suzuki J, Takaku A: Nonsurgical treatment of chronic subdural hematoma. J Neurosurg 33: 548–553, 1970
    1. Miyagami M, Kagawa Y: Effectiveness of Kampo medicine Gorei-San for chronic subdural hematoma. No Shinkei Geka 37: 765–770, 2009. (Japanese)
    1. Kwon S, Jin C, Cho KH: Oreongsan, an herbal medicine prescription developed as a new alternative treatment in patients with chronic subdural hematoma: a narrative review. Integr Med Res 8: 26–30, 2019
    1. Cho KH, Kwon S, Jung WS, Moon SK: Herbal medicine, oreongsan for recurrent chronic subdural hematoma: a case report. Explore (NY) 13: 139–141, 2017
    1. Goto S, Kato K, Yamamoto T, Shimato S, Ohshima T, Nishizawa T: Effectiveness of Goreisan in preventing recurrence of chronic subdural hematoma. Asian J Neurosurg 13: 370–374, 2018
    1. Muramatsu M, Yoshikawa T, Hanabusa K: Effectiveness of kampo medicine gorei-san-ryo for chronic subdural hematoma in very elderly patients. No Shinkei Geka 33: 965–969, 2005. (Japanese)
    1. Okamura A, Kawamoto Y, Sakoda E, Murakami T, Hara T: Evaluation of recurrence factors and Gorei-san administration for chronic subdural hematoma after percutaneous subdural tapping. Hiroshima J Med Sci 62: 77–82, 2013
    1. Wakabayashi Y, Yamashita M, Asano T, et al. : Effect of Gorei-san with tranexamic acid for preventing recurrence of chronic subdural hematoma. No Shinkei Geka 40: 967–971, 2012. (Japanese)
    1. Katayama K, Matsuda N, Kakuta K, et al. : The effect of Goreisan on the prevention of chronic subdural hematoma recurrence: multi-center randomized controlled study. J Neurotrauma 35: 1537–1542, 2018
    1. Okano A, Oya S, Fujisawa N, et al. : Analysis of risk factors for chronic subdural haematoma recurrence after burr hole surgery: optimal management of patients on antiplatelet therapy. Br J Neurosurg 28: 204–208, 2014
    1. McKenzie CR, Rengachary SS, McGregor DH, Dixon AY, Suskind DL: Subdural hematoma associated with metastatic neoplasms. Neurosurgery 27: 619–624; discussion 624–625, 1990
    1. Mori K, Yamamoto T, Horinaka N, Maeda M: Arachnoid cyst is a risk factor for chronic subdural hematoma in juveniles: twelve cases of chronic subdural hematoma associated with arachnoid cyst. J Neurotrauma 19: 1017–1027, 2002
    1. Nakaguchi H, Tanishima T, Yoshimasu N: Factors in the natural history of chronic subdural hematomas that influence their postoperative recurrence. J Neurosurg 95: 256–262, 2001
    1. Neidert MC, Schmidt T, Mitova T, et al. : Preoperative angiotensin converting enzyme inhibitor usage in patients with chronic subdural hematoma: associations with initial presentation and clinical outcome. J Clin Neurosci 28: 82–86, 2016
    1. Qiu S, Zhuo W, Sun C, Su Z, Yan A, Shen L: Effects of atorvastatin on chronic subdural hematoma: a systematic review. Medicine (Baltimore) 96: e7290, 2017
    1. Basaldella L, Perin A, Orvieto E, et al. : A preliminary study of aquaporin 1 immunolocalization in chronic subdural hematoma membranes. J Clin Neurosci 17: 905–907, 2010
    1. Papadopoulos MC, Verkman AS: Aquaporin water channels in the nervous system. Nat Rev Neurosci 14: 265–277, 2013
    1. Yano Y, Yano H, Takahashi H, et al. : Goreisan inhibits upregulation of Aquaporin 4 and formation of cerebral edema in the rat model of juvenile hypoxic-ischemic encephalopathy. Evid Based Complement Alternat Med 2017: 3209219, 2017
    1. Yasunaga H: Effect of Japanese herbal Kampo medicine Goreisan on reoperation rates after burr-hole surgery for chronic subdural hematoma: analysis of a national inpatient database. Evid Based Complement Alternat Med 2015: 817616, 2015
    1. Soleman J, Lutz K, Schaedelin S, et al. : Subperiosteal vs subdural drain after burr-hole drainage of chronic subdural hematoma: a randomized clinical trial (cSDH-Drain-Trial). Neurosurgery 85: E825–E834, 2019
    1. Harada Y, Yoshida K, Nojiri S, Kurihara Y, Kobayashi H, Arai H: Identification of chronic subdural hematoma types most responsive to Goreisan, Kampo medicine: a retrospective study. J Clin Neurosci 78: 198–202, 2020
    1. Miki K, Abe H, Morishita T, et al. : Double-crescent sign as a predictor of chronic subdural hematoma recurrence following burr-hole surgery. J Neurosurg 131: 1905–1911, 2019

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