Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Controlled Clinical Trial
. 2025 Mar 12;48(1):293.
doi: 10.1007/s10143-025-03394-4.

Effects of the Japanese traditional medicine Goreisan on adverse events affecting mucosal edema in patients with subarachnoid hemorrhage treated with clazosentan

Yosuke Akamatsu  1 , Kohei Chida  2 , Kenya Miyoshi  2 , Daigo Kojima  3 , Koji Yoshida  4 , Toshinari Misaki  4 , Takahiro Koji  2 , Shunrou Fujiwara  2 , Yoshitaka Kubo  2 , Hiroshi Kashimura  3 , Kuniaki Ogasawara  2
Affiliations
Controlled Clinical Trial

Effects of the Japanese traditional medicine Goreisan on adverse events affecting mucosal edema in patients with subarachnoid hemorrhage treated with clazosentan

Yosuke Akamatsu et al. Neurosurg Rev. .

Abstract

Despite successful management of pulmonary complication with fluid restriction protocol in aneurysmal subarachnoid hemorrhage (aSAH) patients treated with clazosentan, management of symptoms related to mucosal edema, such as diarrhea, stuffy nose, and difficulty in breathing, remains challenging. Hence, we investigated the effect of Goreisan shown to be effective in the treatment of symptoms related with mucosal edema in aSAH patients treated with clazosentan. Patients with aSAH who received clazosentan for vasospasm after aneurysm obliteration were prospectively enrolled in the study. Fluid balance parameters and the incidence of vasospasm, pulmonary edema, mucosal edema-related symptom (such as diarrhea and swelling of the nasal mucosa) were compared between these patients treated with Goreisan (Group G) and without Goreisan (Group NG). As results, Groups NG and G comprised 29 and 40 consecutive patients, respectively. No significant differences in fluid intake, urine volume, frequency of furosemide injection, incidence of vasospasm, pulmonary edema, or discontinuation of clazosentan treatment between the two groups were found over the treatment course, although refractory hyponatremia occurred less frequently in Group G than in Group NG (0% and 10.3%, p = 0.039, respectively). The incidence of diarrhea and the relative mucosal thickness was also significantly lower in Group G than in Group NG (7.3% and 21.9%; p = 0.0004, 113.8% vs. 175.4%; p = 0.001). Clazosentan combined with diuretics and Goreisan effectively reduced diarrhea and nasal mucosal swelling in patients with aSAH. This protocol may offer a viable approach for managing clazosentan-associated adverse events in aSAH patients.

Keywords: Clazosentan; Goreisan; Mucosal edema; Subarachnoid hemorrhage.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethical approval: The ethics committee of Iwate Medical University School of Medicine reviewed and approved the study protocol (No. MH2023-106). Consent to participate: Each patient provided written informed consent prior to participation. Consent for publication: Each patient provided written informed consent prior to publication. Disclosures: The authors have no personal, financial, or institutional interests in any of the drugs, materials, or devices described in this article. Previous presentations: None. Competing interests: The authors declare no competing interests.

References

    1. Akamatsu Y, Chida K, Miyoshi K et al (2024) Fluid balance management with loop diuretics in patients with aneurysmal subarachnoid hemorrhage treated with clazosentan: a case series. Brain Hemorrhages 5:74–78. https://doi.org/10.1016/j.hest.2023.10.003 - DOI
    1. Egidy G, Juillerat-Jeanneret L, Korth P, Bosman FT, Pinet F (2000) The endothelin system in normal human colon. Am J Physiol Gastrointest Liver Physiol 279:G211–222. https://doi.org/10.1152/ajpgi.2000.279.1.G211 - DOI - PubMed
    1. Endo H, Hagihara Y, Kimura N et al (2022) Effects of clazosentan on cerebral vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage: two randomized phase 3 trials in Japanese patients. J Neurosurg 137:1707–1717. https://doi.org/10.3171/2022.2.JNS212914 - DOI - PubMed
    1. Frontera JA, Claassen J, Schmidt JM et al (2006) Prediction of symptomatic vasospasm after subarachnoid hemorrhage: the modified Fisher scale. Neurosurgery 59:21–27 discussion 21–27. https://doi.org/10.1227/01.neu.0000243277.86222.6c - DOI - PubMed
    1. Fujimura M, Joo JY, Kim JS, Hatta M, Yokoyama Y, Tominaga T (2017) Preventive effect of clazosentan against cerebral vasospasm after clipping surgery for aneurysmal subarachnoid hemorrhage in Japanese and Korean patients. Cerebrovasc Dis 44:59–67. https://doi.org/10.1159/000475824 - DOI - PubMed

Publication types

MeSH terms

Supplementary concepts

LinkOut - more resources