Evidence map›Paper›PMID 33208583›Full record

Trial reportNeurologia medico-chirurgica2021

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurologia medico-chirurgica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05713630 (TRACE STUDY), which is not on this map. Cited by 16 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 6 pooled it
1.8field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05713630 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma

TypeinterventionalSponsorUnity Health TorontoRan2026 to 2030Enrolled130ConditionsSubdural HematomaArmsTranexamic acid (TXA), Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 6 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  16. Japanese herbalSurgical neurology international · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Naoaki FujisawaDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Soichi OyaDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Shinsuke YoshidaDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Tsukasa TsuchiyaDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Takumi NakamuraDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Masahiro IndoDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Toru MatsuiDepartment of Neurosurgery, Saitama Medical Center, Saitama Medical University.
Saitama Medical University · JPSocial Insurance Saitama Chuo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Medicine, KampoSecondary PreventionAdultAgedAged, 80 and overDrainageDrugs, Chinese HerbalFemaleHematoma, Subdural, ChronicHumansJapanMaleMiddle AgedRecurrenceTrephiningDrugs, Chinese Herbaloryeongsanchronic subdural hematomaGoreisanprospective randomized trialrecurrence

Identifiers

PMID33208583
PMCPMC7812313
OpenAlexW3100228446

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.