Evidence map›Paper›PMID 40527845›Full record

Trial reportMedicine2025

Effectiveness of Hangeshashinto in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer: Preliminary finding of a randomized clinical trial.

Yumiko Kawashita, Masahiro Umeda, Maho Murata, Masako Yoshimatsu, Chiaki Shiraishi, Aya Omori, Takuya Yamazaki, Hideaki Nishi, Sakiko Soutome, Takashi Ukai and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Yumiko KawashitaDepartment of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID 0000-0001-9624-105
Masahiro UmedaDivision of Research and Treatment for Oral and Maxillofacial Congenital Anomalies, School of Dentistry, Aichi Gakuin University, Aichi, Japan.
Maho MurataMurata Dental Clinic, Mie, Japan.
Masako YoshimatsuOral Management Center, Nagasaki University Hospital, Nagasaki, Japan.
Chiaki ShiraishiOral Management Center, Nagasaki University Hospital, Nagasaki, Japan.
Aya OmoriDental Hygiene Section, Nagasaki University Hospital, Nagasaki, Japan.
Takuya YamazakiDepartment of Radiation Oncology, Sasebo Chuo Hospital, Nagasaki, Japan.
Hideaki NishiDepartment of Otolaryngology-Head and Neck Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Sakiko SoutomeDepartment of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Takashi UkaiOral Management Center, Nagasaki University Hospital, Nagasaki, Japan.
Ryo ToyaDepartment of Radiation Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Yoshihiko KumaiDepartment of Otolaryngology-Head and Neck Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of Hangeshashinto (TJ-14) during radiotherapy administration in patients with head and neck cancer remains unknown. We investigated the effectiveness of TJ-14 in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer.

methodsThe trial involved 28 participants, allocated in a 1:1 ratio, to either the control or intervention group using a stratified randomization method adjusted for primary cancer location and treatment type.

resultsKaplan-Meier curves showed that the 50% incidence rate of grade 2 pharyngeal mucositis between the intervention and control group (46 Gy vs 34 Gy, P = .49). Six participants in the intervention group stopped taking TJ-14 during the development of grade 1 pharyngeal mucositis (mean oral medication period: 2.7 days).

conclusionThe findings of this single-center randomized clinical trial showed that taking TJ-14 from the onset of grade 1 mucositis tended to delay the development of grade 2 mucositis. However, patient compliance was poor in the intervention group. Therefore, multicenter randomized controlled trials should be planned with considering the low compliance of this population to understand the effectiveness of TJ-14.

Indexed as

Drugs, Chinese HerbalHypopharyngeal NeoplasmsLaryngeal NeoplasmsMucositisRadiation InjuriesAdultAgedFemaleHumansKaplan-Meier EstimateMaleMiddle AgedDrugs, Chinese HerbalHangeshashinto (TJ-14)head and neck cancermucositisradiotherapyrandomized clinical trial

Identifiers

PMID40527845
PMCPMC12173290

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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.