Evidence map›Paper›PMID 37979045›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2023

Hangeshashinto for prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized phase II study.

Masako Yoshimatsu, Yumiko Kawashita, Sakiko Soutome, Maho Murata, Yasushi Sawayama, Tadafumi Kurogi, Noriko Nakao, Yasushi Miyazaki, Masahiro Umeda, Takashi Ukai

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
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

10 authors at 3 institutions in 1 country.

Masako YoshimatsuOral Management Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. yoshi@nagasaki-u.ac.jp.
Yumiko KawashitaDepartment of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Sakiko SoutomeDepartment of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Maho MurataDepartment of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Yasushi SawayamaDepartment of Hematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Tadafumi KurogiOral Management Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Noriko NakaoOral Management Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Yasushi MiyazakiDepartment of Hematology, Atomic Bomb Disease and Hibakusha Medicine Unit, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Masahiro UmedaDepartment of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Takashi UkaiOral Management Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Nagasaki University · JPNagasaki University Hospital · JPJapanese Red Cross Society, Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOral mucositis (OM) is a side effect associated with cancer treatment. Hangeshashinto (HST), a Kampo medicine, was originally prescribed to treat diarrhea, gastritis, and stomatitis. Several reports have described the effects of HST for OM induced by chemotherapy in patients with gastric or colorectal cancer. In this study, the effects of HST for prevention of OM were investigated in patients undergoing hematopoietic stem cell transplantation (HSCT).

methodsThirty patients scheduled to receive allogeneic grafts were enrolled from July 2020 to December 2021. They were randomly assigned to two groups and instructed to wash their mouth using HST dissolved in saline solution or using only saline solution three times a day. The observation period was from the initiation date of the conditioning regimen to the date of engraftment, and the end point was the incidence of OM.

resultsEighteen patients developed OM, the most severe of which was Grade (G)3. There was no significant difference in the incidence of OM between the HST group and the control group. However, a negative correlation tended to be observed between the duration using HST use and the duration of OM (G2-3: P = 0.027, G3: P = 0.047).

conclusionsThe present study demonstrated that HST use did not clearly inhibit onset of OM but showed a tendency to inhibit OM exacerbation. However, further studies are necessary to fully understand the effects of HST on OM in patients undergoing HSCT.

trial registrationThis study was registered in the Japan Registry of Clinical Trials on 7 May 2020 (jRCTs071200012).

Indexed as

Hematopoietic Stem Cell TransplantationStomatitisHumansIncidenceSaline SolutionTransplantation ConditioningSaline SolutionConditioning regimenHangeshashintoHematopoietic stem cell transplantationOral mucositis

Identifiers

PMID37979045
PMCPMC10657322
OpenAlexW4388796518

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.