Evidence map›Paper›PMID 31691810›Full record

Trial reportJournal of radiation research2020

Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial.

Taro Murai, Masayuki Matsuo, Hidekazu Tanaka, Yoshihiko Manabe, Taiki Takaoka, Kae Hachiya, Takahiro Yamaguchi, Shinya Otsuka, Yuta Shibamoto

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of radiation research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

9 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. 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

9 authors at 3 institutions in 1 country.

Taro MuraiDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Masayuki MatsuoDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Hidekazu TanakaDepartment of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.
Yoshihiko ManabeDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Taiki TakaokaDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Kae HachiyaDepartment of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.
Takahiro YamaguchiDepartment of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.
Shinya OtsukaDepartment of Radiology, Okazaki City Hospital, Okazaki, Japan.
Yuta ShibamotoDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Nagoya City University · JPGifu University · JPOkazaki City Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.

Indexed as

Acute DiseaseAdultAgedAged, 80 and overDrugs, Chinese HerbalEnteritisFemaleHumansMaleMiddle AgedRadiation InjuriesTreatment OutcomeDrugs, Chinese Herbalhange-shashintoacute radiation-induced enteritisBan Xia Xie Xin Tang)cervical cancerherbal medicinepelvic radiotherapyTJ-14 (hangeshashinto

Identifiers

PMID31691810
PMCPMC7022136
OpenAlexW2986606076

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.