Evidence map›Paper›PMID 26162646›Full record

Trial reportJournal of gastroenterology2016

Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study).

Hidetoshi Katsuno, Koutarou Maeda, Masatoshi Ohya, Kazuhiko Yoshioka, Akira Tsunoda, Keiji Koda, Hiroyoshi Matsuoka, Hiroki Ohge, Satoshi Morita, Shigetoyo Saji and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
3.2field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Observational
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 at 12 institutions in 1 country.

Hidetoshi KatsunoDepartment of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan. katsuno@fujita-hu.ac.jp.
Koutarou MaedaDepartment of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan.
Masatoshi OhyaDepartment of Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
Kazuhiko YoshiokaDepartment of Surgery, Kansai Medical University Takii Hospital, Moriguchi, Japan.
Akira TsunodaDepartment of Surgery, Kameda Medical Center, Kamogawa, Japan.
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.
Hiroyoshi MatsuokaDepartment of Surgery, Kyorin University Hospital, Mitaka, Japan.
Hiroki OhgeDepartment of Surgery, Hiroshima University School of Medicine, Hiroshima, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shigetoyo SajiJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Takashi KanematsuNagasaki City Hospital Organization, Nagasaki, Japan.
Masaki KitajimaInternational University of Health and Welfare, Otawara, Japan.
Dokkyo Medical University Saitama Medical Center · JPFujita Health University · JPFujita Health University Hospital · JPHiroshima University · JPInternational University of Health and Welfare · JPJapanese Foundation for Multidisciplinary Treatment of Cancer · JPKameda Medical Center · JPKansai Medical University · JPKyorin University Hospital · JPKyoto University · JPNagasaki Municipal Hospital · JPTeikyo University Chiba Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer.

methodsEighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8.

resultsSeventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups.

conclusionsDaikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.

Indexed as

AdultAgedAged, 80 and overColectomyContrast MediaDouble-Blind MethodFemaleGastrointestinal AgentsGastrointestinal MotilityHumansIleusMaleMiddle AgedPanaxPlant ExtractsSigmoid NeoplasmsContrast Mediadai-kenchu-toGastrointestinal AgentsPlant ExtractsColon cancerDaikenchutoHerbal medicineRadiopaque markerTransit analysis

Identifiers

PMID26162646
OpenAlexW1149916049

What OpenQuestion holds

Textmetadata
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.