Evidence map›Paper›PMID 25972515›Full record

Trial reportJapanese journal of clinical oncology2015

Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902).

Hidetoshi Katsuno, Koutarou Maeda, Takashi Kaiho, Katsuyuki Kunieda, Kimihiko Funahashi, Junichi Sakamoto, Toru Kono, Hirotoshi Hasegawa, Yoshiyuki Furukawa, Yoshihiro Imazu and 2 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 6 pooled it
4.4field-weighted citation impact, top 5% 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

22 citing papers in PubMed, 6 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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  10. Duagnosis: Locating Clinical Uncertainty in the Diagnostic Framework.Journal of evaluation in clinical practice · 2026
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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

12 authors at 10 institutions in 1 country.

Hidetoshi KatsunoDepartment of Surgery, Fujita Health University, School of Medicine, Toyoake katsuno@fujita-hu.ac.jp.
Koutarou MaedaDepartment of Surgery, Fujita Health University, School of Medicine, Toyoake.
Takashi KaihoDepartment of Surgery, Kimitsu Chuo Hospital, Kisarazu.
Katsuyuki KuniedaDepartment of Surgery, Gifu Prefectural General Medical Center, Gifu.
Kimihiko FunahashiDepartment of General and Gastroenterological Surgery, Toho University Omori Medical Center, Tokyo.
Junichi SakamotoTokai Central Hospital, Kagamihara.
Toru KonoAdvanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Sapporo.
Hirotoshi HasegawaDepartment of Surgery, Keio University School of Medicine, Tokyo.
Yoshiyuki FurukawaKawasaki South Hospital, Kawasaki.
Yoshihiro ImazuShiba Daimon Imazu Clinic, Tokyo.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto.
Masahiko WatanabeDepartment of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Fujita Health University · JPGifu Prefectural General Medical Center · JPKawasaki Hospital · JPKeio University · JPKisarazu Hospital · JPKitasato University · JPKyoto University · JPSapporo Higashi Tokushukai Hospital · JPToho University · JPTokai Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer.

methodsA total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study (JFMC39-0902). Patients received either placebo or Daikenchuto (15.0 g/day, t.i.d) between post-operative day 2 and post-operative day 8. Primary end-points included time to first bowel movement, frequency of bowel movement and stool form. The incidence of intestinal obstruction was evaluated post-operatively. The safety profile of Daikenchuto until post-operative day 8 was also evaluated.

resultsThe results for 336 patients (Daikenchuto, n = 174; placebo, n = 162) were available for statistical analysis. The time to first bowel movement did not differ significantly between the two groups. All patients reported having diarrhea or soft stools immediately after surgery, and the time until stool normalization (50th percentile) in the Daikenchuto and placebo groups was 6 days and 7 days, respectively. The placebo group had a significantly greater number of hard stools at post-operative day 8 (P = 0.016), and bowel movement frequency continued to increase until post-operative day 8 as well. In contrast, bowel movement frequency in the Daikenchuto group increased until post-operative day 6, however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group (P = 0.024).

conclusionThe moderate effects of Daikenchuto were observed ∼1 week after the operation. Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer, this study did not show its clinical benefits adequately.

Indexed as

AdultAgedColectomyColonic NeoplasmsDefecationDouble-Blind MethodFemaleHumansIntestinesJapanMaleMiddle AgedPanaxPeristalsisPlant ExtractsPostoperative Perioddai-kenchu-toPlant Extractsbowel movementcolon cancerDaikenchutoherbal medicine

Identifiers

PMID25972515
PMCPMC4485603
OpenAlexW2124204816

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.