Evidence map›Paper›PMID 24315882›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2014

Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea.

Shin Fukudo, Motoko Ida, Hiraku Akiho, Yoshihiro Nakashima, Kei Matsueda

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01225237 (Post-marketing Clinical Study of Ramosetron Hydrochloride), which is not on this map. Cited by 41 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 4 pooled it
5.6field-weighted citation impact, top 4% 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.

NCT01225237 phase4completednot on this map

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

TypeinterventionalSponsorAstellas Pharma IncRan2010 to 2011Enrolled296ConditionsIrritable Bowel SyndromeArmsRamosetron, Placebo
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Review
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  11. Low anterior resection syndrome.Annals of gastroenterological surgery · 2023
    Review
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  19. Sex-Gender Differences in Irritable Bowel Syndrome.Journal of neurogastroenterology and motility · 2018
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Shin FukudoDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.
Motoko IdaClinical Development III, Astellas Pharma Inc, Tokyo, Japan.
Hiraku AkihoClinical Development III, Astellas Pharma Inc, Tokyo, Japan.
Yoshihiro NakashimaData Science, Astellas Pharma Inc, Tokyo, Japan.
Kei MatsuedaSakura Life Clinic, Tokyo, Japan.
Astellas Pharma (Japan) · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsRamosetron, a serotonin (5-hydroxytryptamine)-3 receptor antagonist with high selectivity, reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats. However, there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome (IBS-D). We performed a randomized, double-blind, placebo-controlled trial to determine whether ramosetron reduces diarrhea in these patients.

methodsOur study included 296 male outpatients with IBS-D treated at 52 centers in Japan. Patients were given 5 μg oral ramosetron (n = 147) or placebo (n = 149) once daily for 12 weeks after a 1-week baseline period. The primary end point was increased stool consistency in the first month. Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life.

resultsMore patients given ramosetron (74, 50.3%) than those given placebo (29, 19.6%) reported improved stool consistency in the first month (P < .001). The relative risk and number needed to treat were 2.57 (95% confidence interval, 1.79-3.70) and 3.25 (95% confidence interval, 2.44-4.89), respectively. The ramosetron group had significantly higher monthly rates of relief of overall IBS symptoms and IBS-related quality of life than the placebo group.

conclusionsRamosetron (5 μg oral, once daily for 12 weeks) improved stool consistency in male patients with IBS-D, compared with placebo. These study results, along with the pharmacologic profile of ramosetron, indicate that increased stool consistency is the best end point for studies of ramosetron in patients with IBS-D. Clinicaltrials.gov No, NCT01225237.

Indexed as

Chemical PhenomenaFecesAdministration, OralAdultAnimalsBenzimidazolesDiarrheaDouble-Blind MethodGastrointestinal AgentsHumansIrritable Bowel SyndromeJapanMaleMiddle AgedPlacebosRatsBenzimidazolesGastrointestinal AgentsPlacebosramosetron5-Hydroxytryptamine (5-HT)Abdominal DiscomfortAbdominal PainGlobal Improvement

Identifiers

PMID24315882
OpenAlexW2017242867

What OpenQuestion holds

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Registered trials

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.