Evidence map›Paper›PMID 28293280›Full record

ArticleBioPsychoSocial medicine2017

Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea.

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

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BioPsychoSocial medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00918411 (Post-marketing Clinical Study of Ramosetron Hydrochloride), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.2field-weighted citation impact, top 48% 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.

NCT00918411 phase4completednot on this map

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

TypeinterventionalSponsorAstellas Pharma IncRan2009 to 2009Enrolled98ConditionsIrritable Bowel SyndromeArmsRamosetron, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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

6 authors at 2 institutions in 1 country.

Motoko IdaJapan-Asia Planning & Administration, Medical & Development, Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411 Japan.ORCID 0000-0003-4850-9298
Akito NishidaDevelopment Project Management, Astellas Pharma Inc., Tokyo, Japan.
Hiraku AkihoJapan-Asia Clinical Development 2, Development, Astellas Pharma Inc., Tokyo, Japan.
Yoshihiro NakashimaJapan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.
Kei MatsuedaSakura Life Clinic, Tokyo, Japan.
Shin FukudoDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Astellas Pharma (Japan) · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies have indicated that ramosetron, a 5-hydroxytryptamine-3 receptor antagonist, achieves global improvement in irritable bowel syndrome (IBS) symptoms in male patients with IBS with diarrhea (IBS-D). However, in addition to global assessment it was deemed important to assess "clinically meaningful improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms". We performed a randomized, placebo-controlled, phase IV pilot study to explore and examine efficacy variables that allow such evaluation of ramosetron in male patients with IBS-D.

methodsWe performed a prospective study of 115 male outpatients with IBS-D (according to the Rome III criteria), from June 2009 to December 2009 at 25 centers in Japan. After a one-week baseline period, subjects received either 5 μg of ramosetron (

resultsChange in IBSSI-J overall score from baseline was -133.5 ± 110.72 in the ramosetron 5 μg group and -108.2 ± 94.44 in the placebo group (

conclusionsFurther examination will be needed before IBSSI-J can be used in clinical trials of agents for IBS-D. However, this study revealed that response on global assessment was correlated with improvement in the IBSSI-J, suggesting that global assessment reflects improvement of the symptom severity of patients with IBS-D. (Clinicaltrials.gov ID: NCT00918411 Registered 9 June 2009).

Indexed as

5-hydroxytryptamine (5-HT)Abdominal discomfortAbdominal painGlobal improvementIrritable bowel syndrome severity indexStool consistency

Identifiers

PMID28293280
PMCPMC5346243
OpenAlexW2593317556

What OpenQuestion holds

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LicenceCC BY
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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.