Evidence map›Paper›PMID 24106924›Full record

Trial reportNeurogastroenterology and motility2014

Effect of prucalopride on symptoms of chronic constipation.

J Tack, V Stanghellini, D Dubois, A Joseph, L Vandeplassche, R Kerstens

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00485940 (A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
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.

NCT00485940 phase3completednot on this map

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation

TypeinterventionalSponsorMovetisRan1998 to 1999Enrolled641ConditionsConstipationArmsPrucalopride, Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 79 citations in OpenAlex.

  1. Trial
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  7. Protective actions of a luminally acting 5-HTNeurogastroenterology and motility · 2023
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Safety/Efficacy of Prucalopride in Korean Patients with Chronic Constipation: Post-marketing Surveillance.The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2021
    Article
  14. Review
  15. Prokinetic actions of luminally acting 5-HTNeurogastroenterology and motility · 2021
    Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

6 authors at 3 institutions in 3 countries.

J TackDivision of Gastroenterology, University Hospital, Leuven, Belgium.
V Stanghellini
D Dubois
A Joseph
L Vandeplassche
R Kerstens
AZ Turnhout · BEUniversité Libre de Bruxelles · BEUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrucalopride is a 5-HT4 receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three 12-week, double-blind trials evaluated the effect of prucalopride 2 mg q.d. on common constipation symptoms in women in whom laxatives had failed to provide adequate relief. The effect of prucalopride on bowel function was outside the scope of the analysis and has been described elsewhere.

methodsWomen with self-reported inadequate relief from laxatives and included in the prucalopride 2 mg or placebo arm of the trials were selected for analysis. Symptom severity was determined with the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Observed changes from baseline in individual item scores were also evaluated by calculating Cohen's D effect sizes using baseline standard deviation (SD) (>0.2-0.5, >0.5-0.8 and >0.8 for small, moderate and large effects, respectively). KEY

resultsData were analyzed for 936 women. The proportion of women with a PAC-SYM severity score >2 at baseline was 50.0% for abdominal symptoms, 71.4% for stool symptoms, and 15.5% for rectal symptoms. Excluding the women without presence of a symptom at baseline from the effect size calculations showed that prucalopride 2 mg had a large effect (>0.8) on all PAC-SYM items, including abdominal pain, abdominal discomfort, bloating, straining, and painful bowel movements. For abdominal symptoms and stool symptoms, effect sizes with prucalopride 2 mg were 1.3-2.3 times larger than those with placebo. CONCLUSIONS & INFERENCES: Prucalopride 2 mg q.d. for 12 weeks alleviates common constipation symptoms in women in whom laxatives had failed to provide adequate relief.

Indexed as

AdolescentAdultAgedAged, 80 and overBenzofuransChronic DiseaseConstipationDouble-Blind MethodFemaleHumansLaxativesMiddle AgedSerotonin 5-HT4 Receptor AgonistsTreatment OutcomeYoung AdultBenzofuransLaxativesprucaloprideSerotonin 5-HT4 Receptor Agonistsabdominal discomfortbloatingchronic constipationPAC-SYMpainful bowel movementsprucalopride

Identifiers

PMID24106924
PMCPMC4282451
OpenAlexW2002379938

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.