Evidence map›Paper›PMID 22882724›Full record

Trial reportNeurogastroenterology and motility2012

Prucalopride in the treatment of chronic constipation in patients from the Asia-Pacific region: a randomized, double-blind, placebo-controlled study.

M Ke, D Zou, Y Yuan, Y Li, L Lin, J Hao, X Hou, H J Kim

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurogastroenterology and motility, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 5 pooled it
7.2field-weighted citation impact, top 3% 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

57 citing papers in PubMed, 5 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. [Seoul Consensus on Clinical Practice Guidelines for Functional Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Guideline
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  3. Pooled it
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  16. [Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  17. Article
  18. Comparison of enteral prucaloprideFrontiers in pharmacology · 2024
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 8 institutions in 2 countries.

M KeDepartment of Gastroenterology, Peking Union Medical College Hospital, Beijing, China. kemypumch2006@yahoo.com.cn
D Zou
Y Yuan
Y Li
L Lin
J Hao
X Hou
H J Kim
Beijing Chaoyang Emergency Medical Center · CNCapital Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNJiangsu Province Hospital · CNKyung Hee University Dental Hospital · KRRuijin Hospital · CNSecond Military Medical University · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe study evaluated efficacy and safety of the 2 mg dose of prucalopride compared to placebo in patients with chronic constipation (CC) from the Asia-Pacific region.

methodsRandomized, placebo-controlled, parallel-group, phase III study with 2-week run-in, 12-week treatment phase, and 1-week follow-up. Adult patients with CC (≤2 spontaneous bowel movements per week) received 2 mg prucalopride or placebo, once-daily, for 12 weeks. Primary efficacy measure was percentage of patients with average of ≥3 spontaneous complete bowel movements (SCBMs) per week (Responders) during the 12-week treatment. A key secondary endpoint was Responders during first 4 weeks of treatment. Other efficacy assessments were based on patient diaries, their assessments of symptoms and quality of life, and investigator's assessment on efficacy of treatment. Safety assessments included adverse events, laboratory values, and cardiovascular events. KEY

resultsEfficacy and safety were evaluated for 501 patients who received study drug. On the primary endpoint, prucalopride was significantly more effective than placebo with 83 (33.3%) vs 26 (10.3%) patients having a weekly average of ≥3 SCBMs during the 12-week treatment (P < 0.001). Respective percentages were 34.5%vs 11.1% over first 4 weeks (P < 0.001). On other secondary endpoints, clinical improvement was generally larger and statistically superior (P < 0.001) in the prucalopride group. Most frequently reported adverse events were diarrhea, nausea, abdominal pain, and headache. CONCLUSION & INFERENCES: Prucalopride 2 mg given once-daily significantly improved bowel function, associated symptoms, and satisfaction in CC over a 12-week treatment period, and was safe and well tolerated by patients in the Asia-Pacific region.

Indexed as

AdolescentAdultAgedAsian PeopleBenzofuransChronic DiseaseConstipationDouble-Blind MethodFemaleGastrointestinal AgentsHumansMaleMiddle AgedYoung AdultBenzofuransGastrointestinal Agentsprucalopride

Identifiers

PMID22882724
PMCPMC3509366
OpenAlexW1947591645

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.