Evidence map›Paper›PMID 24095618›Full record

Trial reportDigestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver2014

Pilot trial: pregabalin on colonic sensorimotor functions in irritable bowel syndrome.

Johanna Iturrino, Michael Camilleri, Irene Busciglio, Duane Burton, Alan R Zinsmeister

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 92% 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

3 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
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

5 authors at 2 institutions in 1 country.

Johanna IturrinoClinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
Michael CamilleriClinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States. Electronic address: camilleri.michael@mayo.edu.
Irene BusciglioClinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
Duane BurtonClinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
Alan R ZinsmeisterDepartment of Health Sciences Research, Division of Biomedical Statistics and Informatics, College of Medicine, Mayo Clinic, Rochester, MN, United States.
Mayo Clinic · USMayo Clinic in Florida · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
Bile Acids, Genetic Control and Colonic Function in Irritable Bowel SyndromeR01DK092179 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2011 to 2015
$1.8M
NCATS NIH HHS UL1 TR000135NCATS NIH HHS UL1-TR000135NCRR NIH HHS M01 RR000585NIDDK NIH HHS R01 DK092179NIDDK NIH HHS R01-DK092179
6 · The paper itself

Abstract

backgroundIn prior studies, pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome and healthy adults, suggesting reduction of afferent function.

aimTo assess effects of pregabalin on colonic compliance, sensory and motor functions in patients with constipation-predominant irritable bowel syndrome.

methodsIn a pilot, double-blind, placebo-controlled, parallel-group study, we tested oral pregabalin, 200mg, in 18 patients with constipation-predominant irritable bowel syndrome. With a barostatically controlled polyethylene balloon in the left colon, we assessed sensation thresholds and colonic compliance using ascending method of limits, sensation ratings over 4 levels of distension, fasting and postprandial colonic tone and phasic motility. Analysis of covariance (adjusted for the corresponding pre-drug response) was used to compare placebo and pregabalin. After 45% participants completed studies, we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial.

resultsPregabalin did not significantly affect colonic compliance, sensation thresholds, sensation ratings, fasting or postprandial tone or motility index. The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size.

conclusionPregabalin, 200mg, might not reduce distension-related colonic pain in constipation-predominant irritable bowel syndrome patients.

Indexed as

ColonComplianceGastrointestinal MotilitySensationAdultAnalgesicsConstipationDouble-Blind MethodFemalegamma-Aminobutyric AcidHumansIrritable Bowel SyndromeMaleMiddle AgedPainPilot ProjectsAnalgesicsgamma-Aminobutyric AcidPregabalinAnalgesiaColonic complianceGas sensationPain sensation

Identifiers

PMID24095618
PMCPMC3946640
OpenAlexW1982918887

What OpenQuestion holds

Textmetadata
LicenceTDM
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.