Evidence map›Paper›PMID 21914041›Full record

Trial reportNeurogastroenterology and motility2011

Lubiprostone does not influence visceral pain thresholds in patients with irritable bowel syndrome.

W E Whitehead, O S Palsson, L Gangarosa, M Turner, J Tucker

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.4field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. New Options in Constipation Management.Current oncology reports · 2015
    Review
  11. Article
  12. Observational
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. 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 1 institution in 1 country.

W E WhiteheadCenter for Functional Gastrointestinal and Motility Disorders and Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, NC 27599, USA. william_whitehead@med.unc.edu
O S Palsson
L Gangarosa
M Turner
J Tucker
University of North Carolina at Chapel Hill · US

Funding

UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD: BPCAUL1RR025747 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$44.6M
PSYCHOPHYSIOLOGY OF IRRITABLE BOWEL SYNDROMER01DK031369 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WHITEHEAD, WILLIAM E · 1986 to 2012
$6.3M
Gastrointestinal Biopsychosocial Research CenterR24DK067674 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WHITEHEAD, WILLIAM E · 2004 to 2008
$4.5M
NCRR NIH HHS UL1 RR025747NIDDK NIH HHS R01 DK031369NIDDK NIH HHS R24 DK067674
6 · The paper itself

Abstract

backgroundIn clinical trials, lubiprostone reduced the severity of abdominal pain. The primary aim was to determine whether lubiprostone raises the threshold for abdominal pain induced by intraluminal balloon distention. A secondary aim was to determine whether changes in pain sensitivity influence clinical pain independently of changes in transit time.

methodsSixty-two patients with irritable bowel syndrome with constipation (IBS-C) participated in an 8-week cross-over study. All subjects completed a 14-day baseline ending with a barostat test of pain and urge sensory thresholds. Half, randomly selected, then received 48 μg day(-1) of lubiprostone for 14 days ending with a pain sensitivity test and a Sitzmark test of transit time. This was followed by a 14-day washout and then a crossover to 14 days of placebo with tests of pain sensitivity and transit time. The other half of the subjects received placebo before lubiprostone. All kept symptom diaries. KEY

resultsStools were significantly softer when taking lubiprostone compared to placebo (Bristol Stool scores 4.20 vs 3.44, P < 0.001). However, thresholds for pain (17.36 vs 17.83 mmHg, lubiprostone vs placebo) and urgency to defecate (14.14 vs 14.53 mmHg) were not affected by lubiprostone. Transit time was not significantly different between lubiprostone and placebo (51.27 vs 51.81 h), and neither pain sensitivity nor transit time was a significant predictor of clinical pain. CONCLUSIONS & INFERENCES: Lubiprostone has no effect on visceral sensory thresholds. The reductions in clinical pain that occur while taking lubiprostone appear to be secondary to changes in stool consistency.

Indexed as

AdultAlprostadilCross-Over StudiesDefecationDilatationDouble-Blind MethodFemaleHumansIrritable Bowel SyndromeLubiprostoneMalePainPain ThresholdAlprostadilLubiprostone

Identifiers

PMID21914041
PMCPMC3184461
OpenAlexW1860428680

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.