Evidence map›Paper›PMID 23891925›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2014

Effects of clonidine in women with fecal incontinence.

Adil E Bharucha, Joel G Fletcher, Michael Camilleri, Jessica Edge, Paula Carlson, Alan R Zinsmeister

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00884832 (A Placebo-Controlled Study of Clonidine for Fecal Incontinence.), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
5.3field-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.

NCT00884832 phase2completednot on this map

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

TypeinterventionalSponsorMayo ClinicRan2008 to 2012Enrolled44ConditionsFecal IncontinenceArmsClonidine, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Faecal incontinence in adults.Nature reviews. Disease primers · 2022
    Review
  12. Review
  13. Article
  14. Article
  15. Constipation and Fecal Incontinence in the Elderly.Current gastroenterology reports · 2020
    Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Evidence-Based Update on Treatments of Fecal Incontinence in Women.Obstetrics and gynecology clinics of North America · 2016
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Adil E BharuchaClinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: bharucha.adil@mayo.edu.
Joel G FletcherDepartment of Radiology, Mayo Clinic, Rochester, Minnesota.
Michael CamilleriClinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
Jessica EdgeClinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
Paula CarlsonClinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
Alan R ZinsmeisterDivision of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
Mayo Clinic · USMayo Clinic in Florida · US

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Pathophysiology of Anorectal DisordersR01DK078924 · NIDDK · MAYO CLINIC ROCHESTER · PI BHARUCHA, ADIL E. · 2008 to 2023
$5.0M
NCATS NIH HHS 1 UL1TR000135NCRR NIH HHS UL1 RR024150NIDDK NIH HHS R01 DK078924PHS HHS R01 DKDK78924
6 · The paper itself

Abstract

BACKGROUND &

aimsSome women with urge-predominant fecal incontinence (FI) have diarrhea-predominant irritable bowel syndrome and a stiffer and hypersensitive rectum. We evaluated the effects of the α2-adrenergic agonist clonidine on symptoms and anorectal functions in women with FI in a prospective, placebo-controlled trial.

methodsWe assessed bowel symptoms and anorectal functions (anal pressures, rectal compliance, and sensation) in 43 women (age, 58 ± 2 y) with urge-predominant FI, randomly assigned to groups given oral clonidine (0.1 mg, twice daily) or placebo for 4 weeks. Before and after administration of the medication, anal pressures were evaluated by manometry, and rectal compliance and sensation were measured using a barostat. Anal sphincter injury was evaluated by endoanal magnetic resonance imaging. Bowel symptoms were recorded in daily and weekly diaries. The primary end point was the FI and Constipation Assessment symptom severity score.

resultsFI scores decreased from 9.1 ± 0.3 to 7.6 ± 0.5 among subjects given placebo and from 8.1 ± 0.4 to 6.5 ± 0.6 among patients given clonidine. Clonidine did not affect FI symptom severity, bowel symptoms (stool consistency or frequency), anal pressures, rectal compliance, or sensation compared with placebo. However, when baseline data were used to categorize subjects as those with or without diarrhea, clonidine reduced the proportion of loose stools in patients with diarrhea only (P = .018). Clonidine also reduced the proportion of days with FI in patients with diarrhea (P = .0825).

conclusionsOverall, clonidine did not affect bowel symptoms, fecal continence, or anorectal functions, compared with placebo, in women with urge-predominant FI. Among patients with diarrhea, clonidine increased stool consistency, with a borderline significant improvement in fecal continence. ClinicalTrials.gov, Number NCT00884832.

Indexed as

Administration, OralAdolescentAdrenergic alpha-2 Receptor AgonistsAgedAnal CanalClonidineFecal IncontinenceFemaleHumansManometryMiddle AgedPlacebosProspective StudiesTreatment OutcomeYoung AdultAdrenergic alpha-2 Receptor AgonistsClonidinePlacebosFICAIBSMRIRandomized Controlled TrialStool Consistency

Identifiers

PMID23891925
PMCPMC3900592
OpenAlexW2065547757

What OpenQuestion holds

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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.