Evidence map›Paper›PMID 23757096›Full record

SynthesisThe Cochrane database of systematic reviews2013

Drug treatment for faecal incontinence in adults.

Muhammad Imran Omar, Cameron Edwin Alexander

2 registry-linked trialsOpen access · bronzeAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in The Cochrane database of systematic reviews, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
11.1field-weighted citation impact, top 1% 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.

NCT05616208 phase1active not recruitingnot on this mapstarted 2022, after this paper: background citation

Phase 1 Treatment Study to Assess Safety and Proof of Concept to Assess Potential Efficacy of the Implanted Internal Anal Sphincter BioSphincterTM Bioengineered From Autologous Cells to Treat Patients With Severe Passive Fecal Incontinence

TypeinterventionalSponsorCellf Bio LLCRan2022 to 2027Enrolled10ConditionsFecal IncontinenceArmsBioengineered Internal Anal Sphincter
NCT06166615 phase2 / phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Psyllium (Agio®) for the Treatment of Fecal Incontinence: Multicenter Randomized Trial (SERAFI)

TypeinterventionalSponsorSeoul National University HospitalRan2023 to 2024Enrolled148ConditionsFecal IncontinenceArmsRamosetron, Psyllium
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Sacral nerve stimulation for faecal incontinence and constipation in adults.The Cochrane database of systematic reviews · 2015
    Pooled it
  4. Plugs for containing faecal incontinence.The Cochrane database of systematic reviews · 2015
    Pooled it
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  6. Trial
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  10. Review
  11. Article
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  15. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Muhammad Imran OmarAcademic Urology Unit, University of Aberdeen, Aberdeen, UK. m.i.omar@abdn.ac.uk
Cameron Edwin Alexander
University of Aberdeen · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFaecal incontinence (leakage of bowel motions or stool) is a common symptom which causes significant distress and reduces quality of life.

objectivesTo assess the effects of drug therapy for the treatment of faecal incontinence. In particular, to assess the effects of individual drugs relative to placebo or other drugs, and to compare drug therapy with other treatment modalities. SEARCH

methodsWe searched the Cochrane Incontinence Group Specialised Register of Trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE in process, and handsearching of journals and conference proceedings (searched 21 June 2012) and the reference lists of relevant articles. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials were included in this systematic review. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts, extracted data and assessed risk of bias of the included trials. MAIN

resultsSixteen trials were identified, including 558 participants. Eleven trials were of cross-over design. Eleven trials included only people with faecal incontinence related to liquid stool (either chronic diarrhoea, following ileoanal pouch or rectal surgery, or due to use of a weight-reducing drug). Two trials were amongst people with weak anal sphincters, one in participants with faecal impaction and bypass leakage, and one in geriatric patients. In one trial there was no specific cause for faecal incontinence.Seven trials tested anti-diarrhoeal drugs to reduce faecal incontinence and other bowel symptoms (loperamide, diphenoxylate plus atropine, and codeine). Six trials tested drugs that enhance anal sphincter function (phenylepinephrine gel and sodium valproate). Two trials evaluated osmotic laxatives (lactulose) for the treatment of faecal incontinence associated with constipation in geriatric patients. One trial assessed the use of zinc-aluminium ointment for faecal incontinence. No studies comparing drugs with other treatment modalities were identified.There was limited evidence that antidiarrhoeal drugs and drugs that enhance anal sphincter tone may reduce faecal incontinence in patients with liquid stools. Loperamide was associated with more adverse effects (such as constipation, abdominal pain, diarrhoea, headache and nausea) than placebo. However, the dose may be titrated to the patient's symptoms to minimise side effects while achieving continence. The drugs acting on the sphincter sometimes resulted in local dermatitis, abdominal pain or nausea. Laxative use in geriatric patients reduced faecal soiling and the need for help from nurses.Zinc-aluminium ointment was associated with improved quality of life, with no reported adverse effects. However, the observed improvement in quality of life was seen in the placebo group as well as the treatment group.It should be noted that all the included trials in this review had small sample sizes and short duration of follow-up. 'Risk of bias' assessment was unclear for most of the domains as there was insufficient information. There were no data suitable for meta-analysis. AUTHORS'

conclusionsThe small number of trials identified for this review assessed several different drugs in a variety of patient populations. The focus of most of the included trials was on the treatment of diarrhoea, rather than faecal incontinence. There is little evidence to guide clinicians in the selection of drug therapies for faecal incontinence. Larger, well-designed controlled trials, which use the recommendations and principles set out in the CONSORT statement, and include clinically important outcome measures, are required.

Indexed as

AdultAntidiarrhealsDiarrheaEpinephrineFecal IncontinenceGastrointestinal AgentsHumansLactuloseRandomized Controlled Trials as TopicValproic AcidZinc CompoundsAntidiarrhealsEpinephrineGastrointestinal AgentsLactuloseValproic AcidZinc Compounds

Identifiers

PMID23757096
PMCPMC7098421
OpenAlexW1555107348

What OpenQuestion holds

Textmetadata
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.