Evidence map›Paper›PMID 24697851›Full record

ArticleAlimentary pharmacology & therapeutics2014

Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials.

P Schoenfeld, M Pimentel, L Chang, A Lembo, W D Chey, J Yu, C Paterson, E Bortey, W P Forbes

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
8.8field-weighted citation impact, top 2% 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.

NCT00269412 phase2completednot on this map

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2005 to 2008Enrolled525ConditionsIrritable Bowel SyndromeArmsRifaximin
NCT00724126 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2008 to 2009Enrolled637ConditionsNon-Constipation Irritable Bowel SyndromeArmsRifaximin, Placebo
NCT00731679 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2008 to 2009Enrolled623ConditionsNon-Constipation Irritable Bowel SyndromeArmsRifaximin, Placebo
NCT06312683 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2024 to 2027Enrolled16ConditionsPouchitisArmsRifaximin 550 MG Oral Tablet [XIFAXAN]
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 100 citations in OpenAlex.

  1. Trial
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  3. Nutrients · 2019
    Trial
  4. Trial
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  6. Evaluating the Risk ofJournal of clinical medicine · 2026
    Article
  7. Article
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  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Diarrhea-Predominant Irritable Bowel Syndrome: Medical Management Update.Journal of the Canadian Association of Gastroenterology · 2020
    Article
  19. Second Asian Consensus on Irritable Bowel Syndrome.Journal of neurogastroenterology and motility · 2019
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

P SchoenfeldUniversity of Michigan School of Medicine, Ann Arbor, MI, USA.
M Pimentel
L Chang
A Lembo
W D Chey
J Yu
C Paterson
E Bortey
W P Forbes
University of Michigan–Ann Arbor · USBeth Israel Deaconess Medical Center · USCedars-Sinai Medical Center · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of rifaximin, a nonsystemic, gut-targeted antibiotic for reducing non-constipation-predominant irritable bowel syndrome (non-C IBS) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double-blind, placebo-controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow-up periods are lacking.

aimTo assess and determine the frequency of rifaximin and placebo adverse events (AEs) in phase 2b and phase 3 non-C IBS trials.

methodsA post hoc pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three times daily for 2 weeks) studies was performed. Data on treatment and post-treatment AEs were collected. Patients were followed up for 12 weeks and 10 weeks post-treatment in the phase 2b and phase 3 trials, respectively.

resultsPatients receiving rifaximin (n = 1103) and placebo (n = 829) had a similar incidence of drug-related AEs (12.1% vs. 10.7%), serious AEs (1.5% vs. 2.2%), drug-related AEs resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal-associated AEs (12.2% vs. 12.2%) and infection-associated AEs (8.5% vs. 9.5%). There were no cases of Clostridium difficile colitis or deaths.

conclusionsThe safety and tolerability profile of rifaximin during treatment and post-treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of C. difficile colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non-constipation-predominant irritable bowel syndrome (ClinicalTrials.gov: NCT00269412, NCT00731679, and NCT00724126).

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-Bacterial AgentsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDouble-Blind MethodFemaleFollow-Up StudiesGastrointestinal AgentsHumansIrritable Bowel SyndromeMaleMiddle AgedRandomized Controlled Trials as TopicAnti-Bacterial AgentsGastrointestinal AgentsRifamycinsRifaximin

Identifiers

PMID24697851
PMCPMC4112801
OpenAlexW2061365505

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.