Evidence map›Paper›PMID 40471839›Full record

SynthesisThe American journal of gastroenterology2026

The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.

Jonathan A Busam, Nisha Batta, Eric D Shah, LiJin Joo, Caroline Marshall, Ali Rezaie, Mark Pimentel

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in The American journal of gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Article
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

7 authors.

Jonathan A BusamDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-1905-5170
Nisha BattaDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-0239-8054
Eric D ShahDivision of Gastroenterology, Michigan Medicine, Ann Arbor, Michigan, USA.ORCID 0000-0003-3611-8628
LiJin JooMedically Associated Science and Technology (MAST) Program, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0003-0440-9527
Caroline MarshallMedical Library, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-2800-6514
Ali RezaieMedically Associated Science and Technology (MAST) Program, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-0106-372
Mark PimentelMedically Associated Science and Technology (MAST) Program, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID 0000-0002-0619-5115

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUnderstanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.

methodsPubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.

resultsFifty-four trials met inclusion criteria. For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 ( P < 0.01), 53 ( P = 0.59), 59 ( P < 0.01), 58 ( P = 0.03), and 16 ( P < 0.01), respectively. For diarrhea-predominant IBS pharmacotherapies, the NNH for alosetron and eluxadoline was 14 ( P < 0.01) and 32 ( P < 0.01) whereas the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value. For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 ( P < 0.01). Many AEs were transient without long-term sequela. DISCUSSION: Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.

Indexed as

Gastrointestinal AgentsIrritable Bowel SyndromeCarbolinesConstipationHumansIndolesIsoquinolinesLubiprostoneNatriuretic PeptidesPeptidesRisk AssessmentSulfonamidesalosetronCarbolinesGastrointestinal AgentsIndolesIsoquinolineslinaclotideLubiprostoneNatriuretic PeptidesPeptidesplecanatideSulfonamidestegaserodtenapanoradverse eventsirritable bowel syndromepatient safetypharmacotherapysystematic review and meta-analysis

Identifiers

PMID40471839
PMCPMC12940625

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.