Evidence map›Paper›PMID 18848833›Full record

ReviewGastroenterology2008

Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles.

Michael Camilleri, Lin Chang

Registry-linked trialOpen access · bronzeAbstract readReview
In one paragraph

Review in Gastroenterology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00561535 (Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
5.9field-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.

NCT00561535 phase2completednot on this map

Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2007 to 2010Enrolled60ConditionsIrritable Bowel SyndromeArmsLactobacillus FARCIMINIS, placebo (starch)
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.

  1. Guideline
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 1 country.

Michael CamilleriClinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota 55905, USA. camilleri.michael@mayo.edu.
Lin Chang
Mayo Clinic · USVA West Los Angeles Medical Center · US

Funding

Women's Health and Functional Visceral Disorders CenterP50DK064539 · NIDDK · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MAYER, EMERAN A · 2002 to 2017
$17.5M
NEUROENDOCRINE ALTERATIONS IN FIBROMYALGIA AND IBSR01AR046122 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHANG, LIN · 1999 to 2010
$2.4M
ALPHA 2 ADRENERGIC CONTROL OF COLONIC FUNCTION IN IBSR01DK054681 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L · 1999 to 2007
$1.5M
NIAMS NIH HHS R01 AR046122NIDDK NIH HHS P50 DK064539NIDDK NIH HHS R01 DK054681
6 · The paper itself

Abstract

Recent advances in our understanding of basic neuroenteric mechanisms and the role of effectors and transmitters in the brain-gut axis have provided opportunities to develop new therapeutic agents for irritable bowel syndrome (IBS). Furthermore, human pharmacodynamic studies utilizing transit, colonic, or rectal sensitivity and brain imaging have been useful in determining therapeutic efficacy (particularly for drugs that act on motor function). This review provides an overview of medications that have not yet been approved for treatment of patients with IBS yet have shown promise in phase IIB trials. These include drugs that act on the serotonin receptor and transporter system: antidepressants, norepinephrine reuptake inhibitors, opioids, cholecystokinin antagonists, neurokinin-antagonists, chloride channel activators, guanylate cyclase C agonists, atypical benzodiazepines, probiotics, and antibiotics. The changing landscape in the regulatory approval process has impacted the development of IBS drugs. Guidance documents from regulatory agencies in Europe and the United States have focused on patients' reported outcomes and associated quality of life. After a decade of experience with different end points that have generated some data on psychometric validation and unprecedented information about responsiveness of the binary or global end points to drug therapy, it is necessary to pursue further validation studies before or during pivotal phase IIB or III trials. The hope of providing relief to patients should galvanize all parties to achieve these goals.

Indexed as

Anti-Bacterial AgentsGastrointestinal AgentsHumansIrritable Bowel SyndromeProbioticsSerotonin AgentsTreatment OutcomeAnti-Bacterial AgentsGastrointestinal AgentsSerotonin Agents

Identifiers

PMID18848833
PMCPMC2671226
OpenAlexW2064433763

What OpenQuestion holds

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LicenceTDM
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.