Evidence map›Paper›PMID 12870789›Full record

Trial reportDigestive diseases and sciences2003

Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy.

Susan Gordon, Vanessa Ameen, Barbara Bagby, Britt Shahan, Priti Jhingran, Eric Carter

2 registry-linked trialsAbstract readClinical TrialRandomized Controlled TrialValidation Study
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2003. 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 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
–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.

NCT01327300 phase2completednot on this mapstarted 2010, after this paper: background citation

Randomized, Double-blind, Cross-over Study of the Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

TypeinterventionalSponsorUniversity of FloridaRan2010 to 2012Enrolled7ConditionsIrritable Bowel SyndromeArmsMesalamine, Placebo
NCT04612803 unknown statusnot on this mapstarted 2020, after this paper: background citation

Observational Study of the Prevalence of Antihistamine Responsive Gastrointestinal Symptoms in Patients Diagnosed With Irritable Bowel Syndrome With Diarrhea

TypeobservationalSponsorUniversity of CincinnatiRan2020 to 2021Enrolled100ConditionsIrritable Bowel Syndrome, Dermatographism, Post-prandial DiarrheaArmsAntihistamine
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  6. Effect of Oral Intake ofNutrients · 2022
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  14. A treatment trial of acupuncture in IBS patients.The American journal of gastroenterology · 2009
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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

6 authors.

Susan GordonDepartment of Gastroenterology, GlaxoSmithKline, Research Triangle Park, North Carolina 27709, USA.
Vanessa Ameen
Barbara Bagby
Britt Shahan
Priti Jhingran
Eric Carter

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Global Improvement Scale (GIS) assesses multiple irritable bowel syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from symptoms substantially worse to substantially improved. To evaluate the scale as an efficacy end point, data were collected from two 12-week randomized, double-blind, placebo-controlled studies of female nonconstipated IBS patients. GIS responders were defined as having substantial or moderate improvement in IBS symptoms. GIS responders had more days with satisfactory control of urgency, firmer stools, fewer stools per day, and fewer days with incomplete evacuation compared to nonresponders. Substantially more GIS responders (90% and 89% in studies 1 and 2, respectively) were satisfied or very satisfied with their treatment overall compared to nonresponders (13% and 11%) (r = 0.8 in both studies). GIS responders had greater satisfaction with medication relief of pain and discomfort and the time needed to return to usual activities. Favorable correlations between GIS and work and nonwork productivity losses were observed. Correlation of the GIS measure with IBS clinical end points establishes the validity of the GIS for measuring improvement in IBS symptoms. The GIS may be useful in assessing the efficacy of IBS interventions in future clinical trials.

Indexed as

Severity of Illness IndexAdultColonic Diseases, FunctionalFemaleHumansMiddle AgedPatient SatisfactionRandomized Controlled Trials as TopicRemission InductionTreatment Outcome

Identifiers

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.