Evidence map›Paper›PMID 30370492›Full record

Trial reportDigestive diseases and sciences2019

Double-Blind Placebo-Controlled Study of Rifaximin and Lactulose Hydrogen Breath Test in Gulf War Veterans with Irritable Bowel Syndrome.

Ashok K Tuteja, Nicholas J Talley, Gregory J Stoddard, G Nicholas Verne

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
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  12. The Prevalence, Humanistic Burden, and Health Care Impact of Irritable Bowel Syndrome Among United States Veterans.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2023
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Ashok K TutejaGeorge E. Whalen Veterans Affairs Medical Center, Salt Lake City, UT, USA. Ashok.Tuteja@hsc.utah.edu.
Nicholas J TalleyUniversity of Newcastle, Callaghan, NSW, 2308, Australia.
Gregory J StoddardDivision of Epidemiology, University of Utah, Salt Lake City, UT, USA.
G Nicholas VerneDepartment of Medicine, Tulane University School of Medicine, New Orleans, LA, USA.
Tulane University · USUniversity of Newcastle Australia · AUUniversity of Utah · US

Funding

Mechanisms of Altered Gastrointestinal DysfunctionR01DK099052 · NIDDK · UNIVERSITY OF TEXAS MED BR GALVESTON · PI VERNE, GEORGE NICHOLAS, ZHOU, QIQI · 2013 to 2023
$3.0M
6 · The paper itself

Abstract

backgroundIrritable bowel syndrome (IBS) occurs in up to 33% of Gulf War (GW) Veterans. Alterations in gut microflora including small intestinal bacterial overgrowth (SIBO) during deployment may play a role in development of IBS. Rifaximin is a minimally absorbed antibiotic speculated to improve IBS symptoms, in part, by restoring normal gut microflora. The aim of this study was to compare rifaximin to placebo on IBS symptoms and quality of life (QOL) in GW Veterans with IBS without constipation.

methodsA double-blind, placebo-controlled study was performed. One hundred and twenty-two GW Veterans with IBS (Rome III) from our database and referral to gastroenterology and internal medicine clinics were screened. After a 2-week run-in period, 50 patients were randomized (1:1) to receive either rifaximin 550 gm or placebo twice daily for 2 weeks in a double-blind study. Patients were advised not to change their diet or medications during the study. The symptoms assessed were: (1) stool frequency, (2) stool consistency (Bristol stool scale, 1-7, very hard to watery), (3) urgency (1 = yes/0 = no daily for 7 days), (4) severity of abdominal pain (0-4, none to severe), (5) severity of bloating (1-4, none to severe), and (6) global improvement scale (1-7, substantially worse to substantially improved). These were recorded for 7 consecutive days and then averaged across the 7 days, to generate a continuous variable. The symptom data were compared after 2 weeks of treatment. QOL was assessed using IBS-QOL. The lactulose hydrogen breath test (LHBT) was performed at baseline and after 2 weeks of treatment.

resultsFifty Veterans were randomized to receive treatment; 3 withdrew and 3 were lost to follow-up. Data were analyzed from 44 patients (38 men, 6 women, median age 52, range 33-77 years). Rifaximin was not associated with significant improvement in global symptoms, abdominal pain, bloating, stool urgency, frequency, or consistency (all P ≥ 0.25) or QOL (all P ≥ 0.26). Normalization of SIBO by LHBT was not different between rifaximin- and placebo-treated Veterans (7 vs. 22%, P = 0. 54).

conclusionRifaximin was not effective in improving IBS symptoms and QOL in GW Veterans with non-constipated IBS.

Indexed as

Gulf WarVeteransAdultAgedAnti-Bacterial AgentsBacteriaBreath TestsDefecationDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansIrritable Bowel SyndromeLactuloseMaleMiddle AgedAnti-Bacterial AgentsLactuloseRifaximinDiarrheaGulf War illnessIrritable bowel syndromeRifaximinVeterans

Identifiers

PMID30370492
OpenAlexW2898093380

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.