Evidence map›Paper›PMID 32519140›Full record

Trial reportDigestive diseases and sciences2021

Oral IBGard™ Before Colonoscopy: A Single-Center Double-Blinded, Randomized, Placebo-Controlled Trial.

James Y Han, Zain Moosvi, Erica Duh, Sunhee Park, Gregory C Albers, Jason B Samarasena, William Karnes

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 56% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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 at 2 institutions in 1 country.

James Y HanDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
Zain MoosviDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA. zmoosvi@uci.edu.ORCID 0000-0003-1280-4826
Erica DuhDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
Sunhee ParkDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
Gregory C AlbersDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
Jason B SamarasenaDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
William KarnesDepartment of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.
University of California, Irvine · USUniversity of California, Irvine Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeppermint oil is well known to inhibit smooth muscle contractions, and its topical administration during colonoscopy is reported to reduce colonic spasms.

aimsWe aimed to assess whether oral administration of IBGard™, a sustained-release peppermint oil formulation, before colonoscopy reduces spasms and improves adenoma detection rate (ADR). 

methodsWe performed a single-center randomized, double-blinded, placebo-controlled trial. Patients undergoing screening or surveillance colonoscopies were randomized to receive IBGard™ or placebo. The endoscopist graded spasms during insertion, inspection, and polypectomy. Bowel preparation, procedure time, and time of drug administration were documented. Statistical analysis was performed using the Student's t test and Wilcoxon rank-sum test.

resultsThere was no significant difference in baseline characteristics or dose-timing distribution between IBGard™ and placebo groups. Similarly, there was no difference in ADR (IBGard™ = 47.8%, placebo = 43.1%, p = 0.51), intubation spasm score (1.23 vs 1.2, p = 0.9), withdrawal spasm score (1.3 vs 1.23, p = 0.72), or polypectomy spasm score (0.52 vs 0.46, p = 0.69). Limiting the analysis to patients who received the drug more than 60 min prior to the start of the procedure did not produce any significant differences in these endpoints.

conclusionsThis randomized controlled trial failed to show benefit of orally administered IBGard™ prior to colonoscopy on the presence of colonic spasms or ADR. Because of its low barrier to widespread adoption, the use of appropriately formulated and timed oral peppermint oil warrants further study to determine its efficacy in reducing colonic spasms and improving colonoscopy quality.

Indexed as

ColonoscopyAdenomatous PolypsAdministration, OralAgedCaliforniaColonic NeoplasmsColonic PolypsDelayed-Action PreparationsDouble-Blind MethodFemaleHumansMaleMentha piperitaMiddle AgedParasympatholyticsPlant OilsDelayed-Action PreparationsParasympatholyticspeppermint oilPlant OilsAdenoma detection rateColonic spasmColonoscopyIBGardPeppermint oil

Identifiers

PMID32519140
OpenAlexW3033891243

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.