Evidence map›Paper›PMID 27737636›Full record

Trial reportBMC gastroenterology2016

Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial.

Rupa Banerjee, Hrushikesh Chaudhari, Nirish Shah, Arjunan Saravanan, Manu Tandan, D Nageshwar Reddy

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01324284 (Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 29% 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.

NCT01324284 phase3completednot on this map

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.

TypeinterventionalSponsorAsian Institute of Gastroenterology, IndiaRan2011 to 2011Enrolled442ConditionsColorectal CarcinomaArmsLubiprostone
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Efficacy of ultra-low volume (≤1 L) bowel preparation fluids: Systematic review and meta-analysis.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2022
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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 at 1 institution in 1 country.

Rupa BanerjeeDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India. dr_rupa_banerjee@hotmail.com.
Hrushikesh ChaudhariDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India.
Nirish ShahDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India.
Arjunan SaravananDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India.
Manu TandanDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India.
D Nageshwar ReddyDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, India.
Asian Institute of Gastroenterology · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdequate bowel preparation is an essential prerequisite for complete mucosal visualization during colonoscopy. Polyethylene glycol (PEG) solutions are commonly used. However the large volume of the solution is often poorly tolerated. Addition of Lubiprostone (LB) could improve the adequacy of standard PEG preparation & reduce requirement. The aims to assess adequacy of PEG preparation with addition of single dose LB (24mcg) vs placebo and efficacy of reduced dose PEG + LB compared with full dose PEG + LB.

methodsSingle center prospective double blind randomized controlled trial. Part I: 442 patients for colonoscopy randomized to receive placebo (GrA) or single dose of LB (GrB) prior to PEG preparation. Quality of bowel preparation graded 0-9 according to Boston Bowel Preparation Scale (BBPS). BBPS-9: excellent and BBPS 0-4: repeat procedure. Part II: 146 patients randomized to receive LB + 1.5 L PEG (GrC; 75) or LB + 1 L PEG (GrD; 71). BBPS score compared with GrB (2 L PEG).

resultsPart I: 442 patients (221 GrA & 221 Gr B). LB resulted in significant improvement in total BBPS (7.44 + 0.14 vs. 6.36 + 0.16, p < 0.0001). 66.5 % Gr B vs 38 % Gr A had excellent prep; 42.5 % GrB vs 24 % GrA had adequate prep. Repeat procedure needed 9.5 % Gr B vs 16.7 % Gr A (P < 0.01). Part II: No difference in BBPS scores with lower doses (Gr C&D) compared to standard (GrB) (Mean BBPS 7.44 + 0.14 GrA,7.30 + 0.25 GrC;7.25 + 0.26 GrD;p >0.05).

conclusionSingle dose LB prior to PEG significantly enhanced bowel preparation compared to PEG alone. There was no significant difference in quality of preparation with lower doses of PEG when combined with LB.

trial registrationThe study protocol was approved by institutional review board and the trial was registered on March 22, 2011 with clinicaltrials.gov ( NCT01324284 ).

Indexed as

ColonoscopyAdultCatharticsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLubiprostoneMaleMiddle AgedPolyethylene GlycolsPreoperative CareProspective StudiesTreatment OutcomeCatharticsLubiprostonePolyethylene GlycolsBowel preparationColonoscopyLubiprostonePEG

Identifiers

PMID27737636
PMCPMC5064954
OpenAlexW2531903751

What OpenQuestion holds

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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.