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

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

doi:10.1186/s12876-016-0542-0

Rupa Banerjee, Arjunan Saravanan + Show 4 more

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https://doi.org/10.1186/s12876-016-0542-0

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Journal: BMC gastroenterology	Publication Date: Oct 13, 2016
Citations: 56	License type: cc-by

Affiliation: Asian Institute of Gastroenterology

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).

Highlights

Adequate bowel preparation is an essential prerequisite for complete mucosal visualization during colonoscopy
After observation of significant improvement in bowel preparation with addition of LB, we undertook second part of this study where we evaluated if addition of LB facilitated dose reduction of Polyethylene glycol (PEG)
458 patients were enrolled in the study of which 228 patients were allocated to group A and 230 patients were allocated to group B. 16 patients (7 from group A and 9 from Group B) in whom colonoscopy could not be completed were excluded from the analysis

Summary

Introduction

Adequate bowel preparation is an essential prerequisite for complete mucosal visualization during colonoscopy. 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. Bowel cleansing prior to colonoscopy is the essential prerequisite to ensure complete mucosal visualization and lesion identification [1, 2]. Inadequate preparations have been noted in around 25 % cases in the US [4, 8]. This has been attributed primarily to poor patient tolerance to the standard colon preparations

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Discussion

Conclusion