Randomized, double-blinded, placebo-controlled trial evaluating simethicone pretreatment with bowel preparation during colonoscopy

Abstract

BACKGROUND The presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist’s view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol (PEG) and bisacodyl combination preparation. AIM To evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy. METHODS Described is a prospective, randomized, multi-center, double-blinded, placebo-controlled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies. Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation of the Boston Bowel Preparation Scale (BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events. RESULTS Higher Intraluminal Bubbles grades III and IV (less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash) were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84 ( P = 0.007)]. BBPS total score was 7.42 [standard deviation (SD) = ± 1.51] in the simethicone group and 7.28 (SD = ± 1.44) in the placebo group ( P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group ( P = 0.001). CONCLUSION The addition of simethicone to bowel preparation is well advised for its anti-foaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.

Efficacy of low‐dose versus high‐dose simethicone with polyethylene glycol for bowel preparation: A prospective randomized controlled trial

“…Moreover, it was comparable with that in a previous study that involved administration of 480 mg SIM in addition to split‐dose 4 L PEG . In a study by Rishi et al ., the ADR in the group that received 200 mg SIM in addition to 2 L split‐dose PEG was significantly higher than that in the group that received PEG alone (65.6% vs 34.4%) . In addition, in a meta‐analysis, the pooled ADR (range, 30–35%) achieved with use of supplemental SIM was significantly higher than that achieved with bowel preparation regimens without supplemental SIM .…”

“…It prevents bubble formation and gas retention, which alleviates abdominal pain and bloating; therefore, it is widely prescribed to patients with irritable bowel syndrome . Several recent randomized controlled trials have demonstrated that addition of SIM to bowel preparation regimens can help improve the quality of bowel preparation, ADR and patient tolerance . However, there was considerable variability among these studies with respect to the dosage of SIM used.…”

The Colon Endoscopic Bubble Scale (CEBuS): a two-phase evaluation study

“…The authors performed an evaluation of the agreement using that scale with a kappa of 0.54. Also, Rishi et al [14] adapted previous scales with the same low agreement result, undermining proper evaluation of results. Therefore, a recurrent problem is there to be addressed which is the lack of a scale to evaluate bubbles in colonoscopy, with proven reliability such as we present…”

“…[3,4,[10][11][12][13] Two recently published studies on the influence of simethicone on bowel preparation tried and failed to validate and establish the reliability of a colonic bubble scale, based on previous suggested and non-validated scales, although with only fair to moderate interobserver reliability. [14,15] Therefore, the main goal of this study was to develop and establish the reliability for the use of a comprehensive scale to graduate bubbles in the colon, the Colon Endoscopic Bubble Scale (CEBuS), assessing the inter-and intraobserver reliability of the scale.…”

Effect of Antifoaming Agent on Colorectal Benign Tumours in Colonoscopy: A Meta-Analysis

“…The 20 studies [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] included 6306 patients, of whom 3162 and 3144 patients were assigned to the PEG plus simethicone group and PEG group, respectively (Tables 1 and 2). These studies were performed in ve countries (China, Korean, Italy, the USA, and the Netherlands).…”