Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial

Abstract

Background and study aims For bowel preparation, using a reduced volume of polyethylene glycol (PEG) solution without influencing its effectiveness would be preferable. While simethicone shows great potential as an adjunctive agent, data on its use are limited. We aimed to clarify whether simethicone added to low-volume PEG solution improved bowel cleansing.

Patients and methods Consecutive adult patients registered for colonoscopy were recruited from seven medical centers in South China between 15 April and 15 July 2015 and prospectively randomized into two groups: 2 L PEG (conventional group) and 2 L PEG plus simethicone (simethicone group). The primary endpoint was the effectiveness of bowel cleansing according to the Boston Bowel Preparation Scale (BBPS). Secondary endpoints included cecal intubation time, adenoma detection rate (ADR), patient safety and compliance, and adverse events.

Results We included 290 and 289 patients in the conventional and simethicone groups, respectively, for analysis. The proportion with acceptable bowel cleansing (BBPS ≥ 6) was significantly higher in the simethicone group than in the conventional group (88.2 % vs. 76.6 %; P < 0.001). The mean (SD) BBPS score was significantly lower in the conventional group (6.5 [1.8] vs. 7.3 [1.7]; P < 0.001), as was the bubble score (2.5 [0.7] vs. 2.8 [0.5]; P < 0.001). The average cecal intubation time was significantly shorter in the simethicone group (6.3 [3.1] vs. 7.5 [5.1] minutes; P < 0.001). The ADR in the right colon was higher in the simethicone group than in the conventional group (16.6 % vs. 10.3 %; P = 0.03). Safety and compliance, including the taste, smell, and dosage of PEG, were similar for both groups.

Conclusions Simethicone added to low-volume PEG solution improves bowel-cleansing efficacy, with similar safety and compliance, shorter cecal intubation time, and higher ADR.

• References

• 1 Lei P, Gu F, Hong L. et al. Pediatric colonoscopy in South China: a 12-year experience in a tertiary center. PLoS One 2014; 9: e95933
• 2 Zhang S, Li M, Zhao Y. et al. 3-L split-dose is superior to 2-L polyethylene glycol in bowel cleansing in Chinese population: a multicenter randomized, controlled trial. Medicine (Baltimore) 2015; 94: e472
• 3 Chokshi RV, Hovis CE, Hollander T. et al. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc 2012; 75: 1197-1203
• 4 Lebwohl B, Kastrinos F, Glick M. et al. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc 2011; 73: 1207-1214
• 5 Hassan C, Bretthauer M, Kaminski MF. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 142-150
• 6 Enestvedt BK, Tofani C, Laine LA. et al. 4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis. Clin Gastroenterol Hepatol 2012; 10: 1225-1231
• 7 Chinese Society for Gastrointestinal Endoscopy. Chinese consensus on bowel preparation before endoscopy. Chin J Pract Int Med 2013; 33: 705-707
• 8 Johnson DA, Barkun AN, Cohen LB. et al. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology 2014; 147: 903-924
• 9 Moon CM, Park DI, Choe YG. et al. Randomized trial of 2-L polyethylene glycol+ascorbic acid versus 4-L polyethylene glycol as bowel cleansing for colonoscopy in an optimal setting. J Gastroenterol Hepatol 2014; 29: 1223-1228
• 10 Xie Q, Chen L, Zhao F. et al. A meta-analysis of randomized controlled trials of low-volume polyethylene glycol plus ascorbic acid versus standard-volume polyethylene glycol solution as bowel preparations for colonoscopy. PLoS One 2014; 9: e99092
• 11 Connor A, Tolan D, Hughes S. et al. Consensus guidelines for the safe prescription and administration of oral bowel-cleansing agents. Gut 2012; 61: 1525-1532
• 12 Wexner SD, Beck DE, Baron TH. et al. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Gastrointest Endosc 2006; 63: 894-909
• 13 Park S, Lim YJ. Adjuncts to colonic cleansing before colonoscopy. World J Gastroenterol 2014; 20: 2735-2740
• 14 Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol 2009; 15: 3032-3037
• 15 Matro R, Tupchong K, Daskalakis C. et al. The effect on colon visualization during colonoscopy of the addition of simethicone to polyethylene glycol-electrolyte solution: a randomized single-blind study. Clin Transl Gastroenterol 2012; 3: e26
• 16 Lai EJ, Calderwood AH, Doros G. et al. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009; 69: 620-625
• 17 Parmar R, Martel M, Rostom A. et al. Validated scales for colon cleansing: a systematic review. Am J Gastroenterol 2016; 111: 197-204
• 18 Brahmania M, Ou G, Bressler B. et al. 2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial. Gastrointest Endosc 2014; 79: 408-416
• 19 Wu L, Cao Y, Liao C. et al. Systematic review and meta-analysis of randomized controlled trials of Simethicone for gastrointestinal endoscopic visibility. Scand J Gastroenterol 2011; 46: 227-235
• 20 Yoo IK, Lee JS, Chun HJ. et al. A randomized, prospective trial on efficacy and tolerability of low-volume bowel preparation methods for colonoscopy. Dig Liver Dis 2015; 47: 131-137
• 21 Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc 2004; 59: 482-486
• 22 de Leone A, Tamayo D, Fiori G. et al. Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy. World J Gastrointest Endosc 2013; 5: 433-439
• 23 Aronchick CA, Lipshutz WH, Wright SH. et al. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc 2000; 52: 346-352
• 24 Ferlay J, Soerjomataram I, Dikshit R. et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015; 136: E359-E386
• 25 Zeng H, Zheng R, Guo Y. et al. Cancer survival in China, 2003–2005: a population-based study. Int J Cancer 2015; 136: 1921-1930
• 26 Manes G, Fontana P, de Nucci G. et al. Colon cleansing for colonoscopy in patients with ulcerative colitis: efficacy and acceptability of a 2-L PEG plus bisacodyl versus 4-L PEG. Inflamm Bowel Dis 2015; 21: 2137-2144
• 27 Ajani S, Hurt RT, Teeters DA. et al. Ischaemic colitis associated with oral contraceptive and bisacodyl use. BMJ Case Rep 2012; 2012: bcr1220115451
• 28 Park SS, Sinn DH, Kim YH. et al. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol 2010; 105: 1319-1326
• 29 Oliva S, Cucchiara S, Spada C. et al. Small bowel cleansing for capsule endoscopy in paediatric patients: a prospective randomized single-blind study. Dig Liver Dis 2014; 46: 51-55
• 30 Cheng CL, Kuo YL, Liu NJ. et al. Impact of bowel preparation with low-volume (2-liter) and intermediate-volume (3-liter) polyethylene glycol on colonoscopy quality: a prospective observational study. Digestion 2015; 92: 156-164
• 31 Martel M, Barkun AN, Menard C. et al. Split-dose preparations are superior to day-before bowel cleansing regimens: a meta-analysis. Gastroenterology 2015; 149: 79-88
• 32 Rex DK, Petrini JL, Baron TH. et al. Quality indicators for colonoscopy. Gastrointest Endosc 2006; 63: S16-S28
• 33 Yoo IK, Jeen YT, Kang SH. et al. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore) 2016; 95: e4163
• 34 Barclay RL, Vicari JJ, Doughty AS. et al. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. NEJM 2006; 355: 2533-2541