A total of 668 participants were included in a comparison of 200 mg and 1200 mg of simethicone added to a bowel preparation solution.
Both doses of simethicone resulted in similar rates of adequate bowel preparation (95.8% for 200 mg vs. 97.6% for 1200 mg, P = 0.276).
The was comparable between the two groups (22.3% for 200 mg vs. 25.6% for 1200 mg, P = 0.561).
Participants tolerated and accepted both regimens well, with no significant adverse events related to bowel preparation reported.
Simplified
BACKGROUND: Simethicone (SIM) can enhance bowel preparation efficiency, but the optimal dose for patients undergoing afternoon colonoscopy is still unclear. This study compares bowel preparation efficiency and (ADR) between patients receiving 3 L of polyethylene glycol electrolyte solution (PEG-ELS) with 200 mg SIM or 1200 mg SIM for afternoon colonoscopy.
METHOD: This prospective, randomized, and observer-blinded trial included consecutive patients undergoing colonoscopy. It compared the effects of two SIM dosages (200 mg and 1200 mg) added to a 3 L PEG-ELS regimen. The primary outcome of our study was the rate of adequate bowel preparation, as defined by all 3 segments 2 or 3 on the (BBPS). Secondary outcomes included the Bubble Scale (BS) score and ADR. Adverse effects related to bowel preparation were systematically administered by a trained nurse using standardized patient questionnaire.
RESULTS: A total of 668 participants were randomly assigned to either the 200 mg group (n = 332) or 1200 mg SIM group (n = 336). There were no significant differences in baseline characteristics between the two groups. Additionally, no significant differences were observed in adequate bowel preparation rate (95.8% vs. 97.6%, P = 0.276) and ADR (22.3% vs. 25.6%, P = 0.561). Both regimens were well tolerated and accepted by participants, as assessed through a standardized patient questionnaire.
CONCLUSION: 200 mg versus 1200 mg of SIM in 3 L PEG-ELS for afternoon colonoscopy demonstrated no statistically significant difference in bowel cleansing quality, ADR and bowel preparation-related adverse events. This evidence supports the clinical feasibility of 200 mg simethicone as an effective alternative for optimizing colonic preparation while maintaining procedural standards.
TRIAL REGISTRATION: This clinical trial was retrospectively registered with the Chinese Clinical Trial Registry (Registration No. ChiCTR2400089196) on 3 September 2024.
Key numbers
95.8%
Adequate Bowel Preparation Rate
200 mg SIM group rate compared to 1200 mg group rate of 97.6%.
22.3%
()
Compared to 25.6% in the 1200 mg SIM group.
85.8%
Participant Willingness for Future Use
Willingness in the 200 mg SIM group compared to 84.5% in the 1200 mg group.
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Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Ethical approval was obtained from the from the Institutional Review Board of Shenzhen People’s Hospital (NO. LL-KY-2023212-02), Date: 17 January 2024. Moreover, this trial was registered at Chinese Clinical Trial Registry (NO. ChiCTR2400089196). All participants provided written informed consent prior to enrollment. All authors declare no conflicts of interest related to this research. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
