Skip to main content

Advertisement

SpringerLink
Log in

Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study

  • Original Article—Alimentary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

A Letter to the Editor to this article was published on 02 May 2024

Abstract

Background

We compared the efficacy, tolerability, and safety of oral sulfate tablets (OST, which contains simethicone) and 2 L-polyethylene glycol/ascorbate (2 L-PEG/Asc) with a split-dosing regimen in older individuals aged ≥ 70 years who underwent scheduled colonoscopy.

Methods

This prospective, randomized, investigator-blinded, multicenter study was conducted between June 2022 and October 2023. Participants aged ≥ 70 years were randomized at a ratio of 1:1 to the OST or 2 L-PEG/Asc groups.

Results

In total, 254 patients were evaluated using a modified full analysis set. Successful overall bowel preparation was excellent and similar between the OST and 2 L-PEG/Asc groups for the Boston Bowel Preparation Scale (BBPS) (96.5% vs. 96.6%) and Harefield Cleansing Scale (HCS) (96.5% vs. 97.4%). The overall high-quality preparation rate was higher in the OST group than in the 2 L-PEG/Asc group (BBPS: 55.7% vs. 28.4%, P < 0.001; HCS: 66.1% vs. 38.8%, P < 0.001). The overall adenoma detection rate (54.8% vs. 35.3, P = 0.003) was superior in the OST group compared to the 2 L-PEG/Asc group. Tolerability scores, including overall satisfaction, were generally higher in the OST group than in the 2 L-PEG/Asc group. The incidence of major solicited adverse events was comparable between the two groups (55.7% vs. 68.1, P = 0.051), and there were no clinically significant changes in the serum laboratory profiles on the day of or 7 days after colonoscopy.

Conclusions

OST is an effective and safe low-volume agent for colonoscopy, with better tolerance than 2 L-PEG/Asc, in older individuals aged ≥ 70 years.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Abbreviations

OST:

Oral sulfate tablet

PEG:

Polyethylene glycol

Asc:

Ascorbate

BBPS:

Boston Bowel Preparation Scale

HCS:

Harefield Cleansing Scale

CRC:

Colorectal cancer

OSS:

Oral sulfate solution

PDR:

Polyp detection rate

ADR:

Adenoma detection rate

AE:

Adverse event

mFAS:

Modified full analysis set

References

  1. Nishihara R, Wu K, Lochhead P, et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013;369:1095–105.

    Article  CAS  PubMed  Google Scholar 

  2. Løberg M, Kalager M, Holme Ø, et al. Long-term colorectal-cancer mortality after adenoma removal. N Engl J Med. 2014;371:799–807.

    Article  PubMed  Google Scholar 

  3. Cha JM, Kozarek RA, La Selva D, et al. Risks and benefits of colonoscopy in patients 90 years or older, compared with younger patients. Clin Gastroenterol Hepatol. 2016;14:80-6.1.

    Article  Google Scholar 

  4. Cha JM, Kwak MS, Kim HS, et al. Real-world national colonoscopy volume in Korea: a nationwide population-based study over 12 Years. Gut Liver. 2020;14:338–46.

    Article  PubMed  Google Scholar 

  5. Hassan C, Fuccio L, Bruno M, et al. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012;10:501–6.

    Article  PubMed  Google Scholar 

  6. Hassan C, East J, Radaelli F, et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline—update 2019. Endoscopy. 2019;51:775–94.

    Article  PubMed  Google Scholar 

  7. Jung YS, Lee CK, Eun CS, et al. Low-volume polyethylene glycol with ascorbic acid for colonoscopy preparation in elderly patients: a randomized multicenter study. Digestion. 2016;94:82–91.

    Article  CAS  PubMed  Google Scholar 

  8. Kwak MS, Cha JM, Yang HJ, et al. Safety and efficacy of low-volume preparation in the elderly: oral sulfate solution on the day before and split-dose regimens (SEE SAFE) Study. Gut Liver. 2019;13:176–82.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Yoon JY, Kim HG, Cho YS, et al. 1 L- versus 2 L-polyethylene glycol with ascorbic acid for bowel preparation in elderly patients: a randomized multicenter study. Surg Endosc. 2022;36:5724–33.

    Article  PubMed  Google Scholar 

  10. Di Palma JA, Bhandari R, Cleveland MV, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116:319–28.

    Article  CAS  PubMed  Google Scholar 

  11. Kim JH, Park YE, Kim TO, et al. Comparison of the efficacy and safety between oral sulfate tablet and polyethylene glycol for bowel preparation before colonoscopy according to age. Medicine (Baltimore). 2022;101: e29884.

    Article  CAS  PubMed  Google Scholar 

  12. Lee SE, Oh DJ, Nam JH, et al. Taking oral sulfate tablets with simethicone for bowel preparation leads to higher adenoma detection rate than polyethylene glycol: a propensity score analysis. Dig Dis Sci. 2023;68:867–76.

    Article  CAS  PubMed  Google Scholar 

  13. Jeon SR, Park SK, Yang DH, et al. Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate tablet in bowel preparation for colonoscopy: a prospective, randomized, investigator-blinded, multicenter, non-inferior, phase 3 trial. J Gastroenterol. 2023;58:1114–23.

    Article  CAS  PubMed  Google Scholar 

  14. Hsu CY, Chertow GM. Chronic renal confusion: insufficiency, failure, dysfunction, or disease. Am J Kidney Dis. 2000;36:415–8.

    Article  CAS  PubMed  Google Scholar 

  15. Calderwood AH, Schroy PC 3rd, Lieberman DA, et al. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014;80:269–76.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Halphen M, Heresbach D, Gruss HJ, et al. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013;78:121–31.

    Article  PubMed  Google Scholar 

  17. Hatoum HT, Lin SJ, Joseph RE, et al. Validation of a patient satisfaction scale in patients undergoing bowel preparation prior to colonoscopy. Patient. 2016;9:27–34.

    Article  PubMed  Google Scholar 

  18. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Am J Gastroenterol. 2015;110:72–90.

    Article  PubMed  Google Scholar 

  19. Keswani RN, Crockett SD, Calderwood AH. AGA clinical practice update on strategies to improve quality of screening and surveillance colonoscopy: expert review. Gastroenterology. 2021;161:701–11.

    Article  PubMed  Google Scholar 

  20. Kaminski MF, Thomas-Gibson S, Bugajski M, et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017;49:378–97.

    Article  PubMed  Google Scholar 

  21. Baker FA, Mari A, Nafrin S, et al. Predictors and colonoscopy outcomes of inadequate bowel cleansing: a 10-year experience in 28,725 patients. Ann Gastroenterol. 2019;32:457–62.

    PubMed  PubMed Central  Google Scholar 

  22. Kim KO, Kim EY, Lee YJ, et al. Efficacy, safety and tolerability of oral sulphate tablet for bowel preparation in patients with inflammatory bowel disease: a multicentre randomized controlled study. J Crohns Colitis. 2022;16:1706–13.

    Article  PubMed  Google Scholar 

  23. Yang HJ, Park DI, Park SK, et al. Novel sulfate tablet PBK-1701TC versus oral sulfate solution for colon cleansing: a randomized phase 3 trial. J Gastroenterol Hepatol. 2020;35:29–36.

    Article  CAS  PubMed  Google Scholar 

  24. Park JH, Hong SW, Hwang SW, et al. Efficacy and safety of oral sodium sulfate tablet compared with 1-L polyethylene glycol plus ascorbate: a prospective, randomized, endoscopist-blinded trial. J Gastroenterol Hepatol. 2023;38:2090–6.

    Article  CAS  PubMed  Google Scholar 

  25. Patel V, Nicar M, Emmett M, et al. Intestinal and renal effects of low-volume phosphate and sulfate cathartic solutions designed for cleansing the colon: pathophysiological studies in five normal subjects. Am J Gastroenterol. 2009;104:953–65.

    Article  CAS  PubMed  Google Scholar 

  26. Song JH, Bae JH, Yim JY. Efficacy of oral sulfate tablets for bowel preparation and adenoma detection rate. J Gastroenterol Hepatol. 2023;38:410–5.

    Article  CAS  PubMed  Google Scholar 

  27. Yeh JH, Hsu MH, Tseng CM, et al. The benefit of adding oral simethicone in bowel preparation regimen for the detection of colon adenoma: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2019;34:830–6.

    Article  CAS  PubMed  Google Scholar 

  28. Patel SG, May FP, Anderson JC, et al. Updates on age to start and stop colorectal cancer screening: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2022;162:285–99.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The authors thank the clinical trial department of Pharmbio Korea for their expertise.

Funding

This study was funded by Pharmbio Korea Co., Seoul, Korea; however, clinical trial and manuscript writing were carried out independently.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea

    Ho Suk Kang

  2. Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Soo-Young Na

  3. Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Republic of Korea

    Jin Young Yoon & Jae Myung Cha

  4. Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Republic of Korea

    Yunho Jung

  5. Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University School of Medicine, Iksan, Republic of Korea

    Geom Seog Seo

Authors
  1. Ho Suk Kang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Soo-Young Na
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jin Young Yoon
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yunho Jung
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Geom Seog Seo
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jae Myung Cha
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Concept and design: JMC; data acquisition: HSK, SYN, JYY, YJ, GSS, and JMC; statistical analysis: JYY and JMC; drafting and revision of the manuscript: HSK, and JMC. All the authors approved the final manuscript.

Corresponding author

Correspondence to Jae Myung Cha.

Ethics declarations

Conflict of interest

All authors declare that they have no conflicts of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Clinical trial: Trial Registration: Clinical Trials.gov, Registration number (trial ID): NCT05249335.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 32 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kang, H.S., Na, SY., Yoon, J.Y. et al. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol 59, 402–410 (2024). https://doi.org/10.1007/s00535-024-02089-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00535-024-02089-9

Keywords

Search

Navigation