Yonsei Med J.  2014 Nov;55(6):1542-1555. 10.3349/ymj.2014.55.6.1542.

Comparison of the Efficacy and Safety of Sodium Phosphate Tablets and Polyethylene Glycol Solution for Bowel Cleansing in Healthy Korean Adults

• Lee SH
• Lee DJ
• Kim KM
• Seo SW
• Kang JK
• Lee EH
• Lee DR

• KMID: 2070201
• DOI: http://doi.org/10.3349/ymj.2014.55.6.1542

Abstract

PURPOSE
Bowel cleansing is generally regarded as time-consuming and unpleasant among patients. Patients commonly state that bowel preparation provokes more discomfort than the actual colonoscopic examination. The purpose of this study was to compare two regimens of sodium phosphate (NaP) tablets versus polyethylene glycol (PEG) solution for bowel preparation in healthy Korean adults.
MATERIALS AND METHODS
This was a single center, prospective, open-label, investigator-blinded, randomized, controlled-pilot study. A total of 62 healthy Korean subjects were randomly assigned to two groups (NaP vs. PEG). Efficacy, safety, and patient-related outcomes, as well as procedural parameters, were evaluated.
RESULTS
Although there were no significant differences in total Ottawa bowel quality score, fluid scores and the rate of adequate bowel preparation were significantly better in the NaP group than the PEG group. Additionally, the NaP group showed better results regarding patient tolerance, satisfaction, preference, and rate of adverse events than the PEG group. Significant fluctuations in specific serum electrolytes were common and of a greater magnitude in the NaP group than the PEG group. However, these abnormalities were transient and did not result in serious complications and side effects.
CONCLUSION
In this study, NaP tablets were shown to be an effective, well-tolerated, and acceptable regimen for bowel preparation. Also, our study suggests that NaP tablets may be safe and can be used as a bowel cleansing agent in healthy adults undergoing elective colonoscopy. Further multicenter, large scale studies are needed to confirm these findings.

Keyword

Sodium phosphate tablet; polyethylene glycol; bowel preparation; safety; efficacy

MeSH Terms

Adult
Asian Continental Ancestry Group
*Colonoscopy
Female
Humans
Male
Middle Aged
Phosphates/*administration & dosage/therapeutic use
Pilot Projects
Polyethylene Glycols/*administration & dosage/therapeutic use
Prospective Studies
Republic of Korea
Surface-Active Agents/*administration & dosage
Tablets
Therapeutic Irrigation/*methods
Phosphates
Polyethylene Glycols
Surface-Active Agents
Tablets

Figure

• 

  Fig. 1 Consolidated Standards of Reporting Trials (CONSORT) flow chart detailing the conduct of the study. Visit 1 (the day of colonoscopy and post-preparation); Visit 2 (1 week follow-up after colonoscopy). NaP, sodium phosphate; PEG, polyethylene glycol.

• 

  Fig. 2 Comparison of bowel cleansing efficacy between the NaP tablet group and the PEG solution group. (A) Sub-analysis of Ottawa scale score (cleansing of each colon segment, 5-point scale; total amount of remnant fluids in the entire colon, 3-point scale). (B) Percentage of patients with adequate level of bowel preparation. Adequate level of bowel preparation was defined as a total Ottawa score of ≤4. *p<0.05. NaP, sodium phosphate; PEG, polyethylene glycol; NS, not significant.

• 

  Fig. 3 Comparison of patient-related outcomes between the NaP group and the PEG group. (A) Patient compliance. i) Complete: intake of the whole solution or tablets; ii) Good: intake of at least 75% of the solution or tablets; iii) Poor: intake of <75% of the solution or tablets. (B) Patient acceptance of the assigned bowel cleansing agent (what was the overall impression how difficult it was it to take the study regimen?). (C) Taste, (D) Satisfaction, (E) Preference (patients who would repeat the preparation in future). (F) Adverse events in both groups. *p<0.05. NaP, sodium phosphate; PEG, polyethylene glycol; NS, not significant; VAS, visual analogue scale.

• 

  Fig. 4 Comparison of laboratory tests results between two groups during the study period. (A) Inorganic phosphorus. (B) Total calcium. (C) Potassium. *p<0.05 by the paired t-test; †p<0.05 by independent t-test. NaP, sodium phosphate; PEG, polyethylene glycol; TCa, total calcium; K, potassium; IP, inorganic phosphorus.

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