Elsevier

Gastrointestinal Endoscopy

Volume 75, Issue 3, March 2012, Pages 537-544.e1
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial

https://doi.org/10.1016/j.gie.2011.09.018Get rights and content

Background

Picosulfate, magnesium oxide, and citric acid solution is a small-volume agent for colon cleansing before colonoscopy that is extremely well tolerated by patients, safe, and efficacious. Studies of other cleansing agents have suggested that split-dose regimens may further enhance efficacy.

Objective

To examine whether split-dosing of picosulfate, magnesium oxide, and citric acid solution increases bowel cleansing efficacy while maintaining tolerability and safety.

Design

Prospective, randomized, single-blinded, controlled trial.

Setting

Outpatient tertiary care center.

Patients

A total of 236 patients underwent colonoscopy (mean age 56 years, 53.8% female).

Interventions

Patients in the traditional arm (n = 123) consumed 1 sachet of solution at 5:00 pm and 10:00 pm the night before the colonoscopy. Patients in the split-dose arm (n = 127) consumed 1 sachet at 7:00 pm the night before and another sachet 4 hours before their colonoscopy appointment.

Main Outcome Measurements

Ottawa Bowel Preparation Scale (OBPS) score, Aronchick score, safety, tolerability.

Results

The 113 and 109 patients in the split-dose and traditional arms, respectively, had OBPS scores for analysis. Overall, the OBPS scores in the split-dose group were significantly improved compared with the traditional dose group (4.05 vs 5.51, P < .001). This was mostly attributed to improvements in right-sided colon cleansing (1.22 in split-dose vs 2.14 in traditional arm, P < .001). Both regimens were well tolerated by patients, and no safety issues were identified.

Limitations

This was a single-center study. Disturbances in sleep related to the preparation were not assessed.

Conclusions

The split-dose regimen of picosulfate, magnesium oxide, and citric acid solution is superior to the traditional dosing regimen for colon cleansing before colonoscopy. (Clinical trial registration number: NCT00885274.)

Section snippets

Study design, patient population, and randomization

This was a prospective, randomized study, and the endoscopists were blinded to the dosing regimen. All patients ≥18 years of age undergoing elective outpatient colonoscopy at the Hotel Dieu Hospital in Kingston, Ontario, Canada, were invited to participate in the study. Exclusion criteria included ileus or bowel obstruction, significant constipation (<3 bowel movements per week with or without regular laxatives), previous colorectal surgery, ascites, previously recognized renal impairment

Results

A total of 250 patients were enrolled in the study between October 2008 and March 2010. Fourteen patients were randomized but never participated (6 in the traditional arm, 8 in the split-dose arm) because the target numbers had been reached. An additional 14 patients (8 in the traditional arm, 6 in the split-dose arm) did not have a completed OBPS data sheet available: 9 because of incomplete colonoscopies attributed to technical difficulties (5 in the traditional arm, 4 in the split-dose arm),

Discussion

Previous studies have shown that PSLx is a very effective preparation compared with other existing colon cleansing regimens,9, 23 but enhanced efficacy remains a goal with all preparations. The results of this study show that the split-dose PSLx regimen results in superior overall bowel cleansing compared with the traditional dosing schedule (ie, both doses given the evening before). The magnitude of this difference was substantial given that the absolute difference by using the OBPS was 1.46.

Acknowledgments

The authors thank Natasha Jackson, Jackie McKay, Darlene Brady, and the Hotel Dieu Hospital in Kingston, Ontario, for their support during the study.

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    DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: Drs. Hookey and Vanner are consultants to and educational grant recipients from Ferring Canada and Ferring USA. The other author disclosed no financial relationship relevant to this publication.

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