A Randomized Clinical Study Evaluating the Safety and Efficacy of a New, Reduced-Volume, Oral Sulfate Colon-Cleansing Preparation for Colonoscopy

Palma, Jack A. Di; Rodríguez, Reynaldo; McGowan, John; Cleveland, Mark

doi:10.1038/ajg.2009.389

Cited by 140 publications

(164 citation statements)

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“…An oral sulfate solution has also been assessed as a bowel cleansing agent for colonoscopy [Di Palma et al 2009;Pelham et al 2010;Rex et al 2010Rex et al , 2014aRex et al , 2014b and may also be used as an effective booster agent for CCE.…”

Section: Introductionmentioning

confidence: 99%

Polyethylene glycol plus an oral sulfate solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers

Kashyap

Peled²

2015

Therap Adv Gastroenterol

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Objectives: As with colonoscopy, adequate bowel cleansing is essential prior to colon capsule endoscopy (CCE). Because CCE requires that the capsule traverse the entire gastrointestinal tract during the examination, laxative 'boosters' are used. The objective of this prospective, single-center, single-arm study was to evaluate the safety of a bowel preparation consisting of polyethylene glycol (PEG) plus an oral sulfate solution. Methods: Subjects were healthy volunteers aged 50-75 years old with normal baseline serum chemistry. The bowel preparation consisted of 4 Senna tablets, 4 liters of PEG (split dose), 10 mg metoclopramide, 2 oral sulfate solution boosters (6 oz. and 3 oz.), and 10 mg bisacodyl. Serum chemistry was performed at baseline, following PEG intake, 24 hours after bisacodyl administration, and at 7 days post procedure (in subjects with abnormal 24 hour results). The primary endpoints were the percentage of subjects with a clinically significant change in serum chemistry at the last test and the adverse event (AE) rate. Results: A total of 25 subjects were enrolled. The serum chemistry was normal in all subjects at the final evaluation. One subject showed a slight elevation in creatinine (1.08 mg/dl 7 days post procedure from 0.84 mg/dl at baseline), deemed not clinically significant. Another subject had a transient elevation in serum creatinine (from 1.01 mg/dl at baseline to 1.45 mg/dl at 24 hours after the bowel preparation); values returned to near baseline at 7 days post procedure (1.06 mg/dl). There were no serious AEs, three moderate AEs related to the bowel preparation (nausea, headache, elevated creatinine) and two mild unrelated AEs (chills, abdominal cramping). Conclusions: A bowel cleansing regimen of PEG plus an oral sulfate solution can be used in healthy volunteers. These data provide support for the continued study of this regimen in future CCE clinical trials and in medical practice.

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Section: Introductionmentioning

confidence: 99%

Polyethylene glycol plus an oral sulfate solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers

Kashyap

Peled²

2015

Therap Adv Gastroenterol

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“…Prior studies have demonstrated that split dosing not only to improves patient acceptability, but also cleans the colon better [8] . Of 13 prospective, randomized studies done previously, 12 showed superior cleansing when whole or part of the bowel preparation was given in the morning of the scheduled colonoscopy [9][10][11][12][13][14][15][16][17][18][19][20][21] . However colonoscopies are often scheduled in the afternoon, and split dosing may not leave a clean colon by afternoon.…”

Section: Introductionmentioning

confidence: 99%

Comparison of split-dosingvsnon-split (morning) dosing regimen for assessment of quality of bowel preparation for colonoscopy

Shah

Desai

Samant

et al. 2014

WJGE

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AIM: To compare (using the Ottawa Bowel PreparationScale) the efficacy of split-dose vs morning administration of polyethylene glycol solution for colon cleansing in patients undergoing colonoscopy, and to assess the optimal preparation-to-colonoscopy interval. METHODS:Single-centre, prospective, randomized, investigator-blind stud in an academic tertiarycare centre. Two hundred patients requiring elective colonoscopy were assigned to receive one of the two preparation regimens (split vs morning) prior to colonoscopy. Main outcome measurements were bowel preparation quality and patient tolerability. RESULTS:Split-dose regimen resulted in better bowel preparation compared to morning regimen [Ottawa score mean 5.52 (SD 1.23) vs 6.02 (1.34); P = 0.017].On subgroup analysis, for afternoon procedures, both the preparations were equally effective (P = 0.756). There was no difference in tolerability and compliance between the two regimens. CONCLUSION:Overall, previous evening -same morning split-dosing regimen results in better bowel cleansing for colonoscopy compared to morning preparation. For afternoon procedures, both schedules are equally effective; morning preparation may be more convenient to the patient. Key words: Bowel preparation; Colonoscopy; Morning preparation; Split dose preparation; Preparation to colonoscopy interval Core tip: Split bowel reparation compared to single dose morning preparation resulted in a better bowel cleansing using the Ottawa Bowel Preparation Scale. The average score (± SD) using the Ottawa Scale was 6.02 ± 1.34 when morning preparation was given and 5.52 ± 1.23 when split preparation was given (P = 0.017). However, there was no statistical difference in the mean Ottawa score when the procedures were done in the afternoon with either the morning or the split preparation (6.09 vs 5.94, P = 0.756). Hence, AM only dosing is as effective as split dosing for patients scheduled for a colonoscopy in the afternoon.

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“…report the results of a randomized, multicenter, industry-sponsored, endoscopist-blinded trial of a novel oral sulfate solution for pre-colonoscopic bowel preparation (6) . Study subjects were randomized to one of two therapeutic dosing strategies: same-day (PM before examination) vs. split-dose (PM / AM) preparation.…”

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confidence: 99%

Editorial: A Light Breakfast, a Jug of Salt Water and Bowel

Balaban¹

2009

Am J Gastroenterol

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Successful colonoscopy is predicated on achieving adequate colon cleansing. An ideal bowel preparation would be low in volume, acceptable to patients, reliable in cleansing effi cacy, and safe. The study by Di Palma et al. in this issue shows that a novel, low-volume (960 ml) preparation of mixed sulfate salts can achieve excellent bowel cleansing with acceptable tolerability and minimal electrolyte shifts. A split-dosing strategy, with a proportion of the preparation administered on the day of colonoscopy, achieved a 97.2 % preparation success rate vs. 82.4 % using a regimen provided entirely the day before colonoscopy. These results were comparable with control groups using a commercially available polyethylene glycol solution. Endoscopists and patients alike should be encouraged by the trend toward lower-dose bowel cleansing regimens that achieve equivalent effi cacy compared with large-volume preparations. Am J Gastroenterol 2009; 104:2285-2287 doi: 10.1038/ajg.2009 It could be argued that there is no medication more commonly prescribed by a busy endoscopist than a bowel preparation. Yet, the volume of scientifi c literature on the pharmacokinetics, efficacy, and side eff ects of bowel cleansing agents used for colonoscopy and other medical procedures is scant when compared with other agents used for digestive health. Th e importance of bowel preparation before colonoscopy cannot be understated. Inadequate colon cleansing is associated with lower endoscopic yield for adenomas (1,2) , decreased fi nd rates for fl at lesions (3), and longer examinations (2) . Unfortunately, bowel preparation is oft en inadequate to permit complete examination of the colon (1) , necessitating shorter screening and surveillance intervals. Perhaps most importantly, patients report that the bowel preparation is both the leading deterrent to undergoing screening colonoscopy (4) and the most diffi cult part of the examination (5) .In this issue of the American Journal of Gastroenterology , Di Palma et al . report the results of a randomized, multicenter, industry-sponsored, endoscopist-blinded trial of a novel oral sulfate solution for pre-colonoscopic bowel preparation (6) . Study subjects were randomized to one of two therapeutic dosing strategies: same-day (PM before examination) vs. split-dose (PM / AM) preparation. Case subjects used two 480-ml doses of a solution comprised of sodium, potassium, and magnesium sulfate salts. Controls used two 1-L doses of a commercially available polyethylene glycol solution with electrolytes and ascorbic acid (PEG-EA, MoviPrep, Salix Pharmaceuticals, Morrisville, NC). Th e primary endpoint was bowel preparation success defi ned as a score of " excellent " or " good " using a previously published scale (7,8) . Tolerability was assessed using a questionnaire administered on the date of the examination.Th e intention-to-treat analysis included 387 subjects randomized to the same-day dosing strategy (194 sulfate, and 364 subjects in the split-dose strategy (181 sulfate, 183 PEG-EA). Bowel preparati...

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A Randomized Clinical Study Evaluating the Safety and Efficacy of a New, Reduced-Volume, Oral Sulfate Colon-Cleansing Preparation for Colonoscopy

Abstract: The new 960 -ml oral sulfate solution is effective for colonoscopy cleansing and has an acceptable safety profile.

Cited by 140 publications

References 13 publications

Polyethylene glycol plus an oral sulfate solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers

Polyethylene glycol plus an oral sulfate solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers

Comparison of split-dosingvsnon-split (morning) dosing regimen for assessment of quality of bowel preparation for colonoscopy

Editorial: A Light Breakfast, a Jug of Salt Water and Bowel

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