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Randomised clinical trial: low‐volume bowel preparation for colonoscopy ‐ a comparison between two different PEG ‐based formulations
Author(s) -
Repici A.,
Cestari R.,
Annese V.,
Biscaglia G.,
Vitetta E.,
Minelli L.,
Trallori G.,
Orselli S.,
Andriulli A.,
Hassan C.
Publication year - 2012
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12026
Subject(s) - bisacodyl , medicine , colonoscopy , peg ratio , tolerability , cathartic , laxative , gastroenterology , surgery , adverse effect , constipation , colorectal cancer , finance , cancer , economics
Summary Background Low‐volume bowel preparations with polyethylene glycol ( PEG ) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso‐osmotic sulphate‐free formulation of PEG ‐Citrate‐Simethicone ( PEG ‐ CS ) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG ‐ CS with bisacodyl vs. PEG ‐Ascorbate ( PEG ‐ ASC ) in adult out‐patients undergoing colonoscopy. Methods Randomised, observer‐blind, parallel group study in adult out‐patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2–4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG ‐ CS at 20:00 hours or 2 L of PEG ‐ ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as ‘clinical success’), and mucosal visibility according to a 3‐point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG ‐ CS and bisacodyl ( n = 204, male patient 48%, mean age 59.1 years) or PEG ‐ ASC ( n = 204, male patient 51%, age 59.4 years). In the planned per‐protocol analysis, the rate of successful preparation was 79.1% following PEG ‐ CS with bisacodyl, and 70% following PEG ‐ ASC ( P < 0.05). Mucosal visibility was evaluated as optimal in 56.1% in the PEG ‐ CS and bisacodyl and 46.3% in the PEG ‐ ASC group ( P < 0.05). There were no serious adverse events ( AE ) in each of the two experimental groups. Two subjects in the PEG ‐ ASC group discontinued the study because of AE . Conclusions Polyethylene glycol‐Citrate‐Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG ‐ ASC for out‐patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low‐volume bowel preparations were similar.