AIM:To evaluate the efficacy and safety of adjunctive mosapride citrate for bowel preparation before colonoscopy. METHODS:We conducted a randomized,double-blind, placebo-controlled study with mosapride in addition to ...AIM:To evaluate the efficacy and safety of adjunctive mosapride citrate for bowel preparation before colonoscopy. METHODS:We conducted a randomized,double-blind, placebo-controlled study with mosapride in addition to polyethylene glycol(PEG)-electrolyte solution.Of 250 patients undergoing colonoscopy,124 were randomized to receive 2 L PEG plus 15 mg of mosapride citrate (mosapride group),and 126 received 2 L PEG plus placebo(placebo group).Patients completed a questionnaire reporting the acceptability and tolerability of the bowel preparation process.The efficacy of bowel preparation was assessed by colonoscopists using a 5-point scale based on Aronchick's criteria.The primary end point was optimal bowel preparation rates(scores of excellent/good/fair vs poor/inadequate). RESULTS:A total of 249 patients were included in the analysis.In the mosapride group,optimal bowel preparation rates were significantly higher in the left colon compared with the placebo group(78.2%vs 65.6%,P<0.05),but not in the right colon(76.5%vs 66.4%,P=0.08).After excluding patients with severe constipation,there was a significant difference in bowel preparation in both the left and right colon(82.4%vs 66.7%,80.8%vs 67.5%,P<0.05,P<0.01).The incidence of adverse events was similar in both groups. Among the subgroup who had previous colonoscopy experience,a significantly higher number of patients in the mosapride group felt that the current preparation was easier compared with patients in the placebo group(34/72 patients vs 24/74 patients,P<0.05). CONCLUSION:Mosapride citrate may be an effective and safe adjunct to PEG-electrolyte solution that leads to improved quality of bowel preparation,especially in patients without severe constipation.展开更多
AIM:To evaluate the possibility of reducing the volume of polyethylene glycol(PEG)-electrolyte solution using adjunctive mosapride citrate for colonoscopy preparation. METHODS:This was a single-center,prospective, ran...AIM:To evaluate the possibility of reducing the volume of polyethylene glycol(PEG)-electrolyte solution using adjunctive mosapride citrate for colonoscopy preparation. METHODS:This was a single-center,prospective, randomized,investigator-blinded,non-inferiority study involving 252 patients of both sexes,aged from 20 to 80 years,scheduled for screening or diagnostic colonoscopy in our department.A total of 126 patients was randomized to receive 1.5 L PEG-electrolyte solution plus 15 mg of mosapride(1.5 L group),and 126 received 2 L PEG-electrolyte solution plus 15 mg of mosapride(2 L group).Patients completed a questionnaire on the acceptability and tolerability of the bowel preparation process.The efficacy of bowel preparation was assessed using a 5-point scale based on the Aronchick scale.The primary end point was adequate bowel preparation rates(score of excellent/good/fair) vs(poor/inadequate).Acceptability and tolerability,as well as disease detection,were secondary end points. RESULTS:A total of 244 patients was included in the analysis.There were no significant differences between the 2 L and 1.5 L groups in age,sex,body mass index, number of previous colonoscopies,and the preparation method used previously.The adequate bowel preparation rates were 88.5%in the 2 L group and 82.8%in the 1.5 L group[95%lower confidence limit(LCL)for the difference=-14.5%,non-inferiority P=0.019]in the right colon.In the left colon,the adequate bowel preparation rates were 89.3%in the 2 L group and 81.1%in the 1.5 L group(95%LCL=-17.0%,non-inferiority P=0.066).Compliance,defined as complete (100%)intake of the PEG solution,was significantly higher in the 1.5 L group than in the 2 L group(96.8% vs 85.7%,P=0.002).The proportion of abdominal distension(none/mild/moderate/severe)was significantly lower in the 1.5 L group than in the 2 L group (36/65/22/3 vs 58/48/18/2,P=0.040).Within the subgroup who had undergone colonoscopy previously, a significantly higher number of patients in the 1.5 L group than in the 2 L group felt that the current preparation was easier than the previous one(54.1%vs 28.0%,P=0.001).The disease detection rate was not significantly different between the two groups. CONCLUSION:Although the 1.5 L group had better acceptability and tolerability,15 mg of mosapride may be insufficient to compensate for a 0.5-L reduction of PEG solution.展开更多
文摘AIM:To evaluate the efficacy and safety of adjunctive mosapride citrate for bowel preparation before colonoscopy. METHODS:We conducted a randomized,double-blind, placebo-controlled study with mosapride in addition to polyethylene glycol(PEG)-electrolyte solution.Of 250 patients undergoing colonoscopy,124 were randomized to receive 2 L PEG plus 15 mg of mosapride citrate (mosapride group),and 126 received 2 L PEG plus placebo(placebo group).Patients completed a questionnaire reporting the acceptability and tolerability of the bowel preparation process.The efficacy of bowel preparation was assessed by colonoscopists using a 5-point scale based on Aronchick's criteria.The primary end point was optimal bowel preparation rates(scores of excellent/good/fair vs poor/inadequate). RESULTS:A total of 249 patients were included in the analysis.In the mosapride group,optimal bowel preparation rates were significantly higher in the left colon compared with the placebo group(78.2%vs 65.6%,P<0.05),but not in the right colon(76.5%vs 66.4%,P=0.08).After excluding patients with severe constipation,there was a significant difference in bowel preparation in both the left and right colon(82.4%vs 66.7%,80.8%vs 67.5%,P<0.05,P<0.01).The incidence of adverse events was similar in both groups. Among the subgroup who had previous colonoscopy experience,a significantly higher number of patients in the mosapride group felt that the current preparation was easier compared with patients in the placebo group(34/72 patients vs 24/74 patients,P<0.05). CONCLUSION:Mosapride citrate may be an effective and safe adjunct to PEG-electrolyte solution that leads to improved quality of bowel preparation,especially in patients without severe constipation.
文摘AIM:To evaluate the possibility of reducing the volume of polyethylene glycol(PEG)-electrolyte solution using adjunctive mosapride citrate for colonoscopy preparation. METHODS:This was a single-center,prospective, randomized,investigator-blinded,non-inferiority study involving 252 patients of both sexes,aged from 20 to 80 years,scheduled for screening or diagnostic colonoscopy in our department.A total of 126 patients was randomized to receive 1.5 L PEG-electrolyte solution plus 15 mg of mosapride(1.5 L group),and 126 received 2 L PEG-electrolyte solution plus 15 mg of mosapride(2 L group).Patients completed a questionnaire on the acceptability and tolerability of the bowel preparation process.The efficacy of bowel preparation was assessed using a 5-point scale based on the Aronchick scale.The primary end point was adequate bowel preparation rates(score of excellent/good/fair) vs(poor/inadequate).Acceptability and tolerability,as well as disease detection,were secondary end points. RESULTS:A total of 244 patients was included in the analysis.There were no significant differences between the 2 L and 1.5 L groups in age,sex,body mass index, number of previous colonoscopies,and the preparation method used previously.The adequate bowel preparation rates were 88.5%in the 2 L group and 82.8%in the 1.5 L group[95%lower confidence limit(LCL)for the difference=-14.5%,non-inferiority P=0.019]in the right colon.In the left colon,the adequate bowel preparation rates were 89.3%in the 2 L group and 81.1%in the 1.5 L group(95%LCL=-17.0%,non-inferiority P=0.066).Compliance,defined as complete (100%)intake of the PEG solution,was significantly higher in the 1.5 L group than in the 2 L group(96.8% vs 85.7%,P=0.002).The proportion of abdominal distension(none/mild/moderate/severe)was significantly lower in the 1.5 L group than in the 2 L group (36/65/22/3 vs 58/48/18/2,P=0.040).Within the subgroup who had undergone colonoscopy previously, a significantly higher number of patients in the 1.5 L group than in the 2 L group felt that the current preparation was easier than the previous one(54.1%vs 28.0%,P=0.001).The disease detection rate was not significantly different between the two groups. CONCLUSION:Although the 1.5 L group had better acceptability and tolerability,15 mg of mosapride may be insufficient to compensate for a 0.5-L reduction of PEG solution.
