BACKGROUND: Colon preparations are generally poorly tolerated. OBJECTIVE: To study the efficacy of sugar-free candy drops in improving palatability and tolerability of polyethylene glycol electrolyte solution (PEG-E). DESIGN: Single-blind, randomized, controlled trial. SETTING:University medical center. PATIENTS: Ambulatory patients scheduled for elective colonoscopy. INTERVENTION: Menthol candy drops. Patients were randomly assigned to split-dose, 4-L, PEG-E ± cough drops. Palatability was assessed on a linear scale of 1 to 5 (1 = disgusting; 5 = tasty). Quality of preparation, remaining unconsumed volume, and side effects were secondary outcomes. MAIN OUTCOME MEASUREMENTS: Palatability and tolerability of PEG-E. RESULTS: A total of 99 patients were enrolled (50 control group, 49 candy drops-added group). The mean (± standard deviation) palatability score was significantly better in candy drop users versus controls (3.9 ± 0.7 vs 2.8 ± 1.2, respectively; P < .001) as were the preparations scored as excellent (63.3% vs 34% of controls; P = .004). Side effects were similar except for nausea (24.5% candy drops vs 44% controls; P = .04). The amount of unconsumed PEG-E was not different between candy drop and control groups (128 [± 361 mL] versus 69 [± 194 mL], respectively; P = .32) but was significantly lower in excellent grade preparations versus other grades (31 [± 103 mL] versus 162 [± 384 mL], respectively; P = .024). On multivariate logistic regression, an excellent preparation was associated with candy drops (odds ratio [OR] 3.3, 95% confidence interval [CI], 1.4-7.8; P = .006) and smaller unconsumed volume of same-day PEG-E [OR 0.996, 95% CI, 0.992-1.000; P = .044). LIMITATIONS: Single-center study. CONCLUSION:Sugar-free menthol candy drops are a safe and effective addition to split-dose PEG-E, resulting in improved tolerability and patient compliance, which appears to translate into improved bowel cleansing. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01541683.).
RCT Entities:
BACKGROUND: Colon preparations are generally poorly tolerated. OBJECTIVE: To study the efficacy of sugar-free candy drops in improving palatability and tolerability of polyethylene glycol electrolyte solution (PEG-E). DESIGN: Single-blind, randomized, controlled trial. SETTING: University medical center. PATIENTS: Ambulatory patients scheduled for elective colonoscopy. INTERVENTION: Menthol candy drops. Patients were randomly assigned to split-dose, 4-L, PEG-E ± cough drops. Palatability was assessed on a linear scale of 1 to 5 (1 = disgusting; 5 = tasty). Quality of preparation, remaining unconsumed volume, and side effects were secondary outcomes. MAIN OUTCOME MEASUREMENTS: Palatability and tolerability of PEG-E. RESULTS: A total of 99 patients were enrolled (50 control group, 49 candy drops-added group). The mean (± standard deviation) palatability score was significantly better in candy drop users versus controls (3.9 ± 0.7 vs 2.8 ± 1.2, respectively; P < .001) as were the preparations scored as excellent (63.3% vs 34% of controls; P = .004). Side effects were similar except for nausea (24.5% candy drops vs 44% controls; P = .04). The amount of unconsumed PEG-E was not different between candy drop and control groups (128 [± 361 mL] versus 69 [± 194 mL], respectively; P = .32) but was significantly lower in excellent grade preparations versus other grades (31 [± 103 mL] versus 162 [± 384 mL], respectively; P = .024). On multivariate logistic regression, an excellent preparation was associated with candy drops (odds ratio [OR] 3.3, 95% confidence interval [CI], 1.4-7.8; P = .006) and smaller unconsumed volume of same-day PEG-E [OR 0.996, 95% CI, 0.992-1.000; P = .044). LIMITATIONS: Single-center study. CONCLUSION:Sugar-free menthol candy drops are a safe and effective addition to split-dose PEG-E, resulting in improved tolerability and patient compliance, which appears to translate into improved bowel cleansing. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01541683.).
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