AIM: To compare the efficacy of different doses of sodium phosphate (NaP) and polyethylenglicol (PEG) alone or with bisacodyl for colonic cleansing in constipated and non-constipated patients. METHODS:Three hundred and forty-nine patients, older than 18 years old, with low risk for renal damage and who were scheduled for outpatient colonoscopy were randomized to receive one of the following preparations (prep): 90 mL of NaP (prep 1); 45 mL of NaP + 20 mg of bisacodyl (prep 2); 4 L of PEG (prep 3) or 2 L of PEG + 20 mg of bisacodyl (prep 4). Randomization was stratified by constipation. Patients, endoscopists, endoscopists' assistants and data analysts were blinded. A blinding challenge was performed to endoscopist in order to reassure blinding. The primary outcome was the efficacy of colonic cleansing using a previous reported scale. Secondary outcomes were tolerability, compliance, side effects, endoscopist perception about the necessity to repeat the study due to an inadequate colonic preparation and patient overall perceptions. RESULTS: Information about the primary outcome was obtained from 324 patients (93%). There were no significant differences regarding the preparation quality among different groups in the overall analysis. Compliance was higher in the NaP preparations being even higher in half-dose with bisacodyl: 94% (prep 1), 100% (prep 2), 81% (prep 3) and 87% (prep 4) (2 vs 1, 3 and 4, P < 0.01; 1 vs 3, 4, P < 0.05). The combination of bisacodyl with NaP was associated with insomnia (P = 0.04). In non-constipated patients the preparation quality was also similar between different groups, but endoscopist appraisal about the need to repeat the study was more frequent in the half-dose PEG plus bisacodyl than in whole dose NaP preparation: 11% (prep 4) vs 2% (prep 1) (P < 0.05). Compliance in this group was also higher with the NaP preparations: 95% (prep 1), 100% (prep 2) vs 80% (prep 3) (P < 0.05). Bisacodyl was associated with abdominal pain: 13% (prep 1), 31% (prep 2), 21% (prep 3) and 29% (prep 4), (2, 4 vs 1, 2, P < 0.05). In constipated patients the combination of NaP plus bisacodyl presented higher rates of satisfactory colonic cleansing than whole those PEG: 95% (prep 2) vs 66% (prep 3) (P = 0.03). Preparations containing bisacodyl were not associated with adverse effects in constipated patients. CONCLUSION: In non-constipated patients, compliance is higher with NaP preparations, and bisacodyl is related to adverse effects. In constipated patients NaP plus bisacodyl is the most effective preparation.
RCT Entities:
AIM: To compare the efficacy of different doses of sodium phosphate (NaP) and polyethylenglicol (PEG) alone or with bisacodyl for colonic cleansing in constipated and non-constipatedpatients. METHODS: Three hundred and forty-nine patients, older than 18 years old, with low risk for renal damage and who were scheduled for outpatient colonoscopy were randomized to receive one of the following preparations (prep): 90 mL of NaP (prep 1); 45 mL of NaP + 20 mg of bisacodyl (prep 2); 4 L of PEG (prep 3) or 2 L of PEG + 20 mg of bisacodyl (prep 4). Randomization was stratified by constipation. Patients, endoscopists, endoscopists' assistants and data analysts were blinded. A blinding challenge was performed to endoscopist in order to reassure blinding. The primary outcome was the efficacy of colonic cleansing using a previous reported scale. Secondary outcomes were tolerability, compliance, side effects, endoscopist perception about the necessity to repeat the study due to an inadequate colonic preparation and patient overall perceptions. RESULTS: Information about the primary outcome was obtained from 324 patients (93%). There were no significant differences regarding the preparation quality among different groups in the overall analysis. Compliance was higher in the NaP preparations being even higher in half-dose with bisacodyl: 94% (prep 1), 100% (prep 2), 81% (prep 3) and 87% (prep 4) (2 vs 1, 3 and 4, P < 0.01; 1 vs 3, 4, P < 0.05). The combination of bisacodyl with NaP was associated with insomnia (P = 0.04). In non-constipatedpatients the preparation quality was also similar between different groups, but endoscopist appraisal about the need to repeat the study was more frequent in the half-dose PEG plus bisacodyl than in whole dose NaP preparation: 11% (prep 4) vs 2% (prep 1) (P < 0.05). Compliance in this group was also higher with the NaP preparations: 95% (prep 1), 100% (prep 2) vs 80% (prep 3) (P < 0.05). Bisacodyl was associated with abdominal pain: 13% (prep 1), 31% (prep 2), 21% (prep 3) and 29% (prep 4), (2, 4 vs 1, 2, P < 0.05). In constipatedpatients the combination of NaP plus bisacodyl presented higher rates of satisfactory colonic cleansing than whole those PEG: 95% (prep 2) vs 66% (prep 3) (P = 0.03). Preparations containing bisacodyl were not associated with adverse effects in constipatedpatients. CONCLUSION: In non-constipatedpatients, compliance is higher with NaP preparations, and bisacodyl is related to adverse effects. In constipatedpatientsNaP plus bisacodyl is the most effective preparation.
Authors: B Rembacken; C Hassan; J F Riemann; A Chilton; M Rutter; J-M Dumonceau; M Omar; T Ponchon Journal: Endoscopy Date: 2012-09-17 Impact factor: 10.093
Authors: Milena Di Leo; Andrea Iannone; Monica Arena; Giuseppe Losurdo; Maria Angela Palamara; Giuseppe Iabichino; Pierluigi Consolo; Maria Rendina; Carmelo Luigiano; Alfredo Di Leo Journal: World J Gastroenterol Date: 2021-12-07 Impact factor: 5.742