AIM:To compare the bowel cleansing efficacy,tolerability and acceptability of split 2-L polyethylene glycol(PEG)-citrate-simethicone(PEG-CS)plus bisacodyl(BIS)vs 4-L PEG for fecal occult blood test-positive screening ...AIM:To compare the bowel cleansing efficacy,tolerability and acceptability of split 2-L polyethylene glycol(PEG)-citrate-simethicone(PEG-CS)plus bisacodyl(BIS)vs 4-L PEG for fecal occult blood test-positive screening colonoscopy.METHODS:This was a randomised,observer-blind comparative study.Two hundred and sixty-four subjects underwent screening colonoscopy(mean age 62.5±7.4years,male 61.7%).The primary objective of the study was to compare the bowel cleansing efficacy of the two preparations.Interventions:BIS plus PEG-CS:3 tablets of 5-mg BIS at 16:00,PEG-CS 1-L at 19:00 and 1-L at7:00,4-L PEG:3-L at 17:00,and 1-L at 7:00.Colonoscopy was carried out after 11:00,at least 3 h after the completion of bowel preparation.Bowel cleansing was evaluated using the Harefield Cleansing Scale.RESULTS:Bowel preparation was successful for 92.8%of subjects in the PEG-CS group and for 92.1%of subjects in the 4-L PEG(RR=1.01;95%CI:0.94-1.08).BIS+PEG-CS was better tolerated than 4-L PEG.A greater rate of patients in the BIS+PEG-CS group had no difficulty and/or were willing to repeat the same preparation compared to split-dose 4-L PEG group.Subjects in the BIS+PEG-CS group rated the prep as good or satisfactory in 90.6%as compared to 77%in the 4-L PEG(P=0.003).Subjects receiving BIS+PEGCS stated they fully adhered to instructions drinking all the 2-L solution in 97.1%compared with 87.3%in the4-L PEG(P=0.003).CONCLUSION:BIS plus split 2-L PEG-CS was as effective as but better tolerated and accepted than split4-L PEG for screening colonoscopy.This new procedure may increase the positive attitude and participation to colorectal cancer screening colonoscopy.展开更多
AIM:To evaluate the efficacy of reduced cathartic bowel preparation with 2 L polyethylene glycol(PEG)-4000 electrolyte solution and 10 mg bisacodyl enteric-coated tablets for computed tomographic colonography(CTC).MET...AIM:To evaluate the efficacy of reduced cathartic bowel preparation with 2 L polyethylene glycol(PEG)-4000 electrolyte solution and 10 mg bisacodyl enteric-coated tablets for computed tomographic colonography(CTC).METHODS:Sixty subjects who gave informed consent were randomly assigned to study group A,study group B or the control group.On the day prior to CTC,subjects in study group A were given 20 mL 40% wt/vol barium sulfate suspension before 3 mealtimes,60 mL 60% diatrizoate meglumine diluted in 250 mL water after supper,and 10 mg bisacodyl enteric-coated tablets 1 h before oral administration of 2 L PEG-4000 electrolyte solution.Subjects in study group B were treated identically to those in study group A,with the exception of bisacodyl which was given 1 h after oral PEG-4000.Subjects in the control group were managed using the same strategy as the subjects in study group A,but without administration of bisacodyl.Residual stool and fluid scores,the attenuation value of residual fluid,and discomfort during bowel preparation in the three groups were analyzed statistically.RESULTS:The mean scores for residual stool and fluid in study group A were lower than those in study group B,but the differences were not statistically significant.Subjects in study group A showed greater stool and fluid cleansing ability than the subjects in study group B.The mean scores for residual stool and fluid in study groups A and B were lower than those in the control group,and were significantly different.There was no significant difference in the mean attenuation value of residual fluid between study group A,study group B and the control group.The total discomfort index during bowel preparation was 46,45 and 45 in the three groups,respectively,with no significant difference.CONCLUSION:Administration of 10 mg bisacodyl enteric-coated tablets prior to or after oral administration of 2 L PEG-4000 electrolyte solution enhances stool and fluid cleansing ability,and has no impact on the attenuation value of residual fluid or the discomfort index.The former is an excellent alternative for CTC colorectum展开更多
Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Method...Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Methods: In two randomized, double-blind, placebo-controlled, parallel-group trials, the efficacy and safety of treatment with either bisacodyl or SPS, respectively, were assessed. After a 2-week baseline period patients with functional constipation were randomized to a 4-week treatment with either bisacodyl (2 tablets = 10 mg), SPS (18 drops = 10 mg), or matching placebo in a ratio of active drug to placebo of 2:1. Dose reduction as well as resuming the original dose was permitted. Patients who did not experience a bowel movement for more than 72 h were allowed to use a bisacodyl suppository. The primary endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs) per week during the trial. QoL was assessed using the Patient Assessment of Constipation (PAC)-QoL questionnaire. Results: Active treatment led to a greater improvement of PAC-QoL scores for every domain. Active treatment was also superior to placebo for all individual questions of the questionnaire. Of note, SPS or bisacodyl not only improved satisfaction with stool patterns (“quite a bit/extremely satisfied” in 12.8% of patients on placebo and 50.3% on active treatment) but bloating was also considerably ameliorated (“not at all feeling bloated” in 24.5% on placebo and 41.4% on active treatment). Conclusion: Bisacodyl and SPS not only improve stool variables but also quality of life in patients with chronic functional constipation. (EudraCT Nos. 2007-001991-34 and 2007-002087-10).展开更多
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 ...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%(prep2) 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.展开更多
BACKGROUND Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials(RCT).However,most RCTs do not provide data about clinical outcomes including ...BACKGROUND Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials(RCT).However,most RCTs do not provide data about clinical outcomes including lesions detection rate.Moreover,real-life comparisons are lacking.AIM To compare efficacy(both in terms of adequate bowel preparation and detection of colorectal lesions)and tolerability of a high-volume(HV:4 L polyethylene glycol,PEG)and a low-volume(LV:2 L PEG plus bisacodyl)bowel preparation in a real-life setting.METHODS Consecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016.Patients could choose either LV or HV preparation,with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures.Adequate bowel preparation according to Boston Bowel Preparation Scale(BBPS),clinical outcomes including polyp detection rate(PDR),adenoma detection rate(ADR),advanced adenoma detection rate(AADR),sessile/serrated lesion detection rate(SDR)and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed.RESULTS Total 2040 patients were enrolled and 1815(mean age 60.6 years,50.2%men)finally included.LV was chosen by 52%of patients(50.8%of men,54.9%of women).Split-dose schedule was more common with HV(44.7%vs 38.2%,P=0.005).High-definition scopes were used in 33.4%of patients,without difference in the two groups(P=0.605).HV and LV preparations showed similar adequate bowel preparation rates(89.2%vs 86.6%,P=0.098),also considering the two different schedules(HV split-dose 93.8%vs LV split-dose 93.6%,P=1;HV daybefore 85.5%vs LV day-before 82.3%,P=0.182).Mean global BBPS score was higher for HV preparations(7.1±1.7 vs 6.8±1.6,P<0.001).After adjustment for sex,age and indications for colonoscopy,HV preparation resulted higher in PDR[Odds ratio(OR)1.32,95%CI:1.07-1.63,P=0.011]and ADR(OR 1.29,95%CI 1.02–1.63,P=0.038)and comparable to LV in AADR(OR 1.51,95%CI 0.97-2.35,P=0.069),SDR and cancer detection rate.The use of standard-definition colonoscopes was associated to lower PDR(adjusted OR 1.59,95%CI:1.22-2.08,P<0.001),ADR(adjusted OR 1.71,95%CI:1.26–2.30,P<0.001)and AADR(adjusted OR 1.97,95%CI:1.09-3.56,P=0.025)in patients receiving LV preparation.Mean Visual Analogue Scale tolerability scored equally(7,P=0.627)but a≥75%dose intake was more frequent with LV(94.6%vs 92.1%,P=0.003).CONCLUSION In a real-life setting,PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation.However,with higher PDR and ADR,HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy,especially when colonoscopy is performed with standard resolution imaging.展开更多
Constipation is a common functional gastrointestinal disorder which has caused much discomfort affecting the quality of life. The prevalence of constipation in the general population is approximately 20%(1)Various kin...Constipation is a common functional gastrointestinal disorder which has caused much discomfort affecting the quality of life. The prevalence of constipation in the general population is approximately 20%(1)Various kinds of laxatives were introduced such as bulking agent, stool softener, stimulant, and osmotic agent (2)Fixed dose combination with bisacodyl as a stimulant and docusate sodium as a stool softener, Ducolax STM, was developed as enteric coated tablets targeting colon.展开更多
文摘AIM:To compare the bowel cleansing efficacy,tolerability and acceptability of split 2-L polyethylene glycol(PEG)-citrate-simethicone(PEG-CS)plus bisacodyl(BIS)vs 4-L PEG for fecal occult blood test-positive screening colonoscopy.METHODS:This was a randomised,observer-blind comparative study.Two hundred and sixty-four subjects underwent screening colonoscopy(mean age 62.5±7.4years,male 61.7%).The primary objective of the study was to compare the bowel cleansing efficacy of the two preparations.Interventions:BIS plus PEG-CS:3 tablets of 5-mg BIS at 16:00,PEG-CS 1-L at 19:00 and 1-L at7:00,4-L PEG:3-L at 17:00,and 1-L at 7:00.Colonoscopy was carried out after 11:00,at least 3 h after the completion of bowel preparation.Bowel cleansing was evaluated using the Harefield Cleansing Scale.RESULTS:Bowel preparation was successful for 92.8%of subjects in the PEG-CS group and for 92.1%of subjects in the 4-L PEG(RR=1.01;95%CI:0.94-1.08).BIS+PEG-CS was better tolerated than 4-L PEG.A greater rate of patients in the BIS+PEG-CS group had no difficulty and/or were willing to repeat the same preparation compared to split-dose 4-L PEG group.Subjects in the BIS+PEG-CS group rated the prep as good or satisfactory in 90.6%as compared to 77%in the 4-L PEG(P=0.003).Subjects receiving BIS+PEGCS stated they fully adhered to instructions drinking all the 2-L solution in 97.1%compared with 87.3%in the4-L PEG(P=0.003).CONCLUSION:BIS plus split 2-L PEG-CS was as effective as but better tolerated and accepted than split4-L PEG for screening colonoscopy.This new procedure may increase the positive attitude and participation to colorectal cancer screening colonoscopy.
基金Supported by Grant from Guangdong Provincial Science and Technology Program,No. 2011B031800182
文摘AIM:To evaluate the efficacy of reduced cathartic bowel preparation with 2 L polyethylene glycol(PEG)-4000 electrolyte solution and 10 mg bisacodyl enteric-coated tablets for computed tomographic colonography(CTC).METHODS:Sixty subjects who gave informed consent were randomly assigned to study group A,study group B or the control group.On the day prior to CTC,subjects in study group A were given 20 mL 40% wt/vol barium sulfate suspension before 3 mealtimes,60 mL 60% diatrizoate meglumine diluted in 250 mL water after supper,and 10 mg bisacodyl enteric-coated tablets 1 h before oral administration of 2 L PEG-4000 electrolyte solution.Subjects in study group B were treated identically to those in study group A,with the exception of bisacodyl which was given 1 h after oral PEG-4000.Subjects in the control group were managed using the same strategy as the subjects in study group A,but without administration of bisacodyl.Residual stool and fluid scores,the attenuation value of residual fluid,and discomfort during bowel preparation in the three groups were analyzed statistically.RESULTS:The mean scores for residual stool and fluid in study group A were lower than those in study group B,but the differences were not statistically significant.Subjects in study group A showed greater stool and fluid cleansing ability than the subjects in study group B.The mean scores for residual stool and fluid in study groups A and B were lower than those in the control group,and were significantly different.There was no significant difference in the mean attenuation value of residual fluid between study group A,study group B and the control group.The total discomfort index during bowel preparation was 46,45 and 45 in the three groups,respectively,with no significant difference.CONCLUSION:Administration of 10 mg bisacodyl enteric-coated tablets prior to or after oral administration of 2 L PEG-4000 electrolyte solution enhances stool and fluid cleansing ability,and has no impact on the attenuation value of residual fluid or the discomfort index.The former is an excellent alternative for CTC colorectum
文摘Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Methods: In two randomized, double-blind, placebo-controlled, parallel-group trials, the efficacy and safety of treatment with either bisacodyl or SPS, respectively, were assessed. After a 2-week baseline period patients with functional constipation were randomized to a 4-week treatment with either bisacodyl (2 tablets = 10 mg), SPS (18 drops = 10 mg), or matching placebo in a ratio of active drug to placebo of 2:1. Dose reduction as well as resuming the original dose was permitted. Patients who did not experience a bowel movement for more than 72 h were allowed to use a bisacodyl suppository. The primary endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs) per week during the trial. QoL was assessed using the Patient Assessment of Constipation (PAC)-QoL questionnaire. Results: Active treatment led to a greater improvement of PAC-QoL scores for every domain. Active treatment was also superior to placebo for all individual questions of the questionnaire. Of note, SPS or bisacodyl not only improved satisfaction with stool patterns (“quite a bit/extremely satisfied” in 12.8% of patients on placebo and 50.3% on active treatment) but bloating was also considerably ameliorated (“not at all feeling bloated” in 24.5% on placebo and 41.4% on active treatment). Conclusion: Bisacodyl and SPS not only improve stool variables but also quality of life in patients with chronic functional constipation. (EudraCT Nos. 2007-001991-34 and 2007-002087-10).
文摘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%(prep2) 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.
文摘BACKGROUND Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials(RCT).However,most RCTs do not provide data about clinical outcomes including lesions detection rate.Moreover,real-life comparisons are lacking.AIM To compare efficacy(both in terms of adequate bowel preparation and detection of colorectal lesions)and tolerability of a high-volume(HV:4 L polyethylene glycol,PEG)and a low-volume(LV:2 L PEG plus bisacodyl)bowel preparation in a real-life setting.METHODS Consecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016.Patients could choose either LV or HV preparation,with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures.Adequate bowel preparation according to Boston Bowel Preparation Scale(BBPS),clinical outcomes including polyp detection rate(PDR),adenoma detection rate(ADR),advanced adenoma detection rate(AADR),sessile/serrated lesion detection rate(SDR)and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed.RESULTS Total 2040 patients were enrolled and 1815(mean age 60.6 years,50.2%men)finally included.LV was chosen by 52%of patients(50.8%of men,54.9%of women).Split-dose schedule was more common with HV(44.7%vs 38.2%,P=0.005).High-definition scopes were used in 33.4%of patients,without difference in the two groups(P=0.605).HV and LV preparations showed similar adequate bowel preparation rates(89.2%vs 86.6%,P=0.098),also considering the two different schedules(HV split-dose 93.8%vs LV split-dose 93.6%,P=1;HV daybefore 85.5%vs LV day-before 82.3%,P=0.182).Mean global BBPS score was higher for HV preparations(7.1±1.7 vs 6.8±1.6,P<0.001).After adjustment for sex,age and indications for colonoscopy,HV preparation resulted higher in PDR[Odds ratio(OR)1.32,95%CI:1.07-1.63,P=0.011]and ADR(OR 1.29,95%CI 1.02–1.63,P=0.038)and comparable to LV in AADR(OR 1.51,95%CI 0.97-2.35,P=0.069),SDR and cancer detection rate.The use of standard-definition colonoscopes was associated to lower PDR(adjusted OR 1.59,95%CI:1.22-2.08,P<0.001),ADR(adjusted OR 1.71,95%CI:1.26–2.30,P<0.001)and AADR(adjusted OR 1.97,95%CI:1.09-3.56,P=0.025)in patients receiving LV preparation.Mean Visual Analogue Scale tolerability scored equally(7,P=0.627)but a≥75%dose intake was more frequent with LV(94.6%vs 92.1%,P=0.003).CONCLUSION In a real-life setting,PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation.However,with higher PDR and ADR,HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy,especially when colonoscopy is performed with standard resolution imaging.
文摘Constipation is a common functional gastrointestinal disorder which has caused much discomfort affecting the quality of life. The prevalence of constipation in the general population is approximately 20%(1)Various kinds of laxatives were introduced such as bulking agent, stool softener, stimulant, and osmotic agent (2)Fixed dose combination with bisacodyl as a stimulant and docusate sodium as a stool softener, Ducolax STM, was developed as enteric coated tablets targeting colon.
