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bisacodyl plus split 2-L polyethylene glycol-citrate-simethicone improves quality of bowel preparation before screening colonoscopy

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World Journal of Gastroenterology 2013年第33期19卷 5493-5499页

作者： Flavio Valiante Angelo Bellumat Manuela De Bona Michele De Boni Department of Gastroenterology and Digestive Endoscopy S Maria del Prato Hospital

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.

关键词： Colonoscopy Colon cleansing Bowel preparations Polyethylene glycol Simethicone bisacodyl

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bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

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Open Journal of Gastroenterology 2017年第1期7卷 32-43页

作者： Stefan Müller-Lissner Erika Richter Marion Eberlin Harald Weigmann Tobias Mück Michael A. Kamm Department of Internal Medicine Park-Klinik Weissensee Berlin Germany Sanofi-Aventis GmbH Frankfurt-Hoechst Germany St Vincent’s Hospital University of Melbourne Melbourne Australia

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).

关键词： Constipation Laxative bisacodyl Sodium Picosulfate Quality of Life

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Same-day colonoscopy preparation with Senna alkaloids and bisacodyl tablets:A pilot study

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World Journal of Gastroenterology 2014年第41期20卷 15382-15386页

作者： Erdinc Yenidogan Ismail Okan Huseyin Ayhan Kayaoglu Gokhan Giray Akgul Mufit Sansal Servet Tali Zeki Ozsoy Mustafa Sahin Department of General Surgery Faculty of MedicineGaziosmanpasa University

AIM:To evaluate the efficacy of same-day bowel preparation with Senna alkaloids combined with bisacodyl tablets in routine colonoscopy procedures.METHODS:Between March and June 2013,a sameday bowel preparation was implemented in our endoscopy unit.The preparation consisted of a semi-liquid,fiber-free diet one day prior to the procedure,with two bisacodyl tablets after lunch and dinner,and 250 mL of Senna alkaloid with 1.5 L of drinking water at 6 am the day of the procedure.The quality control parameters of colonoscopy were evaluated and implemented according to the guidelines of the American Society for Gastrointestinal Endoscopy.The pre-procedure,duringprocedure and post-procedure patient data were collected and analyzed:(1) pre-procedure(age,gender,comorbid diseases,colonoscopy indications,complete lack of compliance with the bowel preparation protocol);(2) during-procedure(sedation dose,duration of colonoscopy,withdrawal time,cecal intubation rate,polyp detection rate,Boston Bowel Preparation Scores and presence of foam and clear liquid); and(3) postprocedure(visual analogue scale score,pain during the procedure,patient satisfaction and premature withdrawal due to the insufficient bowel preparation).RESULTS:A total of 75 patients were included in this study with a mean age of 54.64 ± 13.29 years; 53.3%(40/75) were female and 46.7%(35/75) were male.A complete lack of compliance with the bowel preparation protocol was seen in 6.7% of patients(5/75).The mean total duration of colonoscopy was 16.12 ± 6.51 min,and the mean withdrawal time was 8.89 ± 4.07 min.The cecal intubation rate was 93.8%(61/64) and the polyp detection rate was 40%(30/75).The mean Boston Bowel Preparation Score was 7.38 ± 1.81,with the following distribution:right colon,2.34 ± 0.89; transverse colon,2.52 ± 0.67; left colon,2.52 ± 0.63.The mean visual analogue scale score was 4.59 ± 1.57.Due to insufficient bowel preparation,seven patients(7/75; 9.3%) were asked to repeat the procedure.Of these,five patients had poor or modest compliance with

关键词： bisacodyl Bowel preparation Colonoscopy Same-day p

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Pilot study on efficacy of reduced cathartic bowel preparation with polyethylene glycol and bisacodyl

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World Journal of Gastroenterology 2013年第4期19卷 561-568页

作者： Zhi-Yuan Chen He-Song Shen Ming-Yue Luo Chai-Jie Duan Wen-Li Cai Hong-Bing Lu Guo-Peng Zhang Yang Liu Jerome Z Liang Department of Radiology the Sixth Affiliated Hospital of Sun Yat-Sen University Department of Radiology Guangdong Provincial Hospital of Traditional Chinese Medicine Research Center of Biomedical Engineering Graduate School at ShenzhenTsinghua University Department of Radiology Massachusetts General Hospital and Harvard Medical SchoolBostonMA 02114United States Department of Biomedical Engineering The Fourth Military Medical University Departments of Radiology and Computer Science State University of New York at Stony BrookNew YorkNY 11794United States

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

关键词： Colorectal cancer Screening Computed tomographic colonography Polyethylene glycol bisacodyl

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Efficacy and tolerability of high and low-volume bowel preparation compared:A real-life single-blinded large-population study

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World Journal of Gastrointestinal Endoscopy 2021年第12期13卷 659-672页

作者： Vincenzo Occhipinti Paola Soriani Francesco Bagolini Valentina Milani Emanuele Rondonotti Maria Laura Annunziata Flaminia Cavallaro Sara Vavassori Maurizio Vecchi Luca Pastorelli Gian Eugenio Tontini Digestive Endoscopy and Gastroenterology Unit A.Manzoni HospitalASST LeccoLecco 23900Italy Gastroenterology Unit IRCCS Policlinico San DonatoSan Donato Milanese 20097Italy Gastroenterology and Digestive Endoscopy Unit Azienda USL ModenaCarpi HospitalCarpi 41012Italy Scientific Directorate IRCCS Policlinico San DonatoSan Donato Milanese 20097Italy Gastroenterology Unit Ospedale ValduceComo 22100Italy Gastroenterology and Endoscopy Unit Fondazione IRCCS Ca'Granda Ospedale Maggiore PoliclinicoMilan 20122Italy Gastroenterology and Hepatology Unit ASST Santi Paolo e CarloMilan 20142Italy Department of Pathophysiology and Transplantation University of MilanMilan 20122Italy Department of Biomedical Sciences for Health University of MilanMilan 20122Italy

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 detecti

关键词： Bowel preparation volume Polyethylene glycol bisacodyl Colonoscopy Colonic adenomas Tolerability

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Development of triple-layered tablets containing laxatives with a hydrophilic polymer

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Asian Journal of Pharmaceutical Sciences 2016年第1期11卷 134-135页

作者： Woo Heon Song Jin Seob Oh Kyung Soo Lee Jun Sang Park GL PharmTech Corporation

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.

关键词： Hydrophilic polymer Sodium carboxymethylcellulose bisacodyl Triple-layered tablet

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Colonic preparation before colonoscopy in constipated and non-constipated patients:A randomized study

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World Journal of Gastroenterology 2013年第31期19卷 5103-5110页

作者： Lisandro Pereyra Daniel Cimmino Carlos González Malla Mariano Laporte Nicolás Rotholtz Carlos Peczan Sandra Lencinas Silvia Pedreira Hugo Catalano Luis Boerr Department of Endoscopy Hospital Alemán 1118 Buenos Aires Argentina Department of Internal Medicine Hospital Alemán 1118 Buenos Aires Argentina Department of Surgery Hospital Alemán 1118 Buenos Aires Argentina

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 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 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 combinati

关键词： Colonic cleansing Sodium phosphate Polyethylenglicol bisacodyl constipation Colonoscopy

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Diphenyl methane laxatives do not induce electrolyte imbalance

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Open Journal of Gastroenterology 2013年第5期3卷 272-275页

作者： Stefan Müller-Lissner Department of Internal Medicine Park-Klinik Weissensee Schonstrasse Berlin

Aim: To analyse whether there are changes in sodium and potassium serum levels during chronic treatment with the diphenyl methanes bisacodyl and sodium picosulfate. Methods: A literature search was done using PubMed, and the reference lists of pertinent papers were screened for additional studies. Only studies of at least 4 weeks duration were considered for further analysis. Results: Four relevant studies were identified. In three randomised controlled trials with 5 to 10 mg daily of bisacodyl or sodium picosulfate, respectively, over four weeks no electrolyte losses were found. Hypokalemia was also not a problem in a group of patients with paraplegia using bisacodyl suppositories for 2 to 34 years. Conclusions: Electrolyte losses, particularly hypokalemia, are not a problem when bisacodyl or sodium picosulfate are used long-term.

关键词： Laxative bisacodyl Sodium Picosulfate Hyponatremia Hypokalemia

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