A Multicenter Randomized Controlled Trial Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation.

BACKGROUND & AIMS: Failed bowel preparation for colonoscopy occurs commonly, but the optimal regimen for the subsequent attempt is unknown. High-volume preparations often are used but are not well studied. The objective of this study was to compare the efficacy, tolerability, and safety of 2 regimens for use after failed bowel preparation. METHODS: A multicenter, endoscopist-blinded randomized controlled trial was conducted in patients who previously failed bowel preparation despite adequate compliance. Patients were randomized to 1 of 2 split polyethylene glycol (PEG) regimens, preceded by 15 mg bisacodyl: PEG 2 L the evening before and 2 L the day of colonoscopy (PEG 2+2L+bisacodyl), or 4 L and 2 L (PEG 4+2L+bisacodyl). All patients followed a low-fiber diet on both the third and second day before the procedure, followed by a clear fluid diet the day before and the morning of the colonoscopy. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale total score of 6 or higher, with all segment scores of 2 or higher. Secondary outcomes included adenoma detection rate, advanced adenoma detection rate, sessile serrated lesion detection, cecal intubation rate, tolerability, and adverse events. RESULTS: A total of 196 subjects were randomized at 4 academic centers in Canada (mean age, 60.7 y; SD, 11.4 y; 44.9% were women). There were no significant differences between the PEG 2+2L+bisacodyl and the PEG 4+2L+bisacodyl groups in achieving adequate bowel preparation (91.2% vs 87.6%; P = .44). There were no significant differences with regard to mean adenoma detection rate (37.4% vs 31.5%; P = .41), advanced adenoma detection rate (18.7% vs 11.2%; P = .16), sessile serrated lesion detection (8.8% vs 5.6%; P = .41), and cecal intubation rate (96.7% vs 92.1%; P = .19). The 2 regimens were similarly well tolerated, but PEG 2+2L+bisacodyl was associated with a higher willingness to repeat the bowel preparation (91.2% vs 66.2%; P < .001). CONCLUSIONS: Split-dose 4 L-PEG with 15 mg bisacodyl, along with dietary restrictions, has similar efficacy as a higher-volume preparation, and should be considered for patients who previously failed bowel preparation (ClinicalTrials.gov number, NCT02976805).

Long-term Use of Bisacodyl in Pediatric Functional Constipation Refractory to Conventional Therapy.

OBJECTIVES: Standard therapy for pediatric constipation includes osmotic laxatives with stimulant laxatives use only as rescue therapy. Limited information is available on regular and long-term use of bisacodyl in pediatric population despite its common use in adult and pediatric constipation. METHODS: Retrospective review of patients with functional constipation refractory to conventional therapy (regular use of osmotic laxatives and intermittent use of stimulant laxatives only as a rescue therapy) referred to tertiary care children's hospital (January 2007-December 2014). Patients had a bowel movement (BM) frequency of ≤2 per week and were treated with bisacodyl regularly for longer than 4 weeks. Demographic variables, bisacodyl dose and treatment duration, number of BM/week before and after treatment, side effects, and length of follow-up were recorded. Response to therapy was successful when frequency of BM increased from baseline to ≥3 BM/wk. RESULTS: A total of 164 patients were included, 52% girls, median age 9.45 years (0.9-21 years). Bisacodyl median dose was 5 mg/day, median duration of treatment was 14 months (1-77 months) with 90% of patients taking the medication for <36 months. Median number of BM/wk doubled after initiation of bisacodyl from 2 to 4 bm/w (P < 0.001). Approximately 57% of patients had successful response. At long-term follow-up 55% of patients were successfully weaned off bisacodyl (median time of 18 months). Side effects reported in 9% of patients. CONCLUSIONS: Bisacodyl is effective and well tolerated in the long-term treatment of pediatric functional constipation refractory to conventional therapy. Most of patients with a favorable response were successfully weaned off the medication.

A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study.

BACKGROUND: The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons. METHODS: This multicenter feasibility study included patients aged 18 - 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety. RESULTS: 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 - 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P < 0.001) and median BBPS score (from 3.0 [IQR 0.0 - 5.0] to 9.0 [IQR 8.0 - 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0-28.3) and 34.0 minutes (IQR 25.0 - 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period. CONCLUSIONS: This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

Long term treatment with stimulant laxatives - clinical evidence for effectiveness and safety?

OBJECTIVES: Bisacodyl and sodium picosulfate are classified both as stimulant laxatives, approved for short-term treatment of constipation and sold without prescription (OTC). Stimulant laxatives are associated with harmful long-term colonic effects and possible carcinogenic risk - and evidence support that these agents are used for longer periods. We aimed to compile and review the clinical trial evidence describing the effectiveness and safety of long-term treatment (>14 continuous days) with stimulant laxatives. METHODS: The PubMed database was searched for all randomised clinical trials (RCTs) examining the effect of bisacodyl or sodium picosulfate in adult patients diagnosed with constipation. RESULTS: Five RCTs (one open-label and four double-blinded) with intervention periods of four weeks duration were eligible. These included 1008 patients, whereof 26% dropped out. A positive global assessment of efficacy was obtained in 78-99% of the patients treated with bisacodyl or sodium picosulfate. Notably, the same global assessment was obtained in 46-54% of the placebo-treated patients. Compared to placebo, an improvement in stool consistency and a significant increase in number of bowel movements peer week were seen in favor of bisacodyl and sodium picosulfate. However, for pyridostigmine, a significant difference was seen compared to bisacodyl. AEs were generally mild, but frequent (up to 72%) mostly diarrhea and abdominal pain. CONCLUSION: The evidence base does not support use of stimulant laxatives for more than four weeks. Due to the substantial use of stimulant laxatives including sold OTC, longer term RCTs and epidemiological studies investigating effects and safety on the longer term are warranted.

Bowel Preparation for Colonoscopy in Children: 1 Day PEG-3350 with Bisacodyl versus 3 Day Sennosides.

BACKGROUND AND OBJECTIVES: Bowel preparation (BP) for colonoscopy is a challenging procedure in children and different regimens have been used for this purpose. Polyethylene glycol (PEG) is the most preferred agent in recent years. The primary aim of this study was to evaluate the efficacy of 1-day PEG-3350 with bisacodyl (PEG-B) and comparing it with 3-day sennosides A+B. METHOD: In this prospective, randomized, and single-blinded study, children aged 2-18 years were included in the PEG-B group for 1 day or in Senna group for 3 days. The effectiveness of BP was assessed according to the Ottawa and Boston BP scales, compliance and adverse effects were also recorded. Pre- and post-preparation biochemistry were obtained for investigation of safety of both regimens. RESULTS: Successful BP was observed in 88.3% (n = 53/60) of PEG-B and 86% (n = 55/64) of Senna groups according to Boston scale, and it was 85% (n = 51/60) and 84.4% (n = 54/64), respectively, according to Ottawa scale. The cecal intubation rate was 96.7% (n = 58/60) in the PEG-B group and 93.8% (n = 60/64) in the Senna group. Ease of administration and disturbance in regular daily activities was better in the PEG-B group (p < 0.05). There was no major adverse event and biochemical abnormality in both groups. The correlation between Ottawa and Boston scales was found to be excellent (r2 = -0.954, p < 0.01). CONCLUSIONS: The efficacy, safety, and adverse effect profile of 1-day BP with PEG-B regimen was found to be similar to 3-day sennosides regimen, however, the PEG-B regimen had advantages such as short duration, ease of administration, and better patient comfort. Also, high correlation rate between the Boston and Ottawa scales in pediatric patients was remarkable.

Comparison of efficacy of pharmacological treatments for chronic idiopathic constipation: a systematic review and network meta-analysis.

OBJECTIVE: To compare efficacy of pharmacotherapies for chronic idiopathic constipation (CIC) based on comparisons to placebo using Bayesian network meta-analysis. DATA SOURCES: We conducted searches (inception to May 2015) of MEDLINE, EMBASE, Scopus and Cochrane Central, as well as original data from authors or drug companies for the medications used for CIC. STUDY SELECTION: Phase IIB and phase III randomised, placebo-controlled trials (RCT) of ≥4 weeks' treatment for CIC in adults with Rome II or III criteria for functional constipation; trials included at least one of four end points. DATA EXTRACTION AND SYNTHESIS: Two investigators independently evaluated all full-text articles that met inclusion criteria and extracted data for primary and secondary end points, risk of bias and quality of evidence. OUTCOMES: Primary end points were ≥3 complete spontaneous bowel movements (CSBM)/week and increase over baseline by ≥1 CSBM/week. Secondary end points were change from baseline (Δb) in the number of SBM/week and Δb CSBM/week. RESULTS: Twenty-one RCTs (9189 patients) met inclusion and end point criteria: 9 prucalopride, 3 lubiprostone, 3 linaclotide, 2 tegaserod, 1 each velusetrag, elobixibat, bisacodyl and sodium picosulphate (NaP). All prespecified end points were unavailable in four polyethylene glycol studies. Bisacodyl, NaP, prucalopride and velusetrag were superior to placebo for the ≥3 CSBM/week end point. No drug was superior at improving the primary end points on network meta-analysis. Bisacodyl appeared superior to the other drugs for the secondary end point, Δb in number of SBM/week. CONCLUSIONS: Current drugs for CIC show similar efficacy. Bisacodyl may be superior to prescription medications for Δb in the number of SBM/week in CIC.

Comparison of a split-dose bowel preparation with 2 liters of polyethylene glycol plus ascorbic acid and 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl before colonoscopy.

BACKGROUND AND AIMS: Recently, a low-volume polyethylene glycol formulation containing ascorbic acid (PEG-Asc) has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc formulation and a 1-L PEG-Asc formulation with bisacodyl (10 mg) to determine the quality of bowel cleansing and patient tolerability. METHODS: A single-center, randomized, observer-blinded study was performed between May 2015 and September 2015. Two hundred outpatients referred for colonoscopy were prospectively enrolled and assigned to either the split-dose 2-L PEG-Asc group or the 1-L PEG-Asc with bisacodyl 10-mg group. The Boston Bowel Preparation Scale (BBPS) and Aronchick Bowel Preparation Scale (ABPS) were used to evaluate bowel cleansing. The tolerability of the regimens and satisfaction of patients was determined based on a questionnaire. RESULTS: Two hundred patients received either 2-L PEG-Asc or 1-L PEG-Asc with bisacodyl. Regarding colon cleansing outcome (BBPS and ABPS), the 1-L PEG-Asc with bisacodyl group showed similar but non-inferior results compared with the 2-L PEG-Asc group on both BBPS (6.92 ± 1.63 vs 6.57 ± 1.37; P = .103) and ABPS (96% vs 95%; P = 1.000) scales. Tolerability was similar for both 1-L PEG-Asc with bisacodyl and 2-L PEG-Asc. CONCLUSIONS: 1-L PEG-Asc is a suitable alternative to low-volume bowel preparation for colonoscopy. Our study showed that the 1-L PEG-Asc plus bisacodyl preparation has comparable tolerability and results in adequate colon cleansing. Bowel preparation with bisacodyl and 1-L PEG-Asc is a suitable alternative to low-volume bowel preparation for colonoscopy. (Clinical trial registration number: NCT02980562.).

[Bisacodyl as laxative in Belgian pharmacy]. / Le laxalif bisacodyl dans les pharmacies belges.

Obstipation is a common complaint in pharmacies and one of the treatment strategies is the delivery of enteric coated bisacodyL tablets. This article reviews the different aspects that are important for pharmacists to guarantee patient safety: whether medical treatment is required or not, which advice should be given on how to use the drug, and to conclude what is the analytical quality of the commercial products on the Belgian market.

Rescue bowel preparation: same day 2 L polyethylene glycol addition, not superior to bisacodyl addition 7 days later.

BACKGROUND: The optimal colon-cleansing method after failure of bowel preparation (BP) for colonoscopy has not been established. AIMS: We aimed to compare BP rescue methods after failed initial BP and to identify risk factors for rescue BP failure. METHODS: Eighty-five patients with BP failure after 4 L polyethylene glycol (PEG) ingestion were prospectively enrolled from March 2008 to March 2012. A second colonoscopy was performed either on the same day after ingestion of another 2 L PEG (group A) or 1 week later after ingestion of 4 L PEG plus 20 mg oral bisacodyl (group B). Differences between groups in terms of BP quality and risk factors for a poor BP on the second colonoscopy were investigated. RESULTS: Median patient age was 59 years, 45 were male (52.9 %), and 17 (20 %) had poor BP on the second colonoscopy. For group B, the multivariable-adjusted odds ratio (OR) for poor BP on the second colonoscopy relative to group A was 0.68 (95 % confidence interval [CI], 0.16-2.95). Adequately ingested PEG during the initial colonoscopy was associated with poor BP on the second colonoscopy (OR 4.05; 95 % CI 1.04-15.75). The two groups had similar patient discomfort rates during the second BP. CONCLUSIONS: The two groups did not differ in rescue BP failure rate. Initial BP failure after adequate consumption of 4 L PEG may be a risk factor for rescue BP failure. A stricter BP regimen should be considered for these patients.

One-day versus two-day cleansing for colon capsule endoscopy: a prospective randomized pilot study.

BACKGROUND: Standard bowel cleansing for colon capsule endoscopy (CCE) requires a liquid diet and bowel laxatives for at least 2 days, which is a major drawback of this procedure and affects tolerance and acceptability. OBJECTIVE: To compare the quality of colon cleanliness achieved with one-day versus two-day bowel preparation in outpatients undergoing CCE. METHODS: Patients were randomly assigned to one of two groups: group I (one-day schedule, n=20) received a fiber-free diet and 3 L of polyethylene glycol (PEG) on day 0; group II (two-day schedule, n=20) received a liquid diet and 3 L of PEG in the evening of day -1, and 1L of PEG in the early morning of day 0. In both groups, the patients received 15 mg bisacodyl on day -1 and one or two additional sodium phosphate (NaP) boosters following capsule ingestion. Each colon segment was assessed for cleanliness using a four-point grading scale (excellent=1, good=2, fair=3, and poor=4). For the final analysis, colon cleanliness was rated as adequate (good or excellent) or inadequate (fair or poor). RESULTS: Overall colon cleanliness was adequate in 94% (CI 91-97) of patients in group I versus 80% (CI 72-88) in group II (P=0.27). No significant differences were observed in the per-segment quality of colon cleansing between the two groups. CCE reached the rectum in 80% (CI 73-87) of patients in group I versus 75% (CI 67-83) in group II (p=0.59). CONCLUSION: The quality of colon cleanliness achieved with one-day bowel preparation is equivalent to that of the standard two-day schedule in patients undergoing CCE.

Risk factors for inadequate bowel preparation in patients using high- and low-volume cleansing products.

INTRODUCTION: Bowel preparation is crucial for colonoscopy completeness and lesions detection. Today, several cleansing products are equally recommended by guidelines, irrespective of patients' characteristics. Identification of preparation-specific risk factors for inadequate bowel preparation may lead to a personalized prescription of cleansing products to refine patients' tolerance and improve endoscopic outcomes. METHODS: We prospectively enrolled consecutive outpatients referred for colonoscopy using either a high-volume [HV: 4 l polyethylene glycol (PEG)] or a low-volume (LV: 2 l PEG + bisacodyl) preparation. Day-before regimen or split-dose regimen was used for morning or afternoon colonoscopies, respectively. Univariate and multivariate analyses were conducted to identify risk factors related to inadequate bowel preparation, according to the Boston bowel preparation scale for HV and LV preparations. RESULTS: We enrolled 2040 patients, of which 1815 were included in the final analysis (average age 60.6 years, 50.2% men). Half of them (52%) used LV preparation. Adequate preparation was achieved by 87.6% without differences between the HV and LV groups (89.2% vs. 86.6%; P = 0.098). The use of day-before regimen and incomplete assumption of PEG were independent predictors of poor visibility for either HV or LV preparation. However, different specific risk factors for HV [diabetes: odds ratio (OR), 3.81; 95% confidence interval (CI), 1.91-7.58; low level of instruction: OR, 1.95; 95% CI, 1.11-3.44; and previous abdominal surgery: OR, 2.27; 95% CI, 1.20-4.30] and for LV (heart disease: OR, 2.06; 95% CI, 1.09-3.88; age > 65 years: OR, 1.51; 95% CI, 1.01-2.27) preparations were identified. CONCLUSION: Day-before preparation and incomplete assumption of the purgative agents affect bowel visibility irrespective of the preparation volume. LV should be preferred to HV preparations in patients with diabetes, low level of instruction, and previous abdominal surgery, whereas an HV preparation should be preferred in patients with heart disease and in older patients.

An Israeli national survey on ischemic colitis induced by pre-colonoscopy bowel preparation (R1).

Background and study aims: Ischemic colitis (IC) may occur as a complication of colonoscopy. The aim of this study was to characterize patients with IC that occurred after exposure to bowel preparation laxatives, prior to an elective colonoscopy. Patients and methods: A survey among Israeli gastroenterologists. Information was collected regarding individual cases. Results: Eight patients, who developed IC after bisacodyl ingestion that was taken as part of pre-colonoscopy bowel preparation protocol, were reported. In all patients, severe abdominal pain and/or hematochezia started shortly after the ingestion of the first dose of bisacodyl. IC was found in 7 patients during the planned colonoscopy and in 1 patient using computerized tomography. All patients received supportive treatment and recovered. Conclusions: IC induced by bisacodyl is a rare phenomenon. Regardless of being rare, we would advise withholding bisacodyl bowel preparation in elderly subjects with risk factors for IC that are scheduled for a colonoscopy.

Oral bisacodyl is effective and well-tolerated in patients with chronic constipation.

BACKGROUND & AIMS: Although stimulant laxatives have been used for many years to treat patients with constipation, their clinical value has been questioned, and there have been few high-quality trials to assess their efficacy. We tested the efficacy and safety of 4 weeks of treatment with oral bisacodyl tablets in patients with chronic constipation, defined by Rome III criteria. METHODS: This randomized, double-blind, placebo-controlled, parallel-group study was conducted in 27 centers in the United Kingdom. After a 2-week baseline period without study medication, patients were randomly assigned, in a 2:1 ratio, to groups that were given 10 mg bisacodyl (n = 247) or placebo (n = 121), once daily, for 4 weeks. Patients used an electronic diary each day to record information relating to their constipation. RESULTS: The mean (± standard error of the mean [SEM]) number of complete spontaneous bowel movements (CSBMs) per week during the treatment period increased from 1.1 ± 0.1 in both groups to 5.2 ± 0.3 in the bisacodyl group and 1.9 ± 0.3 in the placebo group (P < .0001). All secondary end points (number of complete spontaneous bowel movements for each single week, number of spontaneous bowel movement (SBMs), and constipation-associated symptoms) differed significantly between groups, demonstrating efficacy for bisacodyl (P < .0001). Compared with baseline, there was a statistically significant improvement in the overall Patient Assessment of Constipation quality of life (PAC-QOL) score and all subscales (satisfaction, physical discomfort, psychosocial discomfort, worries and concerns) in the bisacodyl-treated patients, compared with those that received placebo (P ≤ .0070). Treatment with bisacodyl was well-tolerated. CONCLUSIONS: Oral bisacodyl is an effective and well-tolerated treatment for patients with chronic constipation. It improves bowel function, constipation-related symptoms, and disease-related QOL.

Two-day bowel preparation with polyethylene glycol 3350 and bisacodyl: a new, safe, and effective regimen for colonoscopy in children.

OBJECTIVES: To assess the safety, efficacy, and acceptance of a 2-day bowel preparation with polyethylene glycol (PEG) 3350 without electrolytes and bisacodyl for colonoscopy in children. PATIENTS AND METHODS: In a prospective study, 111 children of mean age 11.9 years were given 2 g/kg of PEG and a 5-mg tablet of bisacodyl daily for 2 days before colonoscopy. Stool frequency, consistency, and adverse effects were monitored for the duration of the bowel preparation. Compliance and quality of colonic preparation were assessed on the day of the colonoscopy. RESULTS: The average daily stool frequency increased from a baseline of 2, to 4* on day 1, and 6.5* on day 2 of the bowel preparation (*P < 0.001 for difference vs baseline). The colonic preparations were rated as excellent or good in 92% and 93% of the patients in the right and left colon, respectively. Adverse effects were mild nausea (19%), abdominal pain (11%), and vomiting (4%). The compliance was rated as excellent in 95% of the patients. CONCLUSIONS: A 2-day bowel preparation with PEG and bisacodyl is safe, effective, and well accepted for colonoscopy in children without any major adverse effects.

Pico-salax plus two-day bisacodyl is superior to pico-salax alone or oral sodium phosphate for colon cleansing before colonoscopy.

OBJECTIVES: This study examined whether Pico-Salax alone or Pico-Salax plus bisacodyl tablets for two nights before colonoscopy afford superior efficacy, patient tolerance, and safety compared with oral sodium phosphate. METHODS: Patients undergoing outpatient colonoscopy were randomized to receive either Pico-Salax at 5 and 10 PM the night before colonoscopy plus bisacodyl 10 mg at 5 PM in the two earlier evenings (n=105), Pico-Salax alone at 5 and 10 PM the night before colonoscopy (n=109), or oral sodium phosphate at 5 and 10 PM the night (n=101) before colonoscopy. All groups were encouraged to drink 3-4 l of Gatorade or other clear fluids the night before the colonoscopy. RESULTS: Global scoring of cleansing efficacy using the Ottawa scale did not reveal differences among groups, but Pico-Salax plus bisacodyl was superior in cleansing the right colon compared with the other regimens (P=0.003), providing almost 50% improvement over oral sodium phosphate. Patient tolerance of Pico-Salax plus bisacodyl did not differ from Pico-Salax alone but was much better than oral sodium phosphate (P<0.0001). Hemodynamic and biochemical monitoring of patients on Pico-Salax plus bisacodyl suggests this regimen has a very strong safety profile. It does not differ from Pico-Salax alone, which lacks the hyperphosphatemia and hypocalcemia associated with oral sodium phosphate. CONCLUSIONS: Together, these data suggest that Pico-Salax plus bisacodyl provides enhanced colon cleansing in the right colon compared with Pico-Salax alone or oral sodium phosphate, but this finding does not compromise the much greater tolerability or the safety profile of Pico-Salax alone.

Randomized study comparing two regimens of oral sodium phosphates solution versus low-dose polyethylene glycol and bisacodyl.

PURPOSE: Low-volume bowel preparation regimens for colonoscopy are reported to improve patient acceptance and compliance. We sought to compare the bowel cleansing efficacy, tolerability, and acceptability of three low-volume regimens: an oral sodium phosphates solution 45/45 ml (NaP-45/45), a reduced-dose oral sodium phosphates solution 45/30 ml (NaP-45/30), and polyethylene glycol plus bisacodyl (PEG-2L). RESULTS: A total of 121 patients were evaluated (mean age 55.2 +/- 8.9 years). Bowel cleansings rated as excellent and good were significantly different among the groups: NaP-45/45 = 98%, NaP-45/30 = 88%, and PEG-2L = 76% (P < 0.04). Side effects were not significantly different except for greater thirst in the NaP-45/45 group (P = 0.001) and increased vomiting in females using PEG-2L (two-tailed interaction, P < 0.10). Willingness to retake the preparation was higher among the sodium phosphates regimens (88, 95, and 73%, respectively; P = 0.019). CONCLUSIONS: Better cleansing and willingness to retake the regimen was achieved with the oral sodium phosphates solutions than with polyethylene glycol plus bisacodyl.

Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.

BACKGROUND: Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. AIMS: to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. METHODS: Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. RESULTS: Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. CONCLUSIONS: The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis.

INTRODUCTION: The US Food and Drug Administration has withdrawn the bowel cleansing kit HalfLytely (PEG 3500) with 10 mg bisacodyl tablets due to an increased risk of ischaemic colitis compared with the same kit with only 5 mg bisacodyl. This is of interest in Canada given that the bowel cleansing kit Bi-Peglyte (PEG 3500) with 15 mg bisacodyl is currently approved for use. The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)-based and sodium-picosulfate-based products. METHODS AND ANALYSIS: Given the existing volume of the literature, the review will be conducted in two stages. Stage 1 will consist of a scoping exercise by searching MEDLINE, Embase and the Cochrane Library (up to 21 November 2017) to identify randomised controlled trials, quasirandomised studies and non-randomised studies in which any bowel cleanser regimens were compared among persons undergoing colonoscopy. The outcomes will be mapped to establish a listing of the studies and their comparisons and outcomes currently available in the literature. From this, a data synthesis plan will be determined. In stage 2, a systematic review with meta-analyses will be pursued, focused on the bowel cleanser comparisons and outcomes of interest identified in stage 1. Two reviewers will screen, extract and quality assess the articles. Outcomes of interest include ischaemic colitis, electrolyte imbalances and their consequences, seizures, bowel perforation and patient tolerability. If sufficient data exist and studies are of sufficient homogeneity, network meta-analyses (NMAs) will be performed. ETHICS AND DISSEMINATION: Ethics approval was not necessary due to study design. Updating the safety profile of bowel cleansers among the generally healthy population undergoing colonoscopy is pertinent given recent approval changes. This will be the first NMA within this population. Policy considerations may be reconsidered to minimise risk during bowel cleanser use. PROSPERO REGISTRATION NUMBER: CRD42018084720.