-
PloS One 2021Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications.
METHODS
This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months.
RESULTS
Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident).
CONCLUSIONS
Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC.
TRIAL REGISTRATION NUMBER
NCT01642914.
Topics: Adolescent; Adult; Aged; Chronic Disease; Constipation; Female; Humans; Male; Middle Aged; Nonprescription Drugs; Patient Satisfaction; Peptides; Surveys and Questionnaires; Time Factors; Young Adult
PubMed: 33428631
DOI: 10.1371/journal.pone.0243318 -
JGH Open : An Open Access Journal of... Dec 2018Data regarding the comparison of colonoscopic preparation regimens are still variable. We aimed to assess the adequacy and tolerability of two bowel preparation regimens...
BACKGROUND AND AIM
Data regarding the comparison of colonoscopic preparation regimens are still variable. We aimed to assess the adequacy and tolerability of two bowel preparation regimens for afternoon colonoscopy.
METHODS
In a randomized, investigator-blinded trial, two preparation regimens [4-L split-dose polyethylene glycol-electrolytes (PEG-ELS) and 2-L PEG-ELS plus bisacodyl) were compared in terms of bowel cleansing efficacy and adverse effects.
RESULTS
The mean (±SD) age (years) of the 4-L split-dose PEG-ELS group ( = 147) and the 2-L PEG-ELS plus bisacodyl ( = 155) were 44.09 (±15.62) (M:F : 2:1) and 44.12 years (±15.61) (M:F : 1.7:1), respectively. Percentage of patients with excellent and good preparation was higher in the 4-L split-dose PEG-ELS regimen compared with the 2-L PEG-ELS plus bisacodyl regimen (22.44 17.41 and 44.21% 36.12%). Percentage of patients with fair and poor preparation was lower in 4-L split-dose PEG-ELS regimen compared with the 2-L PEG-ELS plus bisacodyl regimen (21.08% 27.74% and 12.24% 18.70%). In comparison with the 2-L PEG-ELS plus bisacodyl group, the incidences of abdominal pain (11% 15%), bloating (9% 12.24%), nausea/vomiting (8.38% 9.52%), and sleep disturbance (11% 12%) were slightly more common in the 4-L split-dose PEG-ELS group. There were no statistically significant differences between the two regimens with regard to bowel cleansing efficacy and adverse events.
CONCLUSIONS
The 2-L PEG-ELS plus bisacodyl (10 mg) preparation is as efficacious as the 4-L split-dose PEG-ELS regimen for afternoon colonoscopy. Optimal preparation for colonoscopy can be achieved with the 2-L PEG-ELS plus bisacodyl regimen with slightly fewer adverse events and lower cost compared to the 4-L split-dose PEG-ELS regimen.
PubMed: 30619933
DOI: 10.1002/jgh3.12077 -
American Journal of Translational... 2022Constipation is a common gastrointestinal problem worldwide. Its impact on health can range from an unpleasant problem to being seriously troublesome. When lifestyle... (Review)
Review
Constipation is a common gastrointestinal problem worldwide. Its impact on health can range from an unpleasant problem to being seriously troublesome. When lifestyle modification fails to deal with constipation, laxatives are the mainstay of therapy. There are several types of laxatives currently available; however, there still remains a need for better laxatives because certain currently available laxatives are not appropriate for or accessible to some patients. Preclinical experiments to study the laxative potential of substances/products of interest are vital to improving that situation. The selection of appropriate experimental models for assessing the laxative activities of substances/products under investigation is crucial to achieving valid and meaningful results. This article provides a scoping review of the literature, outlining, and summarizing models currently being used in preclinical experiments assessing the laxative activities of substances/products under investigation. The review includes both screening models, e.g., the isolated organ bath system, fecal assessment and intestinal transit assay, and confirmation models, e.g., constipation models. Chemical substances/drugs used to induce constipation in constipation models, e.g., loperamide, diphenoxylate, montmorillonite, and clonidine, as well as standard laxative agents used as a positive control in experimental models, e.g., bisacodyl, carbachol, lactulose, sodium picosulfate, castor oil, phenolphthalein, and yohimbine, are described in detail. The purpose of this article is to assist researchers in the design and implementation of preclinical experimental models for assessing laxative activities of substances/products under investigation to achieve valid and meaningful preclinical results prior to experimentation in humans.
PubMed: 35273679
DOI: No ID Found -
Clinical and Translational... Jun 2012We assessed the safety, efficacy, and tolerability of a new preparation of Gatorade and polyethylene glycol (PEG) for colonoscopy with or without bisacodyl compared with...
OBJECTIVES
We assessed the safety, efficacy, and tolerability of a new preparation of Gatorade and polyethylene glycol (PEG) for colonoscopy with or without bisacodyl compared with NuLYTELY.
METHODS
We performed an investigator-blinded, placebo-controlled, randomized trial of 64 oz of Gatorade and 306 g of PEG (G/PEG) with or without 10 mg of bisacodyl and NuLYTELY. A total of 600 outpatients consumed their preparation the day before a morning colonoscopy. The primary endpoint was colon cleanliness assessed by the Boston Bowel Preparation Scale (BBPS). Tolerability was assessed using a subject questionnaire, and safety was assessed from a basic metabolic profile drawn before the colonoscopy.
RESULTS
Adding bisacodyl to G/PEG caused more abdominal bloating/cramps (P<0.01) and did not result in a cleaner colon (P=0.66) compared with G/PEG without bisacodyl. The BBPS scores in both the G/PEG arms and NuLYTELY arm were not significantly different (P=0.19). Compared with subjects in the NuLYTELY arm, subjects in the G/PEG without bisacodyl arm had less nausea (P<0.04), vomiting (P<0.02), abdominal pain (P<0.02), bloating (P<0.005), difficulty drinking the liquid (P<0.0001), and found the overall preparation easier to tolerate (P<0.0001). Subjects in the combined G/PEG arms had a lower serum sodium (P<0.0007), chloride (P<0.007), and BUN (P<0.0001) levels than those in the NuLYTELY arm, but this did not cause any clinical symptoms.
CONCLUSIONS
Bisacodyl added to G/PEG for colon lavage caused more side effects and did not result in a cleaner colon. The G/PEG preparations cleansed the colon as well as NuLYTELY, were far better tolerated, and were equally safe.
PubMed: 23238266
DOI: 10.1038/ctg.2012.11 -
World Journal of Gastrointestinal... Dec 2021Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials (RCT). However, most RCTs do not provide...
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% 38.2%, = 0.005). High-definition scopes were used in 33.4% of patients, without difference in the two groups ( = 0.605). HV and LV preparations showed similar adequate bowel preparation rates (89.2% 86.6%, = 0.098), also considering the two different schedules (HV split-dose 93.8% LV split-dose 93.6%, = 1; HV day-before 85.5% LV day-before 82.3%, = 0.182). Mean global BBPS score was higher for HV preparations (7.1 ± 1.7 6.8 ± 1.6, < 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, = 0.011] and ADR (OR 1.29, 95%CI 1.02-1.63, = 0.038) and comparable to LV in AADR (OR 1.51, 95%CI 0.97-2.35, = 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, < 0.001), ADR (adjusted OR 1.71, 95%CI: 1.26-2.30, < 0.001) and AADR (adjusted OR 1.97, 95%CI: 1.09-3.56, = 0.025) in patients receiving LV preparation. Mean Visual Analogue Scale tolerability scored equally (7, = 0.627) but a ≥ 75% dose intake was more frequent with LV (94.6% 92.1%, = 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.
PubMed: 35070027
DOI: 10.4253/wjge.v13.i12.659 -
World Journal of Gastroenterology Nov 2014To evaluate the efficacy of same-day bowel preparation with Senna alkaloids combined with bisacodyl tablets in routine colonoscopy procedures. (Observational Study)
Observational Study
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 same-day 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, during-procedure 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) post-procedure (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 the protocol, and two patients reported constipation. Premature withdrawal due to insufficient bowel preparation was 2.7% (2/75). The overall satisfaction with the protocol was 86.7% (65/75), with patients reporting they would prefer the same protocol in a repeat procedure.
CONCLUSION
The same-day administration of Senna alkaloids appears to be a safe and effective bowel cleansing protocol for colonoscopy procedures.
Topics: Administration, Oral; Adult; Aged; Alkaloids; Bisacodyl; Cathartics; Colonoscopy; Drug Administration Schedule; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Patient Compliance; Patient Satisfaction; Pilot Projects; Predictive Value of Tests; Senna Extract; Tablets; Time Factors; Turkey
PubMed: 25386088
DOI: 10.3748/wjg.v20.i41.15382 -
Gastroenterology Research and Practice 2020Patient compliance during bowel preparation is important for successful colonoscopy. Bowel preparation with polyethylene glycol (PEG), the most commonly used solution...
A Randomized, Endoscopist-Blinded, Prospective Trial to Compare the Efficacy and Patient Tolerability between Bowel Preparation Protocols Using Sodium Picosulfate Magnesium Citrate and Polyethylene-Glycol (1 L and 2 L) for Colonoscopy.
Patient compliance during bowel preparation is important for successful colonoscopy. Bowel preparation with polyethylene glycol (PEG), the most commonly used solution for cleansing, involves the unpleasant ingestion of a large amount of liquid. Sodium picosulfate magnesium citrate (SP-MC) solution is an alternative option with better palatability than PEG. Therefore, in this study, we compared the efficacy and patient tolerability among the following three bowel preparation protocols: 2 L PEG-ascorbic acid (ASc), 1 L PEG-ASc plus bisacodyl, and SP-MC 340 mL plus bisacodyl. We conducted a randomized prospective endoscopist-blinded study between August 2018 and January 2019. A total of 311 patients were randomly classified into three groups according to the above-described bowel preparation protocols. To evaluate the efficacy of bowel cleansing, we used the Boston Bowel Preparation Scale. The degree of symptoms and the patients' satisfaction with each bowel preparation method were investigated using a questionnaire completed before sedation for colonoscopy. The baseline characteristics were similar among the three groups. There was no significant difference in the bowel preparation quality among the three groups. However, the incidence of symptoms, such as abdominal fullness and pain, was significantly lower ( = 0.006 and 0.027, respectively) while the patients' satisfaction rate was significantly higher ( = 0.012) in the SP-MC plus bisacodyl group than in the two PEG groups. In this study, the efficacy of the SP-MC plus bisacodyl solution was similar to that of the PEG solutions. However, patient tolerability and satisfaction were better in the SP-MC plus bisacodyl group than in the other groups. In conclusion, the use of SP-MC plus bisacodyl bowel preparation solution might be a better method for providing good intestinal cleansing and improving patient compliance.
PubMed: 32190045
DOI: 10.1155/2020/9548171 -
Cureus Dec 2021Screening colonoscopies are recommended for the detection and prevention of colon cancer. Liquid colonoscopy preparations may be poorly tolerated. We evaluated the...
INTRODUCTION
Screening colonoscopies are recommended for the detection and prevention of colon cancer. Liquid colonoscopy preparations may be poorly tolerated. We evaluated the adequacy and tolerability of a novel low-cost colonoscopy preparation consisting of magnesium citrate capsules and bisacodyl (MCCB).
METHODS
This is a single-center, assessor-blinded, randomized controlled trial of 51 patients undergoing screening colonoscopies, who received a bowel preparation of either 4 liters of GoLYTELY (Braintree Laboratories, Inc., Braintree, MA) or MCCB. The primary outcome was the rate of adequate colon cleanliness, defined as a total score ≥ 6 on the Boston Bowel Preparation Scale and no colon segment with a score of zero. The secondary outcome was patient satisfaction, assessed by a validated questionnaire.
RESULTS
A total of 100% of patients in both arms achieved adequate colon cleanliness, and the magnesium citrate arm had superior patient satisfaction (mean satisfaction score: 54.8 vs. 172.8; p < 0.001).
CONCLUSIONS
A pill-based colonoscopy preparation of MCCB may be a low-cost option for patients reluctant to consume a liquid preparation.
PubMed: 35070543
DOI: 10.7759/cureus.20506 -
United European Gastroenterology Journal Jun 2023Various volumes of bowel preparation are used in clinical practice. There is conflicting data on the effectiveness of individual regimens. This study aims to evaluate...
Efficacy of different bowel preparation regimen volumes for colorectal cancer screening and compliance with European Society of Gastrointestinal Endoscopy performance measures.
BACKGROUND
Various volumes of bowel preparation are used in clinical practice. There is conflicting data on the effectiveness of individual regimens. This study aims to evaluate the efficacy and compliance of currently used bowel preparations with the European Society of Gastrointestinal Endoscopy (ESGE) performance measures using data of the Dutch nationwide colorectal cancer screening (CRC) program.
METHODS
In a prospective, multicenter endoscopy database, we identified all CRC screening colonoscopies performed in 15 Dutch endoscopy centers from 2016 to 2020. We excluded procedures without documented bowel preparation or the Boston Bowel Preparation Scale (BBPS) score. Bowel preparation regimens were categorized into three groups, that is, 4-L (polyethylene glycol (PEG)), 2-L (2-L PEG with ascorbic acid) and ≤1-L volumes (sodium picosulfate with magnesium citrate, 1L-PEG with sodium sulfate and ascorbic acid or oral sulfate solution). European Society of Gastrointestinal Endoscopy performance measures included adequate BBPS score (≥6) (>90%), cecal intubation rate (CIR, >90%), adenoma detection rate (ADR, >25%) and polyp detection rate (PDR, >40%). Logistic regression was performed to identify predictive factors for adequate BBPS and patient discomfort.
RESULTS
A total of 39,042 CRC screening colonoscopies were included. Boston Bowel Preparation Scale scores, CIR, ADR and PDR for 4L, 2L and ≤1L regimens all met the minimum ESGE performance measures standards. However, an adequate BBPS score was more frequently seen with 2L regimens (98.0%) as compared to 4L (97.1%) and ≤1L regimens (97.0%) (p < 0.001), respectively. In addition, CIR was higher for ≤1L (98.4%) versus 4L (97.7%) and 2L (97.9%) regimens (p = 0.001), ADR higher for lower volume (≤1L (60.0%) and 2L (61.2)) versus higher volume (4L (58.6%)) regimens (p < 0.001), and PDR higher for ≤1L (70.0%) and 2L (70.8%) versus 4L (67.2%) regimens (p < 0.001). Boston Bowel Preparation Scale for ≤1L regimens was higher when combined with bisacodyl (97.3%) than without (95.6%) (p < 0.001). Overall, bisacodyl use was independently associated with higher patient discomfort (odds ratios = 1.47, confidence intervals = 1.26-1.72).
CONCLUSIONS
Despite variations in bowel preparation volumes, all regimens meet the minimum ESGE performance measures for bowel preparation and other quality parameters. Boston Bowel Preparation Scale can be further improved if ultra low volume regimens are combined with bisacodyl. The choice for either bowel preparation volume can therefore be based on volume-tolerance and patient preference.
Topics: Humans; Bisacodyl; Cathartics; Colonoscopy; Cecum; Prospective Studies; Early Detection of Cancer; Polyethylene Glycols; Colorectal Neoplasms; Ascorbic Acid
PubMed: 37190897
DOI: 10.1002/ueg2.12386 -
Alimentary Pharmacology & Therapeutics May 2006Although laxatives are a first-line treatment for constipation, there are few randomized placebo-controlled trials assessing their efficacy. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Although laxatives are a first-line treatment for constipation, there are few randomized placebo-controlled trials assessing their efficacy.
AIM
To determine the effect and safety of oral bisacodyl on stool frequency and consistency in patients with idiopathic constipation.
METHODS
55 patients (age 19-89 years) with idiopathic constipation were recruited from eight primary care practices and randomized to receive bisacodyl, 10 mg once daily, or placebo, on three successive days following a 3-day run-in period. Patients recorded stool frequency and consistency and adverse events. RESULTS; In each treatment group, 27 patients were evaluable for efficacy. The mean number of stools per day was significantly greater in the bisacodyl-treated group (1.8/day) compared with placebo (0.95/day) over the treatment phase (P=0.0061). Mean stool consistency score improved from 'hard' (run-in) to between 'soft' and 'well-formed' during bisacodyl treatment, remaining between 'moderately hard' and 'hard' for placebo treatment (P<0.0001). The investigator's global efficacy score was superior for the bisacodyl group compared with placebo. Both treatments were well tolerated. Serum electrolyte levels and incidence of adverse events were comparable between treatment groups.
CONCLUSIONS
Bisacodyl is effective and safe in improving stool frequency and consistency in acute treatment of idiopathic constipation.
Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Bisacodyl; Blood Cell Count; Cathartics; Constipation; Defecation; Double-Blind Method; Female; Humans; Male; Middle Aged; Treatment Outcome
PubMed: 16669963
DOI: 10.1111/j.1365-2036.2006.02903.x