Sodium picosulfate 5mg/5ml oral solution sugar free

Colonoscopy is performed for diagnostic and therapeutic purposes. The quality of colonoscopy depends on adequate bowel cleansing. However, there is no standardized protocol for bowel preparation in children. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effectiveness, safety, and tolerability profile of polyethylene glycol (PEG) compared with those of sodium picosulfate magnesium citrate (SPMC) in children. The primary sources of the reviewed studies were Scopus, PubMed, and Cochrane Library. The databases were systematically searched for RCTs comparing PEG 4000 to SPMC as a bowel cleansing solution. Six studies were included. The analysis showed that both PEG and SPMC are effective for bowel cleansing, while a split-dose regimen may be preferable to a day-before one. There were no differences between the two groups regarding adverse events (AEs) such as abdominal pain, nausea, vomiting, bloating, and anal discomfort. Additionally, preparation with SPMC was preferred in terms of acceptability and compliance. Still, the need to place a nasogastric tube was significantly lower in the SPMC group compared to the PEG group and in the split dose regimen compared to the day before. In conclusion, PEG and SPMC are equally effective in obtaining an adequate bowel cleansing with a comparable AE rate; moreover, split-dose administration may be preferable to day-before one in terms of effective bowel cleansing. However, SPMC preparation is more acceptable seems to result in higher compliance, and to reduce the use of a nasogastric tube, that we encounter daily in clinical practice, is perceived as a stressful experience for children and their families.

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BACKGROUND: Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. METHODS: This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

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AIM: Adequate bowel preparation is essential for high-quality colonoscopy and directly affects key quality indicators such as adenoma detection and cecal intubation. Although low-volume, nonpolyethylene glycol (PEG) regimens are widely used in clinical practice, real-world comparative data between stimulant-based preparations and sodium picosulfate-based combinations remain limited. This study aimed to compare the effectiveness and tolerability of sennoside A + B versus sodium picosulfate/magnesium oxide/citric acid (PM/Ca) using the Boston Bowel Preparation Scale (BBPS). METHODS: This prospective, randomized, observer-blinded trial included adults aged 18-80 years undergoing elective outpatient colonoscopy. Participants were randomized 1:1 to receive either sennoside A + B oral solution (split-dose: 250 mL at 21:00 and 250 mL at 23:00) or PM/Ca (two sachets at 19:00 and 21:00), both administered with a low-residue diet and written instructions; rectal enemas were applied as part of the institutional protocol. Bowel cleanliness was assessed using BBPS. Adequate preparation was defined as BBPS > 6. Multivariable logistic regression was performed to identify independent predictors of adequate preparation. RESULTS: A total of 705 patients were included in the primary analysis cohort (341 sennoside A + B; 364 PM/Ca). Adequate bowel preparation (BBPS > 6) was achieved more frequently in the sennoside A + B group than in the PM/Ca group (70.1% versus 56.3; p < 0.001), and the mean BBPS score was higher (6.64 ± 1.78 versus 5.93 ± 1.92; p < 0.001). Polyp detection rates were similar between groups (21.4% versus 26.6; p = 0.138). In multivariable analysis, higher education (OR 1.38; 95% CI 1.06-1.81; p = 0.016) and sennoside A + B (OR 1.77; 95% CI 1.29-2.43; p < 0.001) were independent predictors of adequate preparation, whereas age, BMI, sex, diabetes mellitus, and constipation were not. Preparation intolerance was more frequent in the sennoside A + B group (7.0% versus 0.7%; p < 0.001; tolerance analysis n = 824). Failure to reach the cecum did not differ significantly between regimens (9.3% versus 12.3%; p = 0.216; analyzed in the entire study population n = 791). CONCLUSIONS: In routine clinical practice, sennoside A + B provided higher cleansing efficacy than PM/Ca as reflected by higher BBPS scores and a greater probability of achieving adequate bowel preparation. However, PM/Ca demonstrated a more favorable tolerability profile. Bowel preparation selection should balance efficacy and tolerability while considering patient-related factors such as educational level. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06580366.

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BACKGROUND: Oral sulfate tablets (OSTs) are commonly used in South Korea, but the requirement to ingest 28 tablets and concerns regarding renal and gastrointestinal safety may reduce patient compliance. DWJ1609 is a novel OST formulation that contains sodium picosulfate and 25% less sulfate, requiring only 20 tablets. This modification is expected to improve tolerability while maintaining cleansing efficacy. AIM: To evaluate the bowel cleansing efficacy and safety of DWJ1609 compared with conventional OSTs and to assess adverse events. METHODS: This prospective, randomized, single-blinded (investigator), multicenter, phase III clinical trial was conducted at seven university hospitals in South Korea. The primary endpoint was the non-inferiority of DWJ1609 based on the proportion of participants achieving a "successful" grade A or B on the Harefield Cleansing Scale, as assessed by independent central readers. Safety was monitored through adverse events and laboratory evaluations. RESULTS: Overall, 215 participants were randomized, and 200 were included in the per-protocol analysis (DWJ1609: 99; OST: 101). Successful bowel cleansing was achieved in 96.97% of the DWJ1609 group, which was non-inferior to the OST group (100.00%), with a difference of 3.03%. DWJ1609 showed significantly higher tolerability, with lower incidence of nausea, headache, and dizziness, although vomiting occurred slightly more frequently. CONCLUSION: DWJ1609 demonstrated non-inferior bowel cleansing efficacy, improved tolerability, and a favorable safety profile compared with conventional. DWJ1609 has the potential to improve compliance and overall quality of colonoscopy.

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BACKGROUND: Colonoscopy is the gold standard exam for evaluation of colonic abnormalities and for screening and surveillance for colorectal cancer. However, the efficacy of colonoscopy is dependent on the quality of the pre-colonoscopy bowel preparation. Polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC) have emerged as two of the most commonly used bowel preparation agents. We conducted an evidence-based review of current evidence to further investigate the efficacy and patient tolerability of split-dose SPMC oral solution compared to PEG solution for colonoscopy bowel preparation. METHODS: A systematic search was performed using Pubmed (MEDLINE), Web of Science, EMBASE, and Cochran Central Register of Controlled Trials databases. All studies on split-dose bowel preparation with SPMC and PEG were reviewed. Relevant studies regarding colonoscopy and bowel preparations were also included. Randomized controlled trials were prioritized due to the high quality of evidence. RESULTS: Eight randomized controlled trials were included. Split-dose SPMC and PEG were associated with similar results for adequacy of bowel preparation. Split-dose SPMC was associated with increased patient tolerability and compliance. CONCLUSION: Split-dose SPMC and PEG are both adequate and safe for bowel preparation for outpatient colonoscopy, with split-dose SPMC being more tolerable for patients. Additional RCTs comparing these and other bowel preparation solutions are necessary to further investigate quality of bowel preparation, patient preference, and cost-effectiveness of the various options.

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