Sodium picosulfate 2.5mg capsules

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.

Abstract licence: CC BY-NC

Background and aimsThe adenoma detection rate (ADR), recognized as a surrogate marker for colorectal cancer (CRC) incidence and mortality reduction, is closely linked to the efficacy of bowel cleansing. However, there is a dearth of evidence examining the impact on ADR when using 2 distinct very-low-dose bowel cleansing products. This study sought to compare ADR in an immunochemical fecal occult blood test (iFOBT)-based organized screening program by using 1 L of polyethylene glycol plus ascorbate (1L-PEGA) versus sodium picosulfate with magnesium citrate (SPMC), both administered in a split-dose regimen.MethodsWe conducted a comparative, parallel, randomized, noninferiority, and low-intervention clinical trial targeting individuals from a population CRC screening program aged 50 to 69 years with a positive iFOBT result scheduled for a workup colonoscopy in the morning. Participants were randomized to either 1L-PEGA or SPMC for bowel cleansing. The main outcome was ADR, whereas secondary outcomes were bowel preparation quality, safety, tolerability, and satisfaction.ResultsA total of 1002 subjects, 501 were included in each group. There were no differences between groups with respect to pooled ADR (SPMC, 56.5% [95% CI, 52.1-60.8]; 1L-PEGA, 53.7% [95% CI, 49.3-58.0]; relative risk, .95 [95% CI, .85-1.06]); therefore, SPMC demonstrated noninferiority in ADR compared with 1L-PEGA (difference, 2.8%; 2-sided 95% lower confidence limit, -3.4). In addition, there were no significant differences in mean lesions regardless of size and location between arms. Bowel preparation favored 1L-PEGA (96.2% vs 89.2%, P ConclusionsSPMC emerged as a noninferior laxative compared with 1L-PEGA concerning ADR. Despite the superior bowel preparation quality associated with 1L-PEGA, the safety, tolerability, and overall satisfaction of participants were higher with SPMC. (Clinical trial registration number: EudraCT: 2019-003186-18.).

Abstract licence: CC BY-NC-ND

BackgroundOral 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.AimTo evaluate the bowel cleansing efficacy and safety of DWJ1609 compared with conventional OSTs and to assess adverse events.MethodsThis 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.ResultsOverall, 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.ConclusionDWJ1609 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.

Abstract licence: CC BY-NC