Trial reportJournal of pediatric gastroenterology and nutrition2018
Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial.
Trial report in Journal of pediatric gastroenterology and nutrition, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06349031 (Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- European Society for Paediatric Gastroenterology, Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition guidelines for treatment of functional constipation in children aged 0-18 years.Journal of pediatric gastroenterology and nutrition · 2026Guideline
- Faecal impaction in children aged 0-18 years: a systematic review and metanarrative analysis of definitions used.BMJ paediatrics open · 2025Pooled it
- Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.Health technology assessment (Winchester, England) · 2024Pooled it
- Osmotic and stimulant laxatives for the management of childhood constipation.The Cochrane database of systematic reviews · 2016Pooled it
- Efficacy and palatability of the developed polyethylene glycol-based formula for the treatment of children with functional constipation.World journal of clinical pediatrics · 2025Trial
- Efficacy of Home-Based Versus Hospital-Based Disimpaction with Polyethylene Glycol in Pediatric Functional Constipation: A Randomized Control Study.Digestive diseases and sciences · 2025Trial
- Efficacy of polyethylene glycol 3350 as compared to lactulose in treatment of ROME IV criteria-defined pediatric functional constipation: A randomized controlled trial.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2021Trial
- Comparison of Polyethylene Glycol 3350+Electrolytes vs. Polyethylene Glycol 4000 for Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial.Pediatric gastroenterology, hepatology & nutrition · 2025Article
- The ten "hard" questions in pediatric functional constipation.Italian journal of pediatrics · 2024Review
- Efficacy of Bowel Regimen in Decreasing Postoperative Constipation in Bariatric Surgery Patients.Obesity surgery · 2024Article
- Analysis of the efficacy of lactulose combined with polyethylene glycol in the treatment of functional constipation.American journal of translational research · 2024Article
- Multicentre Study Into the Use of Polyethylene Glycol With Electrolytes Over at Least 6 Months to Treat Constipation in Paediatric Populations.JPGN reports · 2023Article
- An Update of Pharmacological Management in Children with Functional Constipation.Paediatric drugs · 2023Review
- Current use of complementary and conventional medicine for treatment of pediatric patients with gastrointestinal disorders.Frontiers in pharmacology · 2023Review
- Constipation in Children and Adolescents.Deutsches Arzteblatt international · 2022Article
- Effect of Compound Polyethylene Glycol Electrolyte Powder on the Quality of Gastrobowel Preparation before Enteroscopy Intervention.Emergency medicine international · 2022Article
- The Use of Linaclotide in Children with Functional Constipation or Irritable Bowel Syndrome: A Retrospective Chart Review.Paediatric drugs · 2021Article
- Effectiveness ofEvidence-based complementary and alternative medicine : eCAM · 2021Article
- Nationwide Survey for Application of ROME IV Criteria and Clinical Practice for Functional Constipation in Children.Journal of Korean medical science · 2019Article
- Macrogol (polyethylene glycol) 4000 without electrolytes in the symptomatic treatment of chronic constipation: a profile of its use.Drugs & therapy perspectives : for rational drug selection and use · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe long-term efficacy and safety of polyethylene glycol (PEG) in constipated children are unknown, and a head-to-head comparison of the different PEG formulations is lacking. We aimed to investigate noninferiority of PEG3350 with electrolytes (PEG3350 + E) compared to PEG4000 without electrolytes (PEG4000).
methodsIn this double-blind trial, children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, were randomized to receive either PEG3350 + E or PEG4000. Primary outcomes were change in total sum score (TSS) at week 52 compared to baseline, and dose range determination. TSS was the sum of the severity of 5 constipation symptoms rated on a 4-point scale (0-3). Noninferiority margin was a difference in TSS of ≤1.5 based on a 95%-confidence interval [CI]. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence.
resultsNinety-seven subjects were included, of whom 82 completed the study. Mean reduction in TSS was -3.81 (95% CI: -4.96 to -2.65) and -3.74 (95%CI: -5.08 to -2.40), for PEG3350 + E and PEG4000, respectively. Noninferiority criteria were not met (maximum difference between groups: -1.81 to 1.68). Daily sachet use was: 0 to 2 years: 0.4 to 2.3 and 0.9 to 2.1; 2 to 4 years: 0.1 to 3.5 and 1.2 to 3.2; 4 to 8 years: 1.1 to 2.8 and 0.7 to 3.8; 8 to 16 years 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Treatment success after 52 weeks was achieved in 50% and 45% of children, respectively (P = 0.69). Rates of adverse events were similar between groups, and no drug-related serious adverse events occurred.
conclusionsNoninferiority regarding long-term constipation-related symptoms of PEG3350 + E compared to PEG4000 was not demonstrated. However, analysis of secondary outcomes suggests similar efficacy and safety of these agents.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.