Trial reportJournal of gastroenterology2019
Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension.
Trial report in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- [Seoul Consensus on Clinical Practice Guidelines for Functional Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025Guideline
- Guideline
- Treatments for intractable constipation in childhood.The Cochrane database of systematic reviews · 2024Pooled it
- Polyethylene glycol 3350 plus electrolytes for pediatric chronic constipation: An open-label clinical study in Japan.Pediatrics international : official journal of the Japan Pediatric Society · 2020Trial
- Cost-utility analysis of treatment strategies for chronic constipation in Japan.Journal of gastroenterology · 2026Article
- Prophylactic laxative use for postoperative constipation in urological cancer: a real-world cohort study.World journal of urology · 2025Article
- Management of Chronic Constipation: A Comprehensive Review.Internal medicine (Tokyo, Japan) · 2025Review
- Expert Consensus Document: An Algorithm for the Care and Treatment of Patients with Constipation Based on Ultrasonographic Findings in the Rectum.Diagnostics (Basel, Switzerland) · 2024Article
- Review
- Multicentre Study Into the Use of Polyethylene Glycol With Electrolytes Over at Least 6 Months to Treat Constipation in Paediatric Populations.JPGN reports · 2023Article
- 2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation.Journal of neurogastroenterology and motility · 2023Review
- Treatment of Chronic Constipation using Elobixibat in a Real-World Setting: A Retrospective Cohort Study using an Electronic Medical Records Database in Japan.Current therapeutic research, clinical and experimental · 2023Article
- Effect of Compound Polyethylene Glycol Electrolyte Powder on the Quality of Gastrobowel Preparation before Enteroscopy Intervention.Emergency medicine international · 2022Article
- Efficacy of macrogol 4000 plus electrolytes in bowel preparation for colonoscopy in patients with chronic constipation.BMC gastroenterology · 2021Article
- The effectiveness of acupoint herbal patching for functional constipation: Protocol for a meta-analysis and data mining.Medicine · 2021Article
- Tolerance and Efficacy of Polyethylene Glycol 4000 in Elderly Patients with Chronic Constipation: A Retrospective, Single-center, Observational Study.Journal of the anus, rectum and colon · 2021Article
- A Systematic Review and Network Meta-Analysis on the Efficacy of Medications in the Treatment of Chronic Idiopathic Constipation in Japan.Gastroenterology research and practice · 2021Review
- The Efficacy of Short-Duration Polyethylene Glycol plus Electrolytes for Improving Bowel Preparation of Colonoscopy in Patients with Chronic Constipation.Gastroenterology research and practice · 2020Article
- The Effectiveness of Acupuncture in Management of Functional Constipation: A Systematic Review and Meta-Analysis.Evidence-based complementary and alternative medicine : eCAM · 2020Review
- Appropriate Use of Laxatives in the Older Person.Drugs & aging · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most widely used osmotic laxative in Europe, prospective data on its long-term (over 6 months) safety and efficacy are not available to date.
methodsJapanese patients with chronic constipation were randomized to receive PEG3350 + E or placebo for 2 weeks orally. Following this, the patients received PEG3350 + E in the 52-week extension study. The starting dose was 13.7 g/day dissolved in 125 mL of water, and dose titration was allowed (upper limit 41.1 g/day) according to the patient's bowel condition. The primary efficacy endpoint was the change from baseline in frequency of spontaneous bowel movements (SBMs) at week 2 in the double-blind study. Secondary endpoints and adverse events were assessed. Safety and efficacy were also assessed in the extension study.
resultsAmong 204 patients who provided informed consent, 156 were randomized and included in the full analysis. The frequency of SBMs was significantly higher with PEG3350 + E [least squares mean (LSM) 4.3, 95% confidence interval (CI) 3.6-4.9] compared with placebo (LSM 1.6, 95% CI 1.2-2.1; P < 0.0001). A total of 153 patients entered the extension study; PEG3350 + E led to a sustained improvement in bowel function. The common adverse drug reactions during the entire study period were mild gastrointestinal disorders (abdominal pain 4.5%, diarrhea 3.8%, nausea 3.2%, abdominal distension 2.6%).
conclusionsTreatment with PEG3350 + E resolved constipation in the short term, was well tolerated, and led to sustained improvement in bowel function in the long-term treatment of Japanese patients with chronic constipation. CLINICAL TRIAL REGISTRATION NUMBER: Japic CTI-163167.
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