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Cited by 202Gastrointestinal motility and disordersPelvic floor disorders treatmentsGastroesophageal reflux and treatments

Long term efficacy, safety, and tolerabilitity of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation

Open access
Corazziari, E, Badiali, D, Bazzocchi, G, Bassotti, G, Roselli, P, Mastropaolo, G, Lucà, M G, Galeazzi, R +1 more·2000·Gut
DOI 10.1136/gut.46.4.522PMC PMC1727881
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Abstract

AIMS: To assess the long term therapeutic effectiveness, safety, and tolerability of low daily doses of isosmotic PEG electrolyte solutions (PMF-100) administered for a six month period for the treatment of functional constipation, in a double blind, placebo controlled, parallel group study. METHODS: After an initial four week run in period with PMF-100 (250 ml twice daily; PEG 14.6 g twice daily), 70 patients suffering from chronic constipation (58 females, aged 42 (15) years) with normalised bowel frequency (>3 bowel movements (bm)/week) were randomly allocated to receive either PMF-100 or placebo, contained in sachets (one sachet in 250 ml of water twice daily) for 20 weeks. Patients were assessed at four week intervals, and reported frequency and modality of evacuation, laxative use, and relevant symptoms on a diary card. At weeks 1, 12, and 24, a physical examination and laboratory tests were performed. RESULTS: Complete remission of constipation was reported by a significantly (p<0.01) higher number of patients treated with PMF-100 compared with placebo at each four week visit. At the end of the study, 77% of the PMF-100 group and 20% of the placebo group were asymptomatic. Compared with placebo, patients treated with PMF-100 reported hard/pellety stools and straining at defecation less frequently, a significantly higher bowel frequency (week 12: 7.4 (3.1) v 4.3 (2.5) bm/week, 95% CI 1.64, 4.42; week 24: 7.4 (3.2) v 5.4 (2.1) bm/week, 95% CI 0.13,3.93), reduced consumption of laxative/four weeks (week 12: 0.7 (2.7) v 2.2 (3.3), 95% CI −2.29, 0.03; week 24: 0.2 (0.8) v 1.4 (2), 95% CI −2.07, −0.023), reduced mean number of sachets used (week 12: 33 (13) v 43 (12), 95% CI −17.24, 4.56; week 24: 33 (13) v 44 (12), 95% CI −19.68, −2.24), and reduced number of drop outs for therapy failure (16 v 3; p<0.005). Adverse events, physical findings, laboratory values, palatability, and overall tolerance of the solutions did not differ between groups. CONCLUSIONS: Administration of small daily doses of isosmotic PEG electrolyte balanced solutions was effective over a six month period for the treatment of functional constipation. A mean daily dose of approximately 300 ml of PEG solution (PEG 17.52 g) appeared to be safe, well tolerated, and devoid of significant side effects.

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  • PEG likely increases SBMs per week compared with placebo (MD 2.30, 95% CI 1.55-3.06), based on meta-analyzed data from 3 studies.

    “and SBMs per week (MD 2.30, CI 1.55-3.06), based on meta-analyzed data from 3 studies. 37-39”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [37]

    The Results report higher weekly bowel frequency with PMF-100 than with placebo, supporting the direction of the claim. This paper reports one trial, however, not a three-study meta-analysis; it does not give the pooled MD of 2.30 or 95% CI of 1.55–3.06, and describes bowel frequency rather than explicitly reporting spontaneous bowel movements. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • Across 2 studies, a higher rate of individuals met the responder definition with PEG compared with placebo (RR 3.13, 95% CI 2.00-4.89); PEG was associated with 312 more per 1,000 (from 146 more to 569 more).

    “Across 2 studies, a higher rate of individuals met the responder definition, one study defined responder as normalization of bowel moments 37,38 and other defined based on the US Food and Drug Administration (FDA) end points, 40 compared with placebo (RR 3.13, CI 2.00-4.89); PEG was associated with 312 more per 1,000 (from 146 more to 569 more).”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [37]

    The Abstract (page not available) reports more patients asymptomatic with PMF-100 than placebo at study end (77% versus 20%), supporting the direction of the claimed effect. This paper reports one trial, not a two-study pooled estimate; it does not report the stated RR, confidence interval, or absolute difference per 1,000. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

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Cites

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Research works printed but not linked: 2

  1. [6]6. Baldonedo YC, Lugo E, Uzcategui AA, et al. Evaluacion y uso del polietilen glicol en pacientes constipados. Gen (Venezuela) 1991;45:294-7.
  2. [11]11. Davies GJ, Crowder M, Reid B, et al. Bowel function meas- urements of individuals with diVerent eating patterns. Gut 1986;27:164-9.

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Authors
Corazziari, E., Badiali, D., Bazzocchi, G., Bassotti, G., Roselli, P., Mastropaolo, G., Lucà, M. G., Galeazzi, R., & Peruzzi, E.
Affiliations
  • Policlinico Umberto I (IT)
  • University of Padua (IT)
Corresponding author
Corazziari, E
ORCID
Corazziari, E
Venue
Gut
Publisher
BMJ
Published
2000-04-01
Volume
46
Issue
4
Pages
522-526
ISSN
  • 0017-5749 (ISSN-L)
  • 1468-3288
DOI
10.1136/gut.46.4.522
PMC
PMC1727881
OpenAlex
W1973959910
Cited by
202
References
11
Citations by year
2025: 7 · 2024: 4 · 2023: 8 · 2022: 1 · 2021: 7 · 2020: 7 · 2019: 8 · 2018: 8 · 2017: 3 · 2016: 11 · 2015: 7 · 2014: 7 · 2013: 9 · 2012: 10
FWCI
5.96
Type
journal article
Language
en
Open access
Locations
  • Gut (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Gastroenterology › Gastroesophageal reflux and treatments
Keywords
chronic functional constipation, polyethylene glycol electrolyte solution, osmotic laxatives, long-term efficacy, safety and tolerability, stool frequency, laxative use, women, children, infants
MeSH terms
Adolescent, Adult, Aged, Chronic Disease, Constipation, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Polyethylene Glycols, Surface-Active Agents, Treatment Outcome

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