Digestive Diseases and Sciences

, Volume 41, Issue 8, pp 1636–1642

Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation

  • E. Corazziari
  • D. Badiali
  • F. I. Habib
  • G. Reboa
  • G. Pitto
  • G. Mazzacca
  • F. Sabbatini
  • R. Galeazzi
  • Te. Cilluffo
  • I. Vantini
  • E. Bardelli
  • F. Baldi
Intestinal Disorders, Inflammatory Bowel Disease, Immunology, And Microbiology

DOI: 10.1007/BF02087913

Cite this article as:
Corazziari, E., Badiali, D., Habib, F.I. et al. Digest Dis Sci (1996) 41: 1636. doi:10.1007/BF02087913

Abstract

The present multicenter double-blind placebo-controlled trial evaluates the therapeutic effectiveness of small-volume daily doses of an isosmotic polyethylene glycol (PEG) electrolyte solution in the treatment of chronic nonorganic constipation. After a complete diagnostic investigation, patients still constipated at the end of a four-week placebo-treatment run-in period were enrolled and randomized to receive either placebo or PEG solution 250 ml twice a day for the following eight weeks. Patients were assessed at four and eight weeks of treatment, and they reported frequency and modality of evacuation, use of laxatives, and relevant symptoms daily on a diary card. Oroanal and segmental large-bowel transit times were assessed with radiopaque markers during the fourth week of the run-in period and the last week of the treatment period. During the study period, dietary fiber and liquids were standardized and laxatives were allowed only after five consecutive days without a bowel movement. Of the 55 patients enrolled, five dropped out, three because of adverse events and two for reasons unrelated to therapy; another two were excluded from the efficacy analysis because of protocol violation. Of the remaining 48 patients (37 women, age 42±15 years, mean±sd), 23 were assigned to placebo and 25 to PEG treatment. In comparison to placebo, PEG solution induced a statistically significant increase in weekly bowel frequency at four weeks and at the end of the study (PEG: 4.8±2.3 vs placebo: 2.8±1.6;P<0.002) and a significant decrease in straining at defecation (P<0.01), stool consistency (P<0.02), and use of laxatives (P<0.03). Oroanal, left colon, and rectal transit times were significantly shortened by PEG treatment. There was no difference between controls and PEG-treated patients as far as abdominal symptoms and side effects were concerned. In conclusion, PEG solution at 250 ml twice a day is effective in increasing bowel frequency, accelerating colorectal transit times, and improving difficult evacuation in patients with chronic nonorganic constipation and is devoid of significant side effects.

Key words

constipationpolyethylene glycoltransit times

Copyright information

© Plenum Publishing Corporation 1996

Authors and Affiliations

  • E. Corazziari
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • D. Badiali
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • F. I. Habib
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • G. Reboa
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • G. Pitto
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • G. Mazzacca
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • F. Sabbatini
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • R. Galeazzi
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Te. Cilluffo
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • I. Vantini
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • E. Bardelli
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • F. Baldi
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  1. 1.From the Cattedra di Gastroenterologia IUniversitá La SapienzaRome
  2. 2.Clinica ChirurgicaUniversitá degli StudiGenoa
  3. 3.Cattedra di GastroenterologiaII Facoltà di Medicina, Policlinico IINaples
  4. 4.Divisione di GastroenterologiaOspedale Regionale Umberto IAncona
  5. 5.Divisione di Riabilitazione Gastroenterologica, Facoltà di MedicinaUniversitá degli Studi Verona, Ospedale Valeggio S/MItaly
  6. 6.Divisione di GastroenterologiaPoliclinico S. OrsolaBolognaItaly
  7. 7.Cattedra di Gastroenterologia I, Clinica Medica II, Policlinico “Umberto I”RomeItaly