ONS PEP Evidence Summary For Constipation

For Use as an Intervention For Constipation

  • Likely to Be Effective

    Author and Year

    DiPalma, J.A., Cleveland, M.V., McGowan, J., & Herrera, J.L. (2006). An open-labeled study of chronic polyethylene glycol laxative use in chronic constipation. Alimentary Pharmacology and Therapeutics, 25, 703–708.

     doi: 10.1111/j.1365-2036.2006.03228.x

    Study Purpose:

    To extend the safety data of polyethylene glycol used for chronic treatment of chronic constipation.

    Intervention Characteristics/Basic Study Process:

    Polyethylene glycol laxative was administered as a single daily dose of 17 g for 12 months.

    Sample Characteristics:

    • The study reported on a sample of 311 patients with chronic constipation.
    • 117 patients were aged 65 years and older.
    • 184 patients completed all 12 months of treatment.
    • Study participants who met defined criteria for chronic constipation were enrolled.

    Setting:

    • Multicenter
    • 50 centers in the United States

    Study Design:

    This was a randomized, open-label, single-treatment study.

    Measurement Instruments/Methods:

    • Patients returned to their study centers after 2, 4, 6, 9, and 12 months of treatment; blood and urine samples were collected, and adverse events were reviewed.
    • At each visit, patients were queried for Rome constipation criteria and they rated their overall improvement using a global efficacy scale.

    Results:

    • No clinically significant changes were found in hematology or blood chemistry, particularly electrolytes, for the study population as a whole or the older adult group.
    • With respect to the global efficacy assessment, depending on the month of observation, 80% to 88% of enrolled patients and 84% to 94% of older adults were treated successfully. Similar results were obtained from secondary efficacy measures that assessed individual Rome constipation criteria at each visit.
    • The response to treatment was durable over time.
    • Over the one-year course of study representing 218 patient-years at the labeled dose, medication-associated adverse effects were gastrointestinal complaints of diarrhea, loose stool, flatulence, and nausea. The effects were generally mild or moderate in severity.

    Conclusions:

    Polyethylene glycol laxative is safe and effective for treating constipation in adult and older adult patients for periods up to 12 months, with no evidence of tachyphylaxis.

    Limitations:

    • None were identified in the discussion of the results.
    • This study was not related to cancer or to opioid-induced constipation.