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Dioctyl Sulfosuccinate or Docusate (Calcium or Sodium) for the Prevention or Management of Constipation: A Review of the Clinical Effectiveness

Last updated: June 26, 2014
Project Number: RC0561-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Report in Brief

Context
Although definitions of constipation vary, it is often described as a reduced frequency of bowel movements to fewer than three times per week or by symptoms that include difficulty passing stools, hard stools, abdominal cramping, and incomplete stool passage. Constipation may be idiopathic, with no known cause, or it can be caused by diet, medication, or medical conditions. An estimated 2% to 27% of the general population is affected by constipation, and chronic constipation is much more common in the elderly and in patients taking opioids.

Technology
Current treatment options for constipation include dietary or bulking agents (i.e., psyllium seed husk), osmotic laxatives (i.e., lactulose, sorbitol, polyethylene glycol [PEG]), stimulant laxatives (i.e., sennosides, bisacodyl, sodium picosulfate), and stool softeners (i.e., docusate sodium or docusate calcium). In North America, a stool softener and a stimulant laxative are commonly used in bowel treatment protocols for institutionalized elderly and oncology patients.

Issue
Given how frequently stool softeners are prescribed in everyday clinical practice and despite the low cost of these medications, a review of the clinical effectiveness of docusate will help to inform decisions about the prevention and management of constipation.

Methods
A limited literature search was conducted of key resources, and titles and abstracts of the retrieved publications were reviewed. Full-text publications were evaluated for final article selection according to predetermined selection criteria (population, intervention, comparator, outcomes, and study designs).

Results
The literature search identified 367 citations, 15 of which were deemed potentially relevant. An additional 3 articles were retrieved from other sources. Of these 18 studies, 5 met the criteria  for inclusion in this review: 2 systematic reviews, 1 randomized controlled trial, and 2 non-randomized studies.

Key Messages
For the prevention and management of constipation:

  • There is little evidence to support the use of docusate in hospitalized patients or long-term care residents.
  • Docusate does not increase stool frequency or soften stools compared with placebo.
  • Docusate does not improve the symptoms of constipation.
  • Docusate does not improve the difficulties or completeness of stool evacuation in patients taking opioids.

Question

  1. What is the clinical effectiveness of dioctyl sulfosuccinate or docusate (calcium or sodium) for the prevention or management of constipation?

Key Message

There remains a paucity of good quality evidence to support the use of docusate for the prevention or management of constipation in hospitalized patients or long-term care residents. Docusate appears to be no more effective than placebo for increasing stool frequency or softening stool consistency. Furthermore, it does not appear to lessen symptoms associated with constipation (i.e. abdominal cramps) or affect the perceptions associated with completeness of or difficulties with stool evacuation. More robust, high quality primary studies are required to definitively ascertain the clinical effectiveness of docusate for the prevention and management of constipation, no matter what its cause.