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Drug Class Review: Constipation Drugs: Final Report [Internet]

Drug Class Review: Constipation Drugs: Final Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: September 2007

Summary and Discussion

Chronic constipation and constipation associated with IBS are some of the most frequent gastrointestinal complaints in adults and children. Multiple drugs are commonly used to treat these conditions. Many of these drugs are available over the counter and have been available for decades. Despite the high prevalence and the enormous socioeconomic burden associated with these conditions, results of our review highlight that for most treatments, objective evidence from well-conducted studies on efficacy and safety is largely missing.


We identified 535 citations from searches and reviews of reference lists. We included a total of 262 articles on an abstract level and retrieved those as full text articles for background information or to be reviewed for inclusion into the evidence report. Studies published as abstracts only are listed in Appendix B. In total we included 33 studies: seven head-to-head RCTs, 16 placebo controlled trials, one observational extension of an RCT, one meta-analysis, six observational studies, and two pooled data analyses. We retrieved 75 articles for background information.


Chronic constipation is a disorder characterized by unsatisfactory defecation that results from infrequent stools, difficult stool passage, or both over a time period of at least 12 weeks. The diagnosis is primarily symptom-based, relying on the patient's self report of symptoms; however, the description of constipation symptoms varies significantly among patients. Common symptoms may include infrequent bowel movement, hard stool, too small stool, difficulties with stool expulsion (need for excessive straining), feeling of incomplete evacuation or simply a patient description of "a feeling of being constipated" without any of these constipation-related symptoms. While physicians traditionally defined constipation as fewer than three bowel movements per week, more specific diagnostic criteria have been developed to better specify the nature and duration of symptoms (Table 1).


To identify articles relevant to each key question we searched MEDLINE, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts; we used either Medical Subject Headings (MeSH or MH) as search terms when available or key words when appropriate. We combined terms for selected indications (chronic constipation, irritable bowel disorder), drug interactions, and adverse events with a list of seven specific constipation drugs (docusate calcium, docusate sodium, lactulose, lubiprostone, polyethylene glycol, psyllium, tegaserod) and their trade names. We limited the electronic searches to "human" and "English language"; we searched sources from 1985 to 2007 (April) to delimit literature relevant to the scope of our topic.

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