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Constipation is a prevalent complaint encountered in clinical practice, affecting approximately 16% of all adults and 33% of adults 60 and older. There is no universally applicable definition of constipation. Most clinicians commonly define constipation as infrequent bowel movements, usually less than 3 per week. However, patients often describe constipation with a broader range of symptoms, including difficulty passing stool, firmer stool consistency, abdominal cramping, and a feeling of incomplete stool evacuation.[1]

The non-pharmacological management of chronic constipation begins with patient education and adjusting dietary and lifestyle habits. Clinicians must clarify to patients that not having a daily bowel movement is neither abnormal nor necessary. Moreover, increased physical activity has been linked to lower rates of constipation.[2] The dietary changes should promote increased consumption of fluid and fiber-rich foods. If these adjustments do not effectively address constipation, then the use of laxatives becomes necessary.

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The different classes of commonly used laxatives for treating and managing constipation are listed below.

Docusate, also known as dioctyl sulfosuccinate, is of 2 types that can be administered orally. They come in the form of either docusate sodium or docusate calcium salts. Docusate is classified as an over-the-counter (OTC) medication and has the marketing status of “OTC monograph not final,” according to the U.S. National Library of Medicine, DailyMed resource. The U.S. Food and Drug Administration (FDA) has not determined the safety and efficacy of docusate for managing constipation in individuals. As a result, docusate is not featured on the FDA’s rundown of authorized drugs, and there are no approved indications for its use.

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According to the product monograph, docusate is indicated for use when peristaltic stimulants are contraindicated, aiming to alleviate difficult or painful defecation.

Docusate facilitates the passage of hard stools, which can benefit patients with painful anorectal conditions or cardiac comorbidities. Stool softening typically occurs within 12 to 72 hours after initiating therapy with docusate. Notably, several studies have demonstrated that docusate is ineffective for treating constipation in individuals.[5]

A randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy of docusate in managing constipation in hospice patients. A total of 74 hospice patients were included in the study and were assigned to receive either docusate and senna or placebo and senna for 10 days. The results indicated no significant differences between the docusate and placebo groups in the assessed outcomes. Consequently, the study concluded that the use of docusate in managing constipation in hospice patients should be evaluated individually.[6]

Numerous systematic reviews examining the efficacy of docusate have yielded no significant evidence to support its use.[7][8][9][10] Nevertheless, docusate continues to be one of the most frequently prescribed laxatives.[11]

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Furthermore, the summary of evidence by the Canadian Agency for Drugs and Technologies in Health involved a comprehensive search of 367 citations from the literature. Among these, 5 studies were included, comprising 2 systematic reviews, 1 randomized controlled trial, and 2 non-randomized trials. For patients who are on opioid medications, docusate (either calcium or sodium) has not shown to be more effective than a placebo or sennosides alone in increasing the frequency of bowel movements, softening stool consistency, making it easier to pass stools, achieving complete evacuation, or alleviating other symptoms associated with opioid-induced bowel dysfunction, such as abdominal cramps or delayed stomach emptying.[12]

A study with cancer patients found that the sennosides-only protocol resulted in more frequent bowel movements than a stepwise approach that included both sennosides and docusate sodium. A sub-analysis of symptom control or supportive care revealed that patients who adhered to the sennosides-only protocol had significantly more bowel movements, occurring more than 50% of the time, in contrast to those who followed the docusate and sennosides protocol (62.5% versus 31.6%, respectively).[13]

The study conducted by Tarumi et al did not observe any statistical significance in reported interventions when comparing the docusate plus sennosides group to the sennosides-only group in hospice patients (68.6% versus 74.4%, respectively). In contrast, Hawley and Byeon reported that 57% of cancer patients in the docusate plus sennosides protocol required additional interventions such as lactulose, suppositories, or enemas. In contrast, only 40% of cancer patients following the sennosides-only protocol needed such interventions in their symptom control or supportive care sub-analysis.[6][14][13][15]

A recent comprehensive review by McRorie et al in 2021 published in the American Journal of Gastroenterology included 7 randomized placebo-controlled clinical studies between 1956 and 2021 to evaluate the efficacy of docusate for softening stool in constipated patients. No significant difference was observed between docusate (100 to 400 mg per day) and placebo. During the eighth study, the effectiveness of docusate sodium and psyllium in treating patients with chronic idiopathic constipation was compared. The study found that docusate did not have a significant impact on the water content of stool. Therefore, the article concluded that docusate is not an effective stool-softening therapy and does not show any difference from the placebo.[16]

Docusate sodium is sometimes used as a cerumenolytic agent, even though it is not officially approved.[17] According to the American Academy of Otolaryngology guidelines, docusate can be utilized to visualize the tympanic membranes obscured by cerumen. The application of docusate sodium is followed by irrigation if necessary.[18]

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