Per the American Gastroenterological Association guidelines on the medical management of opioid-induced constipation (OIC), traditional laxatives, including docusate, are recommended as the first-line agents in treating OIC; however, the role of docusate or other laxatives in OIC prophylaxis is not explicitly discussed. [1]
A 2021 review evaluating the clinical evidence for docusate use in OIC management identified 13 guidelines or consensus recommendations (CR) and four primary literature studies. The authors noted consistent design limitations in the primary literature and a lack of primary evidence cited in the guidelines or CR to support their recommendations of using docusate for OIC prophylaxis or treatment. Even though docusate is widely prescribed for OIC, the evidence behind this recommendation is collectively weak across most of the guidelines and CR. Therefore, a close assessment of OIC protocols and/or algorithms among institutions and health care providers are warranted to incorporate evidence-based therapy and reduce unnecessary docusate use and associated costs. [2]
A 2020 expert opinion of a multidisciplinary panel of physician experts who treat OIC suggested that prescribers do not limit interventions for OIC to lifestyle changes or dietary/hydration recommendations. Instead, it was suggested to prescribe a laxative for OIC prevention, even though the efficacy of laxatives in OIC was controversial with low patient satisfaction. However, the panel discussion did not cover a standard preventative approach for the clinical management of OIC. [3]
A 2002 nursing-based protocol suggests a prophylactic daily laxative regimen, senna with docusate sodium 2 tablets PO QHS, in patients who receive daily doses of opioids for the first 2 or 3 days. On the other hand, a 2016 British review highlighted that despite the routine prophylactic laxatives at the time of, or before, opioid prescription to prevent OIC, there was little evidence to support this practice. Although in one single-center study, patients who received laxatives (mainly magnesium oxide 62.1%; magnesium oxide + pantethine 14.3%; magnesium oxide + senna 9.9%; senna alone 7.9%) before opioids had a lower incidence of developing constipation, the use of laxatives was not standardized in the trial. Similarly, the American Academy of Pain Medicine stated in its consensus recommendations that prophylactic and first-line over-the-counter (OTC) therapies for OIC did not usually lead to consistent and predictable therapeutic responses based on inadequate literature in such treatments. Regardless, both review articles concluded that the high incidence of OIC, its impact on quality of life, accessibility, and relatively low risk of OTC laxatives may still justify their prophylactic and first-line use for OIC in practice. [4], [5], [6], [7]
A 2014 Canadian review including studies (systematic reviews, randomized controlled trials [RCTs], and non-randomized studies) of adult patients with constipation for whom prevention of constipation is desired (Table 1) concluded that there is a lack of data on supporting the use of docusate for prevention or management of constipation. While the studies were limited based on the small sample size and confounding factors (using additional bowel medications), the authors stated that the study results are more generalizable to patients with opioid-induced constipation. [8]
A 2019 review on OIC in cancer patients stated that anticipating and preventing OIC or treating it when it is mild is always more practical as the management could be more challenging in developed constipation. The authors stated that while the European Society of Medical Oncology (ESMO) has recommended the routine prescription of laxatives for both prophylaxis and treatment of OIC, more supporting evidence is needed to indicate the prophylactic effects of laxatives for OIC prevention. There were no conclusions in regards to using docusate (or stool softeners) versus other laxatives in the prevention of OIC. [9]
A 2021 article reviewing the management of OIC discussed the options for OIC prophylaxis. The authors stated that while increasing dietary fiber, fluid intake, and physical exercise are the backbone of prevention therapy, stool softeners (like docusate) are also ideal for preventing constipation. Another laxative agent mentioned by the author is saline laxative, such as magnesium citrate, which has a delayed onset of action from 30 to 180 mins. The authors also noted that bulk-forming laxatives should be avoided since opioids prevent peristalsis of the increased bulk, leading to bowel obstruction. [10]
Finally, a review article on the management of OIC in palliative care patients does not discuss docusate salts as a laxative option in this population. It states that osmotic agents or stimulant laxatives (if no response in two days) can be considered in clinical practice; however, it notes there is a lack of evidence to guide safe and effective treatment of OIC in this group of patients. [11]