The American Society of Colon and Rectal Surgeons guideline on constipation does not include docusate sodium as one of the treatment options. Dietary modifications are recommended for symptomatic constipation as the first-line therapy. Recommended pharmacological interventions include osmotic laxatives (e.g., polyethylene glycol, lactulose), stimulant laxatives (e.g., bisacodyl – second line, short term only), and “newer agents” (e.g., lubiprostone, linaclotide) in refractory cases. In those with pelvic floor dyssynergia, biofeedback therapy is recommended as the first-line treatment. [1]
The World Gastroenterology Organization guideline states that stool softeners are a viable therapy option for constipation management. It rates evidence of recommendation for dioctyl sulfosuccinate (docusate) as Grade C and level of evidence as III; however, they do not provide descriptions of what these levels indicate. [2]
A position statement on constipation management by the American Gastroenterological Association also does not include docusate as a medical treatment option. Osmotic agents (e.g., milk of magnesia or polyethylene glycol) or stimulant laxatives (e.g., bisacodyl or glycerol suppositories) are recommended depending on stool consistency. [3]
The American College of Gastroenterology’s monograph on chronic idiopathic constipation (CIC) provides no statement on the use of docusate or stool softeners for the treatment of CIC. It lists fiber supplements, polyethylene glycol (PEG), lactulose, sodium picosulfate, bisacodyl, prucalopride, linaclotide, lubiprostone, and biofeedback (for CIC with pelvic floor dyssynergia) as effective treatment options. [4]
Per the European Society for Medical Oncology (ESMO) guidelines for management of constipation in advanced cancer, detergent/stool softeners (i.e., docusate) are generally not recommended in advanced disease as the use of docusate sodium in palliative care is based on inadequate experimental evidence. [5]
Data compiled in systematic reviews also suggest subpar evidence. According to a 2005 systematic review, the efficacy of docusate is modest at best, citing a small study suggesting no benefit with docusate treatment, and another study showing psyllium (5.1 grams twice daily) is superior to docusate (100 mg twice daily). Based on the available evidence, the reviewers rate the quality of evidence as poor (level III – insufficient because of a limited number of power of studies, flaws in their design or conduct), and classify the recommendation as Grade C (poor evidence to support a recommendation for or against the use of the modality). Another systematic review from 2014 on laxative use in functional constipation reports that docusate sodium is commonly used in practice, despite the lack of evidence compared to PEG. The review includes one study that meets its inclusion criteria, which compared docusate to psyllium and found improved efficacy with psyllium (Table 2). [6], [7]
A 2021 review determined that docusate did not show any benefits for constipation in older patients compared with placebo or psyllium or sennosides; psyllium and sennosides were observed to be more effective compared with docusate. This lackluster evidence of stool softeners for constipation in geriatrics was further reiterated in another 2021 review article. Soluble fibers that promote bulking, osmotic agents, and stimulants are generally recommended for initial or additional treatment. However, elderly patients may require treatment individualization based on medical history and potential adverse events. Overall, there appears to be a lack of data to support the use of docusate for constipation. As such, it is recommended that pharmacists and healthcare providers reassess and reconsider whether to use docusate and add additional medications to an already complex medication regimen in older populations. [8], [9]
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. 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. 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. 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. [10], [11], [12]
A 2015 Canadian study quantified the local pattern of laxative use and estimated some of the associated costs. Docusate was the most frequently prescribed laxative, accounting for over 165,000 doses, requiring an estimated 2,065 nursing hours for administration, with associated costs approaching $60,000 per year. The authors extrapolated their data to suggest that total healthcare spending in North America on docusate products likely exceeds $100,000,000 yearly. It was suggested that while inpatient laxative use is common and frequently persists following discharge, the routine use of docusate products in a constrained healthcare system may be wasteful. [13]
A single-center study attempted to design and apply a program for the comprehensive management of neurogenic bowel in 38 spinal cord injury patients. Docusate was used in 15 (44.1%) of patients, one of which was intolerant to its use (6.7%). Eight patients (53.3%) stopped medication by themselves due to poor results and two patients had the prescription ended due to poor results. By the end of the study, only four of the 15 patients (26.7%) were still on docusate at a mean dose of 150 mg/day (range, 100-200 mg/day). [14]
Various articles have advocated for the removal of docusate from hospital formulary due to lack of benefit. The addition of docusate increases patient polypharmacy and the multiple doses of large capsules or solutions are cited as a burden. A single center cost analysis in Canada found that over 165,000 doses of laxatives were administered, which accounts for an estimated 2000 nursing hours for administration. Such spending on docusate products was estimated to be in the hundreds of millions USD per year. Despite the strong opinions presented by authors, the articles lack documentation of successful removal of docusate from hospital formulary. [15], [16], [17]