Docusate Sodium

As seen in the Consultant Connection June - July 2014 Issue
Alyssa White, PharmD Candidate, Ohio Northern University

Docusate sodium has found its way onto a number of constipation protocols in hospital and palliative care settings alike, even with a lack of supportive statistical evidence. Three recent articles have researched whether this medication is truly beneficial to the patient or just adding to their pill burden.
The first article written in 20001 examined all the published studies that met their criteria of chronically ill or inpatients in a chronic care facility, subject to chronic constipation or had risk factors for constipation. The patients  were given oral docusate, and they measured either stool consistency, stool frequency, or the use of other laxatives. Studies written in English or French and published after 1940 were reviewed. Using key words “constipation”, “dioctyl”, and “docusate” researchers searched a number of databases as well as hand searched through palliative care journals, which yielded only four studies that met all the inclusion criteria. These studies all differed in the setting (hospital, nursing home unit at VA, and retirement center) and study design (randomized double-blind cross-over, randomized unblinded comparative, and time series with randomized single-blind). They also all used varying strengths of docusate (60-240mg QD-BID). However, all studies showed a small trend toward increased frequency and improved stool consistency with docusate compared to placebo. Three of the studies allowed additional laxatives to be used which could have favored the results.
The second study published in 20082, compared the effectiveness of a sennoside-based bowel protocols with and without docusate in hospitalized patients with cancer. The patients in each treatment group were comparable in age, gender, and reason for admittance. Overall 80% of these patients were on opioid therapy and 72% were admitted for supportive care. Only 10% in the docusate plus senna group (DS) were opioid naïve, which based on the protocol were started on docusate only, the other 90% were started on the combination which equated to the first step in the senna only group (S). This resulted in the starting dose of senna for the S group being higher overall than the DS group. Patients in the DS group requested more interventions (ie lactulose, enemas) than the S group, however the S group had more diarrhea (8 vs 4), and both groups had 3 patients complain of cramping. The S protocol was shown to be significantly more effective in producing a bowel movement than the DS protocol in supportive care patients, many of which were taking opioids. The amount of senna in each protocol was the same, but the DS group had an extra step before starting the senna. Due to the increased number of pills in the DS group, physicians may have been reluctant to escalate the DS group, which could account for the differences between groups.
The final study published in 20133 was a double-blind, placebo controlled trial looking at docusate in hospice patients. Again this study had a docusate and senna group (DS) and a senna and placebo group (S). They were measuring stool frequency, volume, and consistency; as well as patient perception of their bowel movement. Both groups were similar regarding age, gender, diagnosis, MMSE score, daily oral intake, and opioid use. However, the DS group had more people on morphine while the S group had more patients on hydromorphone, but there was no difference in the mean morphine equivalent daily dose between the groups. Results showed no statistically significant difference in the number of bowel movements per day, stool volume or consistency between the two treatment groups. Using the Bristol Stool Form Scale patients in the S group tended to have Type 4 (smooth and soft, like a sausage or snake) and Type 5 (soft blobs with clear-cut edges) while patients in the DS group tended to have Type 3 (sausage, cracks in the surface) and Type 6 (mushy, fluffy pieces with ragged edges). There was no significant difference in the patients’ perceptions of the difficulty (amount of straining) or completeness (sense of evacuation) between the two groups.
Docusate is well tolerated with minimal side effects; but it can lead to other problems. These capsules can often be large and doses may require patients to take many capsules multiple times a day, increasing the pill burden on already heavily medicated patients. While the cost of docusate is small (10-16 cents per capsule)2 the impact it has on the nursing workload can become expensive. This along with the limited data and questionable efficacy should be considered when starting or continuing a compromised patient on docusate. Both of the newer studies included mostly patients who were on chronic opioid medications, which may not be applicable to a regular nursing home patient. Until more studies are conducted, continue using your best clinical judgment to do what is in the best interest of the patient.

References:
1. Hurdon V, Viola R, Schroder C. How Useful is Docusate in Patients at Risk for Constipation? A Systematic Review of the Evidence in the Chronically Ill. Journal of Pain and Symptom Management. 2000;19;2:130-136
2. Hawley PH. A Comparison of Sennoside-Based Bowel Protocols with and without Docusate in Hospitalized Patients with Cancer. Journal of Palliative Medicine. 2008;11;4:575-581
3. Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate in the Management of Constipation in Hospice Patients. Journal of Pain and Symptom Management. 2013;45;1:2-13


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