Tarumi, Y., Wilson, M.P., Szafran, O., & Spooner, G.R. (2013). Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. Journal of Pain and Symptom Management, 45(1), 2–13. 

To determine the efficacy of docusate in patients in hospice

Patients were randomly assigned via a code generated by a public domain computer. Randomization was assigned by a pharmacist, and the research assistant, patient, proxy, attending physician, and nurses were blinded to study treatment. The intervention group received two 100 mg docusate tablets in the morning and late afternoon plus one to three sennoside tablets (8.6 mg per tablet) one to three times per day. The placebo group received two cornstarch tablets in the morning and afternoon in addition to one to three sennoside tablets (8.6 mg per tablet) one to three times per day. All medications were administered by hospice nursing staff for a period of 10 days. Docusate pills were rolled in cornstarch and placed into nontransparent blue capsules, and the placebo pills were only cornstarch in blue capsules so that both the intervention and placebo pills looked the same. All patients were allowed to take laxatives and receive other bowel interventions as needed throughout the study. Nurses received multiple education sessions on stool consistency and volume to ensure inter-rater reliability. Nurses recorded data daily for 10 days.

• N = 74
• AGE = ≥ 18 years 
• MALES: 55%, FEMALES: 45%
• KEY DISEASE CHARACTERISTICS: Cancer and non-cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Palliative Performance Scale (PPS) score and Mini-Mental State Examination (MMSE) score of 23

• SITE: Multi-site  
• SETTING TYPE: Inpatient  
• LOCATION: Edmonton, Alberta, Canada

• PHASE OF CARE: End of life care
• APPLICATIONS: Elder care, palliative care

Randomized, double-blind, placebo-controlled study

• Assessment and recording of bowel movements, which included stool frequency and volume, stool consistency, constipation symptoms, and ease with which defecation occurred.
• Type/frequency of other bowel interventions
• Patient perception of completeness of evacuation
• Edmonton Symptom Assessment System (ESAS)
• Bowel movement record

The results revealed no significant difference in stool frequency, volume, or consistency between the two groups. Data showed no significant differences in patients’ perception of the difficulty or completeness of defecation. ESAS scores showed no difference in symptoms experienced between the two groups. No difference was seen in the number of additional bowel-care interventions provided to patients in this study.

There were no significant differences between the docusate group and the placebo group, suggesting that the use of docusate should be considered on a patient-by-patient basis.

• Small sample (< 100)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable

Nurses must assess patient needs versus what is actually happening. Frequent abdominal inspections should be made with or without the use of docusate. Other things that should be assessed include bowel sounds and pattern of bowel function as well as the color, consistency, and amount of stool produced without regard to docusate use.