Efficacy of docusate called into question

Docusate does not significantly improve the management of constipation in hospice patients, show the results of a randomized, placebo-controlled trial.

Patients taking the stool softener had no significant difference in stool frequency, volume, or consistency compared with their counterparts who took a cornflour placebo during the 10-day prospective study.

The findings call into question the general standing orders and policies for using docusate in hospice units, suggest the researchers in the Journal of Pain and Symptom Management.

"Given that these patients are usually taxed with taking multiple medications, eliminating nonefficacious medications is a significant consideration," write Yoko Tarumi (Royal Alexandra Hospital, Edmonton, Canada) and colleagues.

"Removing the number of medications taken and removing a large capsule from this physically vulnerable population has the potential to improve quality of life at the end of life, decrease the time required for medication distribution by nursing staff, and lower the overall cost of care," they add.

Of the 74 study participants, 35 were randomly assigned to receive two docusate 100 mg capsules twice daily plus one to three sennoside (a laxative) tablets one to three times daily, and 39 were assigned to receive placebo plus sennoside. In all, 56 (25 docusate and 31 placebo) participants completed the full 10 days of treatment.

The researchers report that the mean between-group difference in the average number of bowel movements per day was 0.05, which was not statistically significant.

Tarumi et al defined treatment response as either having at least one bowel movement on 50% or more of the study days, or having at least one bowel movement every 3 consecutive days.

Using these two definitions, a respective 56.0% versus 71.0%, and 70.8% versus 80.6% of docusate compared with placebo patients responded, representing a nonsignificant difference regardless of the definition used.

The two groups did not differ significantly in the percentage using additional bowel care interventions (mainly a bisacodyl suppository) during the trial, at 74.4% of the placebo group and 68.6% of the docusate group.

"Research into finding a more effective bowel management protocol/medication is warranted," conclude Tarumi and co-workers.

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