Hawley, P.H., & Byeon, J.J. (2008). A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer. Journal of Palliative Medicine, 11, 575–581.

To determine the efficacy of sennoside-based regimens on the proportion of total days with at least one bowel movement (BM) per day.

During phase I, the first 30 consecutive eligible patients admitted to the ward received docusate plus sennosides (DS) for management of constipation. Dosing was as follows.

• Opioid-naive patients received docusate sodium 200 mg BID.
• For those on opioids or had no BM in 48 hours, the starting dose or next dose was docusate 200 mg BID plus sennosides 17.2 mg every bedtime.
• If patients had no BM in the next 48 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg BID.
• If patients had no BM in the next 24 hours, they received docusate sodium 200 mg TID plus sennosides 17.2 mg TID.
• If patients still had no BM after 24 hours, they received docusate sodium 200 mg TID plus sennosides 25.8 mg TID. 

During phase II, the next 30 eligible patients with constipation received sennosides only. Dosing was as follows.

• Patients received sennosides 17.2 mg every bedtime.
• For those on opioids or had no BM in 48 hours, the starting dose or next dose was sennosides 17.2 mg BID.
• If patients had no BM in the next 24 hours, they received sennosides 17.2 mg TID.
• Finally, if patients had no BM after 24 hours, they received sennosides 25.8 mg TID.

Rescue laxatives included lactulose, a suppository, or enema as needed. Only 12 days of bowel protocol were abstracted from the medical record.

• The study reported on a sample of 60 patients.
• Mean patient age was 59.1 years (SD = 14.8, range 24–87) in the DS group and 62.9 years (SD =13.9, range 25–85) in the sennosides group.
• The sample comprised 45 women and 15 men.
• Fourteen patients in the sennosides group had genitourinary cancer, and seven patients in the DS group had breast cancer. 
• Eighty percent of patients were on opioids and 72% were admitted for symptom control.

• Single site
• Inpatient
• Vancouver Center of British Columbia Cancer Agency in Canada

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability to end-of-life and palliative care.

This was a nonrandomized, nonblinded, sequential cohort study.

Nursing chart review

• The mean study observation period was eight days (range 5–12 days).
• Eighty percent of patients in the sennosides group had a BM on at least 40% of days compared with 60% of the DS group (p = 0.09). However, if patients not taking opioids were excluded, the sennosides group had better results (76% versus 50% of days) than the DS group (not significant).
• Fifty-seven percent of patients in the DS group required additional interventions (lactulose, suppositories, or enemas) compared to 40% in the sennosides group.
• Twenty-seven percent of patients in the sennosides group reported diarrhea compared to 13% in the DS group.

Sennosides only produced more BMs than DS.

• The study had a small sample size (fewer than 100).
• The design was not randomized.
• More patients with genitourinary cancer were recruited in the sennosides group than the DS group, and 90% of patients in the DS group were receiving opioids; therefore, an even comparison in diagnosis was not reflected.
• The dosage of sennosides was higher overall in the sennosides group than the DS group, which could have influenced the results as well.
• Conclusions were based on a chart review, which was performed to look at side effects, versus interview. Data may have been lost if patients were not asked or side effects were not recorded.

Adding a stool softener such as docusate does not necessarily produce superior results than those seen with a laxative alone. However, additional randomized, double-blind studies should be conducted before conclusions and evidence into practice are drawn. The usefulness of this study is questionable because of its design and execution issues.