Senna, a stimulant laxative, is available as a liquid, powder, granules, and tablets to take orally.
Docusate calcium, docusate potassium, and docusate sodium are a part of the class of drugs known as stool softeners.
Ahmedzai, S.H., & Boland, J. (2010, April). Constipation in people prescribed opioids. Clinical Evidence, 2407.
To answer the following questions: What are the effects of oral laxatives, rectal preparations, and opioid antagonists for constipation in people prescribed opioids?
Databases searched were MEDLINE, Embase, Cochrane Central Register of Controlled Trials and Library, NHS Centre for Reviews and Dissemination (CRD), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment, TRIP, and the National Institute for Health and Clinical Excellence (NICE) up to August 2009. Alerts from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare Products Regulatory Agency were included to identify any adverse effects.
Search keyword were constipation and opioids, Lactulose, macrogols, senna, bisacodyl, co-danthrusate/co-danthramer, docusate, ispaghula husk, liquid paraffin, magnesium salts, methylcellulose, arachis oil enema, glycerol suppository, phosphate enema, sodium citrate enema, and opioid antagonists.
Studies were included in the review if they
The GRADE System was used to evaluate study quality. Full information is available online with a subscription.
The final sample comprised 23 systematic reviews, RCTs, or observational studies. This was an update of a previous review that added 1 systematic review and 5 RCTs, with no change in overall recommendations provided.
Nurses should be aware of potential implications related to the use of opioid antagonists in controlling constipation for opioid interactions and changes in pain control. In addition, nurses should routinely assess for pain relief, as well as symptoms of constipation, in this patient population.
Brick, N. (2013). Laxatives or methylnaltrexone for the management of constipation in palliative care patients. Clinical Journal of Oncology Nursing, 17(1), 91–92.
PHASE OF CARE: End of life care
APPLICATIONS: Palliative care
All of the studies investigated variables in laxative types, opioid doses, and frequency of stools. Outcome measures included change in frequency of bowel movements, ease of defection, relief of systemic and abdominal symptoms of constipation, change in quality of life, and the use of rescue laxatives. There were no significant cross-findings, except all participants required rescue laxatives despite the initiation of a constipation prevention regimen. In two studies of (288) participants using methylnaltrexone versus a placebo, a statistically significant difference favored the intervention of rescue-free laxation 4 hours and 24 hours after the first dose of methylnaltrexone. Thirty percent of those participants experienced adverse effects. One study of 33 participants with methylnaltrexone showed a statistical difference favoring higher doses. Adverse effects were similar.
There were no recommendations for optimal laxative management of constipation in palliative care patients.
There was little concrete evidence and too many variables across the studies. There was no information on how the search was conducted. It was very difficult to follow the evidence summary.
The effectiveness of laxatives and the optimum management of constipation in palliative care patients requires further investigation involving the measurement of standardized, clinically relevant outcomes in a clearly defined population.
Candy, B., Jones, L., Larkin, P.J., Vickerstaff, V., Tookman, A., & Stone, P. (2015). Laxatives for the management of constipation in people receiving palliative care. Cochrane Database of Systematic Reviews, 5, CD003448.
PHASE OF CARE: End-of-life care
APPLICATIONS: Palliative care
No difference in effectiveness was demonstrated in lactulose compared with senna; senna plus lactulose compared with magnesium hydroxide plus liquid paraffin; misrakasneham compared with senna; and docusate plus senna compared with placebo plus senna.
The best laxatives for this patient population is unclear.
Very few clinical trials effectively evaluated the use of laxatives in this patient population.
More RCTs are needed to help evaluate the effectiveness and improve the quality of care of patients in palliative care.
Miles, C.L., Fellowes, D., Goodman, M.L., & Wilkinson, S. (2006). Laxatives for the management of constipation in palliative care patients. Cochrane Database of Systematic Reviews, 4, CD003448.
To determine the effectiveness of laxative administration for constipation in patients receiving palliative care; to differentiate among laxatives being used regarding efficacy for constipation management.
Databases searched were Medline, Embase, CANCERLIT, PubMed, CINAHL, System for Information on Grey Literature in Europe (SIGLE), National Technical Information Service (NTIS), Department of Health and Social Security (DHSS-DATA), Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Dissertation Abstracts, and the Index to Scientific and Technical Proceedings. Conference proceedings and references of articles reviewed were also hand searched.
Search keywords were palliative care, cathartics (adverse effects; therapeutic use), constipation (drug therapy), and randomized controlled trial as topic.
Studies were included in the review if they
Studies were excluded if they included healthy volunteers, patients with constipation as a result of drug misuse, patients with bowel obstruction, or other interventions such as opioid antagonists.
Two hundred twelve studies were initially retrieved. After removal of duplicates and studies that did not meet inclusion criteria, three studies were finally included. Study quality was assessed using the Jadad scale and additional criteria identified including issues of accrual, homogeneity, attrition, interventions, quality of outcome measurement, and clarity of results presentation. The review provided extensive detail on quality assessment findings and rationale for study exclusion. Included studies used senna, lactulose, danthron combined with poloxamer, misrakasneham, and magnesium hydroxide combined with liquid paraffin.
The final sample of three studies involved a total of 162 patients, with study samples ranging from 36 to 75.
The treatment of constipation in palliative care patients is not based on sufficient data from RCTs. Recommendations for laxatives may be based as much on cost as on efficacy. Polyethylene glycols are widely used in palliative care despite lack of evidence. The authors did not note evidence in this area in other patient populations that may be applicable.
This review and included studies did not provide sufficient information to draw conclusions about the laxatives in terms of weighing effectiveness versus adverse side effects.
This area could benefit from research to compare effects and cost effectiveness. Some findings suggested effect and preference for lactulose combinations, whereas lactulose tends to be much more expensive than alternatives.
Feudtner, C., Freedman, J., Kang, T., Womer, J.W., Dai, D., & Faerber, J. (2014). Comparative effectiveness of senna to prevent problematic constipation in pediatric oncology patients receiving opioids: A multicenter study of clinically detailed administrative data. Journal of Pain and Symptom Management, 48, 272–280.
To compare patients who receive senna with similar patients who receive other oral bowel medications; to determine the subsequent risk of problematic constipation, assessed as the occurrence of the enemas, escalation of oral bowel medications, and abdominal imaging
Retrospective matched study of hospitalized pediatric patients with cancer from 78 hospitals from 2006–2011 who were started on seven consecutive days or more of opioid therapy and were started on an oral bowel medication within two days of starting the opioid therapy, were evaluated to look at the use of the effectiveness of senna in the regimen. Data were collected from a pediatric health information system and premier perspective databases.
Initiating senna therapy within two days of starting prolonged opioid course compared with initiating another bowel medication had a significantly lower hazard ratio of requiring enemas (HR = 0.01; 95% CI [0.11, 0.91]) or the need for the patient to require radiographic imaging (HR = 0.74; 95% CI [0.55, 0.98]) or escalation or oral bowel medication (HR = 0.78; 95% CI [0.59, 1.03]). Overall, senna had a lower hazard composite endpoint of problematic constipation (HR = 0.7; 95% CI [0.56, 0.88]).
Senna was more effective than other oral medications at improving constipation in pediatric patients with cancer. Patients required fewer enemas and less radiographic imaging. Patients on senna did not require as much dose escalation to control constipation.
Senna is an effective prophylactic bowel regimen for pediatric patients requiring prolonged opioid therapy.
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.
During phase II, the next 30 eligible patients with constipation received sennosides only. Dosing was as follows.
Rescue laxatives included lactulose, a suppository, or enema as needed. Only 12 days of bowel protocol were abstracted from the medical record.
This was a nonrandomized, nonblinded, sequential cohort study.
Nursing chart review
Sennosides only produced more BMs than DS.
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.
Patel, M., Schimpf, M.O., O'Sullivan, D.M., & LaSala, C.A. (2010). The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: A randomized, double-blind, placebo-controlled trial. American Journal of Obstetrics and Gynecology, 202, 479.e1–479.e5.
To compare the time of first bowel movement (BM) following pelvic reconstructive surgery in patients randomized to placebo or senna with docusate.
Patients were enrolled prior to surgery. After surgery, patients were randomized to either senna with docusate or placebo. Dosing was as follows.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blinded, placebo-controlled trial.
The use of a stool softener with a laxative such as senna with docusate decreases the time to first BM following pelvic reconstructive surgery compared with placebo and lessens the need for use of magnesium citrate.
Nurses should be proactive in the management of patients' bowels following reconstructive surgery. Management with medications such as senna with docusate may be an option for patients following this form of surgery.
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.
Randomized, double-blind, placebo-controlled study
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.
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.
National Comprehensive Cancer Network. (2011). NCCN Clinical Practice Guidelines in Oncology: Adult cancer pain [v. 2.2011]. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf
The guidelines recommend the following for management of opioid-induced constipation.
If Constipation Occurs:
Recommendations were identified as having low-level evidence and uniform consensus.
National Comprehensive Cancer Network. (2015). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Palliative care [v.1.2016]. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf
RESOURCE TYPE: Consensus-based guideline
PROCESS OF DEVELOPMENT: Guidelines were developed by a panel
These guidelines did not provide a specific search strategy or information about literature search results.
These recommendations were made mainly by consensus, and the guidelines provided no information about literature search results and appeared to use only one database for searching. All suggestions were based on low-level evidence and uniform consensus.
These guidelines provided numerous suggestions for the management of various symptoms, but they were not truly evidence-based. In those aspects for which there was no research evidence, the guidelines provided expert opinion suggestions for management.