Bisacodyl

Bisacodyl

PEP Topic 
Constipation
Description 

Bisacodyl is a short-term treatment for constipation that is used to empty the bowels before surgery and certain other medical procedures. As a stimulant laxative, bisacodyl increases the activity of the intestines to cause a bowel movement. Bisacodyl is available as a tablet to take by mouth.

Effectiveness Not Established

Systematic Review/Meta-Analysis

Ahmedzai, S.H., & Boland, J. (2010, April). Constipation in people prescribed opioids. Clinical Evidence, 2407.

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Purpose:

To answer the following questions: What are the effects of oral laxatives, rectal preparations, and opioid antagonists for constipation in people prescribed opioids?

Search Strategy:

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

  • Were randomized controlled trials (RCTs), observational studies, or systematic reviews
  • Had a study sample of at least 20 participants
  • Had a maximum loss to follow-up of 30% per year in longitudinal studies.

Literature Evaluated:

The GRADE System was used to evaluate study quality. Full information is available online with a subscription.

Sample Characteristics:

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.

Results:

Oral Laxatives

  • Lactulose, polyethylene glycols (PEGs) plus electrolytes, and senna were identified as beneficial in this systematic review. Evidence in this area was graded as low-to-moderate quality. Lactulose appears to be as effective as PEG in reducing the number of hard stools, and as effective as senna in reducing the number of days without defecation.
  • Preparations identified as unknown effectiveness included bisacodyl, co-danthrusate and co-danthramer, docusate, ispaghula husk, liquid paraffin, magnesium salts, and methylcellulose.
  • Some oral laxatives such as bisacodyl often are prescribed in combination with other agents or rectal suppositories, but no evidence supports this use, particularly in people taking opioids.
  • Liquid paraffin may be harmful in patients who have difficulty swallowing.

Rectal Preparations

  • All of the rectal preparations studied were categorized as unknown effectiveness. The preparations included arachis oil enema, glycerol suppository, phosphate enema, and sodium citrate micro-enema.

Opioid Antagonists

  • Opioid antagonists, including alvimopan, methylnaltrexone, and naloxone, were categorized as beneficial.  Categorization was based on studies comparing those agents to no treatment or placebo.  The most common side effects reported were abdominal pain, nausea, and diarrhea, particularly with higher doses. 
  • A concern with these agents is the potential for use to reverse the therapeutic action of opioids.  Alvimopan and methylnaltrexone are considered safer than naloxone in this regard, as neither of those agents can cross the blood-brain barrier and a few small studies of acute pain have shown success in blocking the constipating effect of opioids without compromising pain relief.

Limitations:

  • Although various combinations of oral laxatives and rectal agents may be used clinically, their effectiveness for constipation in people taking opioids has not been evaluated. This area can benefit from continued well-designed study.
  • Opioid antagonists are considered effective for reducing constipation in people prescribed opioids. However, only a few studies with small groups of patients have examined the effect of these agents on pain relief with opioids. Use of opioid antagonists may also have implications for which type of opioid should be used for pain control.  Long-term use with chronic pain managed by opioids is not well researched.

Nursing Implications:

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.

Research Evidence Summaries

Kienzle-Horn, S., Vix, J.M., Schuitjt, C., Peil, H., Jordan, C.C., & Kamm, M.A. (2006). Efficacy and safety of bisacodyl in acute treatment of constipation: A double-blind, randomized, placebo-controlled study. Aliment Pharmacology and Therapeutics, 23, 1479–1488.

doi: 10.1111/j.1365-2036.2006.02903.x
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Study Purpose:

To determine the effect and safety of oral bisacodyl on stool frequency and consistency.

Intervention Characteristics/Basic Study Process:

Patients received bisacodyl 10 mg (two 5-mg tablets) or placebo (two tablets) orally once daily on three successive days following a three-day run-in period. The study had a three-day baseline period and three treatment days. Patients were asked not to drink milk or take antacids at the same time as study medications because they could dissolve the enteric coating. Randomization was 1:1. Unused medication was collected at the end of the treatment period. Primary endpoints during the three-day treatment period were mean number of stools per day and mean stool consistency.

Sample Characteristics:

  • The study reported on a sample of 54 Caucasian patients with idiopathic constipation, aged 19 to 89 years.
  • The bisacodyl group (n = 27) comprised 19 women and 8 men, whereas the placebo group (n = 27) comprised 20 women and 7 men.
  • Patients were included in the study if they were aged 18 years or older, had a documented history of constipation well known to the investigator, and were otherwise in good health.
  • Patients were excluded if they had constipation associated with drug treatment, organic disease (e.g., tumors), strictures, inflammatory disease, obstructive conditions, other gastrointestinal (GI) disorders, history of GI surgery, or pregnancy.

Setting:

Eight primary care practices in Germany

Study Design:

This was a phase IV, multicenter, double-blind, randomized, placebo-controlled, parallel group design study.

Measurement Instruments/Methods:

  • Constipation was defined as fewer than three bowel movements per week on average during the past three months, or excessive need for straining, hard stool, low-stool weight, or sensation of incomplete evacuation in more than 25% of evacuations.
  • Patients recorded stool frequency and consistency and adverse events in a bowel diary.
  • Blood specimens (complete blood counts and chemistries) were obtained.
  • Global assessment of efficacy was made by the investigator based on severity of constipation compared with baseline on a four-point Likert-type scale.

Results:

  • Twenty-seven patients were evaluable in each group for efficacy.
  • Two patients were excluded secondary to taking restricted concomitant medications.
  • One subject was lost to follow-up before taking study medication.
  • Patient demographics were comparable.
  • Mean number of stools per day was significantly greater in the bisacodyl group (1.8, SD = 1.5) compared to placebo (0.95, SD = 0.6) over the treatment phase (p = 0.0061).
  • Mean stool consistency score improved from hard at baseline for both groups to soft and well formed (2.8, SD = 1.1) during bisacodyl treatment, remaining from moderately hard to hard for placebo (4.2; p < 0.0001).
  • In terms of global efficacy assessment, 19 of 27 patients in the bisacodyl group compared to 14 of 27 patients in the placebo group were assessed as significantly or somewhat improved; the finding was not statistically significant (p = 0.423).

Conclusions:

Bisacodyl is effective and safe in improving stool frequency and consistency.

Limitations:

  • The power analysis needed 28 patients per group, but only 27 patients per group completed the study.
  • All patients were Caucasian.
  • The sample was predominantly female, which is reflective of a higher proportion of women experiencing constipation in the general population.
  • Although adverse events were reported, no evidence suggested patients were specifically asked about abdominal cramping and flatulence, which were listed as objective rather than subjective symptom data by the authors.
  • Patients in the study were in good health; therefore, patients with cancer were excluded.

Kienzle-Horn, S., Vix, J.M., Schuitjt, C., Peil, H., Jordan, C.C., & Kamm, M.A. (2007). Comparison of bisacodyl and sodium picosulfate in the treatment of chronic constipation. Current Medical Research and Opinion, 23, 691–699.

doi: 10.1185/030079907X178865
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Study Purpose:

To compare the safety and efficacy of bisacodyl and sodium picosulphate.

Intervention Characteristics/Basic Study Process:

Patients received 5 to 10 mg of bisacodyl sugar-coated tablets or sodium picosulphate drops daily over four weeks. The study schedule included four visits: an initial screening visit followed by a seven-day baseline period, a randomization visit (1:1 basis) and two follow-up visits on days 15 and 29.

Sample Characteristics:

  • The study reported on a total sample of 144 patients with chronic constipation, defined as fewer than three stools per week for at least six months, or pain or straining with bowel movements for six months.
  • Patients were aged older than 18 years (range 23–64).
  • The study comprised 70 patients in the bisacodyl group ( 21 men and 49 women) and 74 patients in the sodium picosulphate group (19 men and 55 women).
  • Patients were included in the study if they were aged 18 years or older and had a confirmed diagnosis of chronic constipation. 
  • Patients were excluded if they had a history of organic disease of the colon, ileus, any acute surgical abdominal conditions, organic diseases of the rectum and anus, presence of active gastrointestinal disease, obstruction or dehydration, ingestion of any drug affecting gastrointestinal motility, hypersensitivity to triarylmethane compounds, and recent use (within the past seven days) of bisacodyl or sodium picosulphate.

Setting:

15 centers (outpatient clinics and specialist gastroenterology units) in Germany

Study Design:

This was a phase IV, open-label, randomized, parallel group study.

Measurement Instruments/Methods:

  • Primary efficacy was assessed as number of bowel movements per day and daily stool consistency using a five-point scale (from liquid to hard).
  • Secondary efficacy was assessed as degree of straining using a scale from 0 (absent) to 5 (severe) and physician global efficacy assessment.
  • Safety assessments included adverse-event monitoring, tolerability, and changes in laboratory parameters.
  • Physical examination and blood samples were completed on days 1, 15, and 29.

Results:

  • Demographic distribution and baseline characteristics of the two treatment groups were similar.
  • Stool frequency and consistency and occurrence of straining after 14 and 28 days was significantly improved for both groups compared to baseline (p < 0.0001).
  • Physician global rating improved in 74.6% of patients in the bisacodyl group and 79.2% of patients in the sodium picosulphate group.

Conclusions:

Bisacodyl and sodium picosulphate are equally tolerated and effective in the treatment of chronic constipation.

Limitations:

  • The study lacked a placebo group.
  • Secondary efficacy parameters were subjective, but generally accepted.
  • The study evaluated safety over 28 days and did not address potential long-term changes in gastrointestinal mucosa.
  • No patients with cancer or opioid-induced constipation were included in the study.

Guideline/Expert Opinion

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

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Guidelines & Recommendations:

The guidelines recommend the following for management of opioid-induced constipation.

Preventive Measures:

  • Take polyethylene glycol or a combination of stool softener and stimulant laxative daily.
  • Maintain adequate fluid intake.
  • Maintain adequate fiber intake. Compounds such as psyllium are not recommended because they are unlikely to control opioid-induced constipation.

If Constipation Occurs:

  • Rule out other causes and begin treating.
  • Titrate stool softeners and laxatives as needed.
  • Consider coanalgesics to enable opioid dose reduction.

Persistent Constipation:

  • Consider the addition of agents such as magnesium hydroxide, bisacodyl, rectal suppository, lactulose, and sorbitol.
  • Use enemas.
  • Consider methylnaltrexone 0.15 mg/kg subcutaneously daily.

Limitations:

Recommendations were identified as having low-level evidence and uniform consensus.


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