Tools for Practice


#161 Docusate: A Placebo Pill for Soft Poops


CLINICAL QUESTION
Is docusate effective in the prevention and treatment of constipation?

BOTTOM LINE
Docusate appears similar to placebo in increasing stool frequency and is inferior to other products for treating functional, medication-induced, or post-operative constipation.


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EVIDENCE
  • Randomized Controlled Trials (RCTs) of both brands, docusate sodium (Colace™) and docusate calcium (Surfak™).  
    • In functional or medication-induced constipation versus placebo: 
      • 74 Palliative care patients (91% on opioids) on daily senna, received docusate or placebo.1 Over 10 days: 
        • No difference in daily bowel motions (BMs) or sense of complete evacuation. 
      • 74 hospitalized patients (immobilized or semi-ambulatory) in cross-over RCT received docusate or placebo.2 Over 30 days: 
        • Docusate increased weekly BM by ~1/week. 
        • No change in patient satisfaction. 
        • Limitations: 26% lost to follow-up, statistics not performed, and study 60 years old. 
      • Docusate sodium versus docusate calcium compared to placebo: Three week RCT in 46 elderly (mean age 82 years) institutionalized patients.3  
        • Neither significantly changed number of weekly BMs (our calculation as misleading statistics reported). 
      • Other placebo-controlled RCTs limited by: 
        • Enrolled inappropriate patients (example comatose).4  
        • Randomization not described5,6 or incorrect (flipping coin).4  
        • Patients and/or outcome assessors not likely blinded.4,5  
        • Selective reporting on sub-group of patients.5,6  
    • In functional or medication-induced constipation versus active comparator: 
      • Docusate sodium versus psyllium: RCT of 170 patients (mean age 37 years, 92% females) over two weeks:7 
        • Weekly BMs: Increased with psyllium (0.5/week), docusate no change. 
    • Post-operative patients:  
      • Senna and docusate versus: 
        • Placebo: First BM ~1 day sooner8 with senna and docusate but benefit possibly due to senna.  
        • Polyethylene glycol (PEG): First BM 1-2 days sooner with PEG.9 
    • Pregnant/post-partum patients:  
      • No RCTs on docusate alone.10,11 
Context: 
  • Constipation affects 12-19% of North American adults, most commonly children, elderly, and females.12 
  • Despite widespread prevalence, most constipation studies limited by small numbers and short study periods.  
  • Docusate use may be low (~6%) in primary care patients13 but stool softner use more common (26%) in nursing home patients.14 
  • For comparison, osmotic agents increase BMs in adults and children by ~2-3 per week.15 
April 25, 2016

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Author(s):

  • Jenny Carbon BScPharm PharmD Student
  • Michael Kolber BSc MD CCFP MSc

1. Tarumi Y, Wilson MP, Szafran O, et al. J Pain and Symptom Manage. 2013; 45(1):2-13.

2. Cass LJ, Frederik WS. Am J Gastroneterol. 1956; 26(6):691-8.

3. Fain AM, Susat R, Herring M, et al. South Med J. 1978; 71(6):677-80.

4. Goodman J, Pang J, Bessman AN. J Chron Dis. 1976; 29(1):59-63.

5. Castle SC, Cantrell M, Israel D, et al. Geriatrics. 1991; 46(11):84-6.

6. Hyland CM, Foran JD. Practitioner. 1968; 200(199):698-9.

7. McRorie JW, Daggy BP, Morel JG, et al. Aliment Pharmacol Ther. 1998; 12(5):491-7.

8. Patel M, Schimpf MO, O’Sullivan DM, et al. Am J Obstet Gynecol. 2010; 202(5):479.e1-5.

9. Madsen L, Major C, Parker BA. Int J Orthop Trauma Nurs. 2010; 14(2):75-81.

10. Rungsiprakarn P, Laopaiboon M, Sangkomkamhang US, et al. Cochrane Database Syst Rev. 2015, Issue 9. Art. No.: CD011448.

11. Turawa EB, Musekiwa A, Rohwer AC. Cochrane Database Syst Rev. 2014; 9:CD010273.

12. Higgins PDR, Johanson JF. Am J Gastro. 2004; 99:750-9.

13. Shafe ACE, Lee S, Dalrymple JSO, et al. Ther Adv Gastroenterol. 2011; 4(6):343-63.

14. Phillips C, Polakoff DM, Maue SK, et al. J Am Med Dir Assoc. 2001; 2:149-54.

15. Allan GM, Levy M, Kolber MR. Polyethylene Glycol (PEG) for Paediatric and Adult Chronic Constipation. Internet publication. Available at: https://www.acfp.ca/wp-content/uploads/tools-for-practice/1429563797_updatedtfp45pegandchronicconstipationfv.pdf. Last accessed February 3, 2016.

Authors do not have any conflicts to disclose.