#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
- 74 Palliative care patients (91% on opioids) on daily senna, received docusate or placebo.1 Over 10 days:
- 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.
- Docusate sodium versus psyllium: RCT of 170 patients (mean age 37 years, 92% females) over two weeks:7
- 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
- Senna and docusate versus:
- Pregnant/post-partum patients:
- No RCTs on docusate alone.10,11
- In functional or medication-induced constipation versus placebo:
- 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
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