Table 24Evidence profile of the general tolerability and harms of constipation drugs in adults

Evidence Profile: General tolerability and harms of constipation drugs in adults
No. of Studies/ PatientsDesignQualityConsistencyDirectnessMagnitude of EffectOther modifying factorsOverall Grade of the Evidence
Outcome: Tolerability and harms of docusate calcium
No evidence
Outcome: Tolerability and harms of docusate sodium
No evidence
Outcome: Tolerability and harms of lactulose
No evidence
Outcome: Tolerability and harms of lubiprostone
12 abstractsRCTsN/A (published as abstracts only)No inconsistenciesYes for chronic constipation
Yes for IBS-C
N/ANoN/A (published as abstracts only)
Outcome: Tolerability and harms of PEG 3350
4 studies/ 261 patients3 RCTs3 poor quality and 1 fair qualityMinor inconsistencies in the AEs reportedYes for chronic constipation

No for IBS-C
NRYesLow
Outcome: Tolerability and harms of psyllium
2 RCTs / 223 patientsRCTsSerious methodological problems, both poor qualityNo inconsistenciesYes for chronic constipation

No for IBS-C
NRNoLow
Outcome: Tolerability and harms of tegaserod
15 studies/ 21,207 patients (and FDA report on analysis of 29 RCTs)9 RCTsNo serious methodological problemsNo inconsistenciesYes for chronic constipation

Yes for IBS-C
Increased risk of cardiovascular AEs (0.1% vs. 0.01%)

Greater incidence of diarrhea (3.6–10.1% vs. 0.6–3.1%) and GI disturbances (5.8–17.1% vs. 3.1–8.5%)
NoHigh

AE: adverse events; IBS-C: Irritable Bowel Syndrome; N/A: not applicable; NR: not reported

*Imprecise or sparse data; a strong or very strong association; high risk of reporting bias; dose response gradient; effect of plausible residual confounding

From: Results

Cover of Drug Class Review: Constipation Drugs
Drug Class Review: Constipation Drugs: Final Report [Internet].
Gartlehner G, Jonas DE, Morgan LC, et al.
Portland (OR): Oregon Health & Science University; 2007 Sep.
Copyright © 2007, Oregon Health & Science University, Portland, Oregon.

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