TY - JOUR
T1 - Efficacy and Safety of Over-the-Counter Therapies for Chronic Constipation
T2 - An Updated Systematic Review
AU - Rao, Satish S.C.
AU - Brenner, Darren M.
N1 - Funding Information:
Financial support: Medical writing support and literature search was provided by BioCentric, Inc. The development of this manuscript was supported by funding from the Bayer US LLC.
Funding Information:
Potential competing interests: SSCR has served as an advisory board member and consultant for Bayer Pharmaceuticals and previously received unrestricted research grant support from Sun Sweets corporation and California dried plums grower's association.DMB has received consulting fees from Bayer Pharmaceuticals and is supported in research by an unrestricted gift from the Irene D. Pritzker Foundation. Study Highlights WHAT IS KNOWN
Publisher Copyright:
© 2021 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
PY - 2021/6/1
Y1 - 2021/6/1
N2 - INTRODUCTION:Constipation is commonly treated with over-the-counter (OTC) products whose efficacy and safety remain unclear. We performed a systematic review of OTC therapies for chronic constipation and provide evidence-based recommendations.METHODS:We searched PubMed and Embase for randomized controlled trials of ≥4-week duration that evaluated OTC preparations between 2004 and 2020. Studies were scored using the US Preventive Services Task Force criteria (0-5 scale) including randomization, blinding, and withdrawals. The strengths of evidence were adjudicated within each therapeutic category, and recommendations were graded (A, B, C, D, and I) based on the level of evidence (level I, good; II, fair; or III, poor).RESULTS:Of 1,297 studies identified, 41 met the inclusion criteria. There was good evidence (grade A recommendation) for the use of the osmotic laxative polyethylene glycol (PEG) and the stimulant senna; moderate evidence (grade B) for psyllium, SupraFiber, magnesium salts, stimulants (bisacodyl and sodium picosulfate), fruit-based laxatives (kiwi, mango, prunes, and ficus), and yogurt with galacto-oligosaccharide/prunes/linseed oil; and insufficient evidence (grade I) for polydextrose, inulin, and fructo-oligosaccharide. Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported.DISCUSSION:The spectrum of OTC products has increased and quality of evidence has improved, but methodological issues including variability in study design, primary outcome measures, trial duration, and small sample sizes remain. We found good evidence to recommend polyethylene glycol or senna as first-line laxatives and moderate evidence supporting fiber supplements, fruits, stimulant laxatives, and magnesium-based products. For others, further validation with more rigorously designed studies is warranted.
AB - INTRODUCTION:Constipation is commonly treated with over-the-counter (OTC) products whose efficacy and safety remain unclear. We performed a systematic review of OTC therapies for chronic constipation and provide evidence-based recommendations.METHODS:We searched PubMed and Embase for randomized controlled trials of ≥4-week duration that evaluated OTC preparations between 2004 and 2020. Studies were scored using the US Preventive Services Task Force criteria (0-5 scale) including randomization, blinding, and withdrawals. The strengths of evidence were adjudicated within each therapeutic category, and recommendations were graded (A, B, C, D, and I) based on the level of evidence (level I, good; II, fair; or III, poor).RESULTS:Of 1,297 studies identified, 41 met the inclusion criteria. There was good evidence (grade A recommendation) for the use of the osmotic laxative polyethylene glycol (PEG) and the stimulant senna; moderate evidence (grade B) for psyllium, SupraFiber, magnesium salts, stimulants (bisacodyl and sodium picosulfate), fruit-based laxatives (kiwi, mango, prunes, and ficus), and yogurt with galacto-oligosaccharide/prunes/linseed oil; and insufficient evidence (grade I) for polydextrose, inulin, and fructo-oligosaccharide. Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported.DISCUSSION:The spectrum of OTC products has increased and quality of evidence has improved, but methodological issues including variability in study design, primary outcome measures, trial duration, and small sample sizes remain. We found good evidence to recommend polyethylene glycol or senna as first-line laxatives and moderate evidence supporting fiber supplements, fruits, stimulant laxatives, and magnesium-based products. For others, further validation with more rigorously designed studies is warranted.
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U2 - 10.14309/ajg.0000000000001222
DO - 10.14309/ajg.0000000000001222
M3 - Review article
C2 - 33767108
AN - SCOPUS:85107710681
SN - 0002-9270
VL - 116
SP - 1156
EP - 1181
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 6
ER -