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. 2021 Jun 1;116(6):1156-1181.
doi: 10.14309/ajg.0000000000001222.

Efficacy and Safety of Over-the-Counter Therapies for Chronic Constipation: An Updated Systematic Review

Satish S C Rao  1 , Darren M Brenner  2
Affiliations

Efficacy and Safety of Over-the-Counter Therapies for Chronic Constipation: An Updated Systematic Review

Satish S C Rao et al. Am J Gastroenterol. .

Abstract

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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Conflict of interest statement

Guarantor of the article: Darren M. Brenner, MD.

Specific author contributions: S.S.C.R. and D.M.B. conceived the project and developed the search criteria and parameters for the systematic review, reviewed the literature independently, and provided independent recommendations regarding the quality of studies, strength of evidence, and recommendation grading. Both authors equally contributed to the writing of the manuscript and provided extensive revisions.

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.

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.

Figures

Figure 1.
Figure 1.
Flow diagram of study. aOne study added after literature search. bThree studies were included in 2 categories.
See this image and copyright information in PMC

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