Johnson W. McRorie, PhD, FACG, Maria E. Petrey, MS, Kyle J. Sloan, PharmD, Roger D. Gibb, PhD Procter & Gamble, Mason, OH
Introduction: Docusate is marketed as a stool softener. While the vast majority of marketed drugs in the United States achieved FDA approval via a new drug application (NDA) process, which requires clinical evidence of efficacy and safety, this was not the regulatory pathway for docusate. In 1975, FDA began the process of regulating over-the-counter (OTC) products by establishing an OTC laxative monograph for products already being marketed without prior approval, such as docusate. A panel recommended docusate be included in the monograph. The purpose of this study was to assess the published clinical evidence of stool softening efficacy for docusate in a constipated population.
Methods: A comprehensive search was conducted using PubMed and EMBASE for randomized placebo-controlled clinical studies that assessed the efficacy of docusate for stool softening.
Results: The search yielded 7 randomized placebo-controlled clinical studies that assessed the stool softening efficacy of docusate (published 1956-2021). None of the 7 clinical studies reported a significant difference between docusate (100-400mg/day) and placebo for a stool softening effect in a constipated population.
Discussion: It is a misconception that docusate softens hard stool in constipation. The totality of clinical evidence shows that docusate is not different from placebo. Patients would be better served by an effective stool softening therapy. An 8th clinical study directly assessed the putative mechanism of action for docusate, increasing stool water content. This randomized parallel 4-week study (2-week baseline, 2-week treatment, n=170 patients with chronic idiopathic constipation) compared docusate sodium (200mg/day) versus psyllium (non-fermented gel-forming fiber, 10.2g/day) for increasing stool water content, an objective measure of stool softening efficacy. The study showed that docusate had no significant effect on stool water content, remaining below 72% (hard stool) throughout the 2-week dosing period. In contrast, psyllium significantly (p< 0.05 versus docusate) increased stool water content from 70.7% at baseline (hard stool) to 73.7% (normal/formed stool) by dosing day 3 (Figure), an effect that was sustained throughout the 2-week dosing period. Recommendations for stool softening therapies should be evidence-based. To do otherwise takes the risk of perpetuating misconceptions and depriving patients of an effective stool softening therapy..
Figure: Stool water content (%) by dosing day.
Disclosures: Johnson McRorie: Procter & Gamble – Employee. Maria Petrey: Procter & Gamble – Employee. Kyle Sloan: Procter & Gamble – Employee. Roger Gibb: Procter & Gamble – Employee.
Johnson W. McRorie, PhD, FACG, Maria E. Petrey, MS, Kyle J. Sloan, PharmD, Roger D. Gibb, PhD. P1189 - Docusate Is Not Different From Placebo for Stool Softening: A Comprehensive Review, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.
