Is enterosgel safe and effective for the treatment of diarrhea-predominant irritable bowel syndrome?
Enterosgel appears to safely provide a moderate symptomatic benefit for persons with IBS-D. Its cost is $65 for a 3-pack of 225-g tubes on Amazon.com, which is approximately 11 days' worth at the most common study dose of 30 g twice daily. We don't know if it is better than other simple measures like fiber supplementation.
Plan de l'etude:
Randomized controlled trial (double-blinded)
Enterosgel (polymethylsiloxane polyhydrate) is an intestinal absorbent that is not pharmacologically active and is approved for over-the-counter purchase. The researchers identified adults, aged 16 to 75 years, who met the Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D). Those with alarm symptoms or an abdominal pain score less than 2.5 or 3 were excluded. The 440 patients were randomized to receive enterosgel 15 g twice daily or matching placebo. After 5 days, the dose was gradually increased with a target dose of 30 g three times daily. There was an 8-week double-blind phase, followed by an 8-week open-label phase. Retention in the trial was good (421/440 in the double-blind phase), groups were balanced at baseline, and analysis was by intention to treat. Significantly more patients in the enterosgel group reported relief of symptoms, defined as at least a 30% decrease in abdominal pain and at least a 50% reduction in diarrheal stools, at 8 weeks (37.4% vs 24.3%; P = .002; number needed to treat = 8). The odds ratio for this outcome was 1.95 (95% CI 1.28 - 2.99). Significantly more patients in the enterosgel group also reported that their relief of symptoms was "adequate" at 4 weeks (56% vs 22%) and 8 weeks (69% vs 45%). Individual symptoms improved more and loperamide use was decreased more in the enterosgel group. Adverse events were similar and uncommon between groups. It is important to note that the study was funded by the maker of the product and most of the authors had significant conflicts of interest, including one who was CEO of the company.
Mark H. Ebell, MD, MS
University of Georgia