Randomised clinical trial: the analgesic properties of dietary supplementation with palmitoylethanolamide and polydatin in irritable bowel syndrome
What this study found
The supplement reduced abdominal pain/discomfort over time compared with placebo, but it did not improve the primary biologic endpoint or clearly change other IBS symptoms. Abdominal pain severity showed a treatment-by-time interaction of 0.049, whereas pain frequency, bloating, stool variables, and upper GI symptoms were not significantly different. Colonic mast cell count/activation did not change with active treatment or placebo (P = 0.501), and no treatment effect on endocannabinoid/endocannabinoid-like mediators or receptor expression was seen. The regimen was safe and well tolerated,…
- Study & population
- Randomized, placebo-controlled, multicenter clinical trial in adults with irritable bowel syndrome diagnosed by Rome III criteria.
- Intervention
- Co-micronised palmitoylethanolamide/polydatin was given orally at 200 mg/20 mg twice daily for 12 weeks, compared with placebo.
- Key limitation
- Small active-arm sample size (29 randomized, 24 completed) limits precision and generalizability.
View source
Open PDFOriginal abstract
Intestinal immune activation is involved in irritable bowel syndrome (IBS) pathophysiology. While most dietary approaches in IBS involve food avoidance, there are fewer indications on food supplementation. Palmithoylethanolamide, structurally related to the endocannabinoid anandamide, and polydatin are dietary compounds which act synergistically to reduce mast cell activation.