Efficacy of the Punica granatum peels aqueous extract for symptom management in ulcerative colitis patients. A randomized, placebo-controlled, clinical trial

Abstract Objective To investigate the effects of the Punica granatum peel extract on symptoms of patients with ulcerative colitis (UC). Method Patients with UC were randomized to receive an aqueous extract of the P. granatum peel (6 g of dry peel/day) or placebo for four weeks complementary to standard medications. Symptoms were assessed using the Lichtiger Colitis Activity Index (LCAI) at baseline, week 4, and week 10 (follow-up). Clinical response was defined by ≥ 3 point decrease in LCAI. Results The LCAI score was similarly reduced in both the P. granatum (−1.68 ± 3.85, P = 0.019) and placebo groups (−1.39 ± 2.41, P = 0.002). Clinical response was higher with P. granatum compared with placebo at week 4 (41.4% vs. 18.2%, P = 0.055), but not at week 10 (48.3% vs. 36.4%, P = 0.441). Conclusions The P. granatum peel extract seems effective in complementary management of UC. Further studies in a larger sample of patients are warranted. IRCT2014040617156N1.