An integrative curcumin-mesalamine therapy for remission induction in mild-moderate active ulcerative colitis: An international, multi-center, randomized, double-blind, placebo-controlled trial

Background and aims Curcumin, a herbal‐compound, may be efficacious in the treatment of ulcerative colitis (UC). In this study we investigated the efficacy of curcumin add‐on therapy for inducing remission in patients with active mild‐to moderate UC. Methods In this multi‐center randomized, placebo‐controlled double‐blind study, 50 patients with active mild‐moderate UC (defined by score of 5 to12 in the Simple Clinical Colitis Activity Index (SCCAI)) were allo‐cated to receive 3gr daily of curcumin or placebo for one month on top of optimized (oral + topical) 5ASA treatment. Clinical index (SCCAI), endoscopic index (partial Mayo) and serological parameters were determined at entry and conclusion of study period. Results In the intention‐to‐treat analysis, 14/26 (54%) patients receiving cur‐cumin and 0/24 patients receiving placebo achieved clinical remission (SCCAI ≤2) at week 4 (P = 0.01, OR 42.2, 95CI 2.3 to 760). Clinical response (reduction of ≥3 points in SCCAI) was achieved in 17/26 patients receiving curcumin and in 3/24 patients receiving placebo (P < 0.001, OR 13.2, 95CI 3.1 to 56.6). Endoscopic remission (partial Mayo score ≤ 1) was observed in 8/22 (36%) of patients receiving curcumin and in 0/16 (0%) of the patients receiving placebo (P = 0.035, OR 23.5, 95CI 1.2 to 445). The mean change in partial Mayo score was +0,15 ± 0.49 for the placebo arm compared to‐0.55 ± 0.79 in the cur‐cumin arm (P = 0.04). No serious adverse events were recorded. Conclusion Curcumin as add‐on therapy was superior to placebo for inducing clinical and endoscopic remission in mild‐to‐moderate active UC with no apparent adverse effects. Curcumin may be a safe and promising agent in the treatment of inflammatory bowel diseases.