P440 Curcumin add-on therapy for induction of remission in mild-moderate active Ulcerative Colitis: A multi-center, prospective, randomized, double-blind, placebo-controlled trial
A. Lang*1, N. Salomon1, J. Wu2, U. Kopylov1, A. Lahat1, O. Har-noi1, J. Ching2, P.K. Cheong2, B. Avidan1, D. Gamus1, I. Kaimakliotis1, R. Eliakim1, S. NG2, S. Ben-Horin1
1Chaim Sheba Medical Center, Gastroenterology, Ramat Gan, Israel, 2Institute of Digestive Disease, State Key Laboratory of Digestive Diseases, Medicine and Therapeutics, Chinese University of Hong Kong, China
The phytochemical compound curcumin was reported to be effective in ameliorating chemically-induced colitis and for the maintenance of remission in ulcerative colitis (UC) patients1. The current study aimed to investigate curcumin's efficacy in inducing remission in patients with active mild-to-moderate UC.
This was an investigator initiated, multi-center, randomized, placebo-controlled double-blind study. Patients with active mild-to-moderate UC defined by a Simple Clinical Colitis Activity Index (SCCAI) score of ≥5 and ≤12, who failed at least four weeks of maximal (4 gram) oral 5-aminosalycilate (5ASA) therapy and a further two week run-in period of maximal oral and topical 5ASA therapy, were eligible. Patients were randomized to receive 3gr/day of curcumin capsules or identical placebo for one month as add-on to continued 5ASA treatment. The primary outcome was the rate of clinical remission (SCCAI ≤2) at week 4. Clinical and endoscopic responses were also recorded.
Fifty patients entered the study out of 97 patients screened. In the intention-to-treat analysis, 14/26 (54%) of patients receiving curcumin achieved clinical remission at week 4 compared to 0/24 (0%) of patients receiving placebo (P=0.01, OR 42, 95% CI 2.3-760). Clinical response (reduction of ≥3 points in SCCAI) was achieved in 17/26 (65%) in the curcumin group versus 3/24 (12%) in the placebo group (P<0.001, OR13.2, 95%CI 3.1-56.6). Endoscopic remission (partial Mayo score ≤1) was observed in 8/21 (43%) of curcumin-treated patients compared to 0/16 (0%) of the placebo-treated patients (P=0.043, OR 20.7, 95%CI 1.1-393). Adverse events were rare and comparable between the two groups.
In our study curcumin as add-on to 5ASA therapy was superior to placebo for inducing clinical and endoscopic remission in mild-to-moderate active UC patients who failed 5ASA treatment. No apparent adverse effects were observed. Curcumin may be a safe and promising agent in the treatment of UC.