Induction with NCB-02 (curcumin) enema for mild-to-moderate distal ulcerative colitis - A randomized, placebo-controlled, pilot study

Background and aims: Curcumin, an active ingredient of turmeric with anti-inflammatory properties, has been demonstrated to be useful in experimental models of ulcerative colitis (UC). Its efficacy in humans needs to be investigated. Methods: A randomized, double-blind, single-centre pilot trial was conducted in patients with distal UC (<25 cm involvement) and mild-to-moderate disease activity. Forty-five patients were randomized to either NCB-02 (standardized curcumin preparation) enema plus oral 5-ASA or placebo enema plus oral 5-ASA. Primary end point was disease response, defined as reduction in Ulcerative Colitis Diseases Activity Index by 3 points at 8 weeks, and secondary end points were improvement in endoscopic activity and disease remission at 8 weeks. Results: Response to treatment was observed in 56.5% in NCB-02 group compared to 36.4% (p = 0.175) in placebo group. At week 8, clinical remission was observed in 43.4% of patients in NCB-02 group compared to 22.7% in placebo group (p = 0.14) and improvement on endoscopy in 52.2% of patients in NCB-02 group compared to 36.4% of patients in placebo group (p = 0.29). Per protocol analysis revealed significantly better outcomes in NCB-02 group, in terms of clinical response (92.9% vs. 50%, p = 0.01), clinical remission (71.4% vs. 31.3%, p = 0.03), and improvement on endoscopy (85.7% vs. 50%, p = 0.04). Conclusion: In this pilot study we found some evidence that use of NCB-02 enema may tend to result in greater improvements in disease activity compared to placebo in patients with mild-to-moderate distal UC. The role of NCB-02 as a novel therapy for UC should be investigated further. (C) 2013 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.