Induction with NCB-02 (curcumin) enema for mild-to-moderate distal ulcerative colitis — A randomized, placebo-controlled, pilot study. (1st March 2014)

• Record Type: Journal Article
• Authors: Singla, Vikas; Pratap Mouli, Venigalla; Garg, Sushil Kumar; Rai, Tarun; Choudhury, Bikash Narayan; Verma, Prashant; Deb, Rachana; Tiwari, Veena; Rohatgi, Sarika; Dhingra, Rajan; Kedia, Saurabh; Sharma, Piyush Kumar; Makharia, Govind; Ahuja, Vineet
• Is Part Of: Journal of Crohn's and colitis. Volume 8:Number 3(2014)
• Page Start: 208
• Page End: 214
• Publication Date: 2014-03-01
• Subjects: Ulcerative colitis -- NCB-02 -- Curcumin; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1016/j.crohns.2013.08.006
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: 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). It's 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.