医学
溃疡性结肠炎
安慰剂
灌肠
内科学
胃肠病学
随机对照试验
姜黄素
炎症性肠病
临床终点
疾病
药理学
病理
替代医学
作者
Vikas Singla,Venigalla Pratap Mouli,Sushil Kumar Garg,Tarun Rai,Bikash Narayan Choudhury,Prashant Verma,Rachana Deb,Veena Tiwari,Sarika Rohatgi,Rajan Dhingra,Saurabh Kedia,Piyush Kumar Sharma,Govind Makharia,Vineet Ahuja
出处
期刊:Journal of Crohn's and Colitis
[Oxford University Press]
日期:2013-09-05
卷期号:8 (3): 208-214
被引量:169
标识
DOI:10.1016/j.crohns.2013.08.006
摘要
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. 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. 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). 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.
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