- 作者：Vikas Singla vikaspisces@yahoo.co.in" class="auth_mail ; Venigalla Pratap Mouli pratapmouli@yahoo.com" class="auth_mail ; Sushil Kumar Garg sushilaiims@gmail.com" class="auth_mail ; Tarun Rai rai.tarun@gmail.com" class="auth_mail ; Bikash Narayan Choudhury drbikashchoudhury@yahoo.com" class="auth_mail ; Prashant Verma prashverma78@gmail.com" class="auth_mail ; Rachana Deb rachana.deb@gmail.com" class="auth_mail ; Veena Tiwari veena_mishra1@yahoo.com" class="auth_mail ; Sarika Rohatgi rohatgisarika@yahoo.com" class="auth_mail ; Rajan Dhingra drrajandhingra@gmail.com" class="auth_mail ; Saurabh Kedia dr.saurabhkedia@yahoo.com" class="auth_mail ; Piyush Kumar Sharma piyush020691@gmail.com" class="auth_mail ; Govind Makharia govindmakharia@gmail.com" class="auth_mail ; Vineet Ahuja ; vins_ahuja@hotmail.com" class="auth_mail
- 关键词：Ulcerative colitis ; NCB-02 ; Curcumin
- 刊名：Journal of Crohn's and Colitis
- 出版年：1 March, 2014
- 年：2014
- 卷：8
- 期：3
- 页码：208-214
- 全文大小：339 K
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.