Randomized Controlled Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. May 6, 2017; 8(2): 147-154
Published online May 6, 2017. doi: 10.4292/wjgpt.v8.i2.147
Low dose oral curcumin is not effective in induction of remission in mild to moderate ulcerative colitis: Results from a randomized double blind placebo controlled trial
Saurabh Kedia, Vikram Bhatia, Sandeep Thareja, Sushil Garg, Venigalla Pratap Mouli, Sawan Bopanna, Veena Tiwari, Govind Makharia, Vineet Ahuja
Saurabh Kedia, Sushil Garg, Venigalla Pratap Mouli, Sawan Bopanna, Veena Tiwari, Govind Makharia, Vineet Ahuja, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi 110029, India
Vikram Bhatia, Department of Gastroenterology, Institute of Liver and Biliary Sciences, New Delhi 110070, India
Sandeep Thareja, Department of Gastroenterology, Army Hospital - Research and Referral, New Delhi 110070, India
Author contributions: Ahuja V planned and conducted the study, collecting and interpreting data; Kedia S and Ahuja V drafted the manuscript; Garg S analyzed data; Kedia S, Bhatia V, Thareja S, Mouli VP, Bopanna S, Tiwari V and Makharia G critically revised the manuscript for important intellectual content and final approval of the manuscript; all authors have approved the final draft submitted.
Institutional review board statement: The study was reviewed and approved institute ethics committee at All India Institute of Medical Sciences, New Delhi.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Clinical trial registration statement: This trial was done from 2003 till 2005. Since there was no trial registry in India at that time, this trial did not have a registration number.
Conflict-of-interest statement: No conflict of interest for all authors.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Vineet Ahuja, Professor, Department of Gastroenterology, All India Institute of Medical Sciences, Room No. 3093, Third Floor, Teaching Block, AIIMS, New Delhi 110029, India. vins_ahuja@hotmail.com
Telephone: +91-11-26593300 Fax: +91-11-26588663
Received: October 17, 2016
Peer-review started: October 19, 2016
First decision: December 27, 2016
Revised: January 5, 2017
Accepted: March 12, 2017
Article in press: March 14, 2017
Published online: May 6, 2017
Processing time: 199 Days and 6.7 Hours
Abstract
AIM

To evaluate the role of oral curcumin in inducing clinical remission in patients with mild to moderate ulcerative colitis (UC).

METHODS

A prospective randomized double-blind placebo-controlled trial comparing the remission inducing effect of oral curcumin and mesalamine 2.4 g with placebo and mesalamine 2.4 g in patients of ulcerative colitis with mild to moderate severity was conducted from January 2003 to March 2005. The included patients received 1 capsule thrice a day of placebo or curcumin (150 mg) for 8 wk. Patients were evaluated clinically and endoscopically at 0, 4 and 8 wk. The primary outcome was clinical remission at 8 wk and secondary outcomes were clinical response, mucosal healing and treatment failure at 8 wk. The primary analysis was intention to treat worst case scenario (ITT-WCS).

RESULTS

Of 300 patients with UC, 62 patients (curcumin: 29, placebo: 33) fulfilled the inclusion criteria and were randomized at baseline. Of these, 21 patients did not complete the trial, 41 patients (curcumin: 16, placebo: 25) finally completed 8 wk. There was no significant difference in rates of clinical remission (31.3% vs 27.3%, P = 0.75), clinical response (20.7% vs 36.4%, P = 0.18), mucosal healing (34.5% vs 30.3%, P = 0.72), and treatment failure (25% vs 18.5%, P = 0.59) between curcumin and placebo at 8 wk.

CONCLUSION

Low dose oral curcumin at a dose of 450 mg/d was ineffective in inducing remission in mild to moderate cases of UC.

Keywords: Curcumin; Mesalamine; Ulcerative colitis; Ulcerative colitis disease activity index; Mucosal healing

Core tip: Not all patients with mild to moderate ulcerative colitis (UC) respond to available treatment options. Curcumin, an active ingredient of turmeric has anti-inflammatory properties and has been shown to play a protective role in chemically induced mouse models of inflammatory bowel disease and to reduce relapse rates in human UC. However, optimum dose ranging studies for curcumin in ulcerative colitis have not been performed. The present study shows that low dose curcumin (450 mg/d) is ineffective in inducing remission in mild to moderate ulcerative colitis. Therefore, higher doses with effective modes of delivery are required for optimal efficacy of curcumin.