Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis – a double-blind comparison with sustained release mesalazine
Article first published online: 30 NOV 2010
© 2010 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 33, Issue 2, pages 194–202, January 2011
How to Cite
Tang, T., Targan, S. R., Li, Z.-S., Xu, C., Byers, V. S. and Sandborn, W. J. (2011), Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis – a double-blind comparison with sustained release mesalazine. Alimentary Pharmacology & Therapeutics, 33: 194–202. doi: 10.1111/j.1365-2036.2010.04515.x
- Issue published online: 14 DEC 2010
- Article first published online: 30 NOV 2010
- Publication data Submitted 17 March 2010 First decision 7 April 2010 Resubmitted 30 October 2010 Accepted 1 November 2010 EV Pub Online 30 November 2010
Aliment Pharmacol Ther 2011; 33: 194–202
Background Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, and prevents colitis in animal models.
Aim To determine the efficacy and safety of HMPL-004 in patients with mild-to-moderate ulcerative colitis.
Methods A randomised, double-blind, multicentre, 8-week parallel group study was conducted using HMPL-004 1200 mg/day compared with 4500 mg/day of slow release mesalazine (mesalamine) granules in patients with mild-to-moderately active ulcerative colitis. Disease activity was assessed at baseline and every 2 weeks for clinical response, and at baseline and 8 weeks by colonoscopy.
Results One hundred and twenty patients at five centres in China were randomised and dosed. Clinical remission and response were seen in 21% and 76% of HMPL-004-treated patients, and 16% and 82% of mesalazine-treated patients. By colonoscopy, remission and response were seen in 28% and 74% of HMPL-004-treated patients and 24% and 71% of mesalazine-treated patients, respectively. There was no significant difference between the two treatment groups.
Conclusion HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.