Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine

Aliment Pharmacol Ther. 2010 Nov 30. doi: 10.1111/j.1365-2036.2010.04515.x. [Epub ahead of print]

Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine.

Tang T, Targan SR, Li ZS, Xu C, Byers VS, Sandborn WJ.

Hutchison Medipharma Ltd., Shanghai, China. Cedars Sinai Medical Center, Los Angeles, CA, USA. Changhai Hospital, Second Military Medical University, Shanghai, China. Immunology Inc., Incline Village, NV, USA. Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.

Abstract

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.

© 2010 Blackwell Publishing Ltd.
PMID: 21114791 [PubMed - as supplied by publisher]