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


OBJECTIVE
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.


CONCLUSIONS
HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.
Hutchison Medipharma Ltd., Shanghai, China. Tomt@hmplglobal.com
T
T
Tang
S R
SR
Targan
Z-S
ZS
Li
C
C
Xu
V S
VS
Byers
W J
WJ
Sandborn
D027901:Acanthaceae / Q000737:chemistry; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002681:China; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D028321:Plant Preparations / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D028321:Plant Preparations; D019804:Mesalamine