Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis – a double-blind comparison with sustained release mesalazine
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Summary
Background
Andrographis paniculatais an herbal mixture used to treat inflammatory diseases.An extract of the herb, HMPL-004, inhibits TNF-aand IL-1b,andprevents colitis in animal models.
Aim
To determine the efficacy and safety of HMPL-004 in patients with mildto-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-tomoderately 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.
Source: https://pubmed.ncbi.nlm.nih.gov/21114791/
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