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

• Published in: Alimentary pharmacology & therapeutics 2011-01, Vol.33 (2), p.194-202
• Main Authors: Tang, T., Targan, S. R., Li, Z.‐S., Xu, C., Byers, V. S., Sandborn, W. J.
• Format: Article
• Language: English
• Subjects: Acanthaceae - chemistry; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Biological and medical sciences; China; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - physiopathology; Dietary Supplements; Digestive system; Double-Blind Method; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Mesalamine - therapeutic use; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Plant Preparations - therapeutic use; Severity of Illness Index; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Treatment Outcome; Young Adult
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2010.04515.x

Aliment Pharmacol Ther 2011; 33: 194–202 Summary 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.