title: Andrographis paniculata extract (HMPL-004) for active ulcerative colitis.
abstract: OBJECTIVE
  Andrographis paniculata has in vitro inhibitory activity against TNF-α, IL-1β and NF-κB. A pilot study of A. paniculata extract (HMPL-004) suggested similar efficacy to mesalamine for ulcerative colitis.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial evaluated the efficacy of A. paniculata extract (HMPL-004) in 224 adults with mild-to-moderate ulcerative colitis. Patients were randomized to A. paniculata extract (HMPL-004) 1,200 mg or 1,800 mg daily or placebo for 8 weeks.
  
  
  RESULTS
  In total, 45 and 60% of patients receiving A. paniculata 1,200 mg and 1,800 mg daily, respectively, were in clinical response at week 8, compared with 40% of those who received placebo (P=0.5924 for 1,200 mg vs. placebo and P=0.0183 for 1,800 mg vs. placebo). In all, 34 and 38% of patients receiving A. paniculata 1,200 mg and 1,800 mg daily, respectively, were in clinical remission at week 8, compared with 25% of those who received placebo (P=0.2582 for 1,200 mg vs. placebo and P=0.1011 for 1,800 mg vs. placebo). Adverse events developed in 60 and 53% of patients in the A. paniculata 1,200 mg and 1,800 mg daily groups, respectively, and 60% in the placebo group.
  
  
  CONCLUSIONS
  Patients with mildly to moderately active ulcerative colitis treated with A. paniculata extract (HMPL-004) at a dose of 1,800 mg daily were more likely to achieve clinical response than those receiving placebo.
authors.affiliation: University of California San Diego, La Jolla, CA 92093-0956, USA. wsandborn@ucsd.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Stephan R
authors.initials: SR
authors.lastname: Targan
authors.forename: Vera S
authors.initials: VS
authors.lastname: Byers
authors.forename: Dean A
authors.initials: DA
authors.lastname: Rutty
authors.forename: Hua
authors.initials: H
authors.lastname: Mu
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.forename: Tom
authors.initials: T
authors.lastname: Tang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D035685:Andrographis; D000089002:Andrographis paniculata; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D010936:Plant Extracts; C000713167:Andrographis paniculata extract