Andrographis paniculata extract (HMPL-004) for active ulcerative colitis (Am J Gastroenterol) - Oct 10, 2012 - P2, N=224; NCT00659802; 45% of pts receiving HMPL-004 1,200mg (p=0.5924) & 60% of pts receiving 1,800mg HMPL-004 (p=0.0183) daily, were in clinical response at wk 8 vs. 40% of pts receiving PBO; 34% of pts receiving HMPL-004 1,200mg (p=0.2582) & 38% of pts receiving 1,800mg (p=0.1011) daily dose were in clinical remission at wk 8 vs. 25% pts receiving PBO
P2 data • Immunology • Inflammatory Bowel Disease
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Am J Gastroenterol. 2012 Oct 9. doi: 10.1038/ajg.2012.340. [Epub ahead of print]
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OBJECTIVES: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.Am J Gastroenterol advance online publication, 9 October 2012; doi:10.1038/ajg.2012.340.
PMID: 23044768 [PubMed - as supplied by publisher]
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