Andrographis paniculata extract (HMPL-004) for active ulcerative colitis

William J Sandborn, Stephan R Targan, Vera S Byers, Dean A Rutty, Hua Mu, Xun Zhang, Tom Tang, William J Sandborn, Stephan R Targan, Vera S Byers, Dean A Rutty, Hua Mu, Xun Zhang, Tom Tang

Abstract

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.

Figures

Figure 1
Figure 1
Enrollment and treatment through week 8.
Figure 2
Figure 2
Kaplan–Meier estimate of the proportion of patients free of clinical response as defined by the partial Mayo Score through 8 weeks for the combined Andrographis paniculata group, the A. paniculata 1,200 mg group, the A. paniculata 1,800 mg group, and the placebo group. ITT, intention-to-treat.

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Source: PubMed

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