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


ABSTRACT:

Objectives

Andrographis paniculata has in vitro inhibitory activity against TNF-?, IL-1? and NF-?B. 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.

SUBMITTER: Sandborn WJ 

PROVIDER: S-EPMC3538174 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Sandborn William J WJ   Targan Stephan R SR   Byers Vera S VS   Rutty Dean A DA   Mu Hua H   Zhang Xun X   Tang Tom T  

The American journal of gastroenterology 20121009 1


<h4>Objectives</h4>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.<h4>Methods</h4>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 pla  ...[more]

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