Evidence map›Paper›PMID 23044768›Full record

Trial reportThe American journal of gastroenterology2013

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

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02273635 (Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis), which is not on this map. Cited by 58 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02273635 phase1 / phase2unknown statusnot on this mapstarted 2014, after this paper: background citation

Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis

TypeinterventionalSponsorInnobioscience SpARan2014 to 2017Enrolled68ConditionsPrimary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary ProgressiveArmsAndrographolides, placebo
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

William J SandbornUniversity of California San Diego, La Jolla, CA 92093-0956, USA. wsandborn@ucsd.edu
Stephan R Targan
Vera S Byers
Dean A Rutty
Hua Mu
Xun Zhang
Tom Tang

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAndrographis 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.

methodsA 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.

resultsIn 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.

conclusionsPatients 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.

Indexed as

AndrographisPhytotherapyAdministration, OralAdultAndrographis paniculataAnti-Inflammatory AgentsColitis, UlcerativeDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLogistic ModelsMaleMiddle AgedAndrographis paniculata extractAnti-Inflammatory AgentsPlant Extracts

Identifiers

PMID23044768
PMCPMC3538174

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.