Evidence map›Paper›PMID 32380977›Full record

Trial reportBMC neurology2020

Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial.

Ethel Ciampi, Reinaldo Uribe-San-Martin, Claudia Cárcamo, Juan Pablo Cruz, Ana Reyes, Diego Reyes, Carmen Pinto, Macarena Vásquez, Rafael A Burgos, Juan Hancke

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2020. 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 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
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 map

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

18 citing papers in PubMed, 48 citations in OpenAlex.

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  17. Life (Basel, Switzerland) · 2021
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Ethel CiampiNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ethelciampi@gmail.com.ORCID http://orcid.org/0000-0002-7330-5433
Reinaldo Uribe-San-MartinNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Claudia CárcamoNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ccarcamo@med.puc.cl.
Juan Pablo CruzRadiology, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Ana ReyesNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Diego ReyesNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Carmen PintoNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Macarena VásquezNeurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.
Rafael A BurgosPharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.
Juan HanckePharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.
Pontificia Universidad Católica de Chile · CLAustral University of Chile · CL

Funding

Corporación de Fomento de la Producción 14PIE-26946
6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS.

methodsA pilot clinical trial using 140 mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change.

resultsForty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was - 0.679% for the AP group and - 1.069% for the placebo group (mean difference: -0.39; 95% CI [- 0.836-0.055], p = 0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200-1.777], p = 0.06). The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (mean difference: 0.63, p = 0.042). Adverse events related to AP were mild rash and dysgeusia.

conclusionsAP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial.

trial registrationClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.

Indexed as

AgedAndrographisAnti-Inflammatory Agents, Non-SteroidalBrainDisease ProgressionDiterpenesDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedMultiple SclerosisMultiple Sclerosis, Chronic ProgressivePhytotherapyPilot ProjectsandrographolideAnti-Inflammatory Agents, Non-SteroidalDiterpenesAndrographolideBrain atrophyDisability progressionMultiple sclerosisProgressive multiple sclerosis

Identifiers

PMID32380977
PMCPMC7203851
OpenAlexW3020875755

What OpenQuestion holds

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LicenceCC BY
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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.