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

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dc.contributor.authorCiampi, Ethel
dc.contributor.authorUribe-San-Martin, Reinaldo.
dc.contributor.authorCárcamo Rodríguez, Claudia Andrea
dc.contributor.authorCruz, Juan Pablo
dc.contributor.authorReyes, Ana.
dc.contributor.authorReyes, Diego.
dc.contributor.authorPinto, Carmen.
dc.contributor.authorVásquez Torres, Macarena.
dc.contributor.authorBurgos, Rafael A.
dc.contributor.authorHancke, Juan.
dc.date.accessioned2020-05-14T19:22:31Z
dc.date.available2020-05-14T19:22:31Z
dc.date.issued2020
dc.date.updated2020-05-14T07:24:33Z
dc.description.abstractAbstract Background Multiple 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. Methods A 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. Results Forty-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. Conclusions AP 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 registration ClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.
dc.identifier.citationBMC Neurology. 2020 May 07;20(1):173
dc.identifier.doi10.1186/s12883-020-01745-w
dc.identifier.urihttps://doi.org/10.1186/s12883-020-01745-w
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/28912
dc.issue.numeroNo. 173
dc.language.isoen
dc.pagina.final10
dc.pagina.inicio1
dc.revistaBMC Neurologyes_ES
dc.rightsacceso abierto
dc.rights.holderThe Author(s)
dc.subjectMultiple sclerosises_ES
dc.subjectProgressive multiple sclerosises_ES
dc.subjectAndrographolidees_ES
dc.subjectBrain atrophyes_ES
dc.subjectDisability progressiones_ES
dc.subject.ddc616.834
dc.subject.deweyMedicina y saludes_ES
dc.titleEfficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled triales_ES
dc.typeartículo
dc.volumenVol. 20
sipa.codpersvinculados132794
sipa.codpersvinculados127201
sipa.codpersvinculados562
sipa.codpersvinculados17836
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