title: Andrographis paniculata decreases fatigue in patients with relapsing-remitting multiple sclerosis: a 12-month double-blind placebo-controlled pilot study.
abstract: BACKGROUND
  Andrographis paniculata (A. paniculata), a medicinal plant, has shown anti-inflammatory, neuroprotective and antifibrotic effects in animal models as well as clinical efficacy in different studies, including an anti-fatigue effect in autoimmune diseases such as rheumatoid arthritis. In multiple sclerosis (MS), fatigue is rated as one of the most common and disabling symptoms. In the present trial, we investigated the effect of A. paniculata on relapse rate and fatigue in relapsing-remitting MS (RRMS) patients receiving interferon beta.
  
  
  METHODS
  A randomised double-blind placebo-controlled trial assessed the effects of 170 mg of A. paniculata dried extract tablet b.i.d. p.o. on relapse rate and fatigue using the Fatigue Severity Scores (FSS) over 12 months in RRMS patients receiving interferon. The Expanded Disability Status Scale (EDSS) score, inflammatory parameters and radiological findings were also investigated. Twenty-five patients were enrolled, and twenty-two patients were ultimately analysed and randomised to the active or placebo group.
  
  
  RESULTS
  Patients treated with A. paniculata showed a significant reduction in their FSS score as compared to the placebo, equivalent to a 44 % reduction at 12 months. No statistically significant differences were observed for relapse rate, EDSS or inflammatory parameters, with a trend in reducing new lesions among the A. paniculata group. One patient in the A. paniculata group presented with a mild and transient skin rash, which was alleviated with anti-histamine treatment for three weeks.
  
  
  CONCLUSIONS
  A. paniculata was well tolerated in patients and no changes in clinical parameters were observed. A. paniculata significantly reduces fatigue in patients with RRMS receiving interferon beta in comparison to placebo and only interferon beta treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02280876 ; Trial registration date: 20.10.2014.
authors.affiliation: Instituto de Medicina, Universidad Austral de Chile, Valdivia, Chile.
authors.forename: J C
authors.initials: JC
authors.lastname: Bertoglio
authors.affiliation: Departamento de Neurología, Hospital Regional de Valdivia, Valdivia, Chile.
authors.forename: M
authors.initials: M
authors.lastname: Baumgartner
authors.affiliation: Departamento de Neurología, Hospital Regional de Valdivia, Valdivia, Chile.
authors.forename: R
authors.initials: R
authors.lastname: Palma
authors.affiliation: Centro de Esclerosis Multiple, Facultad de Medicina, Pontificia Universidad Católica, Santiago, Chile.
authors.forename: E
authors.initials: E
authors.lastname: Ciampi
authors.affiliation: Centro de Esclerosis Multiple, Facultad de Medicina, Pontificia Universidad Católica, Santiago, Chile.
authors.forename: C
authors.initials: C
authors.lastname: Carcamo
authors.affiliation: Programa de Salud Ambiental, Escuela de Salud Pública, Facultad de Medicina, Universidad de Chile, Santiago, Chile.
authors.forename: D D
authors.initials: DD
authors.lastname: Cáceres
authors.affiliation: Instituto de Medicina Preventiva Veterinaria y Programa de Investigación Aplicada en Fauna Silvestre, Facultad de Ciencias Veterinarias, Universidad Austral de Chile, Valdivia, Chile.
authors.forename: G
authors.initials: G
authors.lastname: Acosta-Jamett
authors.affiliation: Instituto de Farmacología, Facultad de Ciencias Veterinarias, Universidad Austral de Chile, Valdivia, Chile.
authors.forename: J L
authors.initials: JL
authors.lastname: Hancke
authors.affiliation: Instituto de Farmacología, Facultad de Ciencias Veterinarias, Universidad Austral de Chile, Valdivia, Chile. rburgos1@uach.cl.
authors.forename: R A
authors.initials: RA
authors.lastname: Burgos
mesh_terms: D000293:Adolescent; D000328:Adult; D035685:Andrographis; D000818:Animals; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications* / Q000188:drug therapy*; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D016899:Interferon-beta
keywords: Andrographis paniculata; Fatigue; Multiple sclerosis