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Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial

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Abstract

Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) possesses anti-inflammatory effects, attributed to the main constituent andrographolide proposed as alternative in the treatment of autoimmune disease. A prospective, randomized, double blind, and placebo-controlled study in patients with rheumatoid arthritis (RA) was performed. Tablets (Paractin®) made of an extract of A. paniculata (30% total andrographolides) were administered three times a day for 14 weeks, after a 2-week washout period to 60 patients with active RA. The primary outcomes were pain intensity measured using a horizontal visual analog pain scale (VAPS). In addition, ACR, EULAR, and SF36 clinical parameters were recorded. The intensity of joint pain decreased in the active vs placebo group at the end of treatment, although these differences were not statistically significant. A significant diminishing for week in tender joint −0.13 95% confidence interval (CI; −0.22 to 0.06; p = 0.001), number of swollen joints −0.15 95%CI (−0.29 to −0.02; p = 0.02), total grade of swollen joint −0.27 95%CI (−0.48 to −0.07; p = 0.010), number of tender joints −0.25 95%CI (−0.48 to −0.02; p = 0.033), total grade of swollen joints −0.27 95%CI (−0.48 to −0.07; p = 0.01), total grade of tender joints −0.47 95%CI (−0.77 to −0.17; p = 0.002) and HAQ −0.52 95%CI (−0.82 to −0.21; p < 0.001) and SF36 0.02 95%CI (0.01 to 0.02; p < 0.001) health questionnaires was observed within the group with the active drug. Moreover, it was associated to a reduction of rheumatoid factor, IgA, and C4. These findings suggest that A. paniculata could be a useful “natural complement” in the treatment of AR; however, a larger trial and a more extended period of treatment is necessary in order to corroborate these results.

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Acknowledgments

The authors would like to thank Herbal Powers (Miami, USA) for providing the Andrographis paniculata extract (PARACTIN®), Mr. Andrea Giori INDENA SpA (Milano, Italy) for the HPLC and phytochemical characterization of the product, and Mrs. Paola Montenegro for her skillful administrative assistance and devoted concern for all patients of this study.

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Authors and Affiliations

  1. Institute of Pharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, P.O. Box 567, Valdivia, Chile

    R. A. Burgos & J. L. Hancke

  2. Institute of Medicine, Units of Immunology and Infectology, Faculty of Medicine, Universidad Austral de Chile, Valdivia, Chile

    J. C. Bertoglio & M. Calvo

  3. Unit of Critical Patients, Hospital Regional de Valdivia, Valdivia, Chile

    J. C. Bertoglio & M. Calvo

  4. Unit of Rheumatology, Institute of Medicine, Faculty of Medicine, Universidad Austral de Chile, Hospital Regional de Valdivia, Valdivia, Chile

    V. Aguirre

  5. Department of Medicine, Unit of Rheumatology, Hospital Regional de Osorno, Osorno, Chile

    S. Arriagada

  6. Division of Epidemiology, School of Public Health, Faculty of Medicine, Universidad de Chile, Independencia 939, Santiago, Chile

    D. D. Cáceres

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  1. R. A. Burgos
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  2. J. L. Hancke
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  3. J. C. Bertoglio
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  4. V. Aguirre
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  5. S. Arriagada
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  6. M. Calvo
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  7. D. D. Cáceres
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Corresponding authors

Correspondence to R. A. Burgos or D. D. Cáceres.

Additional information

Registration trial no. NCT00749645 (ClinicalTrials. Gov)

This work was financed by CONICYT/FONDEF D04I1240 grant and INNOVA CHILE CORFO 06FC01IPC-91, Patagonia Clinical Trial-CRO, Valdivia, Chile.

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Burgos, R.A., Hancke, J.L., Bertoglio, J.C. et al. Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Clin Rheumatol 28, 931–946 (2009). https://doi.org/10.1007/s10067-009-1180-5

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