Research Article

Randomized double-blind placebo-controlled trial on the potential modes of action of sheaflex70tm in osteoarthritis

  1. Phillip A. Cheras1,*,
  2. Stephen P. Myers1,
  3. Peta-Anne Paul-Brent2,
  4. Kerry H. Outerbridge3,
  5. Gary V. L. Nielsen4

Article first published online: 9 DEC 2009

DOI: 10.1002/ptr.3075

Issue

Phytotherapy Research

Phytotherapy Research

Volume 24, Issue 8, pages 1126–1131, August 2010

Additional Information

How to Cite

Cheras, P. A., Myers, S. P., Paul-Brent, P.-A., Outerbridge, K. H. and Nielsen, G. V. L. (2010), Randomized double-blind placebo-controlled trial on the potential modes of action of sheaflex70tm in osteoarthritis. Phytotherapy Research, 24: 1126–1131. doi: 10.1002/ptr.3075

Author Information

  1. 1

    NatMed-Research, School of Health and Human Sciences, Southern Cross University, Lismore, New South Wales, Australia

  2. 2

    The Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia

  3. 3

    Division of Orthopaedics, Greenslopes Private Hospital, Brisbane, Queensland, Australia

  4. 4

    Orthopaedic Surgery, Mater Health Services, Brisbane, Queensland, Australia

*Correspondence: Phillip A. Cheras, Adjunct Associate Professor, NatMed-Research, The Natural and Complementary Medicine Research Unit, School of Health and Human Sciences, Southern Cross University, Military Rd, Lismore NSW 2480, Australia

Publication History

  1. Issue published online: 9 DEC 2009
  2. Article first published online: 9 DEC 2009
  3. Manuscript Accepted: 19 OCT 2009
  4. Manuscript Revised: 18 OCT 2009
  5. Manuscript Received: 10 DEC 2008

Funded by

  • This study was conducted independently by a University-based group (University of Queensland and Southern Cross University) and the Australian Centre for Complementary Medicine Education and Research (ACCMER) through a sponsorship grant from BSP Pharma Inc. All authors contributed on this basis

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Keywords:

  • nutraceutical;
  • osteoarthritis;
  • biomarkers;
  • randomized controlled trial

Abstract

Extracts from the seed of the African shea tree Vitellaria paradoxa C.F. Gaertn have been used traditionally for the treatment of arthritic conditions. However, little is known about the mechanisms by which benefit is conferred. This single-site, 15-week randomized, double-blind, parallel, placebo-controlled study examined a range of biomarkers in 89 patients with osteoarthritis of the knees and/or hips to determine potential modes of action of SheaFlex70TM, a triterpene-rich extract of Vitellaria paradoxa. In the group of participants with levels of osteoarthritis biomarkers in the upper quartile at baseline, there were significant decreases in inflammation and cartilage breakdown and trend level decreases in bone remodeling in the SheaFlex70TM group versus placebo between commencement and completion of the study. Inflammation marker TNF-alpha fell 23.9% vs 6% (treatment vs placebo), p = 0.041. Cartilage degradation marker CTX-II fell 28.7% vs an increase of 17.6% (treatment vs placebo), p = 0.018. This marker also showed significant falls across the entire study group, 10.6% vs an increase of 11.6%, (treatment vs placebo), p = 0.016. Osteocalcin levels fell 9.2%, p = 0.014 (treatment) vs 1.2%, ns (placebo), p = 0.096 (treatment vs placebo). These findings indicate that in patients with the highest levels of osteoarthritis biomarkers, SheaFlex70TM demonstrated multiple beneficial activities consistent with slowing the disease process. Copyright © 2009 John Wiley & Sons, Ltd.

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