Randomized double-blind placebo-controlled trial on the potential modes of action of SheaFlex70™ in osteoarthritis

Cheras, PA, Myers, SP, Paul-Brent, PA, Outerbridge, KH and Nielsen, GVL (2010) Randomized double-blind placebo-controlled trial on the potential modes of action of SheaFlex70™ in osteoarthritis. Phytotherapy Research, 24 8: 1126-1131. doi:10.1002/ptr.3075


Author Cheras, PA
Myers, SP
Paul-Brent, PA
Outerbridge, KH
Nielsen, GVL
Title Randomized double-blind placebo-controlled trial on the potential modes of action of SheaFlex70™ in osteoarthritis
Journal name Phytotherapy Research   Check publisher's open access policy
ISSN 0951-418X
1099-1573
Publication date 2010-08-01
Year available 2009
Sub-type Article (original research)
DOI 10.1002/ptr.3075
Open Access Status Not Open Access
Volume 24
Issue 8
Start page 1126
End page 1131
Total pages 6
Place of publication Bognor Regis, West Sussex, United Kingdom
Publisher John Wiley & Sons
Language eng
Formatted 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 SheaFlex70™, 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 SheaFlex70™ 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, SheaFlex70™ demonstrated multiple beneficial activities consistent with slowing the disease process. Copyright © 2009 John Wiley & Sons, Ltd.
Keyword Nutraceutical
Osteoarthritis
Biomarkers
Randomized controlled trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Published online 9 December 2009

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
School of Medicine Publications
 
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Created: Sun, 05 Sep 2010, 10:02:32 EST