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Randomized double‐blind placebo‐controlled trial on the potential modes of action of sheaflex70 tm in osteoarthritis
Author(s) -
Cheras Phillip A.,
Myers Stephen P.,
PaulBrent PetaAnne,
Outerbridge Kerry H.,
Nielsen Gary V. L.
Publication year - 2010
Publication title -
phytotherapy research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.019
H-Index - 129
eISSN - 1099-1573
pISSN - 0951-418X
DOI - 10.1002/ptr.3075
Subject(s) - placebo , osteoarthritis , medicine , gastroenterology , quartile , randomized controlled trial , pathology , confidence interval , alternative medicine
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 TM , 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 TM 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 TM demonstrated multiple beneficial activities consistent with slowing the disease process. Copyright © 2009 John Wiley & Sons, Ltd.