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4Orthopaedic Surgery, Mater Health Services, Brisbane, Queensland, Australia 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 benefi t 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 signifi cant decreases in infl ammation and cartilage breakdown and trend level decreases in bone remodeling in the SheaFlex70 TM group versus placebo between commencement and completion of the study. Infl ammation 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 signifi cant 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 fi ndings indicate that in patients with the highest levels of osteoarthritis biomarkers, SheaFlex70 TM demonstrated multiple benefi cial activities consistent with |
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