The findings of the research, published in the peer reviewed journal Phytotherapy Research, showed that in participants with elevated levels of osteoarthritis (OA) biomarkers, who were taking SheaFlex70, there were significant decreases in inflammation and cartilage breakdown, in addition to trend level decreases in bone remodelling as compared to the control group over the duration of the study.
The study, which was conducted at the Australian Centre for Complementary Medicine Education and Research in Brisbane, received funding from BSP Pharma, the holder of the worldwide rights for the ingredient.
The researchers claim that the study was triggered by the fact that while extracts from the seed of the African shea tree Vitellaria paradoxa have traditionally been used for the treatment of arthritic conditions, little is known about the mechanisms by which benefit is conferred.
OA costs more than $60bn per year in the US and is second only to ischemic heart disease as a cause of work disability in men over 50, while approximately seven million people in the UK are reported to have long-term health problems associated with arthritis, where it also results in billions of euro of lost working days.
Commenting on the results, Tonny Jorgensen, CSO of BSP Pharma said that there is a profound need in the market for a new effective joint health ingredient, after 15 years with glucosamine and chondroitin.
The joint health market is dominated by glucosamine, often used in combination with chondroitin sulphate, with sales worth $810m (€563m) in 2005 in the US, according to the Nutrition Business Journal.
Jorgensen maintains that SheaFlex70 has the perfect profile to lift the joint health market to a much higher level. BSP Pharma said that the ingredient is currently being used in FlexNow Joint Formula, which sells in the US and Japan, and from the beginning of 2010 will also be on the maraket in Taiwan and Korea.
CEO Christian Buur said the active ingredient works within two to four weeks, and he claims this factor increases repurchase rates dramatically.
“We are looking for ways to expand the use of SheaFlex70 which includes finding new customers, brands, markets and uses of the ingredient,” he added.
The Australian research was conducted over a period of 15 weeks, and evaluated a range of biomarkers in 89 patients with OA of the knees and/or hips to determine potential modes of action of SheaFlex70.
After a minimum washout period of 3 weeks, participants were randomized to either placebo or SheaFlex70 once daily for 15 weeks, explained the researchers.
They said that blood and urine samples for safety and biomarker assays were taken at baseline, week 1, week 10, and week 15 and at the conclusion of the study, while between the start of the washout and completion of the study only investigator supplied paracetamol was allowed for additional pain relief, added the authors.
They said that eligible candidates had to over 18 years of age, to be in general good health and have X-ray and clinical evidence of OA in the hips or knees according to the American College of Rheumatology criteria.
The researchers added that participants were excluded if they had a history of trauma associated with the signal joint; rheumatoid or other inflammatory joint condition; gout; allergy to sheabutter; use of corticosteroids within four weeks prior to and throughout the study; or use of aspirin three weeks prior to for the duration of the study; or use of any other anti-arthritic complementary medicines six weeks prior to and for the duration of the study.
The results of the study showed that the inflammation marker TNF-alpha fell 23.9 per cent in the treatment group as compared to 6 per cent in the placebo group, while cartilage degradation marker CTX-II fell 28.7 per cent as compared toan increase of 17.6 per cent in the control.
And osteocalcin levels fell 9.2 per cent in the participants taking SheaFlex70 versus 1.2 per cent in the placebo participants, added the authors.
They concluded that their findings indicate that in patients with the highest levels of osteoarthritis biomarkers, SheaFlex70 demonstrated multiple beneficial activities consistent with slowing the disease process.
But the authors stress that these initial findings deserve further investigation in larger populations.
Source: Phytotherapy Research
Published online ahead of print: DOI: 10.1002/ptr.3075
Title: Randomized Double-Blind Placebo-Controlled Trial on the Potential Modes of Action of SheaFlex70 in Osteoarthritis
Authors: P. A. Cheras, S. P. Myers, P. Paul-Brent, K. H. Outerbridge, G. V. L. Nielsen