Triterpenes from the shea nut, an emerging natural treatment for osteoarthritis and other joint problems, can greatly reduce markers of inflammation and cartilage breakdown, according to a new study by Dr. Philip Cheras, director of the Australian Centre for Complementary Medicine Education and Research (ACCMER), Brisbane.
Dr. Cheras is the major proponent of a new model of arthritis pathogenesis, one that posits a propensity toward clotting, blockage of joint microvasculature, and impaired circulation as key drivers of the disease (join www.holisticprimarycare.net and read The Vascular Roots of Osteoarthritis). He has also pioneered research into the clinical application of shea triterpenes, available as a proprietary formula called FlexNow Joint Formula (BSP Pharma) as a non-pharmaceutical option for OA patients.
Shea (Butyrospermum parkii) is a tree found widely throughout West Africa. Its oil-rich nuts contain a number of compounds that can down-regulate inflammatory mediators; it can also reduce total cholesterol as well as LDL.
Dr. Cheras and colleagues have been studying a cohort of 89 individuals with clinical signs and x-ray evidence of osteoarthritis of the knees and/or hips. They were randomized to treatment with the FlexNow Joint Formula, a 100% shea oil extract containing approximately 75% shea triterpene esters, or a placebo of 100% food grade canola oil identically encapsulated. The patients took a daily dose of three 750 mg capsules of the shea extract or the canola oil every morning for a total of 15 weeks.
In addition to assessing symptom severity, the investigators measured a number of biomarkers of inflammation, collagen breakdown, and bone metabolism, including C-telopeptide fragments of type II collagen (CTX-II), TNF-α, IL-6, and osteocalcin. Compared with the placebo-treated group, those treated with FlexNow had consistently lower measures of all of these.
The most striking finding was a mean 31% reduction in CTX-II, an indicator of type II collagen breakdown and a reliable biomarker of impaired joint function. CTX-II levels are significantly elevated in most patients with OA and damaged joints. In essence, CTX-II is a marker of cartilage deterioration, and CTX-II levels correlate with disease progression.
Dr. Cheras said that FlexNow is the first non-pharmaceutical product to show clinically meaningful reductions in CTX-II. At baseline, all 89 patients in the study had markedly elevated CTX-II levels prior to treatment. After 15 weeks, the FlexNow group showed a mean 31% reduction, with many returning to normal range. Placebo-treated patients generally showed no change in CTX-II.
An earlier study of the effect of glucosamine on CTX-II showed no difference between glucosamine supplementation and placebo. Comparatively, FlexNow, in 15 weeks, was 44% more effective than glucosamine was in a year in reducing cartilage breakdown, Dr. Cheras said.
Participants with above-average levels of major inflammatory markers at baseline showed significant reductions after treatment with the shea extract. TNF-α, which is strongly associated with cartilage breakdown and joint impairment, fell by a mean of 17% in the shea-treated patients versus those on placebo.
High sensitivity C-reactive protein (hs-CRP), a marker of low grade systemic inflammation, also showed a mean 12% drop in the FlexNow versus the placebo groups. This marker is typically elevated in OA and other inflammatory joint conditions, and it correlates with pain severity. The FlexNow group also showed a 17.6% drop in IL-6, compared with the placebo group.
These changes in objective measurements correlated well with significant reductions in the pain subscale of the Comprehensive Osteoarthritis Test (COAT), by week 15.
Osteocalcin, the bone-generated hormone that recently grabbed headlines when Columbia University researchers discovered its role in regulating glucose metabolism, is also an important marker of bone turnover. It has relevance in the context of OA and joint impairment because these patients typically show increases in bone formation within the affected joints, and many have abnormally increased osteocalcin levels.
In arthritic joints, new bone forms around islands of dead bone. Over time, this increases bone density within the joint, leading to increased stiffness and increased biomechanical damage to the overlying cartilage, explained Dr. Cheras. The remodeling process—removal of necrotic bone and replacement with new bone—increases osteocalcin levels, which correlate with symptom severity.
Compared with placebo, FlexNow produced a mean 7.75% reduction in osteocalcin—a small but statistically significant difference—in the patients who had above-average osteocalcin levels at baseline. It showed no osteocalcin effect on those with normal baseline measurements. The decrease in serum osteocalcin is consistent with the clinical benefits observed.
“It is highly likely although unproven, that the decrease in osteocalcin that we see in this subgroup but not observed in the folks with average and below average levels of osteocalcin, is a beneficial and stabilising/normalising effect that helps restore balance in an otherwise out of balance bone deposition situation,” Dr. Cheras told Holistic Primary Care.
The recently reported connection between osteocalcin and glucose metabolism begs the question of whether use of the shea nut product would have potentially adverse effects in patients with diabetes or insulin resistance.
Probably not, said Dr. Cheras. “I do not think there are any conclusions that can be drawn from our findings in relation to type II diabetes, except for the obvious one that improving diabetic patients’ osteoarthritis will make them more mobile and thereby more capable of controlling their diabetes through increased physical exercise. I think any other conclusions at this stage would be a gross over-interpretation of the data.”
In assessing the clinical impact of FlexNow, Dr. Cheras and his colleagues also assessed markers of renal, hepatic and hemostatic function. They observed no detrimental changes in connection with daily intake of the shea triterpene formula. Neither were there any significant adverse effects.
“FlexNow is safe and is not associated with any more adverse effects than placebo over 15 weeks of treatment,” said Dr. Cheras, who has no financial relationship with the company that manufactures and markets the formula. “However, it is associated with marked clinical benefit as measured by a significant reduction in pain and other clinical outcome measures. Maximum efficacy appeared to have not been reached by the end of the15-week study period.”
He added that the product holds great promise for patients with severe joint problems who show above-average levels of markers of cartilage breakdown and joint inflammation. The triterpene formula appears to reduce inflammation, collagen breakdown, and bone turnover.
Dr. Cheras’ data has been submitted for publication in an upcoming edition of the journal, Osteoarthritis and Cartilage, the official journal of the Osteoarthritis Research Society International and the International Cartilage Repair Society.