Abstract
Background This study aimed to provide clinical information on general and joint performance from individuals taking Tregocel® (containing curcuminoid and extracts of the herbs Harpagophytum procumbens, Boswellia serrata, Apium graveolens, and Zingiber officinale) alongside a standard therapy of symptomatic mild knee osteoarthritis (OA). Methods This was a multicenter, open-label, prospective, single-arm study, in which Tregocel® was supplemented for 36 weeks. Participants with symptomatic mild knee OA requiring pharmacologic treatment for pain were enrolled. Physical performance (6-minute walk test, WOMAC-pain and functional domain, and heel-thigh distance flexion test), general performance (WOMAC questionnaire), and VAS (Visual Analogue Scale) assessment of knee pain, as well as anti-inflammatory and analgesic medication consumption, were assessed. Results Between January and April 2019, 107 participants were enrolled and analysed in per protocol population. Mean age was 59.7 (SD 10.8) years, and there were 68.2% women. Mean observation time was 291.1 (SD 7.7) days. Mean increase in 6MWT result observed at the end of the study was 26.0 (SD 30.4) m (p < 0.001). Median VAS score decreased from 60.0 (IQR 50–72) mm at the beginning of the study to 21.0 (IQR 14–30) mm after 36 weeks of product administration (p < 0.001). Regular knee OA medications were taken in 99.1% of subjects at baseline decreasing to 55.1% at the end of the Tregocel® supplementation. Conclusions During Tregocel® supplementation, participants observed improved functional capacity confirmed in the distance in 6MWT and in the heel-thigh distance flexion test, decreased level of pain, and improved WOMAC scores for all domains.
Highlights
Osteoarthritis (OA) is the predominant form of arthritis and often hands, knees, feet, and hips are involved
Data modelling from the 2017 Global Burden of Disease study estimated that there were about 303.1 million prevalent cases of hip and knee OA, with a 9.3% increase from 1990 to 2017 [1]
E lifetime risk of developing knee OA is estimated at about 46% [2], with an incidence that increases with age and affects more women than men
Summary
Osteoarthritis (OA) is the predominant form of arthritis and often hands, knees, feet, and hips are involved. Data modelling from the 2017 Global Burden of Disease study estimated that there were about 303.1 million (95% CI 273.3 to 338.6 million) prevalent cases of hip and knee OA, with a 9.3% increase from 1990 to 2017 [1]. E lifetime risk of developing knee OA is estimated at about 46% [2], with an incidence that increases with age and affects more women than men. E rapid increase in OA prevalence results in a growing impact and major challenges for healthcare systems. Is is very true when we realize that OA is frequently associated with disturbed sleep, depression, increased sedentary behaviour, less physical activity, obesity, and polypharmacy, leading to decreased quality of life and overall physical and mental performance. A proprietary form of CAM developed in Australia, Treatment of OA varies widely from lifestyle changes (e.g., weight reduction with exercise and diet), physical aids (e.g., canes or braces), physical therapies, and medications including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), Advances in Orthopedics corticosteroids, and/or complementary and alternative medicines (CAMs) [4,5,6,7].
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