Prospective, Multicenter Evaluation of a Polyherbal Supplement alongside Standard-of-Care Treatment for Mild Knee Osteoarthritis

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.

Improved Physical Function With Complementary Use of a Dietary Supplement for Mild Knee Osteoarthritis: A Subgroup Analysis

“…Logistic regression analysis showed increasing age (OR = 1.103; 95% CI = 1.022 -1.191), self-rated health worse than six months ago (OR = 12.562; 95% CI = 1.178 -125.243), experience of stiffness after waking up in the morning (OR = 12.758; 95% CI = 3.572 -45.569), stiffness after sitting/lying down/resting (OR = 21.517; 95% CI = 2.213 -209.220) and waist circumference (OR = 1.225; 95% CI = 1.017 -1.477) to be the most significantly associated with knee osteoarthritis. In our previous manuscript, we also observed similar problems in functional capacity, pain, and morning stiffness [6]. Therefore, in the present subgroup analysis, we verified whether Tregocel ® supplementation is effective regardless of the baseline functional capacity (distance in 6MWT) as well as the duration of knee OA.…”

“…The study conformed to the STROBE statement for reporting observational studies [11]. A detailed study description was provided earlier [6]. In short, this was a multicenter, open-label, non-randomized, single-arm study which included a 1-week screening/run-in period, followed by 36 weeks of Tregocel ® supplementation and a 4-week follow-up period after the last dose of supplementation.…”

“…Previously we focused on the overall results of clinical administration of a novel combination of standardized herbal actives (Tregocel ® ) administered in parallel with standard therapies to mild knee OA sufferers [6]. The product contains a patented, clinically trailed curcuminoid preparation (Meriva) and extracts of the herbs Harpagophytum procumbens, Boswellia serrata, Apium graveolens, and Zingiber officinale.…”

Efficacy of Herbal and Naturally-Derived Dietary Supplements for the Management of Knee Osteoarthritis: A Mini-Review

“…An exploratory study with Tregocel ® was performed in 2019 and assessed physical performance with a 6-minute walk test (6MWT) and WOMAC indeces in participants with symptomatic mild knee OA (up to grade 2), as well as the perception of pain, general performance, level of standard pharmacological treatment and basic safety parameters, performed according to a registered clinical trial protocol [58]. One hundred and seven subjects completed a 36-week intervention across eight clinical sites in Poland.…”

Clinical Study of Acupotomy for Knee Osteoarthritis Based on the Meridian-Sinew Theory: A Randomized Controlled Clinical Trial

“…Treatments aim to relieve symptoms and restore the function of knee joint [ 1 , 8 ]. One recent study shows that taking Tregocel® (containing curcuminoid and extracts of the herbs Harpagophytum procumbens , Boswellia serrata , Apium graveolens , and Zingiber officinale ) is helpful for mild knee osteoarthritis [ 9 ]. However, such medicines could cause undesirable drug-related adverse reaction in the skin, upper gastrointestinal tract, brain, and kidney and increase risk of cardiovascular disease, while intraarticular injection and surgery may lead to infection and trauma [ 10 , 11 ].…”