Max Biocare’s herbal formulation shown to reduce pain in people suffering from mild knee osteoarthritis
Tregocel is a polyherbal supplement containing Meriva curcumin, and extracts of frankincense, devil's claw, celery and ginger designed to support the health and function of joints with its anti-inflammatory and pain relief properties.
Besides joint health, it also claims to support the immune, digestive, liver and cardiovascular systems with its antioxidant properties.
This study is the first clinical trial of Tregocel in subjects with mild knee osteoarthritis. In such patients, pain is the main symptom for osteoarthritis, which is also associated with disturbed sleep, depression, increased sedentary behaviour, less physical activity, obesity, leading to decreased quality of life and overall physical and mental performance.
Osteoarthritis, especially in the knee and hip affect some 300 million worldwide, and current treatment consist of weight reduction, changing diets, using physical aids (e.g. canes, braces), physical therapies or use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or complementary and alternative medicines (CAMs).
Tregocel contains a patented curcuminoid preparation and extracts of the herbs Harpagophytum procumbens, Boswellia serrata, Apium graveolens, and Zingiber officinale.
“Natural therapies involving supplementation with curcuminoids, boswellic acids, ginger, harpagosides, and luteolin (a type of flavonoid compound of celery) have been demonstrated to support pain relief and physical performance in osteoarthritis,
“However, until now, these substances have not been evaluated clinically in a single dosage form or in the specific combination used in Tregocel,” researchers wrote in Advances in Orthopedics.
Methodology
A total of 107 participants from Poland were enrolled in this multicenter, open-label, prospective, single-arm study, which was funded by Max Biocare.
Most of them suffered from osteoarthritis for a median of 1.8 years, with the longest at 17.7 years.
Only participants with symptomatic mild knee osteoarthritis were recruited. They either felt pain in the target knee at least half of the days in the past month, or scored a maximal pain score ≥ 30 on a 100 mm VAS (Visual Analogue Scale) at screening, or used pain killers.
The study involved a screening period one week prior to the intervention, followed by 36 weeks of supplementation, and a four week follow-up period.
Visits were performed at baseline, week 12, week 24, week 36 and week 40.
Participants were told to take two tablets of Tregocel, once a day for 36 weeks.
The daily dose was equivalent to 1 g of curcuminoid-phospholipid complex (180mg curcumin), which is the primary active ingredient.
Tregocel contains a patented extract of curcuminoids in a phospholipid complex (trademarked as Meriva by Indena), which allows curcuminoids to be taken up by cell membranes and carried into the blood stream better. This improves its bioavailability and enhances the absorption of curcumin by 29 times.
It also contains 1g of Boswellia serrata (Indian frankincense) gum oleoresin extract, 1g of Harpagophytum procumbens (devil’s claw) tuber, 1g of Apium graveolens (celery) seed, and 330g of Zingiber officinale (ginger) rhizome.
During the study, participants were also allowed to take acetaminophen (paracetamol) or NSAIDs, but other steroids, glucosamine, vitamin, mineral, amino acid or related supplements were prohibited.
The primary outcome was a 6-minute walking test to assess physical performance.
The secondary outcome was perception of pain using the VAS (Visual Analogue Scale) assessment and consumption of medication to relieve pain.
Results
After 36 weeks of supplementation, researchers saw a significant improvement in the 6-minute walking test (p<0.001), from about 382m at baseline to 408m at the end of the study.
From the VAS scale, subjective pain levels also significantly decrease from baseline.
As a result, researchers also observed a decrease in the use of regular knee osteoarthritis medications. At baseline, 99.1% of patients regularly took anti-inflammatory/analgesic drugs, decreasing to 55.1% at the end of the study.
The findings suggest that Tregocel supplementation improved walking distance, reduced pain and improved general performance, with differences observed as early as after 12 weeks and improved even further with maximal effect at 36 weeks.
These results are encouraging and warrant verification in a randomised placebo-controlled study.
According to Max Biocare, the current study was originally designed as a randomised controlled trial.
“However, the ethic committee in Poland rejected it due to humanity/ethical aspect, as we target patients who are already in pain and old and are using other medications, so they were worried if the product doesn’t work it will cause more pain to the patients. Therefore, the study design was changed and it took a long time to get this study approved for running.”
“Maybe now that the product has been proven to be effective, some other Ethic Committees may approve a randomised control study. We have discussed the possibility of doing this study in Asian populations, but it will not be this year due to COVID-19.”
According to Francis Tang, regional sales lead, Asia at Max Biocare, the firm will tap onto the clinical findings in this trial to launch in New Zealand, Europe, Vietnam, and Indonesia over the next 24 months.
Source: Advances in Orthopedics
https://doi.org/10.1155/2021/5589597
“Prospective, Multicenter Evaluation of a Polyherbal Supplement alongside Standard-of-Care Treatment for Mild Knee Osteoarthritis”
Authors: Zbigniew Żęgota, et al.
