Evaluation of the effect of a combination of glucosamine and chondroitin sulfate supplemented with native (undenatured) type 2 collagen, ginger extract, B vitamins, and ascorbic acid on the clinical manifestations of different phenotypes of osteoarthritis

Objective. To evaluate the efficacy and safety of Teraflex Ultra compared with Teraflex® in patients with different phenotypes of osteoarthritis (OA). Material and methods. A prospective comparative randomized study included 80 women aged 40–75 years with a confirmed diagnosis of knee OA (Kellgren–Lawrence stages I–III) and pain on walking ≥40 mm on a visual analogue scale (VAS). The study duration was 9 months (6 months of treatment and 3 months of follow-up). Patients were randomized into two groups. Group 1 (n=40) received Theraflex Ultra orally, 2 capsules twice daily. Group 2 (n=40) received Theraflex® orally, 1 capsule three times daily for 3 weeks, followed by 1 capsule twice daily. All patients were allowed to take nonsteroidal anti-inflammatory drugs (NSAIDs) as required: Theraleve 275 (naproxen) up to 3 tablets per day. Treatment efficacy was assessed by changes in pain intensity on the VAS, WOMAC index, KOOS scale, and EQ-5D quality-of-life questionnaire. Results and discussion. The trial demonstrated efficacy of pharmaconutraceutical and the drug in reducing pain on walking (VAS), total WOMAC and its subscales, as well as improving KOOS and EQ-5D scores (p<0.05). However, a more pronounced and rapid clinical effect was observed in the Theraflex Ultra group. Significant differences between the groups were found in the following parameters: pain on the VAS and KOOS after 1 month of therapy (38 [26; 47] vs. 44.5 [37; 53] mm, p=0.02 and 61 [56; 72] vs. 56 [44; 68]%, p=0.04, respectively); pain on the WOMAC after 1, 3, and 9 months (149 [114; 196] vs. 197 [122.5; 254] mm, p=0.036; 104 [57; 172] vs. 158.5 [91.5; 253] mm, p=0.037; 66.5 [39; 106] vs. 111.5 [44.5; 170.5] mm, p=0.04); stiffness on the WOMAC after 1, 3, and 9 months (68 [35; 90] vs. 85 [53; 110.5] mm, p=0.04; 42.5 [18; 79] vs. 77 [25; 102] mm, p=0.03; 24.5 [15; 51] vs. 43.5 [17; 86] mm, p=0.04); functional impairment and total WOMAC after 9 months (252 [148; 440] vs. 417 [159; 705] mm, p=0.02 and 326.5 [243; 543] vs. 555.5 [240; 914.5] mm, p=0.03). Conclusion. The results indicate that Theraflex Ultra provides a faster and more pronounced clinical effect compared with Theraflex® in patients with different phenotypes of OA.