Experience with the use of undenatured type II collagen in patients with stage III knee osteoarthritis: a multicenter, prospective, double-blind, placebo-controlled, randomized trial

Introduction. Current strategies for treating osteoarthritis (OA) are based on a multimodal approach that includes pharmacological and non- pharmacological methods. Undenatured chicken collagen type II (NK2) is considered safe and effective for maintaining joint health and can be used alone and combined with drugs for OA treatment. Aim. To further evaluate the efficacy of the combination of Artneo containing NK2 in patients with stage III knee OA compared with placebo in a multicenter, prospective, double-blind, placebo-controlled, randomized trial. Materials and methods. The study included 212 patients from 12 centers in the Russian Federation, of whom 50 had radiological stage III knee OA: 41 (82.0%) females and 9 (18.0%) males aged 44 to 75. Using the interactive web response system (IWRS), the study population was randomized into two groups: Group 1 (Artneo group) included 28 patients receiving the drug 1 capsule once a day for 180 days, Group 2 (placebo group) included 22 patients receiving placebo with drug-matched presentation and the same regimen as in Group 1. The effectiveness of therapy was assessed by the change of pain using the Visual Analog Scale, the WOMAC index, KOOS, the EQ-5D quality of life questionnaire, and the need for non-steroidal anti-inflammatory drugs. All patients had a complete blood count, urinalysis, blood chemistry, and ultrasonic examination of the target knee joint. Results. A prospective, double-blind, placebo-controlled, randomized trial demonstrated that Artneo containing NK2 was significantly superior to placebo in all studied parameters, improved all clinical manifestations of OA: reduced pain and stiffness, improved joint function and quality of life, and had a good safety profile. Conclusion. Artneo showed high efficacy and safety in the general population of patients, including those with stage III knee OA.