Efficacy and safety of undenatured type II collagen in patients with knee osteoarthritis: a multicenter, prospective, double-blind, placebo-controlled, randomized trial

Author:

Alekseeva Liudmila I.1ORCID,Kashevarova Natalia G.1ORCID,Taskina Elena A.1ORCID,Strebkova Ekaterina A.1ORCID,Korotkova Tatiana A.1ORCID,Sharapova Evgeniia P.1ORCID,Savushkina Natalya M.1ORCID,Lila Aleksander M.1ORCID,Shostak Nadezhda A.2ORCID,Mazurov Vadim I.345ORCID,Nesterovich Irina I.67ORCID,Dedkova Viktoriia A.8,Vasilyuk Vasiliy B.8ORCID,Egorova Natalia V.9,Leontyeva Marina A.10,Yakupova Svetlana P.11ORCID,Vinogradova Irina B.12ORCID,Sorotskaya Valentina N.13ORCID,Shirokova Larisa Yu.1415

Affiliation:

1. Nasonova Research Institute of Rheumatology

2. Pirogov Russian National Research Medical University

3. Mechnikov North-Western State Medical University

4. Clinical Rheumatology Hospital No. 25

5. Medical and Sanitary Unit No. 157 LLC

6. Pavlov First Saint Petersburg State Medical University

7. Meili LLC

8. Research Center “Eco-safety” LLC

9. Санкт-Петербург

10. Zvezdnaya Clinic LLC

11. Kazan State Medical University

12. Ulyanovsk Regional Clinical Hospital

13. Tula State University

14. Yaroslavl State Medical University

15. Institute of Professional Training

Abstract

Background. Non-pharmacological treatments based on collagen as a dietary supplement are emerging as a new area of interest to support preventive or therapeutic effects in patients with osteoarthritis (OA). Aim. In a multicenter, prospective, double-blind, placebo-controlled, randomized study, to evaluate the effectiveness and safety of the use of the Artneo complex containing undenatured chicken collagen type II in patients with OA of the knee joints. Materials and methods. The study enrolled 212 outpatients from 12 centers in the Russian Federation with knee OA, stages II and III according to the Kellgren–Lawrence classification. The participants included 171 women (80.7%) and 41 men (19.3%), with an average age of 60.2±9.0 years (range: 40 to 75 years). The study population was randomly allocated in equal proportions into two groups using an interactive web response system (IWRS). Group 1 (Artneo) consisted of 106 patients who took one capsule of the drug once daily for 180 days. Group 2 (Placebo) also had 106 patients, with the dosage form and regimen identical to Group 1. During the treatment period, the following outcomes were assessed: WOMAC index, KOOS, pain according to VAS, quality of life using the EQ-5D questionnaire, and the need for NSAIDs. All patients underwent a clinical blood test, general urine analysis, biochemical blood test, and ultrasound examination of the affected knee joint. Results. In a prospective, double-blind, placebo-controlled, randomized study, it was demonstrated that the Artneo combination, containing undenatured chicken collagen type II, has a positive effect on all clinical manifestations of OA: it effectively reduces pain, stiffness, and improves the functional state of joints and quality of life. It has a good safety profile and is superior to placebo in all parameters studied. Conclusion. The results of the study confirm the good effectiveness and safety of the Artneo combination in patients with OA of the knee joints.

Publisher

Consilium Medicum

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