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

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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.

About the authors

Liudmila I. Alekseeva

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-7017-0898

доктор мед. наук, нач. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Natalia G. Kashevarova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8732-2720

кандидат мед. наук, науч. сотр. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Elena A. Taskina

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8218-3223

кандидат мед. наук, ст. науч. сотр. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Ekaterina A. Strebkova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8130-5081

кандидат мед. наук, науч. сотр. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Tatiana A. Korotkova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-0394-9249

кандидат мед. наук, зав. 1-м ревматологическим отд-нием с терапевтическими койками

Russian Federation, Moscow

Evgeniia P. Sharapova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-4242-8278

кандидат мед. наук, науч. сотр. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Natalya M. Savushkina

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8562-6077

кандидат мед. наук, науч. сотр. отд. метаболических заболеваний костей и суставов

Russian Federation, Moscow

Aleksander M. Lila

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-6068-3080

чл.-кор. РАН, доктор мед. наук, проф., директор

Russian Federation, Moscow

Nadezhda A. Shostak

Pirogov Russian National Research Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-4669-1006

доктор мед. наук, проф., почет. проф., профессор кафедры факультетской терапии им. акад. А.И. Нестерова лечебного факультета

Russian Federation, Moscow

Vadim I. Mazurov

Mechnikov North-Western State Medical University; Clinical Rheumatology Hospital No. 25; Medical and Sanitary Unit No. 157 LLC

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-0797-2051

акад. РАН, доктор мед. наук, проф., гл. науч. конс., директор Научно-исследовательского института ревматологии, зав. каф. терапии, ревматологии, экспертизы временной нетрудоспособности и качества медицинской помощи им. Э.Э. Эйхвальда, рук. Центра аутоиммунных заболеваний

Russian Federation, Saint Petersburg; Saint Petersburg; Saint Petersburg

Irina I. Nesterovich

Pavlov First Saint Petersburg State Medical University; Meili LLC

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-3199-9537

доктор мед. наук, проф. каф. госпитальной терапии им. акад. М.В. Черноруцкого с клиникой, рук. отд. кардио-ревматологии НИИ ревматологии и аллергологии научно-клинического исследовательского центра

Russian Federation, Saint Petersburg; Saint Petersburg

Viktoriia A. Dedkova

Research Center “Eco-safety” LLC

Email: nat-kash@yandex.ru

врач-терапевт

Russian Federation, Saint Petersburg

Vasiliy B. Vasilyuk

Research Center “Eco-safety” LLC

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-2503-4402

доктор мед. наук, профессор, рук. госпиталя

Russian Federation, Saint Petersburg

Natalia V. Egorova

Health Energy LLC

Author for correspondence.
Email: nat-kash@yandex.ru

глав. врач

Russian Federation, Saint Petersburg

Marina A. Leontyeva

Zvezdnaya Clinic LLC

Email: nat-kash@yandex.ru

врач-кардиолог отд. клинических исследований

Russian Federation, Saint Petersburg

Svetlana P. Yakupova

Kazan State Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-8590-4839

кандидат мед. наук, доц. каф. госпитальной терапии

Russian Federation, Kazan

Irina B. Vinogradova

Ulyanovsk Regional Clinical Hospital

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-5052-912X

кандидат мед. наук, зав. ревматологическим центром

Russian Federation, Ulyanovsk

Valentina N. Sorotskaya

Tula State University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-3684-7310

доктор мед. наук, проф. каф. внутренних болезней

Russian Federation, Tula

Larisa Yu. Shirokova

Yaroslavl State Medical University; Institute of Professional Training

Email: nat-kash@yandex.ru

доктор мед. наук, проф. каф. госпитальной терапии с профпатологией

Russian Federation, Yaroslavl; Yaroslavl

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2. Fig. 1. Change over time of a decrease in the WOMAC pain score (WOMAC-A) and its change from the start of supplement/placebo compared to the baseline. The plot show medians: *p<0.05 when compared between groups (U – criterion Mann–Witney); **p<0.01 when compared between groups (Mann–Whitney U-test).

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3. Fig. 2. Change over time of a decrease in the WOMAC stiffness score (WOMAC-B) and its change from the start of supplement/placebo compared to the baseline. The plot show medians.

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4. Fig. 3. Change over time of a decrease in the WOMAC functional deficit score (WOMAC-C) and its change from the start of supplement/placebo compared to the baseline. The plot show medians.

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5. Fig. 4. Change over time of a decrease in the total WOMAC score (WOMAC-T) and its change from the start of supplement/placebo compared to the baseline. The plot show medians.

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6. Fig. 5. Change over time of a change in the KOOS score and its change from the start of supplement/placebo compared to the baseline. The plot show medians.

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7. Fig. 6. Patients who met the efficacy criteria according to the WOMAC scale on B7, %; *p<0,05, **p<0,01 when compared between groups (two-sided Fisher's exact test)

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