Comparative efficacy of a combination of undenatured type II collagen, Boswellic acids, methylsulfonylmethane, vitamins C and D3 and a combination of chondroitin sulfate and glucosamine hydrochloride in the treatment of primary osteoarthritis of the knee joint

Cover Page

Cite item

Full Text

Abstract

Aim. To evaluate the efficacy of Artneo (AN) in comparison with a combination of glucosamine hydrochloride and chondroitin sulfate (GC) in patients with osteoarthritis (OA) of the knee joint (KJ).

Materials and methods. 70 patients with stages I–III of primary knee OA were randomized into 2 groups. Participants in the 1st (n=35) took AN 1 caps/day, in the 2nd (n=35) GC according to the standard regimen. After 7, 30, 90, 180 days, the Lequesne index (severity of OA), pain when moving according to VAS, WOMAC score were assessed, after 1, 3, 6 months – quality of life SF-36 and morning stiffness, after 6 months – MRI with T2 mapping, laboratory safety indicators.

Results. Over the course of 6 months of use, an improvement in the WOMAC index and a decrease in pain were observed without intergroup differences, and a greater decrease in stiffness in the AN group. After 3 months, the severity of OA decreased from moderate to mild in the AN group and was significantly lower compared to the GC group; quality of life (physical component of SF-36) was higher in the AN group. After 6 months, there was an improvement in cartilage ultrastructure (T2 relaxation time) in both groups and a more pronounced reduction of the synovitis area (MRI) in the AN group (2.95 and 1.37 times in the AN and GC group, respectively). There were no clinically significant adverse reactions observed in both groups.

Conclusion. The use of AN in patients with stage I–III primary knee OA was not inferior in efficacy to the combination of GC. Further studies with greater statistical power (sample size) and follow-up period are warranted including in real clinical practice.

About the authors

Vadim I. Mazurov

Mechnikov North-Western State Medical University; Clinical Rheumatology Hospital 25

Email: belib@mail.ru
ORCID iD: 0000-0002-0797-2051
SPIN-code: 6823-5482
Scopus Author ID: 16936315400

акад. РАН, д-р мед. наук, проф., гл. науч. консультант, дир. Научно-исследовательского института ревматологии, зав. каф. терапии, ревматологии, экспертизы временной нетрудоспособности и качества медицинской помощи им. Э.Э. Эйхвальда ФГБОУ ВО «СЗГМУ им. И.И. Мечникова», рук. Центра аутоиммунных заболеваний СПб ГБУЗ «КРБ №25»

Russian Federation, Saint Petersburg; Saint Petersburg

Irina B. Belyaeva

Mechnikov North-Western State Medical University

Author for correspondence.
Email: belib@mail.ru
ORCID iD: 0000-0002-7981-6349
SPIN-code: 3136-9062

д-р мед. наук, доц., проф. каф. терапии, ревматологии, экспертизы временной нетрудоспособности и качества медицинской помощи им. Э.Э. Эйхвальда

Russian Federation, Saint Petersburg

Evgeniy A. Trofimov

Mechnikov North-Western State Medical University

Email: belib@mail.ru
ORCID iD: 0000-0003-3236-4485
SPIN-code: 4358-1663
Scopus Author ID: 57082588900

д-р мед. наук, проф. каф. терапии и ревматологии им. Э.Э. Эйхвальда 

Russian Federation, Saint Petersburg

Irina E. Itskovich

Mechnikov North-Western State Medical University

Email: belib@mail.ru
ORCID iD: 0000-0001-8352-3955

д-р мед. наук, зав. каф. лучевой диагностики и лучевой терапии

Russian Federation, Saint Petersburg

Artem L. Burulev

Mechnikov North-Western State Medical University

Email: belib@mail.ru
ORCID iD: 0009-0007-5401-5047

канд. мед. наук, доц. каф. лучевой диагностики и лучевой терапии 

Russian Federation, Saint Petersburg

References

  1. Мазуров В.И., Трофимова А.С., Трофимов Е.А. Факторы риска и некоторые аспекты патогенеза остеоартрита. Вестник СЗГМУ им. И.И. Мечникова. 2016;2(8):116-24 [Mazurov VI, Trofimova AS, Trofimov EA. Risk factors and some aspects of the osteoarthritis pathogenesis. Herald of the Northwestern State Medical University named after I.I. Mechnikov. 2016;2(8):116-24 (in Russian)].
  2. Балабанова Р.М., Эрдес Ш.Ф. Распространенность ревматических заболеваний в России в 2012–2013 гг. Научно-практическая ревматология. 2015;53(2):120-4 [Balabanova RM, Erdes SF. The incidence and prevalence of rheumatic diseases in Russia in 2012–2013. Rheumatology Science and Practice. 2015;53(2):120-4 (in Russian)]. doi: 10.14412/1995-4484-2015-120-124
  3. Олюнин Ю.А, Никишина Н.Ю. Остеоартрит: ключевые звенья патогенеза и современные средства патогенетической терапии. Современная ревматология. 2017;3:121-8 [Olyunin YuA, Nikishina NYu. Osteoarthritis: Key elements in its pathogenesis and current agents for pathogenetic therapy. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2007;11:121-8 (in Russian)]. doi: 10.14412/1996-7012-2017-3-121-128
  4. Алексеева Л.И. Новые представления о патогенезе остеоартрита, роль метаболических нарушений. Ожирение и метаболизм. 2019;16(2):75-2 [Alekseeva LI. New ideas about the pathogenesis of osteoarthritis, the role of metabolic disorders. Obesity and Metabolism. 2019;16(2):75-82 (in Russian)]. doi: 10.14341/omet10274
  5. Шостак Н.А., Правдюк Н.Г., Клименко А.А., и др. Остеоартрит и ассоциированная патология – клинико-патогенетические взаимосвязи. РМЖ. Медицинское обозрение. 2019;3(11(II)):44-7 [Shostak NA, Pravdyuk NG, Klimenko AA, et al. Osteoarthritis and associated pathology-clinical and pathogenetic relationships. RMJ. Medical Review. 2019;3(11(II)):44-7 (in Russian)].
  6. Стребкова Е.А., Алексеева Л.И. Остеоартроз и метаболический синдром. Фарматека. 2015;17:15-9 [Strebkova EA, Alekseeva LI. Osteoarthrosis and metabolic syndrome. Farmateka. 2015;17:15-9 (in Russian)].
  7. Лила А.М., Алексеева Л.И., Телышев К.А. Современные подходы к фенотипированию остеоартрита. Современная ревматология. 2019;13(2):4-8 [Lila AM, Alekseeva LI, Telyshev KA. Current approaches to osteoarthritis phenotyping. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2019;13(2):4-8 (in Russian)]. doi: 10.14412/1996-7012-2019-2-4-8
  8. Лила А.М., Алексеева Л.И., Таскина Е.А. Современные подходы к терапии остеоартрита с учетом обновленных международных рекомендаций. РМЖ. Медицинское обозрение. 2019;11(II):48-52 [Lila AM, Alekseeva LI, Taskina EA. Modern approaches to osteoarthritis therapy taking into account updated international guidelines. RMJ. Medical Review. 2019;11(II):48-52 (in Russian)].
  9. Алексеева Л.И. Обновление клинических рекомендаций по лечению больных остеоартритом 2019 г. РМЖ. 2019;4:2-6 [Alekseeva LI. Сlinical guidelines update on the treatment of patients with osteoarthritis in 2019. RMJ. 2019;4:2-6 (in Russian)].
  10. Мазуров В.И., Беляева И.Б., Трофимов Е.А. Анализ терапевтических преимуществ медленнодействующих симптоматических средств при остеоартрите: акцент на структурно-модифицирующем действии. Современная ревматология. 2021;15(6):117-23 [Belyaeva IB, Mazurov VI, Trofimov EA. Analysis of the therapeutic benefits of symptomatic slow acting drugs in osteoarthritis: emphasis on structural-modifying action. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2021;15(6):117-23 (in Russian)]. doi: 10.14412/1996-7012-2021-6-117-123
  11. Беляева И.Б., Мазуров В.И. Безопасная симптом-модифицирующая терапия остеоартрита у коморбидных пациентов с высоким кардиоваскулярным риском. Эффективная фармакотерапия. 2022;18(38):24-31 [Belyayeva IB, Mazurov VI. Safe symptom-modifying therapy of osteoarthritis in comorbid patients with high cardiovascular risk. Effective Pharmacotherapy. 2022;18(38):24-31 (in Russian)]. doi: 10.33978/2307-3586-2022-18-38-24-30
  12. Беляева И.Б., Мазуров В.И., Саранцева Л.Е. Рациональная фармакотерапия коморбидных пациентов с заболеваниями опорно-двигательного аппарата в условиях пандемии COVID-19. Эффективная фармакотерапия. 2021;17(21):40-6 [Belyayeva IB, Mazurov VI, Sarantseva LYe. Rational pharmacotherapy of comorbid patients with musculoskeletal system diseases in the conditions of COVID-19 pandemic. Effective Pharmacotherapy. 2021;17(21):40-6 (in Russian)]. doi: 10.33978/2307-3586-2021-17-21-40-46
  13. Жугрова Е.С., Беляева И.Б., Самигуллина Р.Р. Взгляд на остеоартрит с позиций доказательной медицины и собственного опыта. РМЖ. 2023;7(3):167-73 [Zhugrova ES, Belyaeva IB, Samigullina RR. Insights in osteoarthritis from the perspectives of evidence-based medicine and authors' own experience. RMJ. 2023;7(3):167-73 (in Russian)]. doi: 10.32364/2587-6821-2023-7-3-167-173
  14. Rakesh M, Niranjan RR, Varsha N. Multimodal Anti-Inflammatory Approach to Osteoarthritis Management – Review of T Cell Immunomodulation with Undenatured (Native) Collagen Type II and LOX Inhibition with Boswellia. Nov Tech Arthritis Bone Res. 2019;3(4):555618. doi: 10.19080/NTAB.2019.03.555618.
  15. Lugo JP, Saiyed ZM, Lane NE. Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study. Nutr J. 2016;15:14. doi: 10.1186/s12937-016-0130-8
  16. Crowley DC, Lau FC, Sharma P, et al. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci. 2009;6(6):312-21. doi: 10.7150/ijms.6.312
  17. McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001;45(5):453-61. doi: 10.1002/1529-0131(200110)45:5<453::aid-art365>3.0.co;2-w
  18. Salehi R, Valizadeh L, Negahban H, et al. The Western Ontario and McMaster Universities Osteoarthritis, Lequesne Algofunctional index, Arthritis Impact Measurement Scale-short form, and Visual Analogue Scale in patients with knee osteoarthritis: responsiveness and minimal clinically important differences. Disabil Rehabil. 2023;45(13):2185-91. doi: 10.1080/09638288.2022.2084776
  19. Hawker GA, Mian S, Kendzerska T, French M. Measures of Adult Pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011;63(Suppl. 11):S240-52. doi: 10.1002/acr.20543
  20. Алексенко Е.Ю., Говорин А.В., Цвингер С.М. Качество жизни у больных остеоартрозом. Бюллетень СО РАМН. 2009;6(140):15-8 [Aleksenko EJu, Govorin AV, Cvinger SM. Kachestvo zhizni u bol'nykh osteoartrozom. Bjulleten' SO RAMN. 2009;6(140):15-8 (in Russian)].
  21. Алексеева Л.И., Таскина Е.А., Кашеварова Н.Г. Остеоартрит: эпидемиология, классификация, факторы риска и прогрессирования, клиника, диагностика, лечение. Современная ревматология. 2019;13(2):9-21 [Alekseeva LI, Taskina EA, Kashevarova NG. Osteoarthritis: epidemiology, classification, risk factors, and progression, clinical presentation, diagnosis, and treatment. Modern Rheumatology Journal. 2019;13:9-21 (in Russian)]. doi: 10.14412/1996-7012-2019-2-9-21
  22. Cameron M, Chrubasik S. Oral herbal therapies for treating osteoarthritis. Cochrane Database Syst Rev. 2014;5:CD002947. doi: 10.1002/14651858.CD002947.pub2
  23. Yu G, Xiang W, Zhang T, et al. Effectiveness of Boswellia and Boswellia extract for osteoarthritis patients: a systematic review and meta-analysis. BMC Complement Med Ther. 2020;20(1):225. doi: 10.1186/s12906-020-02985-6
  24. Liu X, Machado GC, Eyles JP, et al. Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis. Br J Sports Med. 2018;52(3):167-75. doi: 10.1136/bjsports-2016-097333
  25. Sadigursky D, Sanches MM, Garcia NM, et al. Effectiveness of the use of non hydrolysed type II collagen in the treatment of osteoarthritis: a systematic review and meta-analysis. Brazilian Journal of Health Review. 2023;6(1):1649-60. doi: 10.34119/bjhrv6n1-131
  26. Sadigursky D, Magnavita VFS, De Sá CKC, et al. Undenatured collagen type II for the treatment of osteoarthritis of the knee. Acta Ortop Bras. 2022;30(2):e240572. doi: 10.1590/1413-785220223002240572

Supplementary files

Supplementary Files
Action
1. JATS XML
2. Fig. 1. Lequesne algofunctional index: a – absolute values; b – changes from the initial value, %.

Download (181KB)
3. Fig. 2. VAS pain when walking: a – absolute values; b – changes from the initial value, %.

Download (183KB)
4. Fig. 3. WOMAC score: a – absolute values; b – changes from the initial value, %.

Download (186KB)
5. Fig. 4. Morning stiffness: a – absolute values; b – changes from the initial value, min.

Download (190KB)
6. Fig. 5. SF-36 quality of life with calculation of the effect size (Kendall’s W concordance coefficient).

Download (149KB)
7. Fig. 6. Assessment by the doctor (a) and the patient (b) of the effecacy of therapy at the end of 6 months of treatment.

Download (144KB)
8. Fig. 7. Area of synovitis after 6 months according to MRI.

Download (77KB)
9. Fig. 8. Area of synovitis in patient V. during Artneo therapy after 6 months: a – visit 2, area of synovitis 8.1 cm2; b – visit 9, area of synovitis 1.5 cm2.

Download (210KB)

Copyright (c) 2023 Consilium Medicum

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
 
 


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies