В статье приведены данные интегративного обзора эффективности и безопасности препарата Траумель® С при использовании в комплексной терапии воспалительных заболеваний разных органов и тканей, включая, в частности, заболевания опорно-двигательного аппарата (тендовагинит, бурсит, стилоидит, периартрит и т.д.) и посттравматических состояний (послеоперационный отек мягких тканей, растяжение мышц и связок). Траумель® С – многокомпонентный препарат, обладающий многоцелевым действием на воспалительно-иммунную сеть. Цель работы: обзор доказательных данных в отношении эффективности применения препарата Траумель® C по основному зарегистрированному показанию. Методы. Анализ данных по определению уровня доказательности проводился с использованием иерархической системы оценки и неиерархическими методами, применялась категория «Терапевтическая польза вмешательства» шкалы уровня доказательности данных Оксфордского центра доказательной медицины. Результаты. Терапевтическая польза применения препарата Траумель® С подтверждается исследованиями с различным уровнем доказательности данных: 6 клинических исследований, оцененных как исследования 2-го уровня доказательности; 7 обсервационных исследований – 3-го уровня; 7 фундаментальных исследований – 5-го уровня. Обсуждение. Существует широкий спектр доказательных данных 2-го уровня, свидетельствующих об эффективности препарата Траумель® С при лечении острых растяжений, травм и остеоартроза коленного сустава.
The article presents the data of an integrative review of the efficacy and safety of Traumeel® S when used in the treatment of inflammatory diseases of various organs and tissues, including, in particular, diseases of the musculoskeletal system (tendovaginitis, bursitis, styloiditis, periarthritis, etc.) and post traumatic conditions (postoperative swelling of soft tissues, stretching of muscles and ligaments). Traumeel® S is a multicomponent drug with multipurpose action on the inflammatory-immune network. Objective: to review evidence supporting the efficacy of Traumeel® S on the basis of the main recorded indication. Methods. Analysis of data on the level of evidence was conducted using a hierarchical assessment system and non-hierarchical methods, the category "Therapeutic use of intervention" of the evidence-level scale of the Oxford Center for Evidence-Based Medicine was used. Results. The therapeutic benefit of using Traumeel® S is confirmed by studies with different levels of evidence: 6 clinical studies evaluated as Level 2 evidence; 7 observational studies - level 3; 7 fundamental research – level 5. Discussion. There is a wide range of evidence level 2 evidence of the effectiveness of Traumeel® S in the treatment of acute distension, injury and osteoarthritis of the knee joint.
Key words: diseases of the musculoskeletal system, pain, bioregulation drugs, clinical studies, Traumeel S.
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2. Andersson G. Epidemiological features of chronic low back pain. Lancet 1999; 354: 581–6.
3. Van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth 2013; 1: 13–8.
4. Oren O, Ablin J. Precision medicine: the emerging approach to the chronic pain patient. Int J Clin Rheumtol 2013; 4: 491–9.
5. Боль: современные подходы в диагностике и лечении. Неврология и Ревматология (Прил. к журн. Consilium Medicum). 2016; 1; 55–7. / Pain: current approaches in diagnosis and treatment. Neurology and Rheumatology (Suppl. Consilium Medicum). 2016; 1; 55–7. [in Russian]
6. Хайне Х. Иммунологическая воспалительная реакция, вызванная антигомотоксической терапией воспалительных заболеваний суставов. Биологическая мед. 1999; 1: 5–8. / Khaine Kh. Immunologicheskaia vospalitel'naia reaktsiia, vyzvannaia antigomotoksicheskoi terapiei vospalitel'nykh zabolevanii sustavov. Biologicheskaia med. 1999; 1: 5–8. [in Russian]
7. Пилипович А.А. Хроническая боль при заболеваниях опорно-двигательного аппарата: применение антигомотоксических препаратов. Consilium Medicum. 2016; 18 (9): 128–32. / Pilipovich A.A. Chronic pain in diseases of the musculoskeletal system: the use of antihomotoxic medications. Consilium Medicum. 2016; 18 (9): 128–32. [in Russian]
8. Van Haselen R. An Integrative Review of the Evidence on the Antihomotoxic Medication Traumeel. 1–29.
9. Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence. CEBM Web site. http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-2.1.pdf. Accessed February 22, 2017.
10. Schneider C. Traumeel: an emerging option to nonsteroidal anti-inflammatory drugs in the management of acute musculoskeletal injuries. Int J Gen Med 2011; 4: 225–34.
11. Müller-Löbnitz C, Göthel D. Review of the clinical efficacy of the multicomponent combination medication Traumeel and its components. Altern Ther Health Med 2011; 17 (Suppl. 2): s18–s31.
12. Speed C, Wolfarth B. Challenges of pain masking in the management of soft tissue disorders: optimizing patient outcomes with a multi-targeted approach. Curr Med Res Opin 2014; 30 (5): 953–9.
13. Conforti A, Bertani S, Metelmann H et al. Experimental studies on the anti-inflammatory activity of a homeopathic preparation. Biomed Ther 1997; 15 (1): 28–31.
14. Conforti A, Bertani S, Lussignoli S, Bellavite P. Wirkungen Antihomotoxischer Präparate auf akute und chronische Entzündungen. Biol Medizin 1998; 27 (2): 63–6.
15. Enbergs H. The effect of selected potentiated suis organ preparations and Traumeel on phagocyte and lymphocyte activity. Biomed Ther 1998; 16 (2): 178–85.
16. Lussignoli S, Bertani S, Metelmann H et al. Effect of Traumeel S, a homeopathic formulation, on blood-induced inflammation in rats. Complement Ther Med 1999; 7 (4): 225–30.
17. Heine H, Andrä F. On the anti-inflammatory mechanism of action of an antihomotoxic compound remedy [in German]. Ärztezeitschriftfür Naturheilverfahren 2002; 43 (2): 96–104.
18. Porozov S, Cahalon L, Weiser M et al. Inhibition of IL-1b and TNF-a secretion from resting and activated human immunocytes by the homeopathic medication Traumeel® S. Clin Dev Immunol 2004; 11 (2): 143–9.
19. Seilheimer B, Wierzchacz C, Gebhardt R. Influence of Traumeel on cultured chondrocytes and recombinant human matrix metalloproteinases: implications for chronic joint diseases. Eur J Integr Med 2009; 1 (4): 252–3.
20. St Laurent G, Tackett M, McCaffrey T, Kapranov P. Deep sequencing transcriptome analysis of Traumeel therapeutic action in wound healing (THU0016). Ann Rheum Dis 2013; 72 (Suppl. 3).
21. Zell J, Connert WD, Mau J, Feuerstake G. Behandlung von Sprunggelenksdistorsionen: Doppelblindstudie zum Wirksamkeitsnachweis eines homöopathischen Salbenpräparats. Fortschr Med 1988; 106 (5): 96–100.
22. Zell J, Connert WD, Mau J, Feuerstake G. Treatment of acute sprains of the ankle: a controlled double-blind trial to test the effectiveness of a homeopathic ointment. Biol Ther 1989; 7 (1): 1–6.
23. Thiel W, Borho B. Posttraumatische Kniegelenksergüsse und intraartikuläre Traumeel-N-Injektion. Orthopädische Prax 1991; 27 (11): 721–5.
24. Thiel W, Borho B. The treatment of recent traumatic blood effusions of the knee joint. Biol Ther 1994; 12 (4): 242–8.
25. Böhmer D, Ambrus P. Treatment of sports injuries with Traumeel ointment: a controlled double-blind study. Biol Ther 1992; 10 (4): 290–300.
26. Arora S, Harris T, Scherer C. Clinical safety of a homeopathic preparation. Biomed Ther 2000; 18 (2): 222–5.
27. González de Vega C, Speed C, Wolfarth B, González J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: A multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract 2013; 67 (10): 979–89.
28. González de Vega C, Gonzáles J. A randomized, controlled, multicenter study on the effectiveness of Traumeel (ointment and gel) in terms of pain reduction and function improvement compared with diclofenac gel in acute ankle sprain. Ann Rheum Dis 2012; 71 (Suppl. 3): SAT0423.
29. Lozada C, del Rio E, Reitberg D et al. A multi-center double-blind, randomized, controlled trial (db-RCT) to evaluate the effectiveness and safety of co-administered Traumeel® (Tr14) and Zeel® (Ze14) intra-articular (IA) injections versus IA placebo in patients with moderate-to-severe pain associated with OA of the knee. Arthritis Rheum 2014; 66 (Suppl.): S1266.
30. Lozada C, del Rio E, Reitberg DP et al. Risk-benefit of co-administered Traumeel® (Tr14) and Zeel® (Ze14) intra-articular (IA) injections in patients with moderate-to-severe pain associated with OA of the knee (OAK) (THU0441). Ann Rheum Dis 2015; 74 (Suppl. 2): 4268.
31. Zenner S, Metelmann H. Application possibilities of Traumeel S injection solution: Results of a multicentric drug monitoring trial conducted on 3,241 patients. Biol Ther 1992; 10 (4): 301–10.
32. Zenner S, Metelmann H. Therapy experiences with a homeopathic ointment: Results of drug surveillance conducted on 3,422 patients. Biol Ther 1994; 12 (3): 204–11.
33. Weiser M, Zenner S. Orale Therapie traumatischer, entzündlicher und degenerativer Affektionen mit einem Homöopathikum. Biol Medizin 1996; 25 (5): 211–16.
34. Zenner S, Weiser M. Oral treatment of traumatic, inflammatory, and degenerative conditions with a homeopathic remedy. Biomed Ther 1997; 15 (1): 22–6.
35. Ludwig J, Weiser M. Treating pediatric trauma with a homeopathic ointment. J Biomed Ther 2001; 2: 8–11.
36. Birnesser H, Oberbaum M, Klein P, Weiser M. The homeopathic preparation Traumeel S compared with NSAIDs for symptomatic treatment of epicondylitis. J Musculoskelet Res 2004; 8 (2, 3): 119–28.
37. Schneider C, Klein P, Stolt P, Oberbaum M. A homeopathic ointment preparation compared with 1% diclofenac gel for acute symptomatic treatment of tendinopathy. Explore (NY). 2005; 1 (6): 446–52.
38. Schneider C, Schneider B, Hanisch J, van Haselen R. The role of a homoeopathic preparation compared with conventional therapy in the treatment of injuries: an observational cohort study. Complement Ther Med 2008; 16 (1): 22–7.
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1. Nevrologiia. Natsional'noe rukovodstvo. Pod red. E.I.Guseva, A.N.Konovalova, V.I.Skvortsovoi, A.B.Gekht. M.: GEOTAR-Media, 2009. [in Russian]
2. Andersson G. Epidemiological features of chronic low back pain. Lancet 1999; 354: 581–6.
3. Van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth 2013; 1: 13–8.
4. Oren O, Ablin J. Precision medicine: the emerging approach to the chronic pain patient. Int J Clin Rheumtol 2013; 4: 491–9.
5. Pain: current approaches in diagnosis and treatment. Neurology and Rheumatology (Suppl. Consilium Medicum). 2016; 1; 55–7. [in Russian]
6. Khaine Kh. Immunologicheskaia vospalitel'naia reaktsiia, vyzvannaia antigomotoksicheskoi terapiei vospalitel'nykh zabolevanii sustavov. Biologicheskaia med. 1999; 1: 5–8. [in Russian]
7. Pilipovich A.A. Chronic pain in diseases of the musculoskeletal system: the use of antihomotoxic medications. Consilium Medicum. 2016; 18 (9): 128–32. [in Russian]
8. Van Haselen R. An Integrative Review of the Evidence on the Antihomotoxic Medication Traumeel. 1–29.
9. Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence. CEBM Web site. http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-2.1.pdf. Accessed February 22, 2017.
10. Schneider C. Traumeel: an emerging option to nonsteroidal anti-inflammatory drugs in the management of acute musculoskeletal injuries. Int J Gen Med 2011; 4: 225–34.
11. Müller-Löbnitz C, Göthel D. Review of the clinical efficacy of the multicomponent combination medication Traumeel and its components. Altern Ther Health Med 2011; 17 (Suppl. 2): s18–s31.
12. Speed C, Wolfarth B. Challenges of pain masking in the management of soft tissue disorders: optimizing patient outcomes with a multi-targeted approach. Curr Med Res Opin 2014; 30 (5): 953–9.
13. Conforti A, Bertani S, Metelmann H et al. Experimental studies on the anti-inflammatory activity of a homeopathic preparation. Biomed Ther 1997; 15 (1): 28–31.
14. Conforti A, Bertani S, Lussignoli S, Bellavite P. Wirkungen Antihomotoxischer Präparate auf akute und chronische Entzündungen. Biol Medizin 1998; 27 (2): 63–6.
15. Enbergs H. The effect of selected potentiated suis organ preparations and Traumeel on phagocyte and lymphocyte activity. Biomed Ther 1998; 16 (2): 178–85.
16. Lussignoli S, Bertani S, Metelmann H et al. Effect of Traumeel S, a homeopathic formulation, on blood-induced inflammation in rats. Complement Ther Med 1999; 7 (4): 225–30.
17. Heine H, Andrä F. On the anti-inflammatory mechanism of action of an antihomotoxic compound remedy [in German]. Ärztezeitschriftfür Naturheilverfahren 2002; 43 (2): 96–104.
18. Porozov S, Cahalon L, Weiser M et al. Inhibition of IL-1b and TNF-a secretion from resting and activated human immunocytes by the homeopathic medication Traumeel® S. Clin Dev Immunol 2004; 11 (2): 143–9.
19. Seilheimer B, Wierzchacz C, Gebhardt R. Influence of Traumeel on cultured chondrocytes and recombinant human matrix metalloproteinases: implications for chronic joint diseases. Eur J Integr Med 2009; 1 (4): 252–3.
20. St Laurent G, Tackett M, McCaffrey T, Kapranov P. Deep sequencing transcriptome analysis of Traumeel therapeutic action in wound healing (THU0016). Ann Rheum Dis 2013; 72 (Suppl. 3).
21. Zell J, Connert WD, Mau J, Feuerstake G. Behandlung von Sprunggelenksdistorsionen: Doppelblindstudie zum Wirksamkeitsnachweis eines homöopathischen Salbenpräparats. Fortschr Med 1988; 106 (5): 96–100.
22. Zell J, Connert WD, Mau J, Feuerstake G. Treatment of acute sprains of the ankle: a controlled double-blind trial to test the effectiveness of a homeopathic ointment. Biol Ther 1989; 7 (1): 1–6.
23. Thiel W, Borho B. Posttraumatische Kniegelenksergüsse und intraartikuläre Traumeel-N-Injektion. Orthopädische Prax 1991; 27 (11): 721–5.
24. Thiel W, Borho B. The treatment of recent traumatic blood effusions of the knee joint. Biol Ther 1994; 12 (4): 242–8.
25. Böhmer D, Ambrus P. Treatment of sports injuries with Traumeel ointment: a controlled double-blind study. Biol Ther 1992; 10 (4): 290–300.
26. Arora S, Harris T, Scherer C. Clinical safety of a homeopathic preparation. Biomed Ther 2000; 18 (2): 222–5.
27. González de Vega C, Speed C, Wolfarth B, González J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: A multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract 2013; 67 (10): 979–89.
28. González de Vega C, Gonzáles J. A randomized, controlled, multicenter study on the effectiveness of Traumeel (ointment and gel) in terms of pain reduction and function improvement compared with diclofenac gel in acute ankle sprain. Ann Rheum Dis 2012; 71 (Suppl. 3): SAT0423.
29. Lozada C, del Rio E, Reitberg D et al. A multi-center double-blind, randomized, controlled trial (db-RCT) to evaluate the effectiveness and safety of co-administered Traumeel® (Tr14) and Zeel® (Ze14) intra-articular (IA) injections versus IA placebo in patients with moderate-to-severe pain associated with OA of the knee. Arthritis Rheum 2014; 66 (Suppl.): S1266.
30. Lozada C, del Rio E, Reitberg DP et al. Risk-benefit of co-administered Traumeel® (Tr14) and Zeel® (Ze14) intra-articular (IA) injections in patients with moderate-to-severe pain associated with OA of the knee (OAK) (THU0441). Ann Rheum Dis 2015; 74 (Suppl. 2): 4268.
31. Zenner S, Metelmann H. Application possibilities of Traumeel S injection solution: Results of a multicentric drug monitoring trial conducted on 3,241 patients. Biol Ther 1992; 10 (4): 301–10.
32. Zenner S, Metelmann H. Therapy experiences with a homeopathic ointment: Results of drug surveillance conducted on 3,422 patients. Biol Ther 1994; 12 (3): 204–11.
33. Weiser M, Zenner S. Orale Therapie traumatischer, entzündlicher und degenerativer Affektionen mit einem Homöopathikum. Biol Medizin 1996; 25 (5): 211–16.
34. Zenner S, Weiser M. Oral treatment of traumatic, inflammatory, and degenerative conditions with a homeopathic remedy. Biomed Ther 1997; 15 (1): 22–6.
35. Ludwig J, Weiser M. Treating pediatric trauma with a homeopathic ointment. J Biomed Ther 2001; 2: 8–11.
36. Birnesser H, Oberbaum M, Klein P, Weiser M. The homeopathic preparation Traumeel S compared with NSAIDs for symptomatic treatment of epicondylitis. J Musculoskelet Res 2004; 8 (2, 3): 119–28.
37. Schneider C, Klein P, Stolt P, Oberbaum M. A homeopathic ointment preparation compared with 1% diclofenac gel for acute symptomatic treatment of tendinopathy. Explore (NY). 2005; 1 (6): 446–52.
38. Schneider C, Schneider B, Hanisch J, van Haselen R. The role of a homoeopathic preparation compared with conventional therapy in the treatment of injuries: an observational cohort study. Complement Ther Med 2008; 16 (1): 22–7.