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Efficacy and safety of piascledine 300 versus chondroitin sulfate in a 6 months treatment plus 2 months observation in patients with osteoarthritis of the knee

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An Erratum to this article was published on 30 April 2010

Abstract

To investigate that a 6-month treatment with avocado soybean unsaponifiable (Piascledine® 300 mg) once daily is as effective as with chondroitin sulfate 400 mg three times daily in femorotibial gonarthrosis, and also the carry-over effect for two more months is comparable. Patients were randomized (1:1) to the treatment groups. They received for 6 months 3 capsules chondroitin sulfate per day or one capsule of avocado soybean unsaponifiable (ASU) in a double-dummy technique. A 2-month post-treatment period followed to determine the carry-over effect. Primary efficacy criterion was the change of the WOMAC-index from study begin to end of treatment. Secondary criteria were the changes in Lequesne-index, pain on active movement and at rest, global assessment of efficacy. Three hundred sixty-four patients have been taken up into the trial. Three hundred sixty one patients were eligible for evaluation. One hundred eighty three received ASU 300 mg once daily, one hundred seventy eight chondroitin sulfate three times daily. The WOMAC-index decreased in both groups for approx. 50% to the end of therapy. During the post-treatment observation there was a further slight improvement. There was no statistical significant difference between the treatment groups during the entire observation. All other observed parameters showed the same pattern. The daily intake of rescue medication was reduced continuously. Overall efficacy has been rated excellent and good in more than 80% of the patients in both groups. Both drugs were safe and well tolerated. The first direct comparison between avocado soybean unsaponifiable 300 mg once daily and chondroitin sulfate three times daily reveiled no difference in efficacy or safety aspects between 1 capsule ASU 300 mg per day and 3 capsules chondroitin sulfate per day. It can be assumed that the once daily intake of ASU will lead to a better compliance in routine therapy.

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References

  1. Cohen ZA, McCarthy DM, Kwak SD, Legrand P, Fogarasi F, Ciaccio EJ, Ateshian GA (1999) Knee cartilage topography, thickness, and contact areas from MRI: in-vitro calibration and in-vivo measurements. Osteoarthr Cartil 7(1):95–109

    Article  CAS  PubMed  Google Scholar 

  2. van Valburg AA, Wenting MJ, Beekman B, Te Koppele JM, Lafeber FP, Bijlsma JW (1997) Degenerated human articular cartilage at autopsy represents preclinical osteoarthritic cartilage: comparison with clinically defined osteoarthritic cartilage. J Rheumatol 24(2):358–364

    PubMed  Google Scholar 

  3. Martini FH et al (2001) Fundamentals of anatomy and physiology, 5th edn. Prentice Hall, Upper Saddle River, New Jersey

    Google Scholar 

  4. Lequesne M, Brandt K, Bellamy N, Moskowitz R, Menkes CJ, Pclletier JP, Altman RD (1994) Guidelines for testing slow acting drugs in osteoarthritis. J Rheumatol 21(suppl 41):GS-73

    Google Scholar 

  5. Dougados M, Devogelaer JP, Annefeld M, Avouac B, Bouvenot G, Cooper C, the Members of the Group for the Respect of Ethics and Excellence in Science et al (1996) Recommendations for the registration of drugs used in the treatment of osteoarthritis. Ann Rheum Dis 55:552–557

    Article  Google Scholar 

  6. Bellamy N, Kirwan J, Altman R, Boers M, Brandt KD, Brooks P, Dougados M, Lequesne M, Strand V, Tygwcll P (1997) Recommandations for a score set of outcome measures for future phase III clinical trials in knee, hip and hand osteoarthritis. Results of consensus development at OMERACT III. J Rheumatol 24:799804

    Google Scholar 

  7. Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA et al (1996) Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results of a Workshop. Osteoarthritis Cart 4:217–243

    Article  CAS  Google Scholar 

  8. Jordan KM et al (2003) EULAR resommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis 62:1145–1155

    Article  CAS  PubMed  Google Scholar 

  9. Zhang W et al (2008) OARSI Recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based expert consensus guidelines. Osteoarthr Cartil 16:137–162

    Article  CAS  PubMed  Google Scholar 

  10. Lequesne M (1994) Les anti-arthrosiques symptomatiques d'action lente: un nouveau concept therapeutique? Rev Rhum 61:75–79

    CAS  Google Scholar 

  11. Mauviel A, Daireaux M, Hartmann DJ, Galera P, Loyaux G, Pujol JP (1987) Effets des insaponifiables d'avocat et de soja (PIAS) sur la production de collagene par des cultures de synoviocytes, chondrocytes articulaires et fibroblastes dermiques. Rev Rhum Mal Osteoartic 56:207–211

    Google Scholar 

  12. Loyau G, Pujol JP, Mauviel A (1991) Effet des insaponifiables d'avocat/soja (Piascledine) sur 1'activite collagenolytique de culture de synoviocytes rhumatoides humains et de chondrocytes articulaires de lapin traites par 1'interleukine 1. Rev Rhum Mal Osteoartic 58:241-S

    Google Scholar 

  13. Mazieres B, Tempesta C, Tiechard M, Vaguier G (1993) Pathologic and biochemical effects of a lipidic avocado and soja extract (LASE) on an experimental post-contusive model of OA (abstract). Osteoarthr Cartil 1:46

    Google Scholar 

  14. Henrotin YE, Labasse AH, Jaspar JM, Dc Groote DD, Zheng SX, Guillou GB, Reginster JYL (1998) Effects of three avocado/soybean unsaponifiable mixtures on metalloproteinases, cytokines and prostaglandin E2 production by human articular chondrocytes. Clinical Rheum 17:31–39

    Article  CAS  Google Scholar 

  15. Boumediene K, Bogdanowicz P, Felisaz N, Galera P, Pujol JP (1999) Avocado/soya unsaponifiables enhance expression of transforming growth factor and plasminogen activator inhibitor-1 in cultured articular chondrocytes. Arthritis Rheum 39:S227

    Google Scholar 

  16. Gabay O et al (2008) Stress-induced signaling pathways in hyaline chondrocytes: inhibition by Avocado–soybean unsaponifiables (ASU). Osteoarthr Cartil 16(3):373–384

    Article  CAS  PubMed  Google Scholar 

  17. Henrotin YE et al (2003) Avocado/soybean unsaponifiables increase aggrecan synthesis and reduce catabolic and proinflammatory mediator production by human osteoarthritis chondrocytes. J Rheumatol 30(8):1825–1834

    CAS  PubMed  Google Scholar 

  18. Henrotin YE et al (2006) Avocado/soybean unsaponifiables prevent the inhibitory effect of osteoarthritic subchondral osteoblasts on aggrecan and type II collagen synthesis by chondrocytes. J Rheumatol 33(8):1668–1678

    PubMed  Google Scholar 

  19. Leeb B, Schweitzer H, Montag K, Smolen JS (2000) A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis. J Rheumatol 24:205–211

    Google Scholar 

  20. Mazieres B, Combe B, Phan-Van A, Tondut J, Grynfel M (2001) Chondroitin sulfate in osteoarthritis of the knee: a prospective, double blind, placebo controlled multicenter clinical study. J Rheumatol 28:173–181

    CAS  PubMed  Google Scholar 

  21. Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L (1996) Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol 23:1385–1391

    CAS  PubMed  Google Scholar 

  22. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, Howell D, Kaplan D, Koopman W, Longley S, Mankin H, McShane DJ, Medsger T, Meeman R, Mikkelsen W, Moskowitz R, Murphy W, Rothschild B, Segal M, Sokoloff L, Wolfe F (1986) Development of criteria for the classification and reporting of osteoarthritis. Arthritis Rheum 29:1039–1049

    Article  CAS  PubMed  Google Scholar 

  23. Kellgren JH, Laurence JS (1957) Radiological assessment of osteoarthritis. Ann Rheum Dis 16:494–501

    Article  CAS  PubMed  Google Scholar 

  24. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15:1833–1840

    CAS  PubMed  Google Scholar 

  25. Lequesne M, Mery C, Samson M, Gerard P (1987) Indexes of severity for osteoarthritis of the hip and knee. Scand J Rheumatol 65:85–89

    Article  CAS  Google Scholar 

  26. Huskisson EC (1974) Measurement of pain. Lancet 2:1127–1131

    Article  CAS  PubMed  Google Scholar 

  27. Blotman F, Maheu E, Wulwik A, Caspard H, Lopez A (1997) Mid-term efficacy and safety of avocado and soya unsaponifiables (ASU) in the treatment of knee and hip osteoarthritis: results of a three-month prospective, randomized, double-blind, placebo-controlled, parallel-groups, multi-center clinical trial. Rev Rhum Engl Ed 64:825–834

    CAS  PubMed  Google Scholar 

  28. Maheu E, Mazières B, Le Loët X, Loyau G, Valat JP, Grouin JM, Bourgeois P, Rozenberg S (1998) Symptomatic efficacy of avocado/soybean unsaponifiables in the treatment of osteoarthritis of the knee and hip. A prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial with a six-month treatment period and a two-month follow-up demonstrating a persistent effect. Arthritis Rheum 41:81–91

    Article  CAS  PubMed  Google Scholar 

  29. Appelboom T, Schuermans J, Verbruggen H, Henrotin Y (2001) Symptoms modifying effect of avocado/soybean unsaponifiables (ASU) in knee osteoarthritis. A double-blind, prospective, placebo-controlled study. Scand J Rheumatol 30:242–247

    Article  CAS  PubMed  Google Scholar 

  30. Lequesne M, Maheu E, Cadet C, Dreiser RL (2002) Structural effect of avocado/soybean unsaponifiables on joint space loss in osteoarthritis of the hip. Arthritis Rheum 47:50–58

    Article  CAS  PubMed  Google Scholar 

  31. Moe RH, Haavardsholm A, Christie A, Jamtvedt G, Dahm KT, Hagen KB (2007) Effectiveness of nonpharmacological and nonsurgical interventions for hip osteoarthritis: an umbrella review of high-quay systematic reviews. Phys Ther 87:1716–1727

    PubMed  Google Scholar 

  32. Christensen R, Bartels EM, Astrup A, Bliddal H (2007) Symptomatic efficacy of avocado-soybean unsaponifiables (ASU) in osteoarthritis (OA) patients: meta analysis of randomized controlled trials. Osteoarthr Cartil 16:399–408

    Article  PubMed  Google Scholar 

  33. Bruyere O, Burlet N, Delmas PD, Rizzoli R, Cooper C, Reginster JY (2008) Evaluation of symptomatic slow acting drugs in osteoarthritis using the GRADE system. BMC Musculoskelet Disord 9:165–174

    Article  PubMed  Google Scholar 

  34. Kahan A et al (1031) STOPP (Study on Osteoarthritis Progression Prevention): etude internationale, prospective, randomisée, en double insu, contrôlée contre placebo, évaluant la prévention de la progression radiologique de l’ arthrose du genou pendant deux ans avec la chontroitine 5 × 6 sulfate. Revue Rheum 2008:73

    Google Scholar 

  35. Reichenbach S et al (2007) Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Ann Intern Med 146:580–590

    PubMed  Google Scholar 

  36. Pavelka K, Gatterova J, Olejarova M, Machacek S, Giacovelli G, Rovati LC (2002) Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3 year, randomized, placebo-controlled, double-blind study. Arch Intern Med 162:2113–2123

    Article  CAS  PubMed  Google Scholar 

  37. Rintelen B, Neumann K, Leeb BF (2006) A Meta-analysis of Controlled Clinical Studies With Diacerein in Treatment of Osteoarthritis. Arch Intern Med 166:1899–1906

    Article  CAS  PubMed  Google Scholar 

  38. Shibakawa A, Aoki H, Masuko-Hongo K, Kato T, Tanaka M, Nishioka K et al (2003) Presence of pannus-like tissue on osteoarthritic cartilage and its histological character. Osteoarthr Cartil 11:133–140

    Article  CAS  PubMed  Google Scholar 

  39. Furuzawa-Carballeda J, Macip-Rodriguez PM, Cabral AR (2008) Osteoarthritis and rheumatoid arthritis pannus have similar qualitative metabolic characteristics and pro-inflammatory cytokine response. Clin Exp Rheumatol 26:554–560

    CAS  PubMed  Google Scholar 

  40. Tarhan S, Unlu Z (2003) Magnetic resonance imaging and ultrasonographic evaluation of the patients with knee osteoarthritis: a comparative study. Clin Rheumatol 22:181–188

    Article  CAS  PubMed  Google Scholar 

  41. Hunter DJ, Zhang Y, Niu J, Goggins J, Amin S, LaValley MP et al (2006) Increase in bone marrow lesions associated with cartilage loss: a longitudinal magnetic resonance imaging study of knee osteoarthritis. Arthritis Rheum 54:1529–1535

    Article  PubMed  Google Scholar 

  42. Boileau C, Martel-Pelletier M, Caron J, Msika P, Gouillou GB, Baudouin C et al (2009) Protective effects of total fraction of avocado/soybean unsaponifiables on the sructural changes in experimental dog osteoarthritis: inhibition of nitric oxide synthase and matrix metalloproteinase-13. Arthritis Res Ther 11:R41

    Article  PubMed  Google Scholar 

  43. Pendleton A, Arden N, Dougados M, Doherty M, Bannwarth B, Bijlsma JWJ et al (2000) EULAR recommendations for the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies including Therapeutic Trials (ESCISIT). Ann Rheum Dis 59:936–944

    Article  CAS  PubMed  Google Scholar 

  44. Jordan KM, Sawyer S, Coakley P, Smith HE, Cooper C, Arden NK (2004) The use of conventional and complementary treatment for knee osteoarthritis in the community. Rheumatology 43:381–384

    Article  CAS  PubMed  Google Scholar 

  45. Tubach F et al (2005) Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 64:29–33

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Institute of Rheumatology, Charles University Prague, Prague, Czech Republic

    Karel Pavelka

  2. Laboratoire Expanscience, Courbevoie, France

    Philippe Coste

  3. Hospital of St. John’s of God, Budapest, Hungary

    Pál Géher

  4. Clinical Investigations Ltd, Imre u. 4, 1093, Budapest, Hungary

    Gerhard Krejci

Authors
  1. Karel Pavelka
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  2. Philippe Coste
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  3. Pál Géher
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  4. Gerhard Krejci
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Correspondence to Gerhard Krejci.

Additional information

The study has been supported by Laboratoire Expanscience, F-92400 Courbevoie, France.

An erratum to this article can be found at http://dx.doi.org/10.1007/s10067-010-1471-x

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Pavelka, K., Coste, P., Géher, P. et al. Efficacy and safety of piascledine 300 versus chondroitin sulfate in a 6 months treatment plus 2 months observation in patients with osteoarthritis of the knee. Clin Rheumatol 29, 659–670 (2010). https://doi.org/10.1007/s10067-010-1384-8

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  • DOI: https://doi.org/10.1007/s10067-010-1384-8

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