Randomised controlled trial of avocado-soybean unsapomfiable (piascledine) effect on structure modification in hip osteoarthritis: The eradias study;Randomizovana kontrolovana klinicka studia zamerana na strukturu modifikujuci uclnok nezmydelniteeneho avokadoveho a sojoveho oleja (piascledine) pri osteoartr6ze bedrovych klbov: §Tudia eradias

Rheumatologia

Volumn 30, Issue 2, 2016, Pages 19-32

  Maheu, E ^a   Cadet, C ^b   Marty, M ^c   Moyse, D ^d   Kerloch, I ^e   Coste, P ^e   Dougados, M ^f   Mazlres, B ^g   Spector, T D ^h   Halhol, H ^e   Grouin, J M ⁱ   Lequesne, M ^j  

^a HÔPITAL SAINT ANTOINE   (France)

^b Clinical Center   (France)

^c HENRI MONDOR HOSPITAL   (France)

^d DM Consultant ^*  (France)

^e Laboratoires Expanscience   (France)

^f UNIVERSITÉ PARIS DESCARTES   (France)

^g CHU PURPAN   (France)

^h KING'S COLLEGE LONDON   (United Kingdom)

ⁱ UNIVERSITÉ DE ROUEN   (France)

^j Léopold Bellan Hospital   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PIASCLEDINE;

ADULT; AGED; ARTICLE; BODY MASS; CONTROLLED STUDY; DISEASE COURSE; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FEMALE; HIP OSTEOARTHRITIS; HUMAN; JOINT CAVITY; JOINT SPACE WIDTH; MAJOR CLINICAL STUDY; MALE; MUSCULOSKELETAL SYSTEM PARAMETERS; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; VISUAL ANALOG SCALE;

EID: 84978768119     PISSN: 12101931     EISSN: None     Source Type: Journal    
DOI: 10.1136/annrheumdis-20l2-202485     Document Type: Article

References (66)

1. Guillemin F, Rat AC, Mazieres B, et al. 3000 Osteoarthritis group. Prevalence of symptomatic hip and knee osteoarthritis: A two-phase po-pulation-based survey. Osteoarthritis Cartilage 2011; 19: 1314 -1322.
2. Pereira D, Peleteiro B, Araujo J, et al. The effect of osteoarthritis definition on prevalence and incidence estimates: A systematic review. Osteoarthritis Cartilage 2011; 19: 1270 -1285.
3. Le Pen C, Reygrobellet C, Gerentes I. Financial cost of osteoarthritis in France. The 'COART' France study. Joint Bone Spine 2005; 72: 567 -570.
4. March LM, Bagga H. Epidemiology of osteoarthritis in Australia. Med J Australia 2004; 180: S6 -S10.
5. Ethgen O, Reginster JY. Degenerative musculoskeletal disease. Ann Rheum Dis 2004; 63: 1 -3.
6. Kurtz S, Onq K, Lau E, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007; 89: 780 -785.
7. Otten R, Van Roermund PM, Picavet HS. Trend in the number of knee and hip arthroplasties: considerably more knee and hip prostheses due to osteoarthritis in 2030. Ned Tijdschr Geneeskd 2010; 154: A1534.
8. Berenbaum F. Targeted therapies in osteoarthritis: A systematic review of the trials on http://www.clinicaltrials.gov. Best Pract Res Clin Rheumatol 2010; 24: 107 -119.
9. Jordan KM, Arden NK, Doherty M, et al. EULAR recommendations 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 2003; 62: 1145 -1155.
10. Zhang W, Doherty M, Arden N, et al. EULAR evidence based recommendations for the management of hip osteoarthritis: Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2005; 64: 669 -681.
11. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16: 137 -162.
12. Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010; 18: 476 -499.
13. Lequesne M, Brandt K, Bellamy N, et al. Guidelines for testing slow acting drugs in osteoarthritis. J Rheumatol 1994; 21 (Suppl 41): 65 -71.
14. Bouvenot G. Considerations on the methodology of studies evaluating treatments for osteoarthritis. Rev Rhum Engl Ed 1994; 61: 74 -76.
15. Dougados M. Clinical assessment of osteoarthritis in clinical trials. Curr Opin Rheumatol 1995; 7: 87 -91.
16. Altman R, Brandt K, Hochberg M, et al. 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 Cartilage 1996; 4: 217 -243.
17. Dougados M, Devogelaer JP, Annefeld M, et al. (the Members of the Group for the Respect of Ethics and Excellence in Science). Recommendations for the registration of drugs used in the treatment of osteoarthritis. Ann Rheum Dis 1996; 55: 552 -557.
18. Bellamy N, Kirwan J, Altman R, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip and hand osteoarthritis: consensus development at OMERACT III. J Rheumatol 1997; 24: 799 -802.
19. Reginster JY, Badurski J, Bellamy N, et al. Efficacy and safety of strontium ranelatein the treatment of knee osteoarthritis: Results of a double-blind, randomisedplacebo-controlled trial. Ann Rheum Dis 2013; 72: 179 -186.
20. Dougados M, Nguyen M, Berdah L, et al. The ECHODIAH investigators study group. Evaluation of the structure-modifying effects of dia-cerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-control-led trial. Evaluation of the chondromodulating effect of diacerein in OA of the hip. Arthritis Rheum 2001; 44: 2539 -2547.
21. Lequesne M, Maheu E, Cadet C, et al. Structural effect of avocado/soybean unsaponifiables on joint space loss in osteoartritis of the hip. Arthritis Rheum Arthritis Rheum 2002; 47: 50 -58.
22. Rozendaal RM, Koes BW, van Osch GJ, et al. Effect of glucosamine sulfate on hip osteoarthritis: A randomized trial. Ann Intern Med 2008; 148: 268 -277.
23. Altman RD, Bloch DA, Dougados M, et al. Measurement of structural progression in osteoarthritis of the hip: The Barcelona consensus group. Osteoarthritis Cartilage 2004; 12: 515 -524.
24. Abadie E, Ethgen D, Avouac B, et al. Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis. Osteoarthritis Cartilage 2004; 12: 263 -268.
25. Ornetti P, Brandt K, Hellio Le Graverand MP, et al. OARSI-OME-RACT definition of relevant radiological progression in hip/knee osteoarthritis. Osteoarthritis Cartilage 2009; 17: 856 -863.
26. EMEA-CHMP. Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis. CPMP/EWP/784/97 Rev.l.http://www.ema.europa.eu/ema/index.jsp?curl.../document.../document...search (accessed 20 Jan 2010).
27. Mauviel A, Daireaux M, Hartmann DJ, et al. Effets des insaponi-fiables d'avocat etde soja (PIAS) sur la production de collagene par des cultures de synoviocytes, chondrocytes articulaires et fibroblastes der-miques. Rev Rhum Mai Ostdoartic 1989; 56: 207 -211.
28. Mauviel A, Loyau G, Pujol JP. Effet des insaponifiables d'avocat/soja (Piasclddine®) sur 1'activity collagnolytique de cultures de synoviocytes rhumatotfdes humains et de chondrocytes articulaires de lapin trails par l'interleukine 1. Rev Rhum Mai Ostooartic 1991; 58: 241 -245.
29. Henrotin Y, Labasse A, Zheng SX, et al. Effects of three avocado/soybean unsaponifiable mixtures on human articular chondrocytes metabolism. Clin Rheumatol 1998; 17: 31 -39.
30. Boumediene K, Felisaz N, Bogdanowicz P, et al. Avocado/soya un-saponifiables enhance expression of transforming growth factor-1 and -2 in cultured articular chondrocytes. Arthritis Rheum 1999; 42: 148 -156.
31. Henrotin YE, Sanchez C, Deberg MA, et al. Avocado/soybean un-saponifiables increase aggrecan synthesis and reduce catabolic and proinflammatory mediator production by human osteoarthritic chondrocytes. J Rheumatol 2003; 30: 1825 -1834.
32. Henrotin YE, Deberg MA, Crielaard JM, et al. Avocado/soybean unsaponifiables prevent the inhibitory effect of osteoarthritic subchondral osteoblasts on aggrecan and type II collagen synthesis by chondrocytes. J Rheumatol 2006; 33: 1668 -1678.
33. Gabay O, Gosset M, Levy A, et al. Stress-induced signaling pathways in hyaline chondrocytes: inhibition by avocado-soybean unsaponifiables (ASU). Osteoarthritis Cartilage 2008; 16: 373 -384.
34. Mazijres B, Tempesta C, Tiechard M, et al. Pathologic and biochemical effects of a lipidic avocado and soya extract on an experimental post-contusive model of OA. Osteoarthritis Cartilage 1993; 1: 46.
35. Cake MA, Read RA, Guillou B, et al. Modification of articular cartilage and subchondral bone pathology in an ovine meniscectomy model of osteoarthritis by avocado and soya unsaponifiables (ASU). Osteoarthritis Cartilage 2000; 8: 404 -411.
36. Boileau C, Martel-Pelletier J, Caron J, et al. Protective effects of total fraction of avocado/soybean unsaponifiables on the structural changes in experimental dog osteoarthritis: inhibition of nitric oxide synthase and matrix metalloproteinase-13. Arthritis Res Ther 2009; 11: R41.
37. Blotman F, Maheu E, Wulwik A, et al. Midterm efficacy and safety of avocado and soya unsaponifiables (ASU) in the treatment of knee and hip osteoarthritis: Results of a three-month prospective, randomized, doub-le-blind, placebo-controlled, paralel groups, multicenter clinical trial. Rev Rhum Engl Ed 1997; 64: 825 -834.
38. Maheu E, Mazicres B, Valat JP, et al. Symptomatic efficacy of avocado/soybean unsaponifiables in the treatment of osteoarthritis of the knee and hip: A prospective, randomized, double-blind, placebo-control-led, multicenter clinical trial with a six-month treatment period and a two-month followup demonstrating a persistent effect. Arthritis Rheum 1998; 41: 81-91.
39. Appelboom T, Schuermans J, Verbruggen G, et al. Symptoms modifying effect of avocado/soybean unsaponifiables (ASU) in knee osteoarthritis. A double blind, prospective, placebo controlled study. Scand J Rheumatol 2001; 30: 242 -247.
40. Ernst E. Avocado-soybean unsaponifiables (ASU) for osteoarthritis -a systematic review. Clin Rheumatol 2003; 22: 285 -288.
41. Christensen R, Bartels EM, Astrup A, et al. Symptomatic efficacy of avocadosoybean unsaponifiables (ASU) in osteoarthritis (OA) patients: A meta-analysis of randomized controlled trials. Osteoarthritis Cartilage 2008; 16: 399 -408.
42. Altman RD, Alarcon G, Appelrouth D, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the hip. Arthritis Rheum 1991; 34: 505 -54.
43. Lequesne M, Mory C, Samson M, et al. Indexes of severity for osteoarthritis of the hip and knee. Scand J Rheumatol 1987; 65 (Suppl): 85 -89.
44. Reis P, Nahal-Sad'd R, Ravaud Ph, et al. Are radiological joint space widths of normal hips asymmetrical? Ann Rheum Dis 1999; 58: 246 -249.
45. Schumacher RH, Chen LX, Buckwalter J. Secondary osteoarthritis. In: Moskowitz R, Altman RD, Hochberg M, et al (Eds). Osteoarthritis. Philadelphia: Lippincott, 2007: 233 -253.
46. Lequesne GM, Laredo JD. The faux profit (oblique view) of the hip in the standing position. Contribution to the evaluation of osteoarthritis of the adult hip. Ann Rheum Dis 1998; 57: 676 -681.
47. Rashad S, Revell P, Hemingway A, et al. Effect of non-steroidal anti-inflammatory drugs on the course of osteoarthritis. Lancet 1989; 2: 519 -522.
48. Maheu E, Cadet C, Marty M, et al. Reproducibility and sensitivity to change of various methods to measure joint space width in osteoarthritis of the hip: A double reading of three different radiographic views taken with a three-year interval. Arthritis Res Ther 2005; 7: R1375 -R1385.
49. Conrozier T, Lequesne MG, Tron AM, et al. The effects of position on the radiographic joint space in osteoarthritis of the hip. Osteoarthritis Cartilage 1997; 5: 17 -22.
50. Lequesne M. Quantitative measurement of joint space during progression of osteoarthritis: "Chondrometry." In: Kuettner K, Goldberg V, eds. Osteoarthritis disorders. Rosemont, IL: American Academy of Orthopaedic Surgeons, 1995: 427 -444.
51. Conrozier T, Brandt K, Piperno M, et al. Reproducibility and sensitivity to change of a new method of computer measurement of joint space width in hip osteoarthritis. Performance of three radiographic views obtained at a 3-year interval. Osteoarthritis Cartilage 2009; 17: 864 -870.
52. Kellgren JH, Lawrence DM. Radiological assessment of osteoarthritis. Ann Rheum Dis 1957; 16: 494 -502.
53. Bellamy N, Buchanan WW, Goldsmith CH, et al. 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 1988; 15: 1833 -1840.
54. Huskisson EC. Measurement of pain. Lancet 1974; 2: 1127 -1131.
55. Lequesne MG, Maheu E. Clinical and radiological evaluation of hip, knee and hand osteoarthritis. Aging Clin Exp Res 2003; 15: 380 -390.
56. Europ Agency Eval Med Products. International Conference Har-monisation (ICH) Topic E9-Step 4 Consensus Guideline: note for guidance on statistical principles for clinical trials. London: European Agency, 1998: 24 -25.
57. EMEA-CHMP. CPMP/EWP/2863/99: Points to Consider on Adjustment for Baseline Covariates. 22 May 2003. http://www.ema.europa.eu/docs/eu-GB/document-library/Scientific-guideline/2009/09/WC500003639.pdf.
58. Siddiqul O, Hung HM, O'Neill R. MMRM vs LOCF: A comprehensive comparison based on simulation study and 25 NDA datasets. I Biopharm Stat 2009; 19: 227 -246.
59. Molenberghs G, Kemvard MG. Missing data in clinical studies. New York: John Wiley & Sons Ed, 2007.
60. Reginster JY, Deroisy R, Rovati LC, et al. Long term effects of glucosamine sulfate on osteoarthritis progression : A randomised, place-bo-controlled clinical trial. Lancet 2001; 357: 251 -256.
61. Pavelka K, Gatterovd J, Olejarova M, et al. Glucosamine sulfate use and delay of progression of knee osteoarthritis. A 3-year, randomized, placebo-controlled, double-blind study. Arch Intern Med 2002; 162: 2113 -2123.
62. Spector TD, Conaghan PG, Buckland-Wright JC, et al. Effect of risedronate on joint structure and symptoms of knee osteoarthritis: Results of the BRISK randomized, controlled trial. Arthritis Res Ther 2005; 7: R625 -R633.
63. Brandt KD, Mazzuca SA, Katz BP, et al. Effect of doxycycline on progression of osteoarthritis. Results of a randomized, placebo-controlled, double-blind trial. Arthritis Rheum 2005; 52: 2015 -2025.
64. Kahan A, Uebelhardt D, De Yathaire F, et al. Long-term effects of chondroitin4 and 6 sulfate on knee osteoarthritis. The study on osteoarthritis progression prevention: A two-year randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2009; 60: 524 -533.
65. Ibbach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: The patient acceptable symptom state. Ann Rheum Dis 2005; 64: 34 -37.
66. Zhang W, Robertson J, Jones AC, et al. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2008; 67: 1716 -1723.