Efficacy and Safety of Hylan versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis

Wen-Li Dai; Ze-Ming Lin; Dong-Hong Guo; Zhan-Jun Shi; Jian Wang

doi:10.1055/s-0038-1641142

The Journal of Knee Surgery, Table of Contents

J Knee Surg 2019; 32(03): 259-268
DOI: 10.1055/s-0038-1641142

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Efficacy and Safety of Hylan versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis

Wen-Li Dai

¹Department of Orthopedic Surgery, Southern Medical University, Nanfang Hospital, Guangzhou, China

,

Ze-Ming Lin

¹Department of Orthopedic Surgery, Southern Medical University, Nanfang Hospital, Guangzhou, China

,

Dong-Hong Guo

¹Department of Orthopedic Surgery, Southern Medical University, Nanfang Hospital, Guangzhou, China

,

Zhan-Jun Shi

¹Department of Orthopedic Surgery, Southern Medical University, Nanfang Hospital, Guangzhou, China

,

Jian Wang

¹Department of Orthopedic Surgery, Southern Medical University, Nanfang Hospital, Guangzhou, China

› Author Affiliations

Abstract

The purpose of this study was to use meta-analytic approach to compare the efficacy and safety of intraarticular hylan and hyaluronic acid (HA) for knee osteoarthritis (OA) treatment. We searched PubMed, Embase, and the Cochrane databases through July 2017 to identify Level I randomized controlled trials (RCTs) that evaluated clinical efficacy and safety of hylan compared with HA for knee OA. The primary outcomes were Visual Analogue Scale (VAS) for pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, and WOMAC function scores. In each study and for the outcome measures (VAS for pain, WOMAC pain, function and stiffness scores, and Lequesne score), we calculated the treatment effect from the difference between the preintervention and postintervention changes in the hylan and HA groups. Twenty-one RCTs involving 3,058 patients were included. Pooled analysis suggested that compared with HA, hylan was associated with similar pain relief and function improvement in patients with knee OA (VAS for pain: mean difference [MD], –3.04; 95% confidence interval [CI], –9.13 to 3.04; p = 0.33; I ² = 76%. WOMAC pain score: MD, 0.23; 95% CI, –0.25 to 0.70; p = 0.35; I ² = 0%. WOMAC function score: MD, –0.47; 95% CI, –6.81 to 5.88; p = 0.88; I ² = 84%). No significant difference was found comparing the patients with treatment-related adverse events. The relationship was robust in sensitivity analysis and consistent in most of the subgroup analyses. As to the primary outcomes (WOMAC pain, function scores, VAS for pain), the difference between hylan and HA did not reach the previously reported minimum clinically important difference (MCID) values (–13.4 for VAS for pain, –2.0 for WOMAC pain score, –7.7 for WOMAC function score). Our meta-analysis showed that there were no statistically and clinically significant differences in pain relief and function improvement between hylan and HA injections for knee OA treatment. In view of its higher costs, we discourage the use of hylan in patients with knee OA in clinical practice. The level of evidence is I, meta-analysis of Level I studies.

Keywords

knee osteoarthritis - hyaluronic acid - hylan

Full Text

References

References
1 Haywood L, McWilliams DF, Pearson CI. , et al. Inflammation and angiogenesis in osteoarthritis. Arthritis Rheum 2003; 48 (08) 2173-2177
2 Carr AJ, Robertsson O, Graves S. , et al. Knee replacement. Lancet 2012; 379 (9823): 1331-1340
3 Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet 2011; 377 (9783): 2115-2126
4 Balazs EA, Watson D, Duff IF, Roseman S. Hyaluronic acid in synovial fluid. I. Molecular parameters of hyaluronic acid in normal and arthritis human fluids. Arthritis Rheum 1967; 10 (04) 357-376
5 Gibbs DA, Merrill EW, Smith KA, Balazs EA. Rheology of hyaluronic acid. Biopolymers 1968; 6 (06) 777-791
6 Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol Suppl 1993; 39: 3-9
7 Hochberg MC, Altman RD, April KT. , et al; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken) 2012; 64 (04) 465-474
8 McAlindon TE, Bannuru RR, Sullivan MC. , et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 2014; 22 (03) 363-388
9 Rutjes AW, Jüni P, da Costa BR, Trelle S, Nüesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann Intern Med 2012; 157 (03) 180-191
10 Bannuru RR, Natov NS, Obadan IE, Price LL, Schmid CH, McAlindon TE. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Arthritis Rheum 2009; 61 (12) 1704-1711
11 Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2006; (02) CD005321
12 Bannuru RR, Natov NS, Dasi UR, Schmid CH, McAlindon TE. Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis--meta-analysis. Osteoarthritis Cartilage 2011; 19 (06) 611-619
13 Reichenbach S, Blank S, Rutjes AW. , et al. Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis. Arthritis Rheum 2007; 57 (08) 1410-1418
14 Adams ME, Atkinson MH, Lussier AJ. , et al. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage 1995; 3 (04) 213-225
15 Wobig M, Bach G, Beks P. , et al. The role of elastoviscosity in the efficacy of viscosupplementation for osteoarthritis of the knee: a comparison of hylan G-F 20 and a lower-molecular-weight hyaluronan. Clin Ther 1999; 21 (09) 1549-1562
16 Schiavinato A, Finesso M, Cortivo R, Abatangelo G. Comparison of the effects of intra-articular injections of Hyaluronan and its chemically cross-linked derivative (Hylan G-F20) in normal rabbit knee joints. Clin Exp Rheumatol 2002; 20 (04) 445-454
17 Zhao H, Liu H, Liang X, Li Y, Wang J, Liu C. Hylan G-F 20 versus low molecular weight hyaluronic acids for knee osteoarthritis: a meta-analysis. BioDrugs 2016; 30 (05) 387-396
18 Pavelka K, Uebelhart D. Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial((R))) vs hylan G-F20 (Synvisc((R))) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study. Osteoarthritis and cartilage / OARS. Osteoarthritis Res Soc 2011; 19: 1294-1300
19 Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of single intra-articular injection of novel hyaluronan (HYA-JOINT Plus) with Synvisc-One for knee osteoarthritis: a randomized, controlled, double-blind trial of efficacy and safety. J Bone Joint Surg Am 2017; 99 (06) 462-471
20 Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord 2015; 16: 57
21 Higgins JPT, Green S. . Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available at: http://handbook.cochrane.org . Accessed November 1, 2017
22 Moher D, Liberati A, Tetzlaff J, Altman DG. ; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339: b2535
23 Altman R, Asch E, Bloch D. , et al; Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Arthritis Rheum 1986; 29 (08) 1039-1049
24 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 (05) 453-461
25 Lequesne MG, Mery C, Samson M, Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation--value in comparison with other assessment tests. Scand J Rheumatol Suppl 1987; 65: 85-89
26 Doganay Erdogan B, Leung YY, Pohl C, Tennant A, Conaghan PG. Minimal clinically important difference as applied in rheumatology: an OMERACT Rasch Working Group systematic review and critique. J Rheumatol 2016; 43 (01) 194-202
27 Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10 (04) 407-415
28 Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001; 45 (04) 384-391
29 Tubach F, Ravaud P, Martin-Mola E. , et al. Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: results from a prospective multinational study. Arthritis Care Res (Hoboken) 2012; 64 (11) 1699-1707
30 Hmamouchi I, Allali F, Tahiri L. , et al. Clinically important improvement in the WOMAC and predictor factors for response to non-specific non-steroidal anti-inflammatory drugs in osteoarthritic patients: a prospective study. BMC Res Notes 2012; 5: 58
31 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003; 327 (7414): 557-560
32 Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997; 315 (7109): 629-634
33 Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50 (04) 1088-1101
34 Gigis I, Fotiadis E, Nenopoulos A, Tsitas K, Hatzokos I. Comparison of two different molecular weight intra-articular injections of hyaluronic acid for the treatment of knee osteoarthritis. Hippokratia 2016; 20 (01) 26-31
35 Khanasuk Y, Dechmaneenin T, Tanavalee A. Prospective randomized trial comparing the efficacy of single 6-ml injection of hylan G-F 20 and hyaluronic acid for primary knee arthritis: a preliminary study. J Med Assoc Thai 2012; 95 (Suppl. 10) S92-S97
36 Iannitti T, Rottigni V, Palmieri B. A pilot study to compare two different hyaluronic acid compounds for treatment of knee osteoarthritis. Int J Immunopathol Pharmacol 2012; 25 (04) 1093-1098
37 Maheu E, Zaim M, Appelboom T. , et al. Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non inferiority, prospective, randomized, controlled trial. Clin Exp Rheumatol 2011; 29 (03) 527-535
38 Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of hylan G-F 20 and sodium hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. Knee 2008; 15 (04) 318-324
39 Atay T, Aslan A, Baydar ML. , et al. The efficacy of low- and high-molecular-weight hyaluronic acid applications after arthroscopic debridement in patients with osteoarthritis of the knee. Acta orthopaedica et traumatologica turcica 2008; 42: 228-233
40 Uluçay C, Altintaş F, Ugutmen E, Beksaç B. The use of arthroscopic debridement and viscosupplementation in knee osteoarthritis [in Turkish]. Acta Orthop Traumatol Turc 2007; 41 (05) 337-342
41 Jüni P, Reichenbach S, Trelle S. , et al; Swiss Viscosupplementation Trial Group. Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial. Arthritis Rheum 2007; 56 (11) 3610-3619
42 Kotevoglu N, Iyibozkurt PC, Hiz O, Toktas H, Kuran B. A prospective randomised controlled clinical trial comparing the efficacy of different molecular weight hyaluronan solutions in the treatment of knee osteoarthritis. Rheumatol Int 2006; 26 (04) 325-330
43 Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage 2006; 14 (02) 154-162
44 Atamaz F, Kirazli Y, Akkoc Y. A comparison of two different intra-articular hyaluronan drugs and physical therapy in the management of knee osteoarthritis. Rheumatol Int 2006; 26 (10) 873-878
45 Rolf CG, Engstrom B, Ohrvik J. , et al. A comparative study of the efficacy and safety of hyaluronan viscosupplements and placebo in patients with symptomatic and arthroscopy-verified cartilage pathology. J Clin Res 2005; 20 05: 15-32
46 Karatosun V, Unver B, Gocen Z, Sen A. Comparison of two hyaluronan drugs in patients with advanced osteoarthritis of the knee. A prospective, randomized, double-blind study with long term follow-up. Clin Exp Rheumatol 2005; 23 (02) 213-218
47 Karatay S, Kiziltunc A, Yildirim K, Karanfil RC, Senel K. Effects of different hyaluronic acid products on synovial fluid levels of intercellular adhesion molecule-1 and vascular cell adhesion molecule-1 in knee osteoarthritis. Ann Clin Lab Sci 2004; 34 (03) 330-335
48 Bayramoğlu M, Karataş M, Cetin N, Akman N, Sözay S, Dilek A. Comparison of two different viscosupplements in knee osteoarthritis -- a pilot study. Clin Rheumatol 2003; 22 (02) 118-122
49 Karlsson J, Sjögren LS, Lohmander LS. Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study. Rheumatology (Oxford) 2002; 41 (11) 1240-1248
50 Hua L, Xin C, Fang SY. Viscosupplementation with sodium hyaluronate for the treatment of osteoarthritis of the knee. Modern Rehabil 2002; 6: 1202-1203
51 Zhou G, Wang Y, Zhou Z. Comparison of two different molecular-weight of sodium hyaluronate on treatment of the osteoarthrosis. Acta Univ Med Second Shanghai 2000; 20: 361-363
52 Adams ME. An analysis of clinical studies of the use of crosslinked hyaluronan, hylan, in the treatment of osteoarthritis. J Rheumatol Suppl 1993; 39: 16-18
53 Sato E, Ando T, Ichikawa J. , et al. High molecular weight hyaluronic acid increases the differentiation potential of the murine chondrocytic ATDC5 cell line. J Orthop Res 2014; 32 (12) 1619-1627
54 Wang CT, Lin J, Chang CJ, Lin YT, Hou SM. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am 2004; 86-A (03) 538-545
55 Lohmander LS, Dalén N, Englund G. , et al; Hyaluronan Multicentre Trial Group. Intra-articular hyaluronan injections in the treatment of osteoarthritis of the knee: a randomised, double blind, placebo controlled multicentre trial. Ann Rheum Dis 1996; 55 (07) 424-431
56 Kemper F, Gebhardt U, Meng T, Murray C. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin 2005; 21 (08) 1261-1269