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A Double Blind, Randomized, Multicenter, Parallel Group Study of the Effectiveness and Tolerance of Intraarticular Hyaluronan in Osteoarthritis of the Knee
RICHARD DAY, PETER BROOKS, PHILIP G. CONAGHAN, and MARISA PETERSEN for the Multicenter Trial Group
ABSTRACT. Methods. A double blind, randomized, parallel group, multicenter (17 centers), saline vehicle-controlled study was conducted over 18 weeks. Patients received either 25 mg (2.5 ml) HA in a phosphate buffered solution or 2.5 ml vehicle containing only the buffer by intraarticular injection. Five injections were given at one week intervals and the patients were followed for a further 13 weeks. The Western Ontario McMaster (WOMAC) OA instrument was used as the primary efficacy variable and repeated measures analysis of covariance was used to compare the 2 treatments over Weeks 6, 10, 14, and 18. Results. Of 240 patients randomized for inclusion in the study, 223 were evaluable for the modified intention to treat analysis. The active treatment and control groups were comparable for demographic details, OA history, and previous treatments. Scores for the pain and stiffness subscales of the WOMAC were modestly but significantly lower in the HA-treated group overall (Weeks 6 to 18; p < 0.05) and the statistically significant difference from the control was not apparent until after the series of injections was complete. The physical function subscale did not reach statistical significance (p = 0.064). Tolerability of the procedure was good and there were no serious adverse events that were considered to have a possible causal relationship with the study treatment. Conclusion. Intraarticular HA treatment was significantly more effective than saline vehicle in mild to moderate OA of the knee for the 13 week postinjection period of the study. (J Rheumatol 2004;31:775-82) Key Indexing Terms:
OSTEOARTHRITIS
From the Department of Clinical Pharmacology and Toxicology, University of New South Wales, Sydney, Australia. Supported by the Seikagaku Corporation, Tokyo, Japan. R. Day, MD, FRACP, Professor of Clinical Pharmacology, University of New South Wales, St. Vincent's Hospital, Sydney; P. Brooks, MD, FRACP, Executive Dean, Health Sciences, University of Queensland, Herston, Queensland, St. Vincent's Hospital; P.G. Conaghan, MB, BS, FRACP, St. Vincent's Hospital (present address: Academic Unit of Musculoskeletal and Rehabilitation Medicine, University of Leeds, Leeds, UK); M. Petersen, PhD, Omnicare Clinical Research, North Ryde, Australia. Address reprint requests to Dr. R. Day, Department of Clinical Pharmacology and Toxicology, University of New South Wales, St. Vincent's Hospital, Victoria Street, Darlinghurst, Sydney 2010 Australia. E-mail: R.Day@unsw.edu.au Submitted October 7, 2002; revision accepted September 3, 2003. |