Document Detail

An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee.
MedLine Citation:
PMID:  16626978     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials. METHOD: Trials were similar in design, patient population and outcome measures - all included the Lequèsne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized. RESULTS: A total of 1155 patients with radiologically confirmed knee OA were enrolled: 619 received three or five IA-HA injections; 536 received "placebo" saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequèsne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequèsne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI: -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses. CONCLUSIONS: This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data.
V Strand; P G Conaghan; L S Lohmander; A D Koutsoukos; F L Hurley; H Bird; P Brooks; R Day; W Puhl; P A Band
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't     Date:  2006-04-19
Journal Detail:
Title:  Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society     Volume:  14     ISSN:  1063-4584     ISO Abbreviation:  Osteoarthr. Cartil.     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-07     Completed Date:  2007-04-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9305697     Medline TA:  Osteoarthritis Cartilage     Country:  England    
Other Details:
Languages:  eng     Pagination:  859-66     Citation Subset:  IM    
Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA.
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MeSH Terms
Double-Blind Method
Drug and Narcotic Control
Hyaluronic Acid / administration & dosage*,  adverse effects,  therapeutic use
Injections, Intra-Articular
Middle Aged
Osteoarthritis, Knee / drug therapy*
Pain / chemically induced
Randomized Controlled Trials as Topic
Treatment Outcome
Reg. No./Substance:
9004-61-9/Hyaluronic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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