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Glucosamine (Gl) And Chondroitin (Ch) Treatment For Osteoarthritis (OA) Of The Knee Or Hip: Meta-Analysis And Quality Assessment Of Clinical Trials T.E. McAlindon, J. Gulin, D.T. Felson Arthritis Ctr., Boston Univ., MA 02118, USA

Background: OA is a major cause of pain and disability in the population for which effective treatment is badly needed. GL and CH have been used for over 10 years in Europe, yet have been neglected as credible OA therapies in the US. Because of their safety, GL and CH would be of value even if only modestly effective. We performed a meta-analysis and quality assessment of clinical trials to evaluate their efficacy, and the quality of the evidence. Studies eligible for inclusion were double-blind placebo-controlled trials of "e4 weeks duration, testing oral or parenteral GL or CH for knee or hip OA, which reported p values and size of treatment effect. Studies were sought using MEDLINE, manual searches of manuscripts and journal supplements, and by contacting authors of published manuscripts and content experts. Study quality was scored independently by two observers using a validated inventory with range 0-65, in which scores £ 33 are considered poor, 34-45 moderate, "e46 good (JAMA 1994 272: 108). Disagreements were treated by adjudication, and by taking averages.

Method: We decided a priori to (i) treat the global pain score in the index joint (or, if unavailable, the Lequesne Index) as the study 1° outcome (ii) classify a trial as positive if the score in the treated group at completion was "e25% lower than the placebo group and significant [p < .05].

We then computed the probability that the observed number of positive studies might have occurred by chance if the treatments were in fact ineffective using the sign test, and the number of negative studies which would be required to make this result null (p "d .5). 13 trials met eligibility criteria: GL (4 papers, 2 abstracts), CH (5 papers, 2 abstracts). Inter-rater ICC for quality scoring was 0.87, p = .0001. Quality scores ranged 8-36, mean 21.1, 95% CI 16.9-25.2, and were substantially lower for abstracts compared with manuscripts (12.2 vs 25.0, p = .001). Deficiencies related to description of randomization, blinding, and completion rates. Only 2 included an intent-to-treat analysis. 5 of the 6 GS studies received industrial support. All studies were classified as positive, and demonstrated large effects - mean score reduction compared to placebo 39.5% (sd 21.9) for GS, 40.2% (6.4) for CS. The probabilities for this outcome in the absence of any true effect are p=0.016 (GS), p=0.008 (CS). The numbers of negative studies required to nullify these probabilities are 45 (GS) & 62 (CS).

Results: Clinical trials of GL and CH show substantial benefits in the treatment of OA, but provide insufficient information about study design and conduct to allow definitive evaluation. We conclude that further studies are needed to test the efficacy of GS and CS.

Source: American College of Rheumatology Annual Meeting November 10, 1998; Abstract: 994. Poster Session D: Osteoarthritis: Clinical Trials


 
 

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