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Glucosamine Sulfate Significantly Reduces Progression Of Knee Osteoarthritis Over 3 Years: A Large, Randomized, Placebo-Controlled, Double-Blind, Prospective Trial. J Y Reginster, R Deroisy, I Paul, R L Lee, Y Henrotin, G Giacovelli, J Dacre, L C Rovati, C Gosset.
Background. Results of clinical trials support a role for glucosamine sulfate as a Symptom Modifying Drug in osteoarthritis (OA). This study was designed to test the long-term effects of the drug on the progression of knee OA joint structural changes and symptoms. Methods. 212 patients with knee OA (ACR criteria) were randomly assigned, in a double-blind fashion, to the continuous treatment with oral glucosamine sulfate 1500 mg once-a-day or placebo for 3 years. Weight-bearing, antero-posterior radiographs of each knee were taken at enrollment and after 1 and 3 years standardizing patient positioning and radiographic procedure. Total mean joint space width (JSW) of the medial compartment of the tibio-femoral joint was assessed by digital image analysis by a validated computerized algorithm, with the narrowest medial joint space at enrollment being taken for the primary evaluation (signal joint). Symptoms were scored at each 4-month visit by the (total) WOMAC index, VA3.0 version. Data was analyzed separately according to a per-protocol (PP) approach on 3-year completers, or on an intention-to-treat (ITT) basis including all Randomized patients by the last-observation-carried-forward. Results. The two groups of 106 patients each were comparable for demographic and disease characteristics. Placebo-treated patients had an average joint space narrowing (JSN) of approximately 0.08-0.1 mm/year, while no JSN occurred in the glucosamine sulfate group. A slight worsening in symptoms was evident at the end of treatment with placebo, compared to the improvement observed after glucosamine sulfate.
| PP
Placebo
(N=71) | PP
Glucosamine
sulfate (N=68) | ITT
Placebo
(N=106)
| ITT
Glucosamine
sulfate (N=105) a |
JSW
enrollment
(in mm)
| 5.46 (0.15) | 5.39 (0.16) | 5.39 (0.12) | 5.23 (0.13) | JSN 3 years
(in mm)
| -0.31 (0.13) | +0.07 (0.12) b | -0.24 (0.10) | +0.12 (0.09) c | WOMAC
enrollment | 894 (59) | 1024 (59) | 940 (47) | 1030 (46) | % variation
3 years | +9.8% (12.3) | -24.3% (6.4) d | +5.5% (8.6) | -15.4% (5.4) e | | | | | | | | Data are presented as mean (SE). a: 1 enrollment radiograph missing; b: p=0.038, c: p=0.007, d: p=0.016, e: p=0.04 vs. placebo (ANOVA) |
Conclusions:. Combined Structure and Symptom Modifying effects suggest that glucosamine sulfate may be a possible Disease Modifying agent in OA.
Disclosure: Work reported in this abstract was supported by the Rotta Research Group Source: American College of Rheumatology 1999 Annual Meeting, Boston, MA Presentation Date: Wednesday, November 17, 1999 ACR Plenary Abstract
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J.R. Rogers is the founder and President of Activex America, Inc. makers of Liquid Glucosamine Formula Syn-flex®
The author's statements have not been evaluated by the Food and Drug Administration and are not provided to diagnose any disease or to suggest that liquid glucosamine and chondroitin will treat, cure, or prevent any disease.
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