Medical Evidence
Glucosamine Sulfate Significantly Reduces
Progression Of Knee Osteoarthritis Over 3 Years: A Large, Randomised,
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 enrolment and after 1 and
3 years standardising 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 computerised 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 were analysed separately
according to a per-protocol (PP) approach on 3-year completers,
or on an intention-to-treat (ITT) basis including all randomised
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 enrolment (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 enrolment |
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
