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Glucosamine
Sulfate Use and Delay of Progression of Knee Osteoarthritis
A 3-Year, Randomized, Placebo-Controlled, Double-blind Study
Karel Pavelká, MD, PhD; Jindriska Gatterová, MD; Marta
Olejarová, MD; Stanislav Machacek, MD; Giampaolo Giacovelli, PhD; Lucio
C. Rovati, MD 
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Background Conventional
symptomatic treatments for osteoarthritis do not favorably affect disease progression.
The aim of this randomized, placebo-controlled trial was to determine whether
long-term (3-year) treatment with glucosamine sulfate can modify the progression
of joint structure and symptom changes in knee osteoarthritis, as previously suggested. Methods Two
hundred two patients with knee osteoarthritis (using American College of Rheumatology
criteria) were randomized to receive oral glucosamine sulfate, 1500 mg once a
day, or placebo. Changes in radiographic minimum joint space width were measured
in the medial compartment of the tibiofemoral joint, and symptoms were assessed
using the algo-functional indexes of Lequesne and WOMAC (Western Ontario and McMaster
Universities). Results Osteoarthritis
was of mild to moderate severity at enrollment, with average joint space widths
of slightly less than 4 mm and a Lequesne index score of less than 9 points. Progressive
joint space narrowing with placebo use was -0.19 mm (95% confidence interval,
-0.29 to -0.09 mm) after 3 years. Conversely, there was no average change with
glucosamine sulfate use (0.04 mm; 95% confidence interval, -0.06 to 0.14 mm),
with a significant difference between groups (P = .001). Fewer patients
treated with glucosamine sulfate experienced predefined severe narrowings (>0.5
mm): 5% vs 14% (P = .05). Symptoms improved modestly with placebo use but
as much as 20% to 25% with glucosamine sulfate use, with significant final differences
on the Lequesne index and the WOMAC total index and pain, function, and stiffness
subscales. Safety was good and without differences between groups. Conclusion Long-term
treatment with glucosamine sulfate retarded the progression of knee osteoarthritis,
possibly determining disease modification. Arch
Intern Med. 2002;162:2113-2123
Author/Article Information
From the Department
of Medicine and Rheumatology, Charles University (Dr Pavelká), and the
Institute of Rheumatology (Drs Pavelká, Gatterová, Olejarová,
and Machacek), Prague, Czech Republic; and the Department of Clinical Pharmacology,
Rotta Research Laboratorium, Monza, Italy (Drs Giacovelli and Rovati).
Corresponding author and reprints: Karel Pavelká, MD, PhD, Institute of
Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic (e-mail: pavelka@revma.cz).
Accepted
for publication February 13, 2002.This study was funded by the Rotta Research/Rottapharm
Group. This
study was presented at the annual meeting of the American College of Rheumatology,
Philadelphia, Pa, November 1, 2000, and at the annual meeting of the European
Congress of Rheumatology, Prague, Czech Republic, June 14, 2001 |