We studied the efficacy and tolerability of glycosaminoglycan polysulf
uric acid (GAGPS) in 80 patients with osteoarthritis (OA) of the knee.
Patients received two series of five intra-articular injections, at 1
-week intervals, of 25 mg (0.5 ml) GAGPS into the knee in a double-bli
nd, parallel, randomized, placebo-controlled trial. There was an immed
iate decrease in pain after the injections of 43% with GAGPS and 33% w
ith placebo (P = 0.047) (Jezek pain index). Pain relief of GAGPS vs pl
acebo was not different at other intervals (10, 14, 22, 26 weeks after
start of treatment). At 6 weeks the Lequesne index decreased 20% afte
r GAGPS and 9% after placebo (P = 0.17). At 10 weeks the Lequesne inde
x decreased 24% after GAGPS and 13% after placebo (P = 0.20). The decr
ease in Lequesne index at 14 weeks was 31% after GAGPS and 15% after p
lacebo (P = 0.06). The other measured parameters tended to be more fav
orably influenced by GAGPS than placebo. GAGPS was well tolerated, wit
h associated mild adverse reactions in 8% of cases. GAGPS may have a r
ole as a symptomatic slow acting drug for OA. Further study appears ap
propriate.