OBJECTIVES: We compare the symptomatic effects of 300 or 600mg daily of ASU in patients with knee osteoarthritis. METHODS: A multicenter, double blind, study comparing a daily intake of 300mg or 600mg of ASU and placebo. The study lasted 3 months and involved patients of both genders, aged 45 to 80 years and presenting with femoro-tibial knee osteoarthritis. The primary endpoint was NSAIDs and analgesics intake between D30 and D90. RESULTS: All efficacy parameters were significantly improved (p<0.01), in the two ASU groups compared to the placebo group. At D90, NSAIDs and analgesics intake decreased by more than 50% in 71% of the patients receiving ASU 300mg or 600mg, compared to 36% of the patients receiving placebo. From DO to D90 Lequesne's index dropped by 3.9 and 2.9 points in ASU 300mg and 600mg groups, respectively, against 1.6 in those receiving placebo. CONCLUSION: The efficacy of ASU at a dosage of 300mg/day and 600mg/day was consistently superior to that of placebo at all endpoints, with no differences observed between the two doses.
RCT Entities:
OBJECTIVES: We compare the symptomatic effects of 300 or 600mg daily of ASU in patients with knee osteoarthritis. METHODS: A multicenter, double blind, study comparing a daily intake of 300mg or 600mg of ASU and placebo. The study lasted 3 months and involved patients of both genders, aged 45 to 80 years and presenting with femoro-tibial knee osteoarthritis. The primary endpoint was NSAIDs and analgesics intake between D30 and D90. RESULTS: All efficacy parameters were significantly improved (p<0.01), in the two ASU groups compared to the placebo group. At D90, NSAIDs and analgesics intake decreased by more than 50% in 71% of the patients receiving ASU 300mg or 600mg, compared to 36% of the patients receiving placebo. From DO to D90 Lequesne's index dropped by 3.9 and 2.9 points in ASU 300mg and 600mg groups, respectively, against 1.6 in those receiving placebo. CONCLUSION: The efficacy of ASU at a dosage of 300mg/day and 600mg/day was consistently superior to that of placebo at all endpoints, with no differences observed between the two doses.