6533b7d7fe1ef96bd126781e

RESEARCH PRODUCT

Aceclofenac versus piroxicam in the management of osteoarthritis of the knee: A double-blind controlled study

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Abstract The objective of this study was to compare the efficacy and tolerability of aceclofenac tablets 100 mg twice daily with piroxicam tablets 20 mg once daily in the treatment of osteoarthritis of the knee or gonarthritis. A randomized, double-blind, controlled study of 3 months' duration was conducted in patients with gonarthritis diagnosed according to the World Health Organization criteria. A total of 212 patients were recruited; 205 patients fully complied with the inclusion-exclusion criteria. Of these, 103 received aceclofenac and 102 received piroxicam. Fourteen patients in the aceclofenac group and 12 patients in the piroxicam group who failed to complete the 3-month treatment period were excluded from the efficacy analysis. Efficacy was evaluated by degree of pain on a visual analogue scale (VAS, 0 to 100 mm), the severity index for gonarthritis (SIG), and the degree of flexion (FLEX) and extension (EXT) of the knee. Clinical symptoms were assessed at baseline, after 15 days (except SIG), and monthly until the end of the treatment. Blood and urine tests were performed at baseline, at 1 month, and at the end of the study. Adverse events were recorded at all observation periods. At baseline, the two treatment groups were homogeneous with regard to demographic data and the variables tested. A significant reduction of pain (decrease in VAS scores) was observed in both groups at 15 days and at 1, 2, and 3 months versus baseline ( P P p P P