Piroxicam 0.5% gel, administered as 5 mg q.i.d. was compared to placebo gel in a double-blind study of the treatment of selected acute
soft tissue injuries (ankle or acromioclavicular
sprains, supraspinatus, or achilles
tendinitis). A total of 200 patients (100 per treatment) were evaluated. Six patients (6%) in the
piroxicam group discontinued treatment due to inefficacy, compared to 42/100 in the placebo group (p less than 0.001). Significantly greater reduction in
pain (spontaneous and on movement), degree of joint restriction, pressure threshold and tenderness of the affected site were observed with
piroxicam gel compared to placebo gel. The time to improvement was significantly less with the
piroxicam gel. The overall evaluation of efficacy and of benefit to injury favoured
piroxicam over placebo (p less than 0.0001). Both
piroxicam and placebo
gels were well tolerated, with 7
piroxicam and 15 placebo patients reporting primarily skin-related adverse effects. This study indicates that
piroxicam 0.5% gel, administered as 5 mg q.i.d. is an effective treatment of musculoskeletal
injuries (
sprains and
tendinitis), is significantly more effective than placebo, and is well tolerated.