Piroxicam 0.5% topical gel compared to placebo in the treatment of acute soft tissue injuries: a double-blind study comparing efficacy and safety.

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.