A Double-Blind Study of the Efficacy of Nimesulide in the Treatment of Ankle Sprain in Comparison with Placebo

Abstract

In a randomised double-blind study, nimesulide 100mg twice daily for 8 days was compared with placebo in the treatment of 60 patients with ankle sprain. On day 4, three nimesulide-treated patients discontinued treatment because of resolution of their symptoms, whereas 11 patients in the placebo group discontinued as a result of worsening symptoms. A significantly greater reduction in pain, functional impairment and swelling was observed with nimesulide compared with placebo; moreover, the time to improvement was significantly shorter with the active treatment. The overall evaluation of efficacy favoured nimesulide over placebo (p < 0.001). Both medications were well tolerated, with 5 patients reporting mild gastralgia (4 treated with nimesulide and 1 with placebo), while 1 placebo-treated patient reported a mild gastrointestinal disturbance. These results suggest that nimesulide is an effective treatment for the short term management of post-traumatic pain states.