Background Ankle sprain is a common acute soft-tissue injury that often results in swelling, pain, inflammation, and ecchymosis.
Objectives We hypothesised that celecoxib, a COX-2 specific inhibitor, would be as effective as conventional NSAIDs and better than placebo in the treatment of ankle sprain.
Methods Two separate multicenter, randomised, double-blind studies were conducted: (1) celecoxib 400 mg/d (n = 147) vs ibuprofen 2400 mg/d (n = 155) or placebo (n = 141) over 10 days, and (2) celecoxib 400 mg/d (n = 198) vs naproxen 1000 mg/d (n = 198) over 8 days. Patients had grade 1 or 2 ankle sprains and moderate-to-severe pain on weight bearing [>/= 45 mm, 100-mm VAS] at baseline.
Results Most patients were male (60% and 67% for ibuprofen and naproxen comparator studies, respectively); mean ages were 31 and 30 years for ibuprofen and naproxen comparator studies, respectively. The first study dose was taken within 48 h after the injury occurred (mean duration: 25.6 and 23.2 hrs for ibuprofen and naproxen comparator studies, respectively). Covariate-adjusted analyses of the primary endpoints (Patient’s Global Assessment of Ankle Injury responder rate, and Patient’s Assessment of Ankle Pain VAS on weight-bearing) demonstrated that celecoxib was significantly more effective than placebo and as effective as ibuprofen and naproxen in improving the signs and symptoms of ankle sprain. Median times to return to normal function/activity or to improve function by at least 2 grades (5-pt scale) were 5 days for celecoxib-, 6 days for ibuprofen-, and 8 days for placebo-treated patients (celecoxib vs placebo, p = 0.001) in the ibuprofen comparator study and 5 days for both groups in the naproxen comparator study.
Conclusion Celecoxib is as effective as the maximum recommended dose of ibuprofen and naproxen for pain and superior to placebo in treating ankle sprains. Celecoxib, with its platelet-function-sparing properties, may offer an advantage over ibuprofen and naproxen in managing ankle sprain injuries.
Sponsored by Pharmacia Corporation and Pfizer Inc.
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