Three trials (n=231), of which two were crossover trials (n=182) and one was a parallel-group trial (n=49), were included.
All three trials were of a high quality and scored a maximum of 5 on the Jadad scale and more than 13 on the 16-point scale.
All the active analgesics were significantly more effective than placebo, with more patients experiencing at least 50% pain relief. The RR for improvement in pain after 6 hours was 1.5 (95% CI: 1.1, 2; based on 303 patients) for rofecoxib 25 mg, 2 (95% CI: 1.6, 2.5; based on 451 patients)for rofecoxib 50 mg, 3 (95% CI: 1.7, 5.4; based on 96 patients) for ibuprofen, and 2 (95% CI: 1.6, 2.5; based on 359 patients) for naproxen sodium. The corresponding NNTs were 5 (95% CI: 3.7, 7.8), 3.2 (95% CI: 2.4, 4.5), 2.4 (95% CI: 1.7, 4.2) and 3.1 (95% CI: 2.4, 4.4), respectively. The results were similar for pain relief after 8 and 12 hours.
The proportions of patients remedicating within 12 hours of the first dose were 29% (rofecoxib 25 mg), 28% (rofecoxib 50 mg), 29% (naproxen sodium), 41% (ibuprofen) and 50% (placebo).
Few adverse events were reported. Those reported were mostly nausea and somnolence, and none were serious. In the single-dose trial, the proportions of patients reporting an adverse event were 10% with rofecoxib 25 mg, 8% with rofecoxib 50 mg, 12% with ibuprofen, and 6% with placebo. For the two multiple-dose trials, these proportions were 23% (rofecoxib 25 mg), 24% (naproxen sodium) and 18% (placebo).