Comparison of bromfenac and naproxen sodium in the management of primary dysmenorrhea.
Objective: To compare a new analgesic with an established standard and placebo in the treatment of primary dysmenorrhea.Methods: Bromfenac (B) 25 or 50 mg prn, up to 4 doses daily, was compared with naproxen sodium (N) (550/275 mg) and placebo (P) in a double-blind crossover randomized trial where 54 women were treated over 4 menstrual periods. Each treatment lasted up to 3 days. The first-dose analysis was based on a 6-hour observation period. Total pain relief (TOPAR) and summed pain intensity difference (SPID) scores were calculated from hourly collected data as areas under the respective time curves.Results: All 3 active treatments were superior to placebo in all summary variables (SPID and TOPAR for 3 and 6 hours) and corresponding peak pain relief and peak PID, duration of pain half-gone, and global assessment. Both B doses were superior to P in providing significant pain relief between hours 1 and 6, whereas N was superior to P at hours 1, 3, and 4. Good to excellent global rating was achieved by 74% of patients on B 50 mg, 59% on B 25 mg, 57% on N and 33% on P (P <.001) after the first dose. Patients rated the trial medication superior to their usual treatment as follows: B 50 mg: 65%, B 25 mg: 55%, N: 51%, P: 29% (P <.001). Adverse events were infrequent and not significantly different among the 4 treatments.Conclusion: Both doses of bromfenac were significantly superior to placebo and at least as efficacious as naproxen sodium in management of primary dysmenorrhea.
Mehlisch
DR
Scirex Corporation, Texas, Austin, USA