The aim of this study was to compare the
analgesic efficacy, including onset and duration of
pain relief, peak effect, and total effect, and tolerability of
ibuprofen arginate with those of conventional
ibuprofen in patients with moderate to severe
pain associated with primary
dysmenorrhea.
METHODS: Patients were administered a single dose of
ibuprofen arginate (200 or 400 mg), conventional
ibuprofen (200 or 400 mg), or placebo during each of 5 menstrual cycles in a single-center, double-blind, randomized, double-dummy, 5-cycle, crossover study. Patients recorded their
pain intensity and
pain relief at regularly scheduled intervals (10, 20, 30, 40, 50, 60, and 90 minutes and 2, 3, 4, 5, and 6 hours) after taking the study medication, and all study observations were recorded in a patient diary.
Pain intensity was rated using the following 4-point categoric rating scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Pain relief was rated on a 5-point scale as 0 = none, 1 = a little, 2 = some, 3 = a lot, and 4 = complete relief. Tolerability of
ibuprofen arginate was based on a comparison of the incidence of spontaneously reported adverse events in each of the treatment groups.
RESULTS: One hundred four patients entered the study. Of these, 81.7% were white; the mean (SD) age was 27.5 (5.0) years. A total of 65.4% of patients reported moderate
pain from
dysmenorrhea, and the remaining 34.6% reported severe
pain; 20.2% of patients did not complete the study. The median time to achieve meaningful
pain relief was ∼30 minutes faster with
ibuprofen arginate 400 mg than with either dose of conventional
ibuprofen. Tolerability was similar across all treatments.
CONCLUSIONS: In this study population of patients experiencing
acute pain as a result of primary
dysmenorrhea,
ibuprofen arginate was associated with effective, tolerable
analgesia and a more rapid onset of action than conventional
ibuprofen. The faster onset of
analgesia may have a role in clinical practice in treating women with
dysmenorrhea. A faster onset of action may be important to women whose personal relationships, productivity, or ability to sleep is being adversely affected by
pain.