ADIDAC trial: analgesia with dexibuprofen versus ibuprofen in patients suffering from primary dysmenorrhea: a crossover trial

Abstract

Background: Primary dysmenorrhea is estimated to affect 40-50% of menstruating young women.

Methods: Randomized, double-blind, 3-cycle crossover, active-controlled clinical trial conducted in 102 outpatients.

Results: 102 patients entered the study and 77 were eligible for analyses. The mean (SD) age was 31.1 (7.0) years, and the mean cycle duration was 28.1 days (1.89) with a mean menstrual phase of 5.3 days (1.28). 40.26% of patients reported moderate pain from dysmenorrhea, and the remaining 59.74% reported severe pain. Compared to ibuprofen 400 mg, both dexibuprofen doses (200 and 300 mg) showed a trend towards superiority for sum of pain intensity difference (sum of PID), PID and total pain relief. Furthermore, dexibuprofen 200 mg had a faster onset of action compared to the double dose of ibuprofen (p = 0.035). A dose-effect relationship could be demonstrated for dexibuprofen in this visceral pain model. Tolerability was similar across all treatments.

Conclusions: In patients experiencing acute visceral pain as a result of primary dysmenorrhea, dexibuprofen was associated with a dose-dependent effective analgesia; this effect was at least equivalent to that of the double dose of ibuprofen. With its lower body-loading dose, dexibuprofen expands the alternatives available to treat this condition.