ADIDAC trial: analgesia with dexibuprofen versus ibuprofen in patients suffering from primary dysmenorrhea: a crossover trial.
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.
Kollenz
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C
Gebro Pharma GmbH, Fieberbrunn, Austria.
Phleps
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W
Kaehler
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D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D010146:Pain / Q000517:prevention & control*; D018709:Statistics, Nonparametric; D013237:Stereoisomerism
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen