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.
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Authors | C Kollenz, W Phleps, S T Kaehler |
Journal | Gynecologic and obstetric investigation
(Gynecol Obstet Invest)
Vol. 67
Issue 1
Pg. 25-31
( 2009)
ISSN: 1423-002X [Electronic] Switzerland |
PMID | 18824862
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Ibuprofen
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Topics |
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage)
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Dysmenorrhea
(drug therapy, pathology)
- Female
- Humans
- Ibuprofen
(administration & dosage)
- Pain
(prevention & control)
- Statistics, Nonparametric
- Stereoisomerism
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