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.

Effectiveness and safety of rectal dexibuprofen versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants with gestational age<34 weeks: A pilot study

“… 39 In addition, compared to ibuprofen 400 mg, Kollenz C et al found both dexibuprofen 200 mg and 300 mg showed a trend towards superiority for sum of pain intensity difference and total pain relief. 40 Furthermore, Liao L et al included 311 URTI children with body temperature higher than 38.5°C. They also reported rectal ibuprofen is as effective as oral group in Chinese patients.…”

Dexibuprofen for fever in children with upper respiratory tract infection

“…It causes discomfort in children, however, and parents want to control fever and express concern over perceived associations of fever with meningitis, convulsions and brain damage . Because of available, effective and safe medications such as ibuprofen, it is therefore difficult to include placebo groups in present‐day clinical trials …”

Dexibuprofen in the Practice of a Family Doctor

“…У міжнародній енциклопедії побічних реакцій і взаємодій «Meyler's Side Effects of Drugs (Sixteenth Edition)» (шістнадцяте видання) наводяться порівняльні дослідження використання дексібупрофену [32].…”