Efficacy and safety of lornoxicam vs ibuprofen in primary dysmenorrhea: a randomized, double-blind, double dummy, active-controlled, cross over study.

ABSTRACT

OBJECTIVES: Study was planned to evaluate the efficacy and safety of lornoxicam in moderate to severe menstrual pain due to primary dysmenorrhea. STUDY DESIGN: This doubled blind, double dummy, randomized, comparable study of lornoxicam versus ibuprofen was conducted at Sir Takhtsinghji General Hospital, Bhavnagar, Gujarat, India. Total 57 primary dysmenorrhea participants having mean age±standard deviation (SD) of 19.2±2.08 were analyzed. The participants were randomly allocated to either lornoxicam 8 mg or ibuprofen 400mg two times a day for maximum of three days on two consecutive menstrual periods. The different medication was taken on each cycle. The analgesic efficacy was compared by a total area under pain relief score to 4 and 8h, pain intensity difference, sum of pain intensity difference to 4 and 8h, peak pain intensity difference to 4 and 8h, peak pain relief to 4 and 8h, total medication consumption, rescue medication and participant global evaluation. Adverse effects were recorded in both groups. RESULTS: In both treatments, efficacy parameters were significantly reduced at measured time points as compared to baseline. No significant difference was observed between lornoxicam and ibuprofen in terms of efficacy parameters total area under pain relief to 4h (8.0±2.6 vs 8.3±2.7), total area under pain relief to 8h (22.4±4.6 vs 23.0±4.4), sum of pain intensity difference to 4h (-5.7±1.9 vs -6.0±2.0), sum of pain intensity difference to 8h (-17.5±3.3 vs -17.8±3.5), peak pain relief to 4h (3.4±0.8 vs 3.5±0.8), peak pain relief to 8h (3.9±0.5 vs 3.9±0.4), peak pain intensity difference to 4h (-2.6±0.7 vs -2.7±0.7), peak pain intensity difference to 8h (-3.3±0.6 vs -3.3±0.6). Total medication consumption, a requirement of rescue medication and global evaluation of efficacy were comparable in both groups. The incidence of adverse effect was also similar in both groups. CONCLUSIONS: Lornoxicam appears to be a new therapeutic agent for the treatment of primary dysmenorrhea.