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

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 lornoxciam 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 400 mg 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 8 h, pain intensity difference, sum of pain intensity difference to 4 and 8 h, peak pain intensity difference to 4 and 8 h peak pain relief to 4 and 8 h, 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 4 h (8.0 +/- 2.6 vs 83 +/- 2.7), total area under pain relief to 8 h (22.4 +/- 4.6 vs 23.0 +/- 4.4), sum of pain intensity difference to 4 h (-5.7 +/- 1.9 vs 6.0 +/- 2.0), sum of pain intensity difference to 8 h (-17.5 +/- 33 vs 17.8 +/- 3.5), peak pain relief to 4 h (3.4 +/- 0.8 vs 3.5 +/- 0.8), peak pain relief to 8 h (3.9 +/- 0.5 vs 3.9 +/- 0.4), peak pain intensity difference to 4 h (-2.6 +/- 0.7 vs 2.7 +/- 0.7), peak pain intensity difference to 8 h (-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. (C) 2015 Elsevier Ireland Ltd. All rights reserved.