2/21/2017 Lysine Clonixinate vs Naproxen Sodium for the Acute Treatment of Migraine: A DoubleBlind, Randomized, Crossover Study Lysine Clonixinate vs Naproxen Sodium for the Acute Treatment of Migraine: A Double-Blind, Randomized, Crossover Study Abouch Valenty Krymchantowski, MD, MSc, PhD, Coordinator; Director, Patrícia Peixoto, MD, Staff Physician, [ ], and Vivian Schutz, RN, Staff Nurse Abstract and Introduction Abstract Background and Objectives The process of inflammation is crucial in migraine, and several nonsteroidal antiinflammatory drugs (NSAIDs) are effective in the treatment of migraine attacks. Despite their efficacy, the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients. Among the available options, lysine clonixinate (LC) and naproxen sodium (NS) have proved effective in migraine. The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks, with a doubleblind, crossover design Methods Seventy subjects (62 women, 8 men) between ages 18 and 71 years (mean age, 41) with migraine according to the criteria of the International Headache Society were prospectively enrolled. The patients were randomized into 2 groups and each participant treated 2 migraine attacks. Group 1 treated the first attack with LC and the second attack with NS. Group 2 treated 2 attacks in a counterbalanced order. Doses were 250 mg of LC or 550 mg of NS, which were encapsulated for equal appearance. Headache intensity, nausea, photophobia, and side effects were evaluated at baseline, 1 hour, and 2 hours after drug administration. Rescue drugs were allowed after 2 hours for those who didn't respond, and this was also compared between groups Results Sixty patients (54 women, 6 men) completed the study. At 1 hour, 13.6% patients who used LC were painfree compared with 11.9% who used NS (P = .78). At 2 hours, 35.6% patients who took LC and 32.2% who took NS were painfree (P = .69). At baseline, 52.5% of the patients randomized to group 1 reported nausea, compared with 33.9% in group 2, and both drugs eliminated nausea: At both 1 hour and 2 hours, nausea diminished significantly for those taking LC, but only after 2 hours for those who took NS (P