COMPARATIVE EFFICACY OF IBUPROFEN ARGININE AND BETA-CYCLODEXTRIN PIROXICAM AS TREATMENT FOR TENSION-TYPE HEADACHE

In this single-centre double-blind crossover trial, 30 patients with r ecurrent tension-type headache were randomised to single dose treatmen t with ibuprofen arginine, beta-cyclodextrin piroxicam, or placebo. Pa in intensity was measured by the patient on a Visual Analogue Scale (V AS) from 0mm (no pain) to 100mm (unbearable pain) just before ingestio n of the study medication (baseline) and at 15, 30, 60, 120, and 240 m inutes thereafter. Ibuprofen arginine and beta-cyclodextrin piroxicam tended to provide more effective pain relief than placebo between 1 an d 4 hours after administration. The overall analgesic effect of ibupro fen arginine (measured by calculating the area under the time vs pain intensity curve) was significantly greater than that of placebo (28 vs 41mm; p < 0.01). More ibuprofen arginine and beta-cyclodextrin piroxi cam recipients than placebo recipients rated overall pain relief as co mplete or considerable (38.5% for each active treatment vs 15.4% for p lacebo; p < 0.02). Two patients experienced nausea during the study: o ne after taking ibuprofen arginine, the other after taking beta-cyclod extrin piroxicam. Neither adverse event was considered to be related t o treatment. Thus, ibuprofen arginine was more effective than placebo and may be a useful alternative to beta-cyclodextrin piroxicam as trea tment for patients with tension-type headache.