DICLOFENAC-K (50 AND 100 MG) AND PLACEBO IN THE ACUTE TREATMENT OF MIGRAINE

The aim of the present study was to assess the efficacy and tolerabili ty of single oral doses of 50 mg and 100 mg of diclofenac-K compared t o placebo in migraine sufferers during three attacks. The study was co nducted in a double-blind, randomized, placebo-controlled, three-perio d, within-patient comparative trial; 72 migraine patients were treated with diclofenac-K (50 mg or 100 mg) or placebo at six centres (1 in S weden and 5 in Finland). The primary efficacy end-point was the change in pain intensity assessed on a 100 mm Visual Analogue Scale (VAS) at 120 min after taking the study medication. We found that 50 mg and 10 0 mg of diclofenac-K reduced the pain intensity significantly better t han placebo (p = 0.003 and p = 0.001, respectively), without differenc e between the doses; 100 mg diclofenac-K was significantly better than placebo in improving phonophobia, photophobia, working ability and ne ed for rescue medication. Diclofenac-K 50 mg or 100 mg is an effective and well-tolerated acute treatment for migraine headache and its asso ciated symptoms. The higher dose of diclofenac-K was only marginally m ore effective than the lower dose.