TOLFENAMIC ACID VERSUS PROPRANOLOL IN THE PROPHYLACTIC TREATMENT OF MIGRAINE

The prophylactic effect of tolfenamic acid and propranolol was studied in a randomized double-blind cross-over trial of 76 patients with mig raine with or without aura. After a 4-week run-in period patients were randomly allocated to treatment with either tolfenamic acid 100 mg th ree times daily or propranolol 40 mg three times daily for 12 weeks. A fter a placebo wash-out period of 4 weeks the patients got the alterna tive drug for 12 weeks; 56 patients completed the study. Both drugs si gnificantly reduced migraine attacks as judged from the reduction in t he efficacy parameters (migraine hours, migraine days, and migraine in tensity) in the treatment periods compared with the run-in period. No statistical significant difference in any efficacy Parameter was found between the two drugs (level 2alpha = 0.05, alpha = 0.10). The advers e effects showed no statistical difference in frequency between the 2 treatments. Twenty patients discontinued the study: 12 patients on pro pranolol and 8 patients on tolfenamic acid. Side effects were the caus e of premature discontinuation of study medicine in 9 patients during propranolol treatment (dizziness, fatigue, and fall in blood pressure) and in 5 patients during tolfenamic acid treatment (gastrointestinal symptoms).