Prophylactic treatment of migraine with angiotensin converting enzyme inhibitor (lisinopril): randomised, placebo controlled, crossover study

Objective To determine the efficacy of an angiotensin converting enzyme inh ibitor in the prophylaxis of migraine. Design Double blind, placebo controlled, crossover study. Setting Neurological outpatient clinic. Participants Sixty patients aged 19-59 years with migraine with two to six episodes a month. Interventions Treatment period of 12 weeks with one 10 mg lisinopril tablet once daily for one week then two 10 mg lisinopril tablets once daily for 1 1 weeks, followed by a two week wash out period. Second treatment period of one placebo tablet once daily for one week and then two placebo tablets fo r 11 weeks. Thirty participants followed this schedule, and 30 received pla cebo followed by lisinopril. Main outcome measures Primary end points: number of hours with headache, nu mber of days with headache. number of days with migraine. Secondary end poi nts: headache severity index, use of drugs for symptomatic relief, quality of life and number of days taken as sick leave, acceptability of treatment Results In the 47 participants with complete data, hours with headache, day s with headache, days with migraine, and headache severity index were signi ficantly reduced by 20% (95%, confidence interval 5%, to 36%), 17% (5% to 3 0%), 21% (9% to 34%), and 20% (3% to 37%), respectively, with lisinopril co mpared with placebo. Days with migraine were fewer by at least 50% in 14 pa rticipants for active treatment versus placebo. Intention to treat analysis of data from 55 patients supported the differences in favour of lisinopril for the primary end points. Conclusion The angiotensin converting enzyme inhibitor, lisinopril, has a c linically important prophylactic effect in migraine.