If Migraine Prophylaxis Does Not Work, Think About Compliance

Data are presented on nine patients with migraine by IHS criteria, recruited from those presenting to the clinic for treatment and needing prophylaxis. Pizotifen 0.5 mg tds was prescribed for 8 weeks and dispensed in special containers with an electronic event recorded concealed in the lid. This responded to the pressure change with each opening of the container and recorded it in real time. The information was later downloaded to a PC for analysis. At trial end, two patients had been lost to follow-up, one had not started the treatment at all, two had dropped out because of alleged side effects (drowsiness), and four patients had completed the study. For these, the quantity of tablets used as a percentage of that prescribed (i.e., compliance assessed on the basis of returned-tablet count) ranged from 62.6% to 91.9%; the percentage of days in which three doses had been taken ranged from only 15.8% to 79%; the percentage of doses taken on schedule (8 h +/- 25% after the previous dose) ranged from 21.1% to 47.3%. It is possible that all evaluations of efficacy and tolerance of migraine prophylactics reported so far have been unsoundly based.