If Migraine Prophylaxis Does Not Work, Think About Compliance

Abstract

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.

Behavioral Facilitation of Medical Treatment for Headache—Part I: Review of Headache Treatment Compliance

“…Overall compliance indicated on pill count over the 8‐week trial was 91% compared to MEMS 66% with a linear trend toward poorer compliance with multiple daily dosing regimens (once < twice < 3 times per day dosing). Similarly, Steiner et al 25 demonstrated similar compliance rates using MEMS to monitor adherence with pizotifen prophylaxis of migraine.…”

“…The meta‐analysis showed compliance decreased as the number of daily doses increased, with compliance decreasing from 71%, to 69%, 65%, and 51% as dosing increased from a once per day regimen through a 4 times per day regimen, respectively. The pattern for adherence decrements with multiple daily doses has similarly been demonstrated among headache patients 22,25,34 …”

Improving Medication Adherence in Migraine Treatment

“…Overall, adherence measured via self-report or prospective diaries tend to report adherence rates typically well above 70 %, while claims-based data using persistence as a proxy for adherence typically report rates below 25 %. Mulleners and colleagues [16] and Steiner and colleagues [17] each compared pill counts to Medication Event Monitoring Systems (MEMS), which record pill bottle opening in real-time. In these two small studies (total combined n=47), they reported that adherence estimates using pill counts were 25-40 % higher than adherence estimates obtained using MEMS.…”

Expert Opinion: Adherence to Prophylactic Migraine Medication

“…Regardless of the nomenclature, this poorly understood phenomenon is a significant problem in headache care, because it prevents achievement of the full benefits of medications. It is possible that most evaluations of efficacy and tolerance of migraine prophylactics to date have been biased in this respect 3‐5 . A large number of studies have addressed the degree of patient non‐adherence to medication in other medical conditions, but the methodological quality is generally poor, which poses obstacles to meta‐analyses 6,7 …”