Patient preference in clinical trials for headache medication: the patient's view.

From a clinical point of view, the subjective preference of the patient regarding headache medication is imperative. Consequently, a new trial design for headache medication, the so-called patient preference trial, has been vividly discussed. However, some critical questions have been raised concerning preference trials, such as whether placebos should be used, the necessity of blinding, and how to assess the data if a patient does not prefer medication A over B. As patient preference is the topic, we passed these questions on to headache patients using a questionnaire, which was handed out to 1112 headache patients. Out of 612, 486 returned questionnaires were correctly completed and analysed. Complete pain relief was the most important factor for 61% of patients to qualify a therapy effective. This is in contrast to the literature, where rapid speed of onset of the drug is discussed as the most important factor for migraineurs. Regarding the study design, 80% of the patients want to decide the time-point of taking acute medication themselves. About 60% of the patients would participate in placebo-controlled clinical trials and agree that studies should be blinded. If patients had to decide between two equally effective drugs, most would vote for the drug which is available in different application forms. Furthermore, we used the same questionnaire to ask headache specialists with expertise in performing headache studies the same questions. This was mailed to and completed by 22 experts in Germany. In this article, we discuss the patient preference compared with the expert preference regarding clinic trials and drug therapy.