A new questionnaire for assessment of adverse events associated with triptans: methods of assessment influence the results. Preliminary results

Triptans are the treatment of choice for migraine sufferers with disabling attacks. However, the proportion of patients reporting side effects after any acute treatment may vary in regard to the method of assessment. This study was conducted in a neurology office focusing on headache in Italy. We prospectively surveyed adult headache sufferers who had been using the same triptan for at least 3 months (from March 2001 to May 2003). Participants were asked about their headache and treatment history. Subjects then completed a standardized questionnaire, assessing adverse events in two different ways. First, subjects were asked if they had any adverse events when using the triptan. If they answered yes, they were asked to list them and grade their severity as mild, moderate, or severe. After returning the first part of the questionnaire, subjects received a second form, where 49 possible adverse events were listed. Most of them were known triptan side effects; some confounders (side effects not expected to be related with triptan use) were added. We contrasted and correlated both sets of answers. We surveyed 108 subjects, (87.1% female, mean age 39.5 years). Most patients (65.5%) reported no side effects in the unprompted questionnaire. However, most of them (54.1%) reported at least one side effect in the prompted questionnaire. The majority of patients that reported side effects in the unprompted questionnaire said they had only one adverse event, while most reported two or more side effects in the prompted questionnaire. Both in the unprompted and in the prompted questionnaires, most side effects were rated as mild or moderate. Two (1.9%) subjects graded their adverse events as severe in the prompted questionnaire, but had not self-reported them. We conclude that when assessing the adverse events of triptans (or any class of medication), the method of data collection may dramatically influence the results.