• migraine;
  • health-related quality of life;
  • over-the-counter migraine medication

Objective.—This study was conducted to assess the health-related quality of life of patients treated with samples of an over-the-counter migraine medication.

Background.—Population-based epidemiologic studies have reported that over 90% of an estimated 28 million migraine sufferers in the United States use both prescription and nonprescription medications for their migraine headaches, with 60% taking over-the-counter medications exclusively. Despite the widespread use of nonprescription drugs, no published literature to date has assessed migraineurs' health-related quality of life associated with use of over-the-counter headache medication.

Methods.—This prospective and observational study evaluated the impact on health-related quality of life of patients from a managed care organization who were diagnosed with migraine and prescribed migraine medications. Patients were enrolled from four different medical groups and were requested to complete health-related quality-of-life questionnaires 2 and 4 months after they were provided with educational materials on migraine and samples of an over-the-counter migraine medication containing a combination of acetaminophen, aspirin, and caffeine.

Results.—A total of 99 patients who chose an over-the-counter medication as their initial treatment for acute migraine occurring over the ensuing 4 months completed a baseline Short-Form 36, a validated and reliable general health status questionnaire. They then were retested at months 2 and 4. Results demonstrated significant improvements at months 2 and months 4 in one to four of the health-related quality-of-life dimensions measured relative to scores recorded before the patients were given access to the over-the-counter medication (P  <  .05). In addition, patients who initially took an over-the-counter medication to treat their migraine headaches reported increased frequency of relief.

Conclusion.—In the 4 months following availability of an over-the-counter migraine medication and educational migraine materials, health-related quality of life and frequency of relief improved for the managed care migraine sufferers who participated in this study.