RESUMEN
BACKGROUND: Despite the high prevalence of headache and migraine in the general population, many people do not receive adequate medical attention and treatment. OBJECTIVE: To evaluate the effects of pharmaceutical care (defined as intensified structured counseling between patient and pharmacist, including the use of drug databases), for patients with headache or migraine, on both clinical and psychological endpoints. METHODS: A prospective, randomized, controlled intervention study was conducted using pharmacies in Northern Germany. A total of 112 pharmacies (26% of all pharmacies in the study region) recruited 410 patients with headaches. Pharmacies were randomly assigned to an intervention or control group. Patients were interviewed by telephone prior to the intervention and again after 4 months. Primary endpoints were number of days with headache, number and severity of headaches, self-efficacy, and the patients' perceptions of their health-related quality of life. RESULTS: Each pharmacy treated an average of 4.6 patients (total time effort 9 h). The intervention group consisted of 201 patients who received pharmaceutical care, whereas the control group comprised 209 patients who received standard counseling. In both groups, the number of headache attacks and intensity of pain in treated headache attacks did not change significantly between the first and second interviews. However, a statistically significant improvement in mental health and self-efficacy was shown in the intervention group. Intensity of pain in untreated headache attacks and the number of days with headache decreased in both groups. Most participants described this intervention as helpful and effective and 90% reported that they would recommend pharmaceutical care to other patients with headache. CONCLUSIONS: A short-term pharmaceutical care intervention improved patients' mental health and self-efficacy, although it did not significantly change the number and severity of headaches. The increase in self-efficacy and mental health associated with pharmaceutical care may be instrumental in improving long-term pharmacotherapy of patients with migraine and headache. To fully assess the effects of pharmaceutical care, a longer study may be required.