Measuring responses to therapy in headache patients: new and traditional end-points.
Changes in numerical indices of the intensity, duration and frequency of attacks are traditionally used to assess the effectiveness of treatments for migraine and other primary headaches. However, recent clinical and therapeutic guidelines and guidelines for conducting clinical trials specify that the essential aim of symptomatic and prophylactic migraine treatments should be to reduce the global impact of the headaches on the patient's life. Some standardised instruments for assessing disability and health-related quality of life seem sensitive to treatment-induced changes in primary headache patients. However, further studies to determine the suitability of these instruments as outcome measures in clinical practice are necessary.