No abstract

In order to investigate the plausible association of migraine recurrence with anxiety and depressive symptoms, a multicentre, randomized, double-blind, placebo-controlled, crossover clinical trial was conducted using sumatriptan as a vehicle drug. Migraineurs were randomly assigned to receive either 50 mg sumatriptan or placebo for three consecutive migraine attacks, and then cross over to the other treatment for three more migraine attacks. The primary measurements were the observed rate of migraine recurrence in relation to (i) patient's mood condition, measured by the Hamilton rating scales for depression and anxiety and (ii) patient's general health and functioning measured by the Symptom Checklist (SCL)-90-R. Migraine recurrence was defined as any migrainous headache that occurred within 24 h post treatment, only when pain free at 2 h was achieved. The analysis of efficacy was performed on 376 migraine attacks treated with sumatriptan and 373 attacks treated with placebo. Recurrence ratio was 14.1% and 5.1%, respectively (P = 0.045). The number needed to treat for pain free at 2 h post dose was 5.4. Recurrence was not affected by Hamilton scores for depression or anxiety, SCL-90-R scores or treatment. Apparently, depressive or anxiety symptoms do not influence headache recurrence in acute pharmaceutical migraine treatment, but further investigation is required.