Should we advise patients to treat migraine attacks early: methodologic issues.

In clinical trials of triptans in acute migraine, patients have traditionally been required to take their medication only when their pain reached moderate or severe intensity. This methodology better ensured that migraine attacks rather than nonmigraine headaches were treated, minimized the placebo response and simplified comparison of improvement as all patients start from the same baseline pain level. In clinical practice, patients do not take medication in this way, and there is some theoretical evidence that early treatment might be beneficial. There are increasing numbers of reports claiming advantages of 'early' treatment, when the pain is mild, over 'late' treatment, when pain is moderate or severe, but these studies raise significant methodologic issues. Treating 'early' may equate with treating 'mild' in slowly progressing attacks only but this may not always be the case in rapidly progressing attacks; these two types of migraine attacks should be distinguished carefully and investigated separately. Trials should be placebo-controlled, blinded, assess the therapeutic gain versus placebo rather than the absolute rates, and use the sustained pain-free endpoint. Early treatment may also increase the risk of medication overuse headaches. At present, there is no scientific support to advise patient to treat early. Patients should be advised to take their medication as soon as they are sure they are developing a migraine headache, but not during the aura phase.