Rescue Therapy for Acute Migraine, Part 1

Triptans, Dihydroergotamine, and Magnesium

Nancy E. Kelley, MD, PhD; Deborah E. Tepper, MD

Disclosures

Headache. 2012;52(1):114-128. 

In This Article

Measures Taken

The International Headache Society's Clinical Trial Subcommittee recommends that the primary endpoint in acute migraine treatment research should be the proportion of patients who are pain-free at 2-hour post-medication administration; but, this criterion is rarely used in studies conducted in the ED setting.[23] Especially if they are headache-free or satisfied with treatment and the ED physician believes them ready for discharge, it is impractical to retain study patients in a busy ED for the full 2 hours required.

Even so, the outcome measures of pain-free at 30 minutes to 2 hours was used in some studies, as was "sustained pain-free" (ie, the proportion of those who were pain-free at 1–2 hours and were still pain-free 24–48 hours after discharge).

More typically reported were "headache relief", which utilizes: (1) a 4-point pain scale (4-PPS) – 0 = none, 1 = mild, 2 = moderate, and 3 = severe; (2) an 11-PPS, where in "0" signifies no pain up to "10" that most often is used to signify the worst pain imaginable or "the worst pain ever experienced"; or (3) a visual analog scale (VAS). A 10-cm horizontal non-hatched line marked from 0 on the left to 100 on the right and upon which patients rate the subjective intensity of these symptoms.

Headache relief is defined as either a >50% decrease in VAS scores following administration of medication and/or a 4-PPS score of 0 or 1 compared with a score of 2 or 3 at baseline. "Sustained headache relief" is defined as having headache relief while still in the ED and persisting for 24–48 hours.

Many studies also evaluated functional disability, with pain assessments in the ED and then at postdischarge follow-up. A 4-point disability scale is typically used: 0 = none (capable of normal daily activities), 1 = mild (some difficulty performing normal activities), 2 = moderate (a great deal of difficulty performing normal activities), 3 = severe (unable to get out of bed). When disability was reported for postdischarge follow-up, it was usually reported as the proportion of patients who achieved sustained disability-free (0 or none) status.

Newer outcome measures attempt to incorporate the patients' overall assessment of a medication's efficacy in treating headache pain and accompanying symptoms, as well as treatment side effects and mode of administration. This assessment is typically reported as the proportion of patients that respond in the affirmative to "would take again" or "satisfied with current treatment."

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