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To the Editor:
The publication on the efficacy of the new second-generation 5-hydroxytryptamine (5HT)1B/1D agonist naratriptan in the acute treatment of migraine is remarkable for the data that are not presented. In our view there are fundamental problems, not in the design of the trial, but in the data presentation and the discussion in relation to the other 5HT1B/1D agonists. Headache severity was rated 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 24 hours after the initial dose of study medication. However, headache relief, a decrease in headache from severe or moderate to none or mild, is only reported at 4, 8, 12, and 24 hours. Readers are told that from 60 minutes both the 1-mg and 2.5-mg dose of naratriptan are significantly better than placebo (p < 0.001) but no substantiating data are presented. Given what seems to be a trial of very high power, with 586 to 602 patients per group receiving three doses of naratriptan and placebo in a crossover design,10 why are data for the very important early time points not presented when we know that patients value speed of onset?11 Some early time points were presented at the American Academy of Neurology meeting (Boston, 1997), and we ask that the authors provide …
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