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Evaluation of Sumatriptan‐Naproxen in the Treatment of Acute Migraine: A Placebo‐Controlled, Double‐Blind, Cross‐Over Study Assessing Cognitive Function
Author(s) -
Edwards Keith R.,
Rosenthal Barbara L.,
Farmer Kathleen U.,
Cady Roger K.,
Browning Rebecca
Publication year - 2013
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1111/head.12052
Subject(s) - migraine , sumatriptan , placebo , cognition , medicine , aura , headaches , cognitive test , anesthesia , physical therapy , psychiatry , receptor , alternative medicine , pathology , agonist
Objective To assess the cognitive effects of acute migraine and the subsequent impact of acute treatment in a controlled setting. Background Cognitive dysfunction may be an associated symptom in patients with migraine with or without aura. The loss of cognitive efficiency in migraine may be disabling and is often under recognized. Methods Thirty migraine patients were prospectively studied for cognitive function before and then at the beginning of a migraine using a computerized cognitive battery ( M ental E fficacy W orkload T est). Each patient then was treated for 2 headaches in a cross‐over manner with sumatriptan‐naproxen ( T reximet®) or placebo in a double‐blind, placebo‐controlled fashion with cognitive testing repeated at 1 and 2 hours post‐dose. Results Twenty‐five of the 30 screened migraine subjects completed study‐specific procedures and were included in the data analyses. There were no significant side effects from T reximet or placebo and no serious adverse events. At the onset of headache, there was a statistically significant decline in overall cognitive efficiency compared with the baseline cognitive testing (migraine‐free) for all subjects ( P = .001 paired samples t ‐test). For subjects taking T reximet compared with taking placebo, there was a statistically significant return to cognitive efficiency by measures of immediate and sustained attention, visual‐spatial awareness, mental flexibility, and reaction time between 1 hour and 2 hours ( P = .05). There was no statistical significance between patients taking T reximet or placebo in measures of complex reasoning or fine motor coordination. Subanalysis showed a correlation between headache severity and Performance Index in the T reximet group but not in the placebo group (∼Fig. [Figure 6. Subanalysis showed a correlation between headache severity and Performance ...]). Conclusions There is a significant decline in global cognitive efficiency at the onset of an attack of migraine. The use of T reximet allows a significantly faster recovery time in some measures of cognitive efficiency compared with placebo. Decline of cognitive efficiency may be independent of headache severity.