OBJECTIVE: To evaluate the effect of acute treatment on ictal behavioral functioning of patients with migraine via ambulatory accelerometry. BACKGROUND: The inability to carry out daily activities often complicates migraine attacks. Research into the effects of pharmacological drugs on this outcome parameter in the acute treatment of migraine has been based on subjective reports only. METHODS: In a double-blind, double-dummy, crossover study, 12 patients with migraine treated 2 migraine attacks with thenonspecific antimigraine drug, naproxen (500-mg capsule) or the more specific antimigraine drug, naratriptan (2.5-mg tablet). The clinical symptoms of headache, nausea, vomiting, photophobia, and phonophobia, and the subjective symptoms reflecting mood, sleepiness, and level of functioning were measured by use of a daily log. RESULTS: During the first 6 hours after intake of the study medication, the objective behavioral parameters showed no significant effect of time and no significant differences between naproxen and naratriptan, but naratriptan was significantly more efficacious than naproxen in relieving headache, nausea, and vomiting; the interval between treatment and relief was significantly shorter after intake of naratriptan. CONCLUSIONS: Consciously perceived clinical and subjective symptoms do not necessarily run in parallel with their behavioral equivalents. It, thus, may be important to assess the effects of treatment on behavioral functioning in the evaluation of the general efficacy of antimigraine drugs in the acute treatment of a migraine attack.
RCT Entities:
OBJECTIVE: To evaluate the effect of acute treatment on ictal behavioral functioning of patients with migraine via ambulatory accelerometry. BACKGROUND: The inability to carry out daily activities often complicates migraine attacks. Research into the effects of pharmacological drugs on this outcome parameter in the acute treatment of migraine has been based on subjective reports only. METHODS: In a double-blind, double-dummy, crossover study, 12 patients with migraine treated 2 migraine attacks with the nonspecific antimigraine drug, naproxen (500-mg capsule) or the more specific antimigraine drug, naratriptan (2.5-mg tablet). The clinical symptoms of headache, nausea, vomiting, photophobia, and phonophobia, and the subjective symptoms reflecting mood, sleepiness, and level of functioning were measured by use of a daily log. RESULTS: During the first 6 hours after intake of the study medication, the objective behavioral parameters showed no significant effect of time and no significant differences between naproxen and naratriptan, but naratriptan was significantly more efficacious than naproxen in relieving headache, nausea, and vomiting; the interval between treatment and relief was significantly shorter after intake of naratriptan. CONCLUSIONS: Consciously perceived clinical and subjective symptoms do not necessarily run in parallel with their behavioral equivalents. It, thus, may be important to assess the effects of treatment on behavioral functioning in the evaluation of the general efficacy of antimigraine drugs in the acute treatment of a migraine attack.