Headache
-
Randomized Controlled Trial Multicenter Study
Sumatriptan and naproxen sodium for the acute treatment of migraine.
To evaluate the efficacy and tolerability of treatment with a combination of sumatriptan 50 mg (encapsulated) and naproxen sodium 500 mg administered concurrently in the acute treatment of migraine. ⋯ This is among the first prospective studies to demonstrate that multi-mechanism acute therapy for migraine, combining a triptan and an analgesic, is well tolerated and offers improved clinical benefits over monotherapy with these selected standard antimigraine treatments. Specifically, sumatriptan 50 mg (encapsulated) and naproxen sodium 500 mg resulted in significantly superior pain relief as compared to monotherapy with either sumatriptan 50 mg (encapsulated) or naproxen sodium 500 mg for the acute treatment of migraine. Because encapsulation of the sumatriptan for blinding purposes may have altered its pharmacokinetic profile and thereby decreased the efficacy responses, additional studies are warranted that do not involve encapsulation of the active treatments and assess the true onset of action of multi-mechanism therapy in migraine. This study did show that the combination of sumatriptan and naproxen sodium was well tolerated and that there was no significant increase in the incidence of adverse events compared to monotherapy.
-
Multicenter Study Comparative Study Clinical Trial
Migraine prevention in children and adolescents: results of an open study with a special butterbur root extract.
To explore the role of a special butterbur root extract for migraine prevention in children and adolescents with severe migraines. ⋯ The results and low rate of adverse events in this open prospective migraine prevention study in children and adolescents are similar to the results of two multicenter placebo-controlled butterbur studies in adults. Butterbur root extract shows a potential as an effective and well-tolerated migraine prophylaxis also for children and teenagers.
-
Multicenter Study
Clinical characteristics and patterns of medication use of migraneurs in Latin America from 12 cities in 6 countries.
The objective of this study was to document the clinical characteristics of migraine and patterns of medication use in residents > or =15 years old in 12 Latin American urban communities. ⋯ Migraine is a common disorder in Latin American urban communities imposing significant burden on individuals, families, and communities. The magnitude of the impact and the range of activities affected by migraine are similar to those of previous reports in other regions. The preponderance of nonprescription medications and the scarcity of migraine-specific triptans from the study findings are especially striking.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Zolmitriptan 5 mg nasal spray: efficacy and onset of action in the acute treatment of migraine--results from phase 1 of the REALIZE Study.
The objective of phase 1 (reported here) of this two-phase study was to assess the efficacy of zolmitriptan 5 mg nasal spray, in terms of ability to provide relief from all migraine symptoms, in a controlled setting, designed to replicate clinical practice. ⋯ These findings confirm the efficacy demonstrated by zolmitriptan nasal spray in previous clinical trials.
-
Multicenter Study Comparative Study Clinical Trial
Prevalence and diagnosis of migraine in patients consulting their physician with a complaint of headache: data from the Landmark Study.
Headache experts have suggested that to improve the recognition of migraine, patients with a stable pattern of episodic, disabling headache and a normal physical exam should be considered to have migraine in the absence of contradictory evidence. The premise upon which this approach is based-that is, that episodic, recurrent primary headache in the clinic is usually migraine-has not been evaluated in prospective clinical studies. ⋯ These findings support the diagnostic approach of considering episodic, disabling primary headaches with an otherwise normal physical exam to be migraine in the absence of contradictory evidence. If in doubt of diagnosis or when assigning a nonmigraine diagnosis, strong consideration should be given to the use of a diary to confirm primary headache diagnosis.