Cephalalgia : an international journal of headache
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Review Meta Analysis
Anticonvulsants in migraine prophylaxis: a Cochrane review.
Several trials have asserted that some anticonvulsant drugs seem to be useful for the prophylaxis of migraine, but systematic reviews are sparse. We independently searched PubMed, EMBASE and the Cochrane Central Register of Controlled Trials until 2005, as well as Headache and Cephalalgia through April 2006, for prospective, controlled trials of anticonvulsant drugs. ⋯ Sodium valproate/divalproex sodium and topiramate were better than placebo, whereas acetazolamide, clonazepam, lamotrigine and vigabatrin were not; gabapentin, in particular, needs further evaluation. Trials designed with sufficient power to compare different drugs are also necessary.
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Meta Analysis
Psychological treatment of recurrent headache in children and adolescents--a meta-analysis.
Psychologically based interventions such as relaxation training, biofeedback and cognitive-behavioural therapy are increasingly discussed as options for the treatment of migraine and tension-type headache in children and adolescents. In order to determine the state of evidence regarding the efficacy of these treatments, a meta-analysis of randomized controlled studies was conducted. In a comprehensive literature search including data from 1966 to 2004, 23 studies were found meeting the inclusion criteria. ⋯ Long-term stability was also confirmed. The analysed treatments lead to improvement (up to 1 year) in headache status in children and adolescents with primary headache. However, more well-designed studies are needed to support and consolidate the conclusions of this meta-analysis and to compare the effects of psychological treatment with those of prophylactic medical interventions (in migraine), to examine potential differences between treatments, to identify moderators of efficacy and to determine effects of treatment on other health-related variables such as quality of life.
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A meta-analysis of pooled individual patient data from four randomized, placebo-controlled, double-blind trials comparing several doses of almotriptan (n = 1,908) with placebo (n = 386) was used to investigate the efficacy, speed of onset and tolerability of almotriptan in the acute treatment of migraine. As early as 30 min after dosing, almotriptan 12.5 mg was significantly more effective than placebo for pain relief (14.9% vs. 8.2%; P < 0.05) and pain free (2.5% vs. 0.7%; P < 0.05). ⋯ The incidence of adverse events after almotriptan 6.25 mg and 12.5 mg was not significantly different from that of placebo. This meta-analysis confirms the findings of individual clinical trials, while demonstrating for the first time, significant pain-free efficacy at 30 min compared with placebo.
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Meta Analysis
Placebo effects in oral triptan trials: the scientific and ethical rationale for continued use of placebo controls.
The aim of this study was to determine the characteristics of placebo effects in acute migraine treatment trials of triptans performed over 12 years and assess whether the use of placebo controls in trials of acute migraine treatment remains ethically and scientifically appropriate. We conducted a search for all controlled trials published in English between January 1991 and April 2002 in which adult subjects with migraine were randomly assigned to receive an oral triptan or placebo for the acute treatment of a migraine attack. Thirty-one trials met our criteria for inclusion. ⋯ This variability in placebo response means that active control equivalence trials or the use of historical controls will not provide adequate proof of the safety or efficacy of new drugs, and will not differentiate between drugs that are active vs. placebo but of unknown efficacy relative to each other. The potential for approval of ineffective drugs, inability to compare results of studies performed in different locations, and poor characterization of the tolerability and safety profiles of new drugs represent a greater danger to migraineurs than does the limited-duration use of placebo in carefully monitored clinical trials of consenting subjects. These observations support the view that the inclusion of a placebo group remains of major scientific and ethical importance in trials of migraine medications.
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Meta Analysis
Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials.
The triptans, selective serotonin 5-HT1B/1D agonists, are very effective acute migraine drugs. Soon, seven different triptans will be clinically available at 13 different oral doses, making evidence-based selection guidelines necessary. Triptan trials have similar designs, facilitating meta-analysis. ⋯ Rizatriptan 10 mg, eletriptan 80 mg and almotriptan 12.5 mg provide the highest likelihood of consistent success. Sumatriptan features the longest clinical experience and the widest range of formulations. All triptans are contra-indicated in the presence of cardiovascular disease.