Cephalalgia : an international journal of headache
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
The efficacy and safety of Tanacetum parthenium (feverfew) in migraine prophylaxis--a double-blind, multicentre, randomized placebo-controlled dose-response study.
Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show a dose-response of a new stable extract (MIG-99) reproducibly manufactured with supercritical CO2 from feverfew (T. parthenium). Furthermore, the study should provide data on the safety and tolerability of MIG-99. ⋯ MIG-99 was shown to be effective only in a small predefined subgroup of patients with at least four attacks during the 28-day baseline period where the most favourable benefit-risk ratio was observed with a dosage of three capsules of 6.25 mg MIG-99 extract per day. Because of the low number of patients, these findings need to be verified in a larger sample. The incidence of AEs was similar for all treatment groups.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Intravenous magnesium sulphate in the acute treatment of migraine without aura and migraine with aura. A randomized, double-blind, placebo-controlled study.
Magnesium sulphate has been used in the acute treatment of migraines; some studies found it to be a highly effective medication in the acute control of migraine pain and associated symptoms. This randomized, double-blind, placebo-controlled study assesses the effect of magnesium sulphate on the pain and associated symptoms in patients with migraine without aura and migraine with aura. Sixty patients in each group were assigned at random to receive magnesium sulphate, 1000 mg intravenously, or 0.9% physiological saline, 10 ml. ⋯ The analgesic therapeutic gain was 36.7% at 1 h. A smaller number of patients continued to have aura in the magnesium sulphate group compared with placebo 1 h after the administration of medication. Our data support the idea that magnesium sulphate can be used for the treatment of all symptoms in migraine with aura, or as an adjuvant therapy for associated symptoms in patients with migraine without aura.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
The efficacy and safety of sc alniditan vs. sc sumatriptan in the acute treatment of migraine: a randomized, double-blind, placebo-controlled trial.
This double-blind, placebo-controlled, parallel-group, multicentre, multinational, phase-III trial was designed to assess the efficacy and safety of a single subcutaneous injection of placebo, 2 doses of alniditan (1.4 mg and 1.8 mg) and 6 mg of sumatriptan in subjects with acute migraine. A total of 114 investigators from 13 different countries screened 2021 subjects. In total 924 patients were treated with placebo (157), alniditan 1.4 mg (309), alniditan 1.8 mg (141) and sumatriptan 6 mg (317). ⋯ The difference, however, was small and clinically not important. For alniditan, a dose-dependent adverse event relationship was seen. The safety profile of alniditan 1.4 mg was similar to that of sumatriptan.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of metamizol vs. acetylsalicylic acid in patients with moderate episodic tension-type headache: a randomized, double-blind, placebo- and active-controlled, multicentre study.
We assessed the efficacy and safety of oral single doses of 0.5 and 1 g metamizol vs. 1 g acetylsalicylic acid (ASA) in 417 patients with moderate episodic tension-type headache included in a randomized, double-blind, placebo- and active-controlled, parallel, multicentre trial. Eligibility criteria included 18-65 years of age, history of at least two episodes of tension-type headache per month in the 3 months prior to enrollment, and successful previous pain relief with a non-opioid analgesic. ⋯ A trend towards an earlier onset of a more profound pain relief of 0.5 and 1 g metamizol over 1 g ASA was noticed. All medications including placebo were almost equally safe and well tolerated.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: a randomized, double-blind, placebo-controlled, dose-ranging study.
A total of 729 migraine sufferers with moderate to severe baseline pain evaluated a single 200, 400 or 600 mg dose of a new liquigel formulation of ibuprofen over 8 h. Ibuprofen liquigels were significantly superior to placebo for cumulative headache response (pain reduced to mild or none) from 0.5 (600 mg) or 1 h (200 and 400 mg) to 8 h. At 2 h, respective headache response rates for ibuprofen 200, 400 and 600 mg and placebo were 64%, 72%, 72% and 50%. ⋯ Ibuprofen liquigels were generally superior to placebo for reducing photophobia, phonophobia, or nausea (1-4 h) and for global evaluation. All doses were well tolerated. These data demonstrate that ibuprofen liquigels relieve the pain, ancillary symptoms, and limitation of activity, of migraine.