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document
Comparative efficacy and safety of calcium carbasalate plus metoclopramide versus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks . This randomized , double-blind , double-dummy , multicenter , parallel-group study aimed at comparing the efficacy and safety of calcium carbasalate ( equivalent to 900 mg aspirin ) plus metoclopramide 10 mg ( CM ) with ergotamine tartrate 1 mg plus caffeine 100 mg ( EC ) administered in the treatment of 2 acute migraine attacks . A total of 296 patients fulfilling the International Headache Society diagnostic criteria for migraine were enrolled . In total , one or two migraine attacks were treated in 268 and 235 patients , respectively . The primary endpoint for the first treated attack was headache relief , with intensity decreasing from moderate or severe to mild or absent 2 h after drug intake . Usual secondary efficacy endpoints were assessed . A superiority of CM over EC was observed for both treated attacks for the main endpoint : success in 54 versus 36 % , p = 0.003 for the first attack and 60 versus 44 % , p = 0.02 for the second attack . CM was also significantly superior to EC during the first attack for complete headache relief ( 20 vs. 8 % , p = 0.006 ) , nausea ( 42 vs. 63 % , p = 0 . 007 ) and willingness to take the drug again ( 90 vs. 80 % , p = 0.043 ) . The global efficacy evaluation , rated by the investigators , was significantly more favorable to CM for both attacks ( p = 0.001 for the first attack and p = 0.02 for the second ) . The patients ' evaluation was significant for the first attack ( p = 0.002 ) . The global incidence of adverse events was 45 % higher with EC , though not significant ( 32 vs. 22 % , p = 0.075 ) . They were most often unspecific and mild to moderate in intensity . Gastrointestinal side effects were significantly less frequent with CM than EC ( 7 vs. 21 % , p = 0.001 ) . Thus , CM is more effective and has a better gastrointestinal safety than EC in the acute treatment of migraine attacks .
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Intervention_Pharmacological
calcium carbasalate
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Intervention_Pharmacological
metoclopramide
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Intervention_Pharmacological
ergotamine tartrate
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Intervention_Pharmacological
caffeine
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Intervention_Pharmacological
calcium carbasalate ( equivalent to 900 mg aspirin )
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Intervention_Pharmacological
metoclopramide 10 mg ( CM )
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Intervention_Pharmacological
ergotamine tartrate 1 mg plus caffeine 100 mg ( EC )
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Intervention_Pharmacological
CM
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Intervention_Pharmacological
EC
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Intervention_Pharmacological
CM
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Intervention_Pharmacological
EC
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Intervention_Pharmacological
CM
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Intervention_Pharmacological
EC
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Intervention_Pharmacological
CM
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Intervention_Pharmacological
CM
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Intervention_Pharmacological
EC
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Outcome_Physical
complete headache relief
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Outcome_Adverse-effects
nausea
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Outcome_Mental
willingness to take the drug again
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Outcome_Other
global efficacy evaluation , rated by the investigators
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Outcome_Other
The patients ' evaluation was significant for the first attack ( p = 0.002 )
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Outcome_Adverse-effects
global incidence of adverse events
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Outcome_Adverse-effects
Gastrointestinal side effects
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Outcome_Other
Thus , CM is more effective and has a better gastrointestinal safety than EC in the acute treatment of migraine attacks
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Participant_Condition
acute migraine
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Participant_Sample-size
296
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Participant_Condition
migraine