Abstract
In this study, we compared the efficacy and tolerability of the combination of paracetamol 1,000 mg + caffeine 130 mg (PCF) with sumatriptan 50 mg (SUM) in migraine attacks. This was a multi-center randomized double-blind, double-dummy, cross-over controlled trial. The efficacy was assessed by the sum of pain intensity differences, the curve of mean pain intensity, the number of pain free at 2 h, and the total pain relief. Tolerability was assessed by recording adverse events within 4 h after drug assumption and evaluating the global judgement of patients. The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation. In conclusion, we confirm the efficacy and safety of PCF such as SUM in the treatment of migraine attacks.
Highlights
ObjectivesThe aim of this study was to evaluate the association of paracetamol 1,000 mg ? caffeine 130 mg (PCF) to treat acute migraine attacks and compare the efficacy and safety of this product with a gold standard sumatriptan 50 mg by mouth
Migraine is an intermittent neurological disorder, affecting 10–12 % of the western population
Migraine is a widespread condition that in the majority of cases is self-treated by patients, so the use of safe and effective drugs is a reasonable basis for selecting medicines
Summary
The aim of this study was to evaluate the association of paracetamol 1,000 mg ? caffeine 130 mg (PCF) to treat acute migraine attacks and compare the efficacy and safety of this product with a gold standard sumatriptan 50 mg by mouth
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