A Double-Blind Comparison of Lysine Acetylsalicylate plus Metoclopramide vs Ergotamine plus Caffeine in Migraine
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- Titus, F., Escamilla, C., Gomes da Costa Palmeira, M.M. et al. Clin. Drug Investig. (2001) 21: 87. doi:10.2165/00044011-200121020-00001
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Gastrointestinal symptoms in patients with migraine are not only distressing, but also hinder the absorption of oral antimigraine medication. The present study was specifically designed to compare the efficacy of lysine acetylsalicylate plus metoclopramide (LAS+MTC) and ergotamine plus caffeine (ERG+CAF) against nausea, vomiting and headache in migraine.
Patients and Study Design
Patients meeting International Headache Society criteria were randomised to double-blind treatment with LAS+MTC (1620mg LAS equivalent to 900mg aspirin + 10mg MTC) or ERG+CAF (2mg ERG plus 200mg CAF). Data were collected by means of patient diaries during a 28-day study period. The primary endpoint was the number of patients having no nausea or vomiting after the first drug intake. Headache relief (complete relief and relief from headache intensity) was part of the secondary efficacy criteria.
126 patients were randomised to LAS+MTC and 124 to ERG+CAF. Significantly more LAS+MTC-treated patients than ERG+CAF-treated patients were free of nausea or vomiting two hours after a single administration (65% vs 40%, respectively; p = 0.001). Relief from headache intensity (Glaxo criterion) according to a four-point classification was achieved in a significantly greater proportion of LAS+MTC-treated patients than of ERG+CAF-treated patients (77% vs 61%, respectively; p = 0.01). Adverse events were reported in 17% of patients on LAS+MTC compared with 23% on ERG+CAF.
With the present study doses, LAS+MTC was significantly more effective than ERG+CAF at relieving migraine attack symptoms, particularly the associated nausea and vomiting.