Summary
In a double-blind, parallel-group randomised trial of 3 months’ duration, the efficacy of cyclandelate 800mg twice daily in migraine prophylaxis was compared with that of flunarizine 5mg daily in 40 patients. In comparison with placebo and baseline values, both drugs significantly relieved symptoms of migraine as assessed by indices of pain total index, headache index, analgesic consumption and number of migraine days. Patients taking flunarizine experienced side effects such as drowsiness, weight gain and asthenia, while the most common complaint reported with cyclandelate was gastric upset.
These results suggest that cyclandelate may be a useful alternative in migraine pro-phylaxis.
Résumé
Une étude randomisée en double-insu avec groupes parallèles, d’une durée de 3 mois, a permis de comparer l’efficacité du cyclandélate (800 mg deux fois par jour) à celle de la flunarizine (5 mg par jour) dans la prophylaxie de la migraine chez 40 patients. Par rapport au placebo et aux valeurs de base, les deux médicaments ont significativement réduit les symptômes migraineux évalués par l’index total de la douleur, l’index de céphalée, la consommation d’analgésiques et le nombre de jours de migraine. Les patients traités par la flunarizine ont présenté des effets secondaires à type de somnolence, de gain de poids et d’asthénie alors que les troubles gastriques ont été les principales manifestations indésirables observées sous cyclandélate.
Ces résultats permettent de penser que le cyclandélate peut constituer une alternative utile dans le traitement prophylactique de la migraine.
Riassunto
In un gruppo di ricerche randomizzate a doppio cieco délia durata di 3 mesi, su 40pazienti, l’efficacia di un trattamento con 800 mg di ciclandelato due volte al giorno nella profilassi dell’emicrania, venne paragonata a quella della flunarizina alla dose di 5 mg al giorno. Ambedue i farmaci, paragonati con il placebo ed i valori di base, hanno evidenziato in maniera significativa che i sintomi di emicrania erano valutabili dall’indice totale di sofferenza, dall’Vindice di cefalea, dal consumo di analgesico e dalla durata-giorni dell’emicrania. I pazienti trattati con flunarizina ebbero effetti collaterali quali sonnolenza, aumento di peso ed astenia, mentre il disturbo più comune lamentato dai pazienti trattati con il ciclandelato era insofferenza gastrica.
Questi risultati suggeriscono che il ciclandelato può rappresentare un’ utile alternativa nella profilassi dell’emicrania.
Samenvatting
In een 3 maanden durende aselecte Studie met 40 patiënten werd de effectiviteit van cyclandelaat, toegediend in doses van 2 maal 800 mg per dag, vergeleken met die van flunarizine, 5 mg per dag, bij de profylaxe van migraine. In vergelijking met de placebo- en uit-gangswaarden was er bij beide geneesmiddelen een signiflcante vermindering van de migrai-nesymptomen waar te nemen. Dat blijkt uit de scores van de globale pijnindex, de hoofdpijn index, het analgeticagebruik en het aantal migrainedagen. Proefpersonen die flunarizine toegediend kregen, rapporteerden bijwerkingen zoals slaperigheid, gewichtstoename en asthenie. Bij het gebruik van cyclandelaat werden maagklachten als meest voorkomend gemeld.
Deze resultaten duiden er op dat cyclandelaat een waardevol alternatief kan zijn bij de profylaxe van migraine.
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Nappi, G., Sandrini, G., Savoini, G. et al. Comparative Efficacy of Cyclandelate versus Flunarizine in the Prophylactic Treatment of Migraine. Drugs 33 (Suppl 2), 103–109 (1987). https://doi.org/10.2165/00003495-198700332-00019
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DOI: https://doi.org/10.2165/00003495-198700332-00019