Clinical Drug Investigation

, Volume 21, Issue 2, pp 87–94 | Cite as

A Double-Blind Comparison of Lysine Acetylsalicylate plus Metoclopramide vs Ergotamine plus Caffeine in Migraine

Effects on Nausea, Vomiting and Headache Symptoms
  • Feliu Titus
  • Carlos Escamilla
  • Maria M. Gomes da Costa Palmeira
  • Rogelio Leira
  • Jose M. Pereira Monteiro
Clinical Use

Abstract

Objective

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.

Results

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.

Conclusion

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.

References

  1. 1.
    Rose CF. The history of migraine from Mesopotamia to medieval times. Cephalalgia 1995 Oct; 15Suppl. 15: 1–3PubMedGoogle Scholar
  2. 2.
    Silberstein SD. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995 Jul-Aug; 35(7): 387–96PubMedCrossRefGoogle Scholar
  3. 3.
    Pradalier A, Chabriat H, Danchot J, et al. Safety and efficacy of combined lysine acetylsalicylate and metoclopramide: repeated intakes in migraine attacks. Headache 1999 Feb; 39(2): 125–31PubMedCrossRefGoogle Scholar
  4. 4.
    Hughes F-C, Lacoste J-P, Danchot J, et al. Repeated doses of combined oral lysine acetylsalicylate and metoclopramide in the acute treatment of migraine. Headache 1997 Jul–Aug; 37(7): 452–54CrossRefGoogle Scholar
  5. 5.
    Leone M, Grazzi L, D’Amico D, et al. Areview of the treatment of primary headaches. Parti: Migraine. Ital J Neurol Sci 1995; 16; 577–86PubMedCrossRefGoogle Scholar
  6. 6.
    Volans GN. Absorption of effervescent aspirin during migraine. Br Med J 1974; 4: 265–69PubMedCrossRefGoogle Scholar
  7. 7.
    Volans GN. The effect of metoclopramide on the absorption of effervescent aspirin in migraine. Br J Clin Pharmacol 1975; 2: 57–63PubMedGoogle Scholar
  8. 8.
    Ross-Lee LM, Eadie MJ, Heazlewood V, et al. Aspirin pharmacokinetics in migraine. The effect of metoclopramide. Eur J Clin Pharmacol 1983; 24(6): 777–85PubMedCrossRefGoogle Scholar
  9. 9.
    Tfelt-Hansen P, Olesen J. Effervescent metoclopramide and aspirin (Migravess) versus effervescent aspirin or placebo for migraine attacks: a double blind study. Cephalalgia 1984 Jun; 4(2): 107–11PubMedCrossRefGoogle Scholar
  10. 10.
    Chabriat H, Joire JE, Danchot J, et al. Combined oral lysine acetylsalicylate and metoclopramine in the acute treatment of migraine: a multicentre double-blind placebo controlled study. Cephalalgia 1994 Aug; 14(4): 297–300PubMedCrossRefGoogle Scholar
  11. 11.
    Tfelt-Hansen P, Henry P, Mulder LJ, et al. The effectiveness of combined oral lysine acetylsalicylate and metoclopramide compared with oral sumatriptan for migraine. Lancet 1995 Oct; 346(8980): 923–26PubMedCrossRefGoogle Scholar
  12. 12.
    Pradalier A, Guérard Des Lauriers A, Scheck F, et al. Association carbasalate calcique-metoclopramide versus dihydroergotamine dans le traitement de la crise de migraine [in French]. Path Biol 1995 Nov; 43(9): 806–13Google Scholar
  13. 13.
    Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988; 8Suppl. 7: 1–96Google Scholar
  14. 14.
    The Oral Sumatriptan Dose-Defining Study Group: Sumatriptan — an oral dose-defining study. Eur J Neurol 1991; 31: 300–5CrossRefGoogle Scholar
  15. 15.
    Gralla RJ. Metoclopramide. A review of antiemetic trials. Drugs 1983 Feb; 25Suppl. 1:63–73PubMedCrossRefGoogle Scholar

Copyright information

© Adis International Limited 2001

Authors and Affiliations

  • Feliu Titus
    • 1
  • Carlos Escamilla
    • 2
  • Maria M. Gomes da Costa Palmeira
    • 3
  • Rogelio Leira
    • 4
  • Jose M. Pereira Monteiro
    • 5
  1. 1.Servicio de NeurologiaInstitut Universitori Dexeus (Neurodex)BarcelonaSpain
  2. 2.Servicio de NeurologiaClinica Puerta de HierroMadridSpain
  3. 3.Serviço de NeurologiaHospital de Sao JoaoPortoPortugal
  4. 4.Servicio de NeurologiaHospital XeralSantiago de CompostelaSpain
  5. 5.Serviço de NeurologiaHospital Geral de Santo AntonioPortoPortugal

Personalised recommendations