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Published in: The Journal of Headache and Pain 8/2012

Open Access 01-11-2012 | Clinical Trials

Comparison of tolerability and efficacy of a combination of paracetamol + caffeine and sumatriptan in the treatment of migraine attack: a randomized, double-blind, double-dummy, cross-over study

Authors: Luigi Alberto Pini, Simona Guerzoni, Michela Cainazzo, Michela Ciccarese, Maria Pia Prudenzano, Paolo Livrea

Published in: The Journal of Headache and Pain | Issue 8/2012

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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.
Literature
1.
go back to reference Lipton RB, Bigal ME, Diamond M et al (2007) Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 68:343–349CrossRefPubMed Lipton RB, Bigal ME, Diamond M et al (2007) Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 68:343–349CrossRefPubMed
2.
go back to reference Leonardi M, Steiner TJ, Scher AT, Lipton RB (2005) The global burden of migraine: measuring disability in headache disorders with WHO’s Classification of Functioning, Disability and Health (ICF). J Headache Pain 6(6):429–440 (Epub 2005 Dec 15)PubMedCentralCrossRefPubMed Leonardi M, Steiner TJ, Scher AT, Lipton RB (2005) The global burden of migraine: measuring disability in headache disorders with WHO’s Classification of Functioning, Disability and Health (ICF). J Headache Pain 6(6):429–440 (Epub 2005 Dec 15)PubMedCentralCrossRefPubMed
3.
go back to reference Hazard E, Munakata J, Bigal ME, Rupnow MF, Lipton RB (2009) The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis. Value Health 12:55–64 (Epub 2008 Jul 30)CrossRefPubMed Hazard E, Munakata J, Bigal ME, Rupnow MF, Lipton RB (2009) The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis. Value Health 12:55–64 (Epub 2008 Jul 30)CrossRefPubMed
4.
go back to reference Headache Classification Subcommittee of the International Headache Society (2004) The International Classification of Headache Disorders: 2nd edition. Cephalalgia 24(Suppl 1):9–160 Headache Classification Subcommittee of the International Headache Society (2004) The International Classification of Headache Disorders: 2nd edition. Cephalalgia 24(Suppl 1):9–160
6.
go back to reference Bartolini M, Giamberardino MA, Lisotto C, Martelletti P, Moscato D, Panascia B, Savi L, Pini LA, Sances G, Santoro P, Zanchin G, Omboni S, Ferrari MD, Brighina F, Fierro B (2011) A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine. J Headache Pain 12(3):361–368 (Epub 2011 Mar 25)PubMedCentralCrossRefPubMed Bartolini M, Giamberardino MA, Lisotto C, Martelletti P, Moscato D, Panascia B, Savi L, Pini LA, Sances G, Santoro P, Zanchin G, Omboni S, Ferrari MD, Brighina F, Fierro B (2011) A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine. J Headache Pain 12(3):361–368 (Epub 2011 Mar 25)PubMedCentralCrossRefPubMed
7.
go back to reference Sarchielli P, Granella F, Prudenzano MP, Pini LA, Guidetti V, Bono G, Pinessi L, Alessandri M, Antonaci F, Fanciullacci M, Ferrari A, Guazzelli M, Nappi G, Sance G, Sandrini G, Savi L, Tassorelli C, Zanchin G (2012) Italian guidelines for primary headaches: 2012 revised version. J Headache Pain 13(Suppl 2):S31–S70CrossRefPubMed Sarchielli P, Granella F, Prudenzano MP, Pini LA, Guidetti V, Bono G, Pinessi L, Alessandri M, Antonaci F, Fanciullacci M, Ferrari A, Guazzelli M, Nappi G, Sance G, Sandrini G, Savi L, Tassorelli C, Zanchin G (2012) Italian guidelines for primary headaches: 2012 revised version. J Headache Pain 13(Suppl 2):S31–S70CrossRefPubMed
8.
go back to reference Kelley NE, Tepper DE (2012) Rescue therapy for acute migraine, part 3: opioids, NSAIDs, steroids, and post-discharge medications. Headache 52:467–482CrossRefPubMed Kelley NE, Tepper DE (2012) Rescue therapy for acute migraine, part 3: opioids, NSAIDs, steroids, and post-discharge medications. Headache 52:467–482CrossRefPubMed
9.
go back to reference Robbins M (2011) Paracetamol is more effective than placebo for migraine, and paracetamol 1000 mg plus metoclopramide 10 mg is similarly effective to oral sumatriptan 100 mg for migraine relief at 2 h. Evidence Based Med 16:114–115CrossRef Robbins M (2011) Paracetamol is more effective than placebo for migraine, and paracetamol 1000 mg plus metoclopramide 10 mg is similarly effective to oral sumatriptan 100 mg for migraine relief at 2 h. Evidence Based Med 16:114–115CrossRef
10.
go back to reference Migliardi JR, Armellino JJ, Friedman M et al (1994) Caffeine as an analgesic adjuvant in tension headache. Clin Pharmacol Ther 56:576–586CrossRefPubMed Migliardi JR, Armellino JJ, Friedman M et al (1994) Caffeine as an analgesic adjuvant in tension headache. Clin Pharmacol Ther 56:576–586CrossRefPubMed
11.
go back to reference Pini LA, Del Bene E, Zanchin G, Sarchielli P, Di Trapani G, Prudenzano MP, LaPegna G, Savi L, Di Loreto G, Dionisio P, Granella F (2008) Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomized, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium. J Headache Pain 9:367–373PubMedCentralCrossRefPubMed Pini LA, Del Bene E, Zanchin G, Sarchielli P, Di Trapani G, Prudenzano MP, LaPegna G, Savi L, Di Loreto G, Dionisio P, Granella F (2008) Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomized, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium. J Headache Pain 9:367–373PubMedCentralCrossRefPubMed
12.
go back to reference Goldstein J, Silberstein SD, Saper JR, Elkind AH, Smith TR, Gallagher RM, Battikha JP, Hoffman H, Baggish J (2005) Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial. Headache 45:973–982CrossRefPubMed Goldstein J, Silberstein SD, Saper JR, Elkind AH, Smith TR, Gallagher RM, Battikha JP, Hoffman H, Baggish J (2005) Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial. Headache 45:973–982CrossRefPubMed
13.
go back to reference Derosier FJ, Kori SH (2007) Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial-a comment. Headache 47(623):623–625 (author reply)CrossRefPubMed Derosier FJ, Kori SH (2007) Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial-a comment. Headache 47(623):623–625 (author reply)CrossRefPubMed
14.
go back to reference Wenzel RG (2006) A comment on acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial. Headache 46(341):341–343 (author reply)CrossRefPubMed Wenzel RG (2006) A comment on acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial. Headache 46(341):341–343 (author reply)CrossRefPubMed
15.
go back to reference International Headache Society Committee on Clinical Trials (2000) Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 20:765–786CrossRef International Headache Society Committee on Clinical Trials (2000) Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 20:765–786CrossRef
16.
go back to reference Lipton RB, Stewart WF, Ryan RE Jr, Saper J, Silberstein S, Sheftell F (1998) Efficacy and safety of acetaminophen, aspirin, and caffeine in alleviating migraine headache pain: three double-blind, randomized, placebo-controlled trials. Arch Neurol 55:210–217CrossRefPubMed Lipton RB, Stewart WF, Ryan RE Jr, Saper J, Silberstein S, Sheftell F (1998) Efficacy and safety of acetaminophen, aspirin, and caffeine in alleviating migraine headache pain: three double-blind, randomized, placebo-controlled trials. Arch Neurol 55:210–217CrossRefPubMed
17.
go back to reference Diener HC, Peil H, Aicher B (2011) The efficacy and tolerability of a fixed combination of acetylsalicylic acid, paracetamol, and caffeine in patients with severe headache: a post hoc subgroup analysis from a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 31:1466–1476CrossRefPubMed Diener HC, Peil H, Aicher B (2011) The efficacy and tolerability of a fixed combination of acetylsalicylic acid, paracetamol, and caffeine in patients with severe headache: a post hoc subgroup analysis from a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 31:1466–1476CrossRefPubMed
18.
go back to reference Prior MJ, Codispoti JR (2010) A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. Headache 50:819–833CrossRefPubMed Prior MJ, Codispoti JR (2010) A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. Headache 50:819–833CrossRefPubMed
19.
go back to reference Piletta P, Porchet HC, Dayer P (1991) Central analgesic effect of acetaminophen but not of aspirin. Clin Pharmacol Ther 49:350–354CrossRefPubMed Piletta P, Porchet HC, Dayer P (1991) Central analgesic effect of acetaminophen but not of aspirin. Clin Pharmacol Ther 49:350–354CrossRefPubMed
20.
go back to reference Pini LA, Vitale G, Ottani A et al (1997) Naloxone-reversible antinociception by paracetamol in the rat. J Pharmacol Exp Ther 280:934–940PubMed Pini LA, Vitale G, Ottani A et al (1997) Naloxone-reversible antinociception by paracetamol in the rat. J Pharmacol Exp Ther 280:934–940PubMed
21.
go back to reference Sandrini M, Romualdi P, Capobianco A et al (2001) The effect of paracetamol on nociception and dynorphin A levels in the rat brain. Neuropeptides 35:110–116CrossRefPubMed Sandrini M, Romualdi P, Capobianco A et al (2001) The effect of paracetamol on nociception and dynorphin A levels in the rat brain. Neuropeptides 35:110–116CrossRefPubMed
22.
go back to reference Botting RM (2000) Mechanism of action of acetaminophen: is there a cyclooxygenase 3? Clin Infect Dis 31(suppl 5):S202–S210CrossRefPubMed Botting RM (2000) Mechanism of action of acetaminophen: is there a cyclooxygenase 3? Clin Infect Dis 31(suppl 5):S202–S210CrossRefPubMed
24.
go back to reference Diener HC, Pfaffenrath V, Pageler L, Peil H, Aicher B (2005) The fixed combination of acetylsalicylic acid, paracetamol, and caffeine is more effective than single substances and dual combination for the treatment of headache: a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 25:776–787CrossRefPubMed Diener HC, Pfaffenrath V, Pageler L, Peil H, Aicher B (2005) The fixed combination of acetylsalicylic acid, paracetamol, and caffeine is more effective than single substances and dual combination for the treatment of headache: a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 25:776–787CrossRefPubMed
Metadata
Title
Comparison of tolerability and efficacy of a combination of paracetamol + caffeine and sumatriptan in the treatment of migraine attack: a randomized, double-blind, double-dummy, cross-over study
Authors
Luigi Alberto Pini
Simona Guerzoni
Michela Cainazzo
Michela Ciccarese
Maria Pia Prudenzano
Paolo Livrea
Publication date
01-11-2012
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 8/2012
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1007/s10194-012-0484-z

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