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TITLE: Ergotamine versus for the Treatment of Headaches: Comparative Clinical Effectiveness

DATE: 09 June 2010

RESEARCH QUESTION:

What is the comparative clinical effectiveness of ergotamine versus dihydroergotamine for the treatment of migraine headaches in patients over the age of 16 years?

METHODS:

A limited literature search was conducted on key health technology assessment resources, including PubMed, the Cochrane Library (Issue 5, 2010) University of York Centre for Reviews and Dissemination (CRD) databases, ECRI (Health Devices Gold), EuroScan, international health technology agencies, and a focused Internet search. The search was limited to English language articles published between January 1, 1999 and June 3, 2010. No filters were applied to limit the retrieval by study type. Internet links were provided, where available.

RESULTS:

HTIS reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, controlled clinical trials, and observational studies.

One systematic review, six randomized controlled trials, and one clinical controlled trial were identified in the literature search. No relevant health technology assessments, meta-analyses, or observational studies were identified. No studies directly comparing ergotamine with dihydroergotamine were identified. Additional potentially relevant articles are located in the appendix.

Disclaimer : The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report.

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Health technology assessments No literature identified.

Systematic reviews and meta-analyses

1. Colman I, Brown MD, Innes GD, Grafstein E, Roberts TE, Rowe BH. Parenteral dihydroergotamine for acute migraine headache: a systematic review of the literature. Ann Emerg Med. 2005 Apr;45(4):393-401. PubMed: PM15795718

Randomized controlled trials

2. Aurora SK, Rozen TD, Kori SH, Shrewsbury SB. A randomized, double blind, placebo- controlled study of MAP0004 in adult patients with migraine. Headache. 2009 Jun;49(6):826-37. PubMed: PM19545249

3. Lainez MJ, Galvan J, Heras J, Vila C. Crossover, double-blind comparing and ergotamine plus for acute migraine therapy. Eur J Neurol. 2007 Mar;14(3):269-75. PubMed: PM17355546

4. Christie S, Gobel H, Mateos V, Allen C, Vrijens F, Shivaprakash M, et al. Crossover comparison of efficacy and preference for 10 mg versus ergotamine/caffeine in migraine. Eur Neurol. 2003;49(1):20-9. PubMed: PM12464714

5. Diener HC, Jansen JP, Reches A, Pascual J, Pitei D, Steiner TJ, et al. Efficacy, tolerability and safety of oral and ergotamine plus caffeine (Cafergot) in the acute treatment of migraine: a multicentre, randomised, double-blind, placebo-controlled comparison. Eur Neurol. 2002;47(2):99-107. PubMed: PM11844898

6. Edwards KR, Norton J, Behnke M. Comparison of intravenous versus intramuscular dihydroergotamine and for acute treatment of migraine headache. Headache. 2001 Nov;41(10):976-80. PubMed: PM11903525

7. Boureau F, Kappos L, Schoenen J, Esperanca P, Ashford E. A clinical comparison of nasal spray and dihydroergotamine nasal spray in the acute treatment of migraine. Int J Clin Pract. 2000 Jun;54(5):281-6. PubMed: PM10954953

Controlled clinical trials

8. Pradalier A, Lanteri-Minet M, Geraud G, Allain H, Lucas C, Delgado A. The PROMISE study: PROphylaxis of MIgraine with SEglor (dihydroergotamine mesilate) in French primary care. CNS Drugs. 2004;18(15):1149-63. PubMed: PM15581385

Observational studies No literature identified.

PREPARED BY: Health Technology Inquiry Service Email: [email protected] Tel: 1-866-898-8439

Ergotamine versus Dihydroergotamine for the Treatment of Migraine Headaches 2

APPENDIX – FURTHER INFORMATION:

Systematic reviews and meta-analyses

9. Friedman BW, Kapoor A, Friedman MS, Hochberg ML, Rowe BH. The relative efficacy of meperidine for the treatment of acute migraine: a meta-analysis of randomized controlled trials. Ann Emerg Med [Internet]. 2008 Dec [cited Jun 3 2010];52(6):705-13. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2587513 PubMed: PM18632186

Observational studies

10. Silberstein SD, Young WB, Hopkins MM, Gebeline-Myers C, Bradley KC. Dihydroergotamine for early and late treatment of migraine with cutaneous allodynia: an open-label pilot trial. Headache. 2007 Jun;47(6):878-85. PubMed: PM17578539

Clinical practice guidelines

11. Health care guideline: diagnosis and treatment of headache [Internet]. Bloomington (MN): Institute for Clinical Systems Improvement (US); 2009 Mar [cited 2010 Jun 3]. Available from: http://www.icsi.org/headache/headache__diagnosis_and_treatment_of_2609.html

12. Diagnosis and management of headache in adults: a national clinical guideline (SIGN 107) [Internet]. Edinburgh: Scottish Intercollegiate Guidelines Network (GB); 2008 Nov [cited 2010 Jun 3]. Available from: http://www.sign.ac.uk/pdf/sign107.pdf Note: See Section 6.1.2 vs ; Section 6.1.3 D; Section 6.1.4 Ergotamine; Section 9.2 Treatment

13. Diagnosis and management of headache [Internet]. Singapore: Singapore Ministry of Health; 2007 [cited 2010 Jun 3]. Available from: http://www.moh.gov.sg/mohcorp/uploadedFiles/Publications/Guidelines/Clinical_Practice _Guidelines/Headache%20CPG%20Booklet.pdf

Review articles

14. Schurks M. Dihydroergotamine: role in the treatment of migraine. Expert Opin Drug Metab Toxicol. 2009 Sep;5(9):1141-8. PubMed: PM19624283

15. Tfelt-Hansen PC, Koehler PJ. History of the use of ergotamine and dihydroergotamine in migraine from 1906 and onward. Cephalalgia. 2008 Aug;28(8):877-86. PubMed: PM18460007

16. Saper JR, Silberstein S, Dodick D, Rapoport A. DHE in the pharmacotherapy of migraine: potential for a larger role. Headache. 2006 Nov;46 Suppl 4:S212-S220. PubMed: PM17078853

Ergotamine versus Dihydroergotamine for the Treatment of Migraine Headaches 3

17. Saper JR, Silberstein S. of dihydroergotamine and evidence for efficacy and safety in migraine. Headache. 2006 Nov;46 Suppl 4:S171-S181. PubMed: PM17078849

18. ISDB WHO single medicines review: ergotamine for acute migraine [Internet]. Geneva: World Health Organization; 2005 [cited 2010 Jun 4]. Available from: http://archives.who.int/eml/expcom/expcom14/ergotamine/1_ISDB_WHO_ergotamine.pd f

19. Bigal ME, Tepper SJ. Ergotamine and dihydroergotamine: a review. Curr Pain Headache Rep. 2003 Feb;7(1):55-62. PubMed: PM12525272

20. Silberstein SD, McCrory DC. Ergotamine and dihydroergotamine: history, pharmacology, and efficacy. Headache. 2003 Feb;43(2):144-66. PubMed: PM12558771

21. Tfelt-Hansen P. Ergotamine, dihydroergotamine: current uses and problems. Curr Med Res Opin. 2001;17 Suppl 1:s30-s34. PubMed: PM12463275

22. Tfelt-Hansen P, Saxena PR, Dahlof C, Pascual J, Lainez M, Henry P, et al. Ergotamine in the acute treatment of migraine: a review and European consensus. Brain. 2000 Jan;123 ( Pt 1):9-18. PubMed: PM10611116

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