Acute and preventive pharmacologic treatment of cluster headache
Andreas R.Gantenbein, Zurich, Switzerland, andreas.gantenbein@usz.ch
M. Sturzenegger, MD, Bern, Switzerland; F. Riederer, MD, Zurich, Switzerland; P.S. Sandor, MD, Baden, Switzerland; C. Gaul, MD, Essen, Germany
Submitted April 01, 2011
Francis et al. ‘s article may be misunderstood as a binding guideline for CH treatment and may result in suboptimal treatment of these severely affected patients. [1] For example, high dose steroids are highly potent and routinely used in clinical practice even in the absence of valid studies. [6]
The authors did not grade methysergide according to EBM levels because there are so little data. However, methysergide is effective in the treatment of CH despite its association with pulmonary and retroperitoneal fibrosis in long-term use. [7] The authors of the proposed definition for intractable chronic CH [8] and the authors of the European guideline [7] rated methysergide as one of the top three drugs.
Study design using placebo as a control in CH patients might be considered unethical and unacceptable to most patients. We appreciate the data Francis et al. compiled for this article yet past CH treatment guidelines were based on clinical evidence rather than data from randomized controlled trials. [7]
Francis et al. mention civamide as a first line treatment for the prophylaxis of CH with evidence Level B. [1] Aside from one positive randomized controlled trial, this treatment is not mentioned in national or international treatment guidelines. In addition, only the results of one [9] of two clinical trials using civamide have been published. We do not believe civamide is available for regular treatment in the U.S. or Europe. National and international treatment guidelines for cluster headache should be mandatory.
To base therapeutic decisions solely on EBM in rare diseases such as CH may not be feasible, especially in severely affected patients. CH is sometimes called "suicidal headache" as the disease results in suicidal tendencies in 25% of patients. [10] In the clinical context, pragmatic rather than strictly evidence-based approaches are necessary.
References
6. May A. Cluster headache: pathogenesis, diagnosis, and management. Lancet 2005;366:843-855.
7. May A, Leone M, Afra J, Linde M, Sandor PS, Evers S, Goadsby PJ. EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol 2006;13:1066-1077.
8. Goadsby PJ, Schoenen J, Ferrari MD, Silberstein SD, Dodick D. Towards a definition of intractable headache for use in clinical practice and trials. Cephalalgia 2006;26:1168-70.
9. Saper JR, Klapper J, Mathew NT, Rapoport A, Phillips SB, Bernstein JE. Intranasal civamide for the treatment of episodic cluster headaches. Arch Neurol 2002;59:990-994.
10. Jurgens TP, Gaul C, Lindwurm A, Dresler T, Paelecke-Habermann Y, Schmidt-Wilcke T, Lurding R, Henkel K, Leinisch E. Impairment in episodic and chronic cluster headache. Cephalalgia. 2010 Dec 1. [Epub ahead of print].
We are thankful for the discussion with Prof. Arne May and Prof. Peter Goadsby.
Disclosure: Dr. Sandor has served on scientific advisory boards for Pfizer Inc., Allergan, Inc., and Merck Serono; has received funding for travel from Pfizer Inc. and the International Headache Society; serves on the editorial board for the Journal of Headache and Pain; and receives research support from Janssen, the Swiss National Foundation for Research, and the Werner and Paz Selo Foundation. Dr. Gaul declares is a member of the advisory board of Desitin (Germany). C.G. received speakers honoraria from Berlin Chemie AG (Germany), MSD (Germany). C.G. received a travel grant from Medronic (Germany). Drs. Gantebbein, Sturzenegger, and Riederer report no disclosures.
Francis et al. ‘s article may be misunderstood as a binding guideline for CH treatment and may result in suboptimal treatment of these severely affected patients. [1] For example, high dose steroids are highly potent and routinely used in clinical practice even in the absence of valid studies. [6]
The authors did not grade methysergide according to EBM levels because there are so little data. However, methysergide is effective in the treatment of CH despite its association with pulmonary and retroperitoneal fibrosis in long-term use. [7] The authors of the proposed definition for intractable chronic CH [8] and the authors of the European guideline [7] rated methysergide as one of the top three drugs.
Study design using placebo as a control in CH patients might be considered unethical and unacceptable to most patients. We appreciate the data Francis et al. compiled for this article yet past CH treatment guidelines were based on clinical evidence rather than data from randomized controlled trials. [7]
Francis et al. mention civamide as a first line treatment for the prophylaxis of CH with evidence Level B. [1] Aside from one positive randomized controlled trial, this treatment is not mentioned in national or international treatment guidelines. In addition, only the results of one [9] of two clinical trials using civamide have been published. We do not believe civamide is available for regular treatment in the U.S. or Europe. National and international treatment guidelines for cluster headache should be mandatory.
To base therapeutic decisions solely on EBM in rare diseases such as CH may not be feasible, especially in severely affected patients. CH is sometimes called "suicidal headache" as the disease results in suicidal tendencies in 25% of patients. [10] In the clinical context, pragmatic rather than strictly evidence-based approaches are necessary.
References
6. May A. Cluster headache: pathogenesis, diagnosis, and management. Lancet 2005;366:843-855.
7. May A, Leone M, Afra J, Linde M, Sandor PS, Evers S, Goadsby PJ. EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol 2006;13:1066-1077.
8. Goadsby PJ, Schoenen J, Ferrari MD, Silberstein SD, Dodick D. Towards a definition of intractable headache for use in clinical practice and trials. Cephalalgia 2006;26:1168-70.
9. Saper JR, Klapper J, Mathew NT, Rapoport A, Phillips SB, Bernstein JE. Intranasal civamide for the treatment of episodic cluster headaches. Arch Neurol 2002;59:990-994.
10. Jurgens TP, Gaul C, Lindwurm A, Dresler T, Paelecke-Habermann Y, Schmidt-Wilcke T, Lurding R, Henkel K, Leinisch E. Impairment in episodic and chronic cluster headache. Cephalalgia. 2010 Dec 1. [Epub ahead of print].
We are thankful for the discussion with Prof. Arne May and Prof. Peter Goadsby.
Disclosure: Dr. Sandor has served on scientific advisory boards for Pfizer Inc., Allergan, Inc., and Merck Serono; has received funding for travel from Pfizer Inc. and the International Headache Society; serves on the editorial board for the Journal of Headache and Pain; and receives research support from Janssen, the Swiss National Foundation for Research, and the Werner and Paz Selo Foundation. Dr. Gaul declares is a member of the advisory board of Desitin (Germany). C.G. received speakers honoraria from Berlin Chemie AG (Germany), MSD (Germany). C.G. received a travel grant from Medronic (Germany). Drs. Gantebbein, Sturzenegger, and Riederer report no disclosures.