R. Allan Purdy (Halifax, Nova Scotia;a.purdy@dal.ca) and Alan M. Rapoport (Los Angeles, CA; alanrapoport@gmail.com
Submitted April 01, 2011
We read the recent review by Francis et al. who analyzed the quality and levels of evidence of clinical research trials for cluster headache (CH) treatment. [1] However, their hierarchy of treatments does not adequately represent the manner in which headache specialists currently treat CH patients.
The preventive therapies listed (Table 4 [1]) do not reflect our first choices for treatment. Although sodium valproate is "not advised," we consider it a second-line preventive measure. Civamide (a Z isomer of capsaicin) is rated as Class I, Level B for CH prevention yet it is not available in any country. Verapamil (Class II, Level C) is our first choice for prevention of CH and prednisone (Class III, Level U) is our favorite short-term preventive along with verapamil, which is effective and widely used.
The authors state: "There is insufficient evidence to advise the use of dihydroergotamine, ergotamine, somatostatin and presdnisone for the acute treatment of CH (Level U). Although these would not be our first preference, dihydroergotamine, ergotamine and prednisone work well as abortives in CH.
This disconnect between levels of evidence for published clinical research trials and appropriate treatments for CH stresses the importance of understanding the definition and intent of evidence-based medicine (EBM) by Sackett et al. [2] EBM is "the judicious use of the best current evidence in making decisions about the care of the individual patient. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research."[2]
Francis et al. note that "verapamil is generally considered to be the mainstay of preventive therapy"
for CH, and that while both verapamil and lithium "received [level] C advice, they are used much more routinely in clinical practice than [capsaicin]," which received a level B rating. [1] The recommendations for preventive therapy of CH from meta-analysis greatly differ from the way headache specialists actually treat their patients. [3-5] The findings from this study partially appear to reflect the age and generic status of many of the pharmacologic agents used for CH treatment.
Increased scientific rigor is necessary for future clinical studies in CH. Until then, clinical judgment and experience should be relied upon for optimal treatment. [2]
References
1. Francis Gj, Becker WJ, Prinsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology 2010;463-473
2. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-72.
3. Leone M, Rapoport Alan. Preventive and surgical management of cluster headache. In: Olesen J, Goadsby PJ, Ramadan NM, Tfelt-Hansen P, Welch KMA, editors. The Headaches 3rd edition. Philadelphia: Lippincott, Williams and Wilkins; 2006:809-814.
4. Dodick DW, Campbell JK. Cluster Headache: Diagnosis, management and treatment. In: Silberstein SJ, Lipton RB, Dalessio DJ, editors. Wolff's Headache And Other Head Pain. New York: Oxford University Press; 2001:283-309.
Disclosure: Dr. Peterlin serves as a consultant for Nautilus Pharmaceuticals; serves on the speakers bureau for GSK, Endo and Merck; receives grant support from GSK; has an intellectual property provisional patent for the use of adiponectin modulating drugs for migraine; and serves an Associate Editor for the journal Headache. Dr. Purdy has been on the Medical Advisory Boards for Merck Canada, Pfizer Canada; has received support for clinical trial research from Allergan, and Merck for trials of new agents for the treatment of migraine; serves as an Associate Editor of Cephalalgia and Supplement Editor of Headache. Dr. Rapoport served on the scientific advisory board of MAP, Zogenix, Pfizer, Nautilus Neurosciences and NuPathe; received honoraria as part of a speakers bureau from Zogenix, Nautilus Neurosciences, Merck, Pfizer, and Endo; is an editorial board member of Headache and Neurology Reviews; and served as a consultant for Gerson Lehman Group and Medacorp; and has testified as an expert witness for both the defense and the plaintiff in occasional legal proceedings.
We read the recent review by Francis et al. who analyzed the quality and levels of evidence of clinical research trials for cluster headache (CH) treatment. [1] However, their hierarchy of treatments does not adequately represent the manner in which headache specialists currently treat CH patients.
The preventive therapies listed (Table 4 [1]) do not reflect our first choices for treatment. Although sodium valproate is "not advised," we consider it a second-line preventive measure. Civamide (a Z isomer of capsaicin) is rated as Class I, Level B for CH prevention yet it is not available in any country. Verapamil (Class II, Level C) is our first choice for prevention of CH and prednisone (Class III, Level U) is our favorite short-term preventive along with verapamil, which is effective and widely used.
The authors state: "There is insufficient evidence to advise the use of dihydroergotamine, ergotamine, somatostatin and presdnisone for the acute treatment of CH (Level U). Although these would not be our first preference, dihydroergotamine, ergotamine and prednisone work well as abortives in CH.
This disconnect between levels of evidence for published clinical research trials and appropriate treatments for CH stresses the importance of understanding the definition and intent of evidence-based medicine (EBM) by Sackett et al. [2] EBM is "the judicious use of the best current evidence in making decisions about the care of the individual patient. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research."[2]
Francis et al. note that "verapamil is generally considered to be the mainstay of preventive therapy" for CH, and that while both verapamil and lithium "received [level] C advice, they are used much more routinely in clinical practice than [capsaicin]," which received a level B rating. [1] The recommendations for preventive therapy of CH from meta-analysis greatly differ from the way headache specialists actually treat their patients. [3-5] The findings from this study partially appear to reflect the age and generic status of many of the pharmacologic agents used for CH treatment.
Increased scientific rigor is necessary for future clinical studies in CH. Until then, clinical judgment and experience should be relied upon for optimal treatment. [2]
References
1. Francis Gj, Becker WJ, Prinsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology 2010;463-473
2. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-72.
3. Leone M, Rapoport Alan. Preventive and surgical management of cluster headache. In: Olesen J, Goadsby PJ, Ramadan NM, Tfelt-Hansen P, Welch KMA, editors. The Headaches 3rd edition. Philadelphia: Lippincott, Williams and Wilkins; 2006:809-814.
4. Dodick DW, Campbell JK. Cluster Headache: Diagnosis, management and treatment. In: Silberstein SJ, Lipton RB, Dalessio DJ, editors. Wolff's Headache And Other Head Pain. New York: Oxford University Press; 2001:283-309.
5. Ekbom K, Hardebo JE. Cluster Headache: Aetiology, Diagnosis and Management. Drugs 2002;62:61-69.
Disclosure: Dr. Peterlin serves as a consultant for Nautilus Pharmaceuticals; serves on the speakers bureau for GSK, Endo and Merck; receives grant support from GSK; has an intellectual property provisional patent for the use of adiponectin modulating drugs for migraine; and serves an Associate Editor for the journal Headache. Dr. Purdy has been on the Medical Advisory Boards for Merck Canada, Pfizer Canada; has received support for clinical trial research from Allergan, and Merck for trials of new agents for the treatment of migraine; serves as an Associate Editor of Cephalalgia and Supplement Editor of Headache. Dr. Rapoport served on the scientific advisory board of MAP, Zogenix, Pfizer, Nautilus Neurosciences and NuPathe; received honoraria as part of a speakers bureau from Zogenix, Nautilus Neurosciences, Merck, Pfizer, and Endo; is an editorial board member of Headache and Neurology Reviews; and served as a consultant for Gerson Lehman Group and Medacorp; and has testified as an expert witness for both the defense and the plaintiff in occasional legal proceedings.