Being migraine specialists within the field of neurology, we read the article by Guyuron et al.1 with great interest. We have several questions concerning methodologic issues, which we would like to politely ask the authors to comment on in a reply to this letter.
First, in our view, there is insufficient information concerning the included migraine patients. The process of selection is not characterized. There is no information on the gender of the patients. Data on previous medication or medication overuse are missing. Therefore, it is unclear whether the groups that were compared in this study belong to the same clinical group of patients, or whether baseline differences could account for the significant results.
Second, patients who responded to a single injection of botulinum toxin type A (25 IU) were selected for inclusion. As there is no scientific evidence for the efficacy of this type of treatment in episodic migraine patients, the best interpretation of this selection process in our view is that placebo responders were selected.
Third, blinding did not actually take place. As corrugator surgery results in an alteration of facial expression, successful surgical treatment would invariably have been associated with an unblinding of the procedure.
Fourth, the statistics are severely flawed. Not only was there no correction concerning the described baseline differences, but parametric tests have been used without demonstrating normal distribution; also, multiple comparisons were not correctly dealt with in the analysis.
Finally, the underlying pathophysiologic concept of trigger points being the cause of migraine headaches lacks any scientific evidence, and does not play a role in the current discussions on migraine pathophysiology.2
None of the authors has any financial relationships within the field of migraine surgery. All of the authors receive funding and honoraria for migraine research from different foundations, government grants, and companies. Dr. Hans-Christoph Diener received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin Chemie, CoLucid, Böhringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Grünenthal, Janssen-Cilag, Lilly, La Roche, 3M Medica, Minster, MSD, Novartis, Johnson & Johnson, Pierre Fabre, Pfizer, Schaper and Brümmer, Sanofi Aventis, and Weber & Weber. Financial support for research projects was provided by Allergan, Almirall, AstraZeneca, Bayer, GlaxoSmithKline, Janssen-Cilag, and Pfizer. Headache research at the Department of Neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, and the European Union. Dr. Diener has no ownership interest and does not own stocks of any pharmaceutical company.
Charly Gaul, M.D.
Peter S. Sandor, M.D.
Hans-Christoph Diener, M.D.
Department of Neurology
1. Guyuron B, Reed D, Kriegler JS, Pashmini N, Amini S. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg.
2. Charles A. Advances in the basic and clinical science of migraine. Ann Neurol.
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