I write this letter to address the questions raised by Dr. Charly Gaul et al.
In response to their first question, it is correct that the gender was not mentioned in our article. We have gone back and reviewed the information, and there were 63 female patients and 13 male patients included in the study. As for the baseline medications, perhaps our colleagues failed to realize that the patients were selected by a reputable neurologist who specializes in headache, and she excluded those patients who were felt to have medication overuse. It is also clearly stated in the article that there was no statistical difference in the baseline data between the actual surgery group and the sham surgery group.
Regarding the second issue, they state that because there is no evidence that botulinum toxin is efficacious, we only selected patients who were placebo responders. This is an incorrect assumption. We have demonstrated that botulinum toxin is efficacious if injected in the proper site by someone who is knowledgeable about the anatomy of the nerves and muscles.1–4 The fact that botulinum toxin is used by such a vast number of neurologists internationally who specialize in headaches is in support of our findings. In a study by Dr. Dodick and colleagues that was presented at the International Headache Society meeting in September of 2009, treatment with botulinum toxin was shown to be efficacious.5 No one with fair logic would expect an 83 percent placebo effect that lasts 1 year or longer.
In response to their third point, no matter how hard one tries, complete elimination of the eyebrow depressor function will not be possible unless one eliminates the orbicularis function as well, which is not part of this operation. For that reason, essentially every patient who has complete corrugator resection still has some eyebrow movement. In addition, simple exploration of the muscle may cause some initial dysfunction in that muscle. Nevertheless, there is some truth in the statement that patients who had frontal migraine headaches may not have been blinded completely. However, what is troubling is that Dr. Gaul et al. totally dismissed the other two groups of patients in which there is nothing discernible to them. These groups constitute close to two-thirds of the patients. This flagrant omission by Dr. Gaul et al. is puzzling.
In response to their fourth issue, in our analysis, instead of testing for normality, we used both parametric (paired t test) and nonparametric (Wilcoxon signed rank test) tests, and the results of these tests were identical. On the multiple comparison issue, we provided the actual p values in the tables so the readers were conscious of and could make their own conclusions about the effect of type I error (testing many parameters), and could apply the Bonferroni multiple testing correction. This does not make our analysis methods flawed. It simply becomes a type I error issue when many variables are tested. In addition, neither our biostatistician nor that of Plastic and Reconstructive Surgery, who are experts in this field, found any flaws with the way the statistics in this article were analyzed.
To address the fifth issue, most neurology colleagues agree that the pathophysiology of migraine headaches is not clearly understood and would consider any evidence-based information with an open mind. None of the existing and accepted pathophysiology theories has resulted in finding medical treatment that results in elimination of migraine headaches whereby the medications can be stopped and the patients can remain symptom-free. The peripheral mechanism theory was introduced by a neurologist, not a plastic surgeon, years ago and was cast aside. We have coined the term trigger points for migraine headaches as a descriptor, and this term makes the most sense to the patients who often experience their headaches as starting from a certain point and either extending inward (imploding) or outward (exploding), as described by Jakubowski et al.6
Plastic surgeons were not looking for a cure for migraine headaches. It was the patients who brought to our attention that their headaches went away after forehead rejuvenation. About the same time, patients claimed their headaches were eliminated following injection of botulinum toxin. It is the elimination of muscle function that is shared by these modalities, one being temporary and the other causing a long-lasting effect. If this group of neurology colleagues has difficulty with the term “trigger site,” we are open to any type of suggested term that would be acceptable to them. However, ruling out the efficacy because the term is not understandable to some neurologists is not logical and is not in the best interest of the patients. We need to join our efforts and put our terminology differences and even personal biases aside for the benefit of patients and try to embrace the solutions that serve these patients.
Bahman Guyuron, M.D.
Department of Plastic Surgery
University Hospitals Case Medical Center and
Case Western Reserve University
1. Guyuron B, Tucker T, Davis J. Surgical treatment of migraine headaches. Plast Reconstr Surg.
2. Guyuron B, Tucker T, Kriegler J. Botulinum toxin A and migraine surgery. Plast Reconstr Surg.
3. Behmand RA, Tucker T, Guyuron B. Single site botulinum toxin A injection for the elimination of migraine trigger points. Headache
4. Guyuron B, Kriegler J, Amini SB, Davis J. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg.
5. Dodick DW, Aurora SK, Turkel CC, et al. Botulinum neurotoxin type A for treatment of chronic migraine: Double-blind, randomized, placebo-controlled PREEMPT trials. Paper presented at the 14th Congress of the International Headache Society; September 10, 2009; Philadelphia, Pa.
6. Jakubowski M, McAllister PJ, Bajwa ZH, Ward TH, Smith P, Burstein R. Exploding vs. imploding headache in migraine prophylaxis with botulinum toxin A. Pain
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