Peled Migraine Surgery Blog

Information and knowledge about migraine relief surgery.


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Botulinum toxin has been used for quite some time to manage chronic migraines, specifically as a preventative agent. Like any treatment modality, the possibility for variable results exists. Certainly some people have had great results with treatment, but many have not. Very recently people have asked what their results with this treatment modality mean. Unfortunately, the answer is not straightforward for a number of reasons that I will delineate below.   Please keep in mind that these thoughts/opinions are general comments and not meant to be interpreted as specific to any particular patient’s situation. You will have to have a discussion with your treating physician as to how to interpret your specific results.

Botlinum toxin is most commonly used according to what’s known as the PREEMPT protocol. Briefly, this protocol calls for 31 injections for a total of approximately 155 units of botulinum toxin with some modifications allowed at the discretion of the treating physician. The PREEMPT protocol has been discussed in a number of journal articles, including a major article published back in 2010 in the journal Headache. In this study, patients were given either injections of botulinum toxin or placebo (both patients and physicians were blinded as to what was being given) and then followed for a total of 24 weeks. Botlinum toxin was injected at time 0 and again at 12 weeks with the final endpoint metrics assessed at 24 weeks. The authors demonstrate statistically significant differences in migraine and headache frequency (among other metrics) during the treatment period, in those patients receiving botulinum toxin as compared with placebo-treated patients. They conclude that botulinum toxin is a useful treatment modality for prevention of migraine headaches. So why doesn’t everyone use it? In my opinion, I believe there are a couple of very relevant criticisms of this study and the conclusions you can draw from it.

First, while clearly disclosed on the title page, the authors of this study are either employees of, have received research dollars from, or are paid consultants for the company that makes the specific form of botulinum toxin used; certainly a potential a conflict of interest although one that doesn’t necessarily invalidate the data presented. Second, while the data are somewhat obtuse and I am certainly no mathematician, if my calculations are correct (and I have redone them several times just to check) the patients in the Botox arm of the study had about 5 fewer headache days in about 6 months compared with those that were injected with placebo. If I told you as a patient that I would poke you with a needle 62 times over two visits and that if you were lucky and responded, you would have 5 fewer headache days in 6 months, would that be worth it? Perhaps and it’s better than nothing, but this result is hardly the wow factor many clinicians make it out to be. Second, let’s play devil’s advocate and say that a huge number of Botox patients had a complete response and had no headaches for the entire 24 weeks. My question to them would be: ‘Which of the 31 injections you got in each round was responsible for the great results?’ The answer would be impossible to give because botulinum toxin doesn’t work right away (it takes several days to become effective) and you got all 31 injections at the same time. So do you really need 31 injections or just 21, or perhaps just 5? You would have no idea. Third and going along with this line of thinking, if you had a great result with Botox, the presumption would be that you would need to continue with this type of therapy in perpetuity - not such a great proposition if you’ve got 40 years of injections to look forward to. I have also wondered what would happen to the neck muscles if they were constantly relaxed by botulinum toxin. Would they atrophy and weaken over time and if so, how would that affect your posture and your ability to lift your head? I don’t know the answer, but I would not want to find out on myself. The take home message is that you should have an open and honest discussion with your treating clinician about what you/they hope to accomplish with the results of any treatment you select along with the potential risks and benefits. Hope that helps.

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Dr Peled on Tri-County News on Headaches and Migra...


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