Neurologists Don't Buy 'Facelift Treatment' for Migraine

Pauline Anderson

July 05, 2013

BOSTON — A growing number of migraine surgical centers — some of which are open 24 hours — are offering a procedure to deactivate trigger sites, which some say is a "cure" for debilitating headaches, but neurologists attending a debate on the topic were not much swayed by arguments in favor of this treatment.

During the debate, which took place at the 2013 International Headache Congress (IHC), Bahman Guyuron, MD, chairman, Department of Plastic and Reconstructive Surgery, University Hospitals Case Medical Center, and professor of plastic surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio said it was "serendipity" 13 years ago when a patient who had undergone forehead rejuvenation surgery commented that she no longer had headaches.

When a second patient claimed the same result, Dr. Guyuron did some research and found that in 314 patients who had undergone similar procedures, almost all of those with a history of migraines became symptom-free or were greatly improved afterwards.

Since then, Dr.Guyuron has left his plastic surgery practice to concentrate on perfecting a procedure that involves the removal of corrugator supercilii muscles and transection of the zygomaticotemporal branch of the trigeminal nerve. The idea in altering the muscles and nerves is to prevent migraine triggers.

Trigger Points

According to Dr. Guyuron, there are 4 relevant trigger points — frontal, temporal, rhinogenic, and occipital — in this region. But although patients with a single trigger site have the best outcome following surgery, most migraineurs have at least 2 trigger points. He operates on all relevant points during the same procedure.

To date, Dr. Guyuron has performed 957 surgeries involving 2400 trigger sites, and claims that 80% of the patients "are doing well." The "tears of joy" from patients whose lives have been changed by the surgery drives his "passion" to pursue this work, which he said he does not do for economic gain. "If anything, I'm worse off, significantly worse off, than when I was doing cosmetic surgery."

Dr. Guyuron outlined some of the 20 articles involving 38 different authors highlighting the rationale and benefits of this surgical approach. The research, which includes basic science, a retrospective study, a pilot study, and a follow-up of up to 5 years, shows that the procedure reduces the "frequency, intensity, and duration" of headache attacks, he said. He also pointed out that neurologists were "intimately involved" in carrying out the studies.

One published study he described (Plast Reconstr Surg 2009;124:461-468) was a randomized trial comparing the decompression procedure with a sham procedure, in which the surgeon does not touch any nerves or muscles. That study showed that 41 of 49 in the treatment group (83.7%) benefitted from surgery in that they had a minimum of 50% reduction in migraine headaches compared with 15 of 26 in sham surgery (57.7%) (P < .05).

Although for 28 patients in the "real" surgery group, the headaches, for only 1 in the sham surgery group were the headaches completely eliminated, said Dr. Guyuron.

Compared with the control group, the actual surgery group demonstrated statistically significant improvements in all validated migraine headache measurements at 1 year.

Dr. Guyuron insisted that placebo response cannot explain the surgery success he has documented. "If anyone in this room believes that 80% or 90% placebo response can last for 5 years, please raise your hand."

But even assuming that it is a placebo effect, "if the patient is happy, let it be; just give it a chance," he said.

He added that he does not claim to "cure" patients and that if any reference to a cure exists on his Web site, it would be removed immediately.

Managing Patients' Expectations

Initially, success with botulinum toxin type A (Botox) was a prerequisite for the procedure. Surgeons would inject Botox into each corrugator supercilii muscle, and patients in whom the injection resulted in complete elimination of headaches then underwent resection of the corrugator supercilii muscles.

Those who experienced only significant improvement underwent transection of the zygomaticotemporal branch of the trigeminal nerve with repositioning of the temple soft tissues, in addition to removal of the corrugator supercilii muscles.

Dr. Guyuron pointed out that most neurologists would agree that there is a role for Botox in the treatment of headaches and that the procedure he uses operates on the same principle. "What you're getting with Botox temporarily, and what I get with Botox temporarily, I'm surgically getting for a long period of time."

Because of logistics — most of his patients come in from out of state — Dr. Guyuron no longer routinely uses Botox before surgery; rather, he uses other methods to verify presence of migraine.

Responding to criticism during the question phase of the debate that the operation is expensive, Dr. Guyuron said that research shows that in terms of socioeconomic savings, the costs of the surgery would be defrayed within 3 years.

Also during this phase, Rebecca Well, MD, assistant professor of neurology, Wake Forest Baptist Medical Center, North Carolina, said that she worries about the high rate of psychiatric comorbidies among patients with migraine. One of her patients became manic 2 days following the procedure, and a colleague committed suicide after a failed procedure, she said.

"My concern is that with such high expectations for cure or remission in patients with high baseline comorbidity that we could be creating a lot of further problems beyond just that of placebo, if it is just placebo effect."

Dr. Guyuron responded by saying that although many people tell him he is their "last resort," he warns patients that the procedure might not work, and he stressed the importance of involving patients in discussions throughout the entire process.

Strongly Discouraged

Arguing against the procedure, Hans Christoph Diener, MD, PhD, professor and head of neurology, University Hospital and Essen Headache Center, in Germany, said it should be strongly discouraged.

Migraine, Dr. Diener pointed out, is a multi-gene-related disorder of the brain, so it does not make sense that deactivating a nerve would be useful.

"Let's face it: migraine is a very complex disease of the brain; how could surgery affect the epigenetics of 22 different genes?"

He noted that "biological plausibility" and "experimental evidence" are "totally absent" in the studies of the procedure.

Commenting on the study that had a sham control, he said, "the paper does not answer the question of how patients were selected; there are no data on prior treatment or failed prior treatment; there are no data on medication use or medication overuse; there are no data on relevant comorbidities like depression and anxiety or on other pain syndromes."

The study, he added, "unfortunately has all the methodological mistakes that can be made in a randomized trial," said Dr. Diener. "My clear conclusion from reading the study is that surgical treatment of migraine according to the method you heard is an invasive and expensive placebo treatment."

In addition, "sham was not sham" in this study, as "patients were clearly unblinded because they know exactly whether it was a real operation or not," he said.

Dr. Diener also pointed out that Botox is not superior to placebo in episodic migraine. "Analysis of all the trials that were ever done in episodic migraine were negative, so you are using an ineffective therapy which is similar to placebo to pick out the patients who will undergo surgery."

He later said that acupuncture would be a better "placebo" because it "won't hurt anyone."

During a rebuttal phase, Dr. Guyuron addressed the issue of blinding by clarifying that he never personally enters the study data, remains isolated from data analysis, and attempts to "create as many firewalls as possible to make the research scientifically acceptable."

He pointed out that subtly conveying information that might reveal study group assignment can occur in any trial.

At the end of the debate, only a handful of attendees agreed that the procedure is "ready for prime time" — about the same number as at the outset.

Dr. Guyuron is a surgeon, has ownership interest in Innovative Medical Equipment; Plastic Surgery, Indications and Practice, Elsevier; and Rhinoplasty Elsevier. Dr. Diener has support from a number of companies, including Astra-Zeneca, sanofi-aventis, Pfizer, Bayer, Janssen-Cilag, Novartis, Schering, J&J, Wyeth, Solvay, and Allergan. He was successful in getting insurance companies to agree not to reimburse for this procedure for the treatment of migraine.

2013 International Headache Congress (IHC). Debate Session 1.


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