Update on Migraine
Surgical Migraine 'Cure' Triggers Doubts
Experts say Botox may not be effective for episodic migraine.
By John Gever, MedPage Today
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SUNDAY, June 30, 2013 (MedPage Today) —A plastic surgeon's passionate defense of his pioneering but controversial treatment for migraine failed to win many converts among headache specialists here.
A show of hands by some 500 attendees at the International Headache Congress, after an hour-long debate between surgeon Bahman Guyuron, MD, of University Hospitals and Case Medical Center in Cleveland, and a German neurologist who has been a vocal skeptic of Guyuron's procedure, suggested that fewer than 10 believed the evidence supports the intervention's clinical value.
Guyuron has performed more than 950 surgeries on migraine patients aimed at relieving peripheral nerve compression at various locations on the outside of the skull. Originally a cosmetic surgeon specializing in rhinoplasties and facelifts, he said he stumbled on the anti-migraine effect in 1999 after two female migraineurs reported that their headaches were abolished after browlifts.
Since then, he has devoted his practice to researching so-called trigger sites for migraine that can be relieved temporarily by botulinum toxin A (Botox) injections and permanently via relatively superficial surgery. Such procedures are now offered by dozens of surgical centers nationwide, including one in New York City offering procedures at any time of the day or night.
He has published some 30 papers describing his results, mostly open-label case series but also including a randomized, sham-controlled trial in 2009. But they have all been published inPlastic and Reconstructive Surgery, not in neurology journals. He told congress attendees that he had submitted manuscripts to the latter but they have always been rejected.
In the controlled trial, Guyuron and colleagues (including a neurologist) randomized 75 patients with a history of migraine 2:1 to receive the actual surgery or a sham procedure, in which only an incision was made and then sutured.
They reported that 57% of those in the active treatment group claimed complete eradication of headaches versus 4% (one patient) of the 26 controls.
Hans-Christoph Diener, MD, PhD, of the University of Essen, was chosen to represent the "con" side of the debate, and he focused his attack on the randomized trial.
He argued that the study was methodologically flawed in nearly every respect, ranging from patient selection and description, to their blinding, to the evaluation and reporting of outcomes.
Diener was especially critical of the methods used to select patients for the trial. Starting with 130 patients reporting largely episodic migraine (fewer than 15 moderate-severe headache days per month), Guyuron and colleagues identified the likely trigger points and injected them with Botox. Patients whose headaches disappeared were then selected for the surgery trial.
"Botox is not effective for episodic migraine," Diener declared, citing a meta-analysis showing exactly that. In the U.S., the drug is approved for prophylaxis of chronic migraine (patients reporting at least 15 moderate-severe headache days per month) but not for the episodic form.
He said that, in effect, Guyuron had enriched his sample with proven placebo-responders, so it was no surprise that so many reported headache freedom after the procedure.
He noted studies of other migraine treatments had shown responder rates of 50%, and those responses had lasted up to 1 year. Diener characterized Guyuron's procedure as nothing more than another placebo, and a more dangerous one than others. However, he did not say how this explanation could account for the very low responder rate in the control group, which might have been considered a red flag in and of itself.
An audience member commented that, if response to a placebo is very high, it should be considered irrespective of its mechanism. Diener replied, "If you want to use a placebo, use acupuncture. You won't hurt anyone."
For his part, Guyuron said the adverse event rate in his patients was very low, with rates of various surgical complications all less than 5%, with the exception of hollowing at the temple (an effect also seen with Botox) that occurred in 20%.
Both men admitted to biases. Guyuron noted that he is a plastic surgeon who earns his living by performing procedures, although he insisted that he had sacrificed income by pursuing the trigger-site surgery rather than staying with cosmetic procedures.
"I have such a passion for what I'm doing, and I'm so enamored with the responses I'm getting from the patients," he said.
Diener showed a disclosure slide listing financial relationships with 27 drug and device companies, and also said he had felt so strongly that the procedure is bogus that he successfully lobbied German insurance companies to deny coverage for it.
Debate moderator David Dodick, MD, of the Mayo Clinic in Scottsdale, Ariz., said the question of the surgery's value was important because it is being promoted nationwide by a network of surgeons, some, but not all, of whom were trained by Guyuron.
Some of the surgical centers offering such procedures bill it is a "cure," Dodick noted. The American Headache Society issued a statement in April 2012 declaring that no treatment for migraine can be called a cure, and that the Guyuron procedure lacked "convincing or definitive data that show its long-term value."
Guyuron assured attendees here that he did not consider the procedure to be a cure, and readily admitted that some patients do fail -- although he also claimed that "80% to 90%" have obtained substantial relief if not complete abolition of symptoms.
Pressed by Diener to persuade other surgeons to scale back the exaggerated claims, Guyuron agreed. "The website of people I know, who I've trained, will be cleaned up," he said.
Deborah Friedman, MD, of the University of Texas Southwestern Medical Center in Dallas, told Guyuron during the question-and-answer session that the treatment's real value could only be determined by a carefully designed, sham-controlled trial, and that the government would have to fund it.
"Most of us do not have the same luxury that you do, of being able to bring our patients into the surgery center and not charge them for sham surgery," she pointed out. "It's going to have to be an NIH trial and I hope it gets done."
She also speculated that, if the procedure does have value, it's because it somehow "modulates" patients' pain, like Botox's presumed effect against chronic migraine, rather than permanently "curing the disease."
Before the debate began, Dodick asked attendees to raise their hands if they thought the existing evidence supported Guyuron's procedure. Only a few went up. When he repeated the call at the session's end, the same few hands were raised.
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