While, in the end, the story injects some appropriate caution and skepticism, it carries so many unproven assumptions that it is hard to tease them all out. In the first two sentences alone, we are told, unequivocally, that a forehead lift ended a patient’s migraine headaches but offered no proof. Then we are told that the same patient had taken drugs for “decades” and undergone several “lifestyle changes,” but, again, we are given no proof. The story continues in that vein for far too long and, despite the question headline, leaves readers with the overwhelming impression that a facelift might be a good option for their migraines. In fact, the bookending framing of the story at the beginning and at the end leave readers with that impression. Given that very few credible, board certified plastic surgeons are likely to offer their patients a surgical migraine treatment, that is a dangerous message. We don’t know how this approach compares to other established treatments and for which patients it should be applied.
The problem with this story is that it is just that – a story. A “good” (Dr. Guyuron) vs. “evil” (the medical establishment) or an “innovator” vs. “establishment” is the tone of this piece. But the evidence is so shaky as to make the newsworthiness of this questionable. A doctor who has probably spent much of his career developing and promoting this novel approach may have a treatment that can help a small number of patients with headaches. One can view the results of his small randomized clinical trial as worthy of further investigation. In the scientific community, that investigation would traditionally come from an independent group of investigators. Because Dr. Guyuron operates outside of the traditional headache research community, no such studies have yet been published (not sure if any are in consideration or underway). Only such studies that repeat his trial in a new setting by new investigators and then studies comparing this treatment to established treatments can assess whether this really is a novel, breakthrough procedure or not.
The story does talk about costs and the fact that the procedure is not covered by many insurers. We would like to find any insurer that would cover a cosmetic procedure like this that has no scientific support. The story says, “He has also taught 250 plastic surgeons around the world (none in the Philadelphia area) to perform the outpatient operation, which costs an average of $10,000 and is not covered by many insurers.”
The story stated:
Guyuron conducted a clinical trial, the most rigorous design, in which 75 patients were randomly assigned to migraine surgery or a sham procedure.
Of those who underwent the real thing, 57 percent said their migraines were eliminated, compared with 4 percent in the control group. Headache pain, frequency, and duration were reduced by at least half in 84 percent of surgery patients compared with 58 percent of controls – a difference too big to occur by chance. The most common complication was slight hollowing of the temple.
The story makes a passing reference to harms. It says, “Last week, following Boston media stories about migraine surgery, the headache society issued a warning: ‘No convincing or definitive data show its long-term value,’ it may cause irreversible side effects, and it can be ‘extremely expensive.'” It also lists some of the side effects seen in the small studies conducted by the surgeon who is the focus of the story. Given how serious the decision is to undergo surgery for a migraine headache, we think a much fuller discussion of side effects and harms was warranted, including quantifying what’s been observed.
One of the first mistakes the story makes is conflating cosmetic procedures to marshal evidence behind surgical treatment for migraines. It says that the surgery “idea was unorthodox, but not far-fetched. Botox, which paralyzes muscles by blocking nerve signals, was then being tested for migraines. In 2010, the U.S. Food and Drug Administration approved it for prevention of chronic migraines, the frequent, relentless headaches that afflict 3 percent of ‘migraineurs.’” Botox is not surgery. As the story explains, it blocks nerve signals temporarily. It does not permanently rearrange a person’s facial structure. Then the story says that “Guyuron, chair of plastic surgery at University Hospitals Case Medical Center in Cleveland, went on to identify four common ‘trigger sites’ and publish studies showing that, in selected patients, surgical decompression of nerves in one or more of these sites provides lasting migraine relief.” Where were those studies published? How many patients were involved? None of these questions are answered. Later it says, “Neurology journals have declined to publish Guyuron’s submissions.” That casts even more doubt on the underlying evidence for these procedures.
Finally, the story does not adequately frame this one small RCT from the group of “true believers”. While these results are intriguing, it doesn’t provide adequate proof that this treatment is safe and that it works.
The numbers are there – but disconnected – in the story.
In one place we learn that there are “36 million hapless Americans who suffer from migraines.”
In another we learn that the FDA approved Botox for chronic migraines that afflict “3 percent of migraineurs.”
In another place, a neurologist says the approach may be “helpful to a subgroup of migraineurs.”
We wish the story had made it clear – in one place – that not all migraines are the same and not all might be candidates for an approach like this.
The story takes far too long to bring in independent experts, and their voices, while strongly in opposition to surgery, may be drowned out by all the space devoted go Guyuron and his patients, who claim to have been miraculously cured. One has to wonder why a quote like this would not have made the newspaper have doubts about publishing the story: “’I know most of the headache experts in the country and they don’t support’ migraine surgery, said neurologist Stephen Silberstein, director of Thomas Jefferson University’s Headache Center, one of the nation’s leading programs. ‘I certainly wouldn’t recommend it, or say insurance should cover it’ at this point. Neither would the American Headache Society, whose board includes Jefferson neurologist William Young.”
The story does not present a meaningful comparison of alternative treatments to surgery. But it does list a variety of treatments. “The first line of treatment is an ever-growing arsenal of pharmaceuticals – most not approved for migraine – including over-the-counter and prescription analgesics, triptans, ergotamines, antiseizure drugs, antidepressants, cardiovascular drugs, and opioid painkillers. For migraines that are focused at the back of the head, newer treatments include shots to numb the occipital nerves at the nape of the neck, or an implantable device that stimulates those nerves. Botox, given every three months, is injected into neck and forehead muscles.” We wish that the story had helped readers sort through this list to understand which treatments tend to provide the biggest relief. Instead, it goes straight to another patient whose only credentials appear to be a “migraine odyssey” that “inspired an educational book and her website, helpforheadaches.com.”
Just listing the alternatives isn’t the same thing as comparing them. This treatment hasn’t been adequately compared to others that are listed as being used in these patients.
The story does make it clear that this is an experimental approach and that the surgeon in question may be one of the few practicing this technique – although he claims to have trained 250 surgeons around the world. .
The story does an adequate job referencing earlier research and using independent experts to put the work in question.
The story does not rely on a press release.