Migraine Trigger Site Deactivation Surgery - Ready for Prime Time?
One of the hottest topics among migraine patients today is surgery for migraine prevention. It's only natural that this be a major topic for a few reasons:
- Finding effective preventives can be extraordinarily difficult. Although we have over 100 treatments that can be used for migraine prevention, not a single one of them was originally developed for migraine. All are hand-me-downs that were originally developed for other conditions, then found to help with migraine.
- The thought of bringing our migraine under control with surgery and not needing to take preventive medications is remarkably attractive.
- The media has sensationalized the topic.
- Some "doctors" have said they can "cure" migraine with surgery.
In a research poster presented at the American Headache Society's annual scientific meeting in June (2014), Dr. Paul Matthew reviewed the evidence for migraine surgery from two studies that advocated the surgical procedures.
"To provide a critical evaluation of migraine trigger site deactivation surgery (MTSDS)."
Background: MTSDS is a term that encompasses four procedures performed for migraine prevention:
- For intranasal onset headaches, septoplasty and turbinectomy are performed.
- For frontal onset headaches, the corrugator supercilii, depressor supercilii and procerus are resected.
- For temporal onset headaches, a trigeminal nerve segment is resected.
- For occipital onset headaches, a portion of semispinalis capitis muscle is removed, and the greater occipital nerve is shielded using a flap.
Multiple studies have demonstrated some efficacy of these procedures, but evaluation of study methodologies reveal major flaws.
Methods: A critical evaluation of two studies advocating these procedures was performed. The studies were:
- "A placebo-controlled surgical trial of the treatment of migraine headaches"
- "Five year outcome of surgical treatment of migraine headaches."
- The two studies had numerous flaws in their methodology including unclear patient selection and unmatched groups.
- It's unclear who performed post-surgical evaluations, and whether they were blinded.
- The five-year study improperly uses the term control group, as there was no sham surgery group.
- Multiple procedures were performed simultaneously in some cases, so the effectiveness of any single procedure can't be determined.
- Botox injections and nerve blocks were used as screening tools even though both of these agents have demonstrated non-site specific efficacy for the treatment of migraine.
- It's unclear what abortive and preventative medications were used before and after the surgical procedures were performed.
- The unvalidated endpoints utilized included 50% reduction in frequency, intensity, duration, or the migraine headache index (frequency X intensity X duration).
- Some patients experienced "significant improvement" after surgery, but proceeded with additional surgery during follow-up periods. These patients and others were _excluded _ from the final data analysis for unclear reasons.
"MTSDS may be useful in a subset of migraine patients with or without coexisting headache disorders, but the supporting data at this time are not convincing. In addition to unclear efficacy, these procedures can also have complications including worsening pain and permanent itching. These procedures are often not covered by insurance, and can have an out of pocket cost of $10,000 - $15,000. Future studies should include imaging that demonstrates clear surgical targets that involve nerve compression (supraorbital neuralgia, occipital neuralgia) or intranasal contact points (contact point headache). MTSDS should be considered experimental at best based on available data, and patients considering surgery should have it performed as part of a clinical trial."
Summary and Comments:
Drugs must undergo a series of rigidly structured clinical trials to demonstrate both their effectiveness and safety before being approved by the FDA, and they must be approved by the FDA before they can be prescribed. These trials must include trials in which one group gets the new drug, and another group gets a placebo. This is a placebo-controlled trial. These trials must also be double-blinded, which means that neither the patients nor the investigators know who's getting the drug and who's getting the placebo.
There is no such process for surgical procedures, something I'm not sure most patients know. There have been very few clinical trials or migraine trigger site deactivation surgery, and as Dr. Mathew pointed out, they were flawed. That's not to say that these procedures don't have potential value for some patients, but solid, unflawed clinical trials are needed.
Yes, many of us are desperate for effective treatment and relief, but the risks need to be weighted against the potential benefits. Without proper clinical trials, nobody can even state with certainty what those risks may be. Both surgeon and patient need to set realistic goals and expectations as well. There is absolutely no evidence that surgery can stop all migraine attacks, and it certainly cannot "cure" a genetic neurological disease such as migraine disease.
We must look at surgery more like we'd look at pharmacological treatments, expecting solid clinical trials with all data included in the published results. We deserve nothing less, and we shouldn't take undue chances with treatments such as surgery that have yet to be proven to be safe and effective.
Mathew, P.G. "A Critical Evaluation of Migraine Trigger Site Deactivation Surgery." Poster Presentation. 56th Annual Scientific Meeting; American Headache Society. Los Angeles. June, 2014.
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