Episode 26: Migraine & Rhinosinusitis: The Same Disease?

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Voice-over: Welcome to Spotlight on Migraine, a podcast series hosted by the Association of Migraine Disorders. Through personal stories and interviews with experts, we expose the true scope of migraine by exploring symptoms, treatments, research topics, and more. This episode is brought to you in part by our generous sponsors, Amgen, Novartis, and Alder BioPharmaceuticals.

In this episode, we share a presentation given by otolaryngologist Dr. Mark Mehle. Despite being geared for the continuing education of other physicians, the content should prove to be very useful for patients to discuss with their own doctors regarding their rhinosinusitis symptoms. Dr. Mehle found that three out of four of the sinus headache patients referred to him were also positive for migraine. He believes anyone treating rhinosinusitis should be well-versed in migraine care and that they are two parts of the same disease.

Since 2015, Amgen and Novartis have been working together to develop pioneering therapies in Alzheimer’s disease and migraine. Together, Amgen and Novartis share in a mission to fight migraine and the stereotypes and misconceptions surrounding this debilitating disease.

Dr. Mark Mehle: Sinus headache and migraine are two things that are tied together for a couple of really fun reasons. My disclosures have no bearing on this. But it starts out with a very simple question: what is sinus headache? So some of the earlier studies looking at that simple question actually were studies looking at patient complaints. At the Mayo Clinic in Phoenix, Arizona, Dr. Eross, who’s a neurologist there, put an ad in the paper in Phoenix — the Phoenix Sun, I think it’s called — and said, “Got a sinus headache? Give us a call for a free evaluation.” 

And what he found is the accrual of 100 patients was reportedly the fastest accrual of patients he’d ever had in a clinical study. He took, no questions asked, 100 in a row. And what Dr. Eross found is when patients self-report sinus headache, that about 86% of them have migraine or probable migraine, when they looked into what diagnosis they were given. About 3% of them have a sinus infection. So 3 out of 100 had sinus disease. It was substantial. Almost 90% of them had migraine. 

Now, the reason why I’m beating that simple point home is because if you go to the west side of Cleveland where I practice, and you go to the urgent care, and you point at your nose and say, “I got a sinus headache,” you’re probably going to walk out of there with a Z-Pak and Allegra-D [laughter]. You’re going to get an antibiotic for your troubles and probably a decongestant. And if I asked the ER docs — I said, “Hey, what are you thinking?” they’d say, “Mark, I’m playing the odds. I’m playing the odds that sinus headache may be infection, and we’re going to treat it as such.”

A lot of times, they think about that, but 3% — the odds are 3% that that’s sinus infection. The odds are almost 90% that they’re dealing with migraine. And every sinus presentation of migraine that I see has a history of multiple antibiotic treatments with the appearance of efficacy. That’s the problem. We’re going to talk about why when we jump to that a little bit further.

We have to start out with some definitions, and I think two important definitions — one is sinus headache. What is that? What sinus headache is, is a patient complaint. Be aware of that. We’re not erasing sinus headache. It is a patient complaint, but again usually represents migraine. Rhinogenic headache is our test to separate that from sinus headache complaints. Rhinogenic headache is a headache that’s cause by pathology — sinusitis, tumor, whatever — in the paranasal sinuses. So our task is to sort out rhinogenic headache and identify the migraineurs, all of which complain of sinus headache complaints when they walk in the door.

So back to how often is sinus headache migraine. A much larger study was done after Eross’s study that I mentioned earlier — it was actually published before but done slightly afterward — looking at 3,000 patients with complaints of sinus headache. 3,000 patients, multi-center study — it was industry-sponsored, in all fairness. What they found was when they really look at these patient populations, 88% of them are found to have migraine or probable migraine. I’m going to define those for you shortly. 

But he also asked an interesting question. Curt Schreiber said, “While we’re designing this, let’s see what they’re complaining of.” What happens to your nose during these episodes? And it turns out a lot of times, they complain of pressure in the mid-face. A lot of times, they complain of a stuffy, snotty nose, drippiness (phonetic) of the nose, or rhinorrhea in 40% of these. It draws everybody off their game because there’s a lot of nasal symptoms with the onset of these sinus-headache-presenting migraines that really will allow us to miss the diagnosis unless we’re careful.

Now, the question is how can we be careful and make that diagnosis? And for my otolaryngology colleagues in the room here, this may be the most important slide of the day. Be familiar with the migraine diagnostic criteria. In all fairness to the specialists here, these have been criticized as being not sensitive enough, but they’re very specific. And if people satisfy this criteria, they very highly likely have migraine. 

So 4 to 72 hours — we’re going to come back to that again — 4 to 72 hours for the typical migraine attack. You need two of the four main symptoms: unilaterality, throbbing sensation, worse with movement, and then moderate to severe pain. You need two of those four to be at least probable migraine. Remember, it does not have to be severe. You can have a mild migraine headache. It doesn’t have to be rip-roaring bad. It doesn’t have to be unilateral. 40% of migraine is bilateral. 

And I know you’re thinking — as an ENT guy, you’re thinking, “Well, gee, that’s a lot of questions.” I usually ask these questions when I’m looking at their ears. I’m a busy guy. I’m rolling them through. Neurology is a lot more stately in their treatment of patients. ENT’s a production line. We just, boom, get ’em in, get ’em out. But I ask these questions every time when patients complain about their sinuses. It is amazing the number of migraineurs you’re going to pick up. And then you complete the diagnosis with nausea or vomiting or don’t like lights and sounds, that photophobia, phonophobia thing. That allows you to make a complete diagnosis here. Again, probable migraine on the left and migraine headache diagnosis to the right, as long as you’re confining it to those hours — those 4 to 72 hours, rather. 

So these criteria become part of your armamentarium as a rhinologist. A large part of my practice is nose stuff. These are my standard questions. But still, there’s some wonderment here as well. Why do they think they’re having a sinus problem in the first place? Why do they think they have sinus headache? And we talked earlier about that stuffy, drippy sensation. One of the key take-homes is that often, the ones that present to ENT, to allergy, and to the emergency room are mid-facial migraineurs. Frederick Godley and I have talked about terminology quite a bit with this sort of thing. Mid-facial is probably a good description of what goes on. It’s a V2 migraineur, or a five-two migraineur. It’s a mid-face — basically, that fifth cranial nerve, the trigeminal nerve, that mid-face, and what we’re talking about with the presentation. Where does this lady end up? Does that end up in the primary care office diagnosed with migraine? No. This lady ends up in your office. You’re going to get this referred to you with that mid-facial complaint.

Be aware we also have that secondary parasympathetic thing that our earlier speakers did a wonderful job of summarizing. Here, we’re talking about the five-seven reflex arc. The trigeminal nerve triggers that respond to the parasympathetics associated with the facial nerve complex, and you get that stuffy, snotty nose. So mid-facial presentation, stuffy, snotty nose, and guess what. The last six ER docs put them on antibiotics. “It’s my sinuses, Doc.” And that’s what they come in to you to see, in an ENT office. So yes, you’ll see this if you look for it. 

Now, as far as rhinogenic headache, we’re going to differentiate these two things. If you ask your neurology colleagues, “Well, how do you diagnose rhinogenic headache? Does it exist?” Neurologists say, “Yep, it does.” You can have acute sinusitis-related headache. You can have chronic sinusitis-related headache. They still consider questionable whether you can have a septal spur or a nasal contact point headache. ENT literature has actually come strongly against that concept in recent years, and I’ll get back to it. 

The bottom line is neurology says, yep, you can have pain related to sinus disease, but it’s got to go along with the sinus disease. Your headache has to have onset with that sinusitis. That onset has to last temporally, time-wise, along with your sinus problem. It’s got to get worse when the sinus problem gets worse. It’s got to get better when the sinus problem gets better. If it’s one-sided, it’s got to be on that side. So you have to nail the diagnosis of sinusitis and find a headache that’s along for the ride.

So if you look at the ENT literature regarding diagnosis of rhinosinusitis, we start seeing a few little problems, a couple little problems. First of all, our diagnosis of acute sinusitis — this is from IFAR, Orlandi’s publication. A lot of good people worked on this, and it’s 2016. Acute rhinosinusitis is symptom-based. It’s a symptom-based diagnosis. So what do you need? Well, you need either stuffy or drippy. What else do you need? You need either facial pressure or reduction or loss of smell. 

But remember the time factor. If you’ll ask a good otolaryngologist, and you’ve asked an infectious disease specialist — sitting down the end there, still paying attention; thank you — listening to all this, they’re going to say, “Well, you don’t reach for an antibiotic at least for 10 to 14 days.” And guess what. That headache has to run along with that course. 10 to 14 days of achiness along with a gunky or stuffy nose? Sure, you may have a headache related to acute rhinosinusitis. 3% of people — in Eross’s study, 3% of them had that. So it isn’t zero, but it’s not 100%.

Chronic rhinosinusitis is better than 12 weeks, and again, the diagnostic criteria this time include objective findings. So stuffy nose, nasal drainage, facial pain/pressure, decrease or loss of smell. You need two of the four. You need two of those four, not just pressure. You’ve got to have something else going on, and then you need confirmatory findings: endoscopy, radiographically, or both. So again, our diagnosis of sinusitis is important, but there’s a lot of cross-over. 

And those of you who are paying attention say, “Hey, Mark. You know what. Those first criteria match the migraine criteria for acute migraine diagnosis.” And if it crosses over in 4 to 72 hours, you know you have to follow that time answer or time question for sorting this out because the symptoms are the same: the drippy nose, mid-facial pressure, yeah. We’ve satisfied the diagnosis that we published in ENT for sinusitis, but the timing is different. So be aware that’s one of our key questions.

Now, if you look at the neurology literature on primary headache, and this was actually published also in IFAR by Devyani Lal, and again at Mayo in Phoenix. It turns out if you look at people who have no sinus disease who do have primary headache syndromes — migraine is the biggie here, but also tension headache was included — better than half of them report stuffy, drippy, snotty noses and a sensation of needing to blow the nose. So your patients aren’t going to sort this out, so it’s important that you try to sort it out as well as you can in your office. How many otolaryngologists here, ENT doctors? Very nice. Good. So lots of you. That’s nice to see. A lot of non-ENT doctors. So I’m going to focus on what presents to me, but we’re going to talk about this more globally.

As far as an ENT setting, what walks into my office? Well, it turns out when I actually looked at that, when I was first learning about this — and a little aside. The reason why I got into this topic is because of my surgical failures. Being a surgeon is a humbling business when the patients come back, and [inaudible] well, I have the beautiful ethmoid cavity. I was so proud of myself, patting myself on the back, as any good surgeon does. And then “Are you feeling any better?”

“Nope. Nope, I still got this. You know, it’s my nose, Doc. You didn’t help me. I still have that pounding.” 

And “No, I opened up the sinus. I could see it.” 

“Well, I still got the pounding there.”

And I realize that I totally missed the boat on this diagnosis my first 10 years of practice. It’s embarrassing to me. So again, that’s why I’m here, correcting my wrongs by realizing that three out of four of my sinus headache referrals are positive for migraine.

Now, Perry, years before that, actually looked at, in a tertiary care setting — this is referrals from other ENT doctors. Half of his were migraine, and these were referrals to him as a tertiary rhinologist. Another tertiary rhinologist is John DelGaudio’s group in Emory in Atlanta. Just throws triptans at people. Here’s a migraine medicine. 82% response rate with triptans. When somebody walks in the door and uses sinus headache, that’s part of what they’re complaining of. 

Again, these are people who were referred from other ENT docs, so I don’t suggest you use that diagnostic. You use the criteria that I talked about. But still, it’s impressive. 16% of all otolaryngology patients are positive for migraine, when we really look at this. Dr. Godley was part of this study. And again, it’s often severe migraine, or it’s often daily migraine. It’s often more of a chronic migrainous condition we can chat about later, but it’s impressive. It’s impressive what a problem this is if you look for it. If you don’t look for it, like me in my first 10 years of practice, you’ll never see it. You’ll just see the failures.

So that’s our goal is to avoid that. Another ENT practice, they looked at migraine, and this is Anita Jackson’s study. She was published as a poster, actually. Half of her patient with sinus headache population had migraine, but often it wasn’t migraine alone. They had migraine and allergy. They had migraine and sinusitis. 6% of them had migraine plus sinusitis plus allergy at the same time. That’s usually my last patient on Friday afternoon, entirely everything going wrong with the patient, but migraine can be part of that.

Two morals of the story here [inaudible] paying attention here. One is that if you have the diagnosis of sinusitis, you have your diagnosis of allergy, you have not eliminated migraine unless you ask the questions. Lots of people have sinusitis and migraine. A lot of people have allergy and migraine. Once you have a diagnosis, still ask the migraine questions, because only 13% of her patients had migraine alone. The rest had other stuff going on simultaneously. The migraine’s a threshold disease. A lot of times, that threshold is changed by active sinus disease or active allergies. So be aware. You’ll see it, but you got to sort it out. And those diagnostic criteria are a good way to do that. That’s one of the ways you can sort it out very effectively.

So how do you do this, then? You’re sitting in the office, primary care, or you’re sitting in the office, otolaryngology. What do you do? First thing is a thorough history. Please focus on time. Most migraineurs, 4 to 72 hours. It’s a cyclic thing. They’ve had at least five episodes like that. It may run in families. Make sure you take the right questions. They sometimes say, “Oh, yeah, I have migraine and sinus headache. That’s two different things.” No, it’s a different manifestation, if you satisfy those criteria. Second of all, you’ve got to look for signs of sinus disease. We ENT docs, we cheat. We use the nasal endoscope. I get a really good look up inside there. It’s my job to find sinus pathologies. We look for the gunk draining. We look for polyps. We look for things to confirm chronic rhinosinusitis or even acute disease. Then finally, we have radiographic studies, X-rays. Gee, that sounds like a great way to sort this out. Let’s get X-rays. 

Well, it turns out, in my own study, those X-rays didn’t help. When I look at the migraineurs versus the non-migraineurs, the X-rays were just as positive in both groups. I thought I was going to save the world a ton of money. When I came up with this study design, I thought, “Boy, I’m going to find a bunch of migraine. I’m going to find a bunch of clean CAT scans, pat myself on the back yet again.” I was going to save the world a ton. It turns out, if you look at migraine’s presence or absence and you look at the scores on CAT scans — referred to as a Lund-Mackay score, if the rhinologists are familiar. It’s just how bad does that CAT scan look. It didn’t differ. It made no difference. We had a ton of patients who had positive scans and had migraine. Remember that migraine and chronic rhinosinusitis can be two parts of the same disease. They can actually be in the same people, and one can exacerbate the other.

If you look at more recent studies than mine, there are a number of studies looking at this. Yeo’s study, for example, showed no correlation between pain location and chronic sinus disease. So we love to blame the positive CAT scan and say, “Yup, there’s our chronic sinus disease. Let’s go to surgery.” But be aware it doesn’t correlate. It doesn’t correlate well at all. And if you look at Hsueh’s study, if the patient does have a pretty good history for migraine — you’ve got some photophobia and headache there; pain’s the biggest complaint — then that may be negatively predictive, but not 100%. And they recommended still getting the scans because you could not rely on that to predict those normal scans.

Jayawardena, on the other hand, said, “You know, that upfront CAT scan is helpful. If it’s clean, you know you can write off chronic sinusitis, for example, and really focus.” But again, I don’t think that’s a great first step because good look with your insurance friends with that one. But the bottom line’s that, basically, an upfront CAT scan won’t necessarily allow you to find the migraine in the ones with positive CAT scans. Walking down the street, normal people getting brain scans for other reasons, 30% of them have abnormal sinus scans. 30% of normal people with no disease in the sinus. So, yeah, not nearly as useful as you’d want it to be. So again, radiographic studies don’t bite on that. 

ENT doctors out there, you get referrals for maxillary sinus retention cysts all of the time — which means nothing, by the way, the non-ENT folks. But a maxillary sinus retention cyst, unless it’s enormous, really, is not real pathology. But if they have mid-facial migraine and that, it’s referred to me for surgery every time. And in Cleveland, Ohio, there’s a schmuck down the street who’s going to operate on that patient. So again, beware that you’re going to see a lot of this if you’re paying attention.

So as far as trigger points, when we look at the trigger points, it was beaten to death by Nicholas Jones. I mentioned him earlier to one of my colleagues here too. He’s a sinus headache expert in Scotland — fantastic at publishing — really thoroughly looked at the whole issue of contact points. It turns out, if you have hemifacial or hemicranial headaches, the contact point’s in the opposite side half the time. Contact points have no association with an actual headache trigger in the vast, vast majority of our patients. If you look at the correlation with sinus headache patients where you resect that contact point, often they’ll describe a partial improvement or have [late?] recurrences. 

And don’t — like me, don’t jump into anaesthetizing that. So if you induce pain during a migraine headache, you’ll temporarily downregulate the migraine, and it’ll have the illusion of a successful intervention. Be careful with that. So if you induce pain in a migraineur, a mid-facial one, you abort the migraine — don’t pat yourself on the back again and say, “Ooh, it’s that contact point.” I was taught that’s how you tell if it’s a contact point. This certainly is no good evidence that that is actually the case, so don’t jump to surgery at any point in this without doing those migraine diagnostic questions that I mentioned earlier. So [inaudible] mucosal contact points, etc., they’re not good predictors of what’s causing that headache. Good history wins the race every time.

Last thing I want to talk about is a little bit about rhinogenic headache because this is kind of fun. Some new information I’ve been presenting at our academy meetings the last couple of years — it’s different from the talk that some of my colleagues here had attended. For rhinogenic headache, basically, we want to look at what the nose does when it causes headache, and as surgeons, boy, can we fix that, or should we try? So one of the new technologies in sinus surgery over the last 10 years, 15 years, has been balloon sinuplasty. And balloon sinuplasty is coveted. People like it because it can be done in offices, and it seems easy, and it’s lucrative for the surgeons doing it and seems like a wonderful way to operate on minimal disease. Somebody told me you can operate on normal CAT scans with this and not feel bad about it [laughter]. I’m going to amend that. And I’m going to give you plenty of reasons to feel bad about it shortly, trust me. 

But if you google it, guess who they’re selling this to? Where have you seen this picture? And the answer is my lady on the migraine slide. That’s what they’re selling it for. This is what happens. This is the first eight hits when you google sinuplasty images. The other hits — these aren’t eight in a row. They’re two or three or my smiling colleagues holding one of the devices, but other than that, this is what you find. So be aware that this is being pitched to your patients in your waiting rooms, frequently, for sinus headache.

Now, the problem that we have is our own literature is all over the map but is largely supportive of surgery for sinus headache. If you look from 1994 on — and this is no criticism of these people. Howard Levine, for example, trained me. Great guy. A lot of success reported, sometimes with as little as 4 weeks follow-up. A lot of success reported with surgical intervention helping headache, resolving headache, and 79% improved, for example. But in 2008, Zachary Soler presented a paper, and this paper is actually summarized in Tim Smith’s surgical series. He was a fellow at the time, from what I understand. And looked at each and every individual symptom that we’re doing surgery for for endoscopic sinus surgery, and the one symptom that he found didn’t get better, the one that didn’t get better — headache. I wonder why. So headache was the one symptom that didn’t improve. 

There’s a large meta-analysis done by Chester — Raj Sindwani, who’s a rhinologist on this, if you know him. Bottom line is in 2009, the meta-analysis, 21 series were studied of all the symptoms: stuffy, anosmia, drippy, quality of sleep, etc. Everything they looked at in the meta-analysis, the thing that is least likely to improve is headache. Again, not a surprise. The goal is to try to avoid that surgery and try to avoid those disappointed patients who have those residual headache problems, which often — in Soler’s study, when they asked, “What’s your main reason going for surgery?” the number one complaint people had in the series was pain and pressure. That was their number one complaint, was headache. That was their goal for going for the surgery, many times, in addition to this. And these are well-diagnosed patients with very good surgeons.

So there’s a little message to be had here that perhaps surgery isn’t the panacea that we thought it was for that mid-facial headache, which again, better than 50% of the patients in some of these studies seem to improve. And the moral of the story is we’re learning a lot more about surgical placebo effect. Now, the U.K. literature — the British Medical Journal has been all over this for years. We’re just starting to pay attention to this now. 

But a couple of sobering studies. The first one was done by Wartolaska — looked at 53 placebo-controlled surgical studies. Now, that’s quite a shocking thought: placebo-controlled surgical study, where you do something, but you don’t do the intervention. Incision’s involved, nasal manipulation’s involved, etc. — back surgery and all versus just putting a needle in there and saying you did something. 74% of these minimally invasive surgery studies showed improvement in a placebo arm. In more than half, the actual interventions was no better than placebo. Half in the placebo did just as well, just sticking in a needle, poking it, as opposed to ballooning the disc space, for example, in one of these studies, worked just as well. When you’re dealing with pain as a complaint, beware that the placebo effect is huge.

Holtedahl’s study in 2015 looked at 12 minimally invasive surgery studies, again looking at these sort of procedures that are pitched as cutting-edge, with a charming surgeon. Having a surgeon’s way more charming than I am, no doubt about it, who can talk the patient into getting it done and that kind of stuff. Well, guess what. People are enthusiastic. New technology — boy, this is really going to make a difference. It turns out that not only in many the studies, the placebo worked just as well as the active intervention — better than half the studies, substantial improvement — but often, that placebo improvement was referred to as a megaplacebo, in over half of the studies. 

What is a megaplacebo? What is an effect size of 0.8? What does that mean in practical terms? What it means is whatever you’re complaining of, headache, back pain, stomach upset — whatever you’re complaining of, you report, with nothing being done, an 80% improvement — 80% improvement of your complaint in placebo arms. So as surgeons, we have to demand placebo-controlled studies because that is shocking. And if you go to some of these conferences where they’re trying to talk, you know, the latest balloon technology, on the podium, somebody will say, “Well, we know placebo’s a 20% effect; therefore, this is clearly advantageous.” I heard it last week. Beware. 80% is our current thought on the placebo rate if it’s fun technology or something different. And this is shocking to me as a surgeon and certainly humbling.

What happens? Well, sometimes, the natural course of disease gets better on its own. Sometimes, the expectations of the patient vary. The more visits to the doctor, you think, well, yeah, I’m just going to tell him I’m feeling better, blah blah blah. That may cause some of it. There’s a phenomenon of neuroplasticity. The neuroplasticity idea is if you induce pain in somebody who’s having headache pain, for example, induction of pain will downregulate the episodic issue. So you’d have patients who have migraine and have sinus surgery, and they’ll come back, “Boy, I was great for 3 or 4 weeks. Now the problem’s back.” Pain will downregulate this. 

There’s cognitive dissonance. I don’t really like that term, but the bottom line is cognitive dissonance is our inherent tendency to defend what we’ve done. We make a choice. We make a choice to buy an expensive car or go through a painful procedure or pay for an office visit. We’re more likely to report a benefit, because otherwise we’re idiots. So basically, we have to say, “No, I did the right thing for myself.” So cognitive dissonance is that tendency for people to support their own decisions. 

And finally, regression toward the mean — and please remember the regression slide, because it sounds like a really fancy technical term, regression toward the mean, but it’s a very simple concept. This, for example, is a headache patient. The headache patient basically has ups and downs. You can make the time line months. You can make it years. You can make it weeks. You can make it hours, if you wanted to. But the bottom line is that, basically, think of this as weeks to months. So when is that patient going to sign up for surgery? The patient’s going to sign up for the operation when? At its stinking worst, because you’re talking surgery. You’re talking about doing something invasive. So you’re going to go ahead and operate on me when I’m at my worst. So you’re going to follow it up down the line, and on the average, when you measure whatever symptom on down the line, it’ll be at the mean. And that’s that regression toward the mean. It refers to the mean of the individual, not a population mean. It’s often misused. So it basically refers to regression toward the mean.

There was a study done in New England where they looked at contact point resection, and they probably said 10 years later, the effects were still there from a contact point effect. 10 years later, we can prove it’s still a difference from when they entered. Remember regression toward the mean. I’m not refuting their findings. Maybe they’re right. But there’s no placebo group, and there’s no evidence-based medicine to support that statement without a placebo group. 

So this is hugely important. The more we learn about surgery, the more you realize that we really have to start thinking in these terms and thinking about these factors that contribute to that placebo effect that we’ve left out of all these studies. There’s virtually never a placebo arm in surgical studies. And part of that’s ethics, but good lord. I mean, look at this. So this sort of thing will really change the way we look at how we interpret that literature, and we need to demand placebo arms. And it’s hard to blind these sometimes, but that’s exactly what we need to do to prove our point, to prove that we’re actually doing something useful.

So with all that said, they designed a balloon sinuplasty study. It was published last year. They said, “Hey, look at that British Medical Journal stuff. It shows placebo’s huge. Let’s do a double-blind placebo-controlled study of balloon sinuplasty for sinus headache. We’ll take pilots who have sinus headaches related to these things. What a great crew.” Half the patients, they stuck the balloon in the nose, blew it up, told them they did something. In half the patients they inflated the sinus ostia. What did they find? Absolutely nothing. There was no difference whatsoever in placebo versus active treatment, showing there’s no evidence that that balloon treatment helped in barosinus headache, which is the one type of headache you’d expect it to help. 

So again, it’s kind of humbling to realize, and we need more of these. They are possible, and as we publish them, I think as surgeons, we’re going to be sobered by this, to say the least, and realize that perhaps we give ourselves too much credit when we have those early successes, realizing that we may have more of a placebo effect. We need to really step back and look at evidence-based medicine. And surgeons in general and people in general love evidence-based medicine. They love evidence-based medicine until that evidence flies in the face of their beliefs, at which time, they throw it right out the window [laughter]. And they say, “Oh, no, I know, this is clinical acumen. You need this balloon thing.” So beware, and be careful, and make sure you operate on the right patients.

So the summary of all this, basically, is that migraine is usually the source of a sinus headache complaint; that rhinogenic headaches exist and they are rare; that as a surgeon, you should look at the correction of headache as the last thing on the list surgically and first thing on the list medically; and that anybody treating these patients with sinus headache needs to be comfortable and well-versed in the management of migraine, at least diagnostically, and hopefully therapeutically as well. And that’s the point of our conference, and thanks for your attention.

[applause]

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