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New treatments

Ketamine is a medicine that is sometimes given intravenously for anesthesia. It is a controlled drug because it can induce euphoria and is potentially addictive. In a previous post I mentioned several anecdotal reports about the beneifical effect of ketamine for a prolonged migraine aura, hemiplegic migraine and other types of headaches.

A presentation at the recent annual meeting of the American Society of Anesthesiologists described the results of ketamine infusion on severe migraines in patients admitted to the Thomas Jefferson University Hospital in Philadelphia from 2014 to 2016. 48 of the 61 patients (77%) responded to this treatment, meaning that their pain levels improved by at least 2 points on a 1 to 10 scale. On average, the infusion had to be given for 5 days. Side effects included sedation (51%), blurry vision (38%), nausea or vomiting (38%), hallucinations (28%), vivid dreams (13%), and low blood pressure (5%). The authors described the adverse effects as mild in nature and only 1 patient discontinued treatment. However, having hallucinations, drop in blood pressure or vomiting does no sound like mild side effects to me. On the other hand, these were patients whose migraine did not respond to other treatments and they needed to be hospitalized, so these side effects could in fact be acceptable if the treatment ultimately provides relief.

Review of patient records admitted to the same hospital between 2006 and 2014 showed the mean headache pain rating using a 0-10 pain scale dropped from 7 on admission to 4 on discharge. The majority (55 out of 77, or 71%) of patients responded by the same definition of an at least 2-point improvement in headache pain at discharge. Only a quarter of responders maintained this benefit at their follow-up office visit. The mean length of infusion was also 5 days. And again, most patients tolerated ketamine well with “very few serious side effects”.

Anecdotal evidence also exists for the use of ketamine infusions to treat depression. There are some outpatient clinics that offer ketamine infusions for chronic pain and depression and a few of my patients have gone there, but unfortunately with little success.

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Medical marijuana has been legalized in NY and more than 20 other states. It is approved in NY for several medical conditions, including pain and some of my patients with headaches (about one out of 3), arthritis, and other pains have found it to be very helpful. Some patients use it acutely (as a vaporizer or tincture) and report relief of pain, and/or nausea and for some it allows them to go to sleep and sleep off their migraines. Tablets of medical marijuana can prevent migraines if taken once or twice a day. Most people need products with a low THC/CBD ratio which does not cause euphoria or other cognitive effect.

Despite the requirement by states to have verified amounts of active ingredients, THC and CBD in the medical marijuana products, the efficacy and the side effects vary from manufacturer to manufacturer. This could be in part due to ingredients other than THC and CBD. Fortunately, many researchers are looking into the effect of pure ingredients and their mechanism of action.

Such a study was presented at the recent meeting of the American Headache Society by scientists from the Missouri State University led by Paul Durham. They developed a new animal model of migraine in rats and triggered a process in the rats’ brains that is similar to a migraine in humans. Administering cannabidiol (CBD) suppressed increased sensitivity in the trigeminal nerve and produced other positive effects, suggesting a possible mechanism by which CBD may relieve migraine and other facial pains. The next logical step would be to add small amounts of THC to see if it enhances the effect of CBD (so called entourage effect).

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Temporal arteritis occurs in one out of 5,000 people over 50. Women are 3-4 times more likely to be affected. It is not common below the age of 60 and becomes more prevalent with the advancing age. Temporal arteritis is also known as giant cell arteritis because it causes inflammation of arteries with giant cells seen under the microscope.

Headache is often the first symptom and it is typically localized to one temple, but it can involve other parts of the head and occur on both sides. If left undiagnosed and untreated temporal arteritis can cause a stroke and blindness, which can affect both eyes.

Besides headaches, temporal arteritis can cause neck and jaw pain, weakness, muscle aches, and a mild fever. The preliminary diagnosis is made by blood tests (ESR and CRP) and it is confirmed by a biopsy of the temporal artery. Polymyalgia rheumatica is a related rheumatological condition, which can occur alone or with temporal arteritis and it causes severe muscle pains.

Temporal arteritis (and polymyalgia rheumatica) are treated with steroid medications, such as prednisone. Although the initial dose is high, relatively small doses are usually effective for maintenance. Since the condition can last for years and long-term intake of prednisone can cause many potentially serious side effects it is very important to perform a temporal artery biopsy in most cases, rather than rely just on blood tests and clinical diagnosis.

Subcutaneous injection of Actemra (tocilizumab) was just approved by the FDA for the treatment of temporal arteritis. This drug has been available since 2010 for the treatment of rheumatoid and other forms of arthritis. Actemra was injected every two weeks for a year along with prednisone, but more patients were able to get off prednisone if they received Actemra rather than a placebo injection. Unfortunately Actemra also has potentially dangerous side effects, such as serious infections and it requires regular blood tests.

Because headache is one of the main symptoms of giant cell arteritis, the condition is often diagnosed by a neurologist or a primary care doctor. The treatment though is typically handled by a rheumatologist and they are already familiar with tocilizumab.

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Medical marijuana was legalized in New York in February of this year. Since then, I’ve prescribed it to over 30 patients and about a third of them have found it to be effective. We are planning an observational study to determine which of the three approved types (inhaled, sublingual, oral) and what ratio of active ingredients (THC/CBD) are preferred by migraine sufferers. Doctors who prescribe medical marijuana do have to take an online training course, but the course does not teach about the optimal use because no one has researched this question. There are also regulatory issues to deal with.

Several sets of guidelines have been published by various medical organizations addressing the proper use of medical marijuana, other than dosing and route of administration. Here are some of the recommendations with my comments:

“The doctor should adhere to current standards of practice and comply with state laws, rules and regulations, which may specify conditions for which a patient may quality.”
Migraine is not one of the conditions listed specifically, but it is often accompanied by neuropathic pain, which is listed.

“The doctor’s office should not be located at a marijuana dispensary or cultivation center. The doctor should not receive financial compensation from or hold a financial interest in marijuana-related businesses or be affiliated with them in any way.”
This one is easy for us.

“The physician should not use marijuana either medicinally or recreationally while actively engaged in the practice of medicine.”
I’ve never tried it.

“There should be an established doctor-patient relationship before the doctor considers the use of medical marijuana.”
I prescribe it only to our established patients.

“The doctor should do a physical exam and gather health history, including documentation of previous therapies used by the patient and information on any personal or family history of substance abuse, mental illness or psychotic disorders. The diagnosis should justify the consideration of medical marijuana.”
All of our patients undergo a thorough evaluation.

“The doctor should review other treatment options. The known benefits and risks of marijuana should be presented, along with the warning that, unlike with FDA-approved drugs, there is variability and lack of standardization in marijuana preparation.”
We use medical marijuana only after other non-drug and drug treatments fail.

“If the medical marijuana is chosen, a specific treatment plan for a limited period of time should be agreed on, with details documented in the medical record. The doctor should instruct the patient not to drive or operate heavy machinery while using marijuana.”
Yes, I do that.

“The patient should be seen for follow-up visits to monitor for efficacy and side effects of medical marijuana.”
This is a standard practice with any treatment.

“Patients with a history of mental health problems, substance abuse or addiction should be referred for further evaluation as needed.”
I typically avoid prescribing medical marijuana to such patients.

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Nausea is a very common symptom that accompanies migraine attacks. Effective treatment of migraine with a drug like sumatriptan often stops the headache, nausea, and other associated symptoms. However, sometimes pain subsides, while nausea does not, or nausea is much more bothersome than the headache. Nausea can also be a side effect of the most effective injectable migraine drug, dihydroergotamine (DHE-45). We often administer this drug in our office after other injectable drugs (magnesium, sumatriptan, ketorolac, dexamethasone, etc) fail. If nausea is already present, we will always give an intravenous injection of a nausea drug such as ondansetron (Zofran) or metoclopramide (Reglan) before giving DHE. Sometimes these drugs are ineffective in preventing nausea and vomiting induced by DHE and we have to look for other options.

Phenothiazine family of drugs, including prochlorperazine (Compazine), chlorpromazine (Thorazine), and promethazine (Phenergan) are very old and effective anti-nausea drugs. However, they have a potential for a rare but devastating side effect, which consists of persistent involuntary movements of the face (grimacing and lip smacking) and body. The onset of this side effect can be delayed, which is why it is called tardive dyskinesia. It is not unusual for these drugs to cause an immediate severe and very unpleasant restlessness (akathisia), which patients sometimes describe as wanting to crawl out of one’s skin. Metoclopramide (Reglan) can also cause these side effects, but less often.

Ondansetron (Zofran) does not cause any such side effects and should be the preferred drug for nausea of migraine, although it is only approved for nausea caused by chemotherapy or radiation and for post-surgical nausea. Since it has become generic and inexpensive, it can be used for other causes of nausea, including migraines. It is available as an injection or as a tablet.

Aprepitant (Emend) is an anti-nausea drug that has a totally different mechanism of action than the medications described above, so it is possible that it can help when other drugs do not or when other drugs cause side effects.

A study just published in Neurology by Dr. Denise Chou and her colleagues describes the use of oral aprepitant in the treatment of DHE-induced nausea in hospitalized patients.

The authors reviewed hourly diary data and clinical notes of patients admitted to the hospital for the treatment of refractory migraine headaches (status migrainosus) with DHE infusions between 2011 and 2015.

They identified 74 such patients, of whom 24 had daily diaries. In 36 of 57 cases in which aprepitant was given, there was a 50% reduction in the number of other anti-nausea medications given to patients. Of 57 patients, 52 reported that the addition of aprepitant improved nausea. Among 21 of 24 patients with hourly diary data, nausea scores were reduced. In all 12 patients with vomiting aprepitant stopped it. Aprepitant was well tolerated and caused no side effects.

The authors concluded that aprepitant can be effective in the treatment of refractory DHE-induced nausea and vomiting. They also suggested that perhaps this drug could be used for nausea of migraine even when DHE is not given. The only problem, and it is a very big problem, is the cost. This drug is not going to be available in a generic form until 2018. A single capsule of Emend costs $105 with a coupon you can get on GoodRx.com. Without a coupon, it is $145. A single vial for injection costs $345, so we are not going to use this drug for nausea due to migraine or DHE for at least two years, when cheaper generic copies become available.

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Fibromyalgia is a condition comorbid with migraine, which means that migraine sufferers are more likely to have fibromyalgia and those with fibromyalgia are more likely to have migraines (such relationships are not always bidirectional). One common finding in these two conditions is low magnesium level and both condition often improve with magnesium supplementation or magnesium infusions.

A new study by Dr. T. Romano of 60 patients with fibromyalgia showed that those who have low red blood cell (RBC) magnesium levels are likely to have low levels of growth hormone (IGF-1, or insulin-like growth factor 1). RBC magnesium level is a more accurate test than the routine serum magnesium level, which is highly unreliable as most of the body’s magnesium sits inside the cells.

Dr. Romano recommends magnesium supplementation and a referral to an endocrinologist. It is possible that treatment with growth hormone will help those who are deficient, although it is also possible that magnesium supplementation alone (oral or intravenous, if oral is ineffective) could increase the production of growth hormone.

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A patient of mine just emailed me about a recent segment of the TV show, The Doctors, which featured a woman whose severe chronic migraines were cured by nasal surgery. The segment was shot a few weeks after the surgery, so it is not clear how long the relief will last in her case. The surgery involved removing a contact point, which occurs in people with a deviated septum. The septum, which consists of a cartilage in the front and bone in the back, divides the left and the right sides of the nose. If the bony septum is very deviated, which often happens from an injury, it sometimes touches the side of the nose, creating a contact point between the septum and the bony side wall of the nose.
contact point headache
Several small reports by ENT surgeons have described dramatic relief of migraine headaches with the removal of the contact point. If headaches are constant, then the constant pressure of the contact point would explain the pain. However, many of the successfully treated migraine sufferers had intermittent attacks. The theory of how a contact point could cause intermittent migraines is that if something causes swelling of the mucosa (lining) of the nasal cavity, then this swelling increases the pressure at the contact point and triggers a headache. This swelling can be caused by nasal congestion due to allergies, red wine, exercise, and possibly other typical migraine triggers.

This is a good theory, but it is only a theory and the dramatic relief seen after surgery could be all due to the placebo effect. The only way to prove that contact point headaches exist and can be relieved by surgery is by conducting a double-blind study, where half of the patients undergoes surgery and the other half does not. Giving both groups sedation and bringing them to the operating room will blind the patient while the neurologist who evaluates them will also not know who was operated on and who was not, making this a double-blind study. This design is also good only in theory because those who had surgery will have bloody nasal discharge and nasal packing, thus breaking the blind.

However, despite the fact that we will not see any double-blind studies in the near future, there is one way to predict who may respond to contact point surgery. An ENT surgeon can spray a local anesthetic, such as lidocaine, around the contact point during a migraine attack and if pain goes away, then surgery is more likely to help. I would not recommend anyone having surgery without such a test.

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A hole between the left and the right side of the heart has been suspected to be the cause of migraines in some people. However, closing this hole has not produced dramatic improvement in several blinded studies that have been conducted in the past few years.

The hole, called atrial septal defect (ASD) is present in utero but begins to close as soon as the baby is born. In about 1.5% of the population (in twice as many women than men) the hole does not close completely. In most people this hole is small and does not cause any symptoms. However, if it is big, it requires intervention because it can lead to heart failure and strokes. Smaller ASD may not cause any symptoms, but has been suspected to be related to migraine headaches, especially migraines preceded by a visual aura.

The closure of ASD is done by threading up through a vein in the groin an umbrella-like device which is positioned and opened inside the heart to close the hole. A recent study looked at the need for different blood thinners to prevent blood clots from forming in the heart after the procedure. Half of the 171 migraine patients in the study were given aspirin and placebo and the other half aspirin and clopidogrel, another blood thinner. Interestingly, those who were given two blood thinners (aspirin and clopidogrel) had less severe migraine attacks than those on one (aspirin and placebo). This suggests, that the benefit seen in some of the previous ASD closure studies was due to the blood thinner rather than the procedure itself.

A trial currently under way at the Columbia University Medical Center is examining whether a different blood thinner, Brilinta will improve migraines in those with an ASD. If you’d like to consider participating and want to learn more about the study, go to this website.

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Inpatient migraine headache treatment in the US is usually limited to a five-day course of intravenous DHE and other medications. Even such brief admissions are not always approved by the insurance companies. Many patients improve after these admissions, but often only for a short time because besides some reduction in pain intensity, very little else changes in the patient’s life and her brain. It makes sense that longer-term inpatient rehabilitation of chronic migraine and pain patients can lead to a major and lasting improvement, but it is almost unheard of in the US. However, it is available in Germany and other countries.

Last November I lectured at one of the leading German inpatient rehabilitation facilities, the Berolina Klinik. My blog post about the Klinik was read by an Englishman with severe chronic migraines who was recently treated there with a three-week program with excellent results. Here is one of the articles that appeared in German press – Westfalen-Blatt 27.10.15.

And, shockingly to us Americans, the cost of treatment is less than $7,000 for a three-week stay in this top facility. Even with travel costs, it’s a bargain. I have been mentioning Berolina Klinik to my patients, although haven’t had anyone make the trip yet.

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Zecuity, a skin patch containing a migraine drug sumatriptan was approved by the FDA almost two years ago, but it became available (by prescription) only last month (see my previous post about Zecuity). The product is not available in retail pharmacies, only from a specialty pharmacy. The doctor who prescribes the patch will usually provide information on where to get it. Otherwise, go to zecuity.com, where you can find a section entitled Migraine Support Solutions. At this site you can verify that your insurance covers this product, get it shipped to you, and then get information on how to apply the patch. A discount coupon is also available on the site and it promises that the copay will be as low as $15. That is a good thing, because it looks like (on GoodRx.com) each patch costs $300. Yes, not $30, but $300 a piece, or $1,200 for a box of 4. I don’t think too many people will be buying this patch if their insurance does not cover it.

So, who is the best candidate for Zecuity? Half of migraine sufferers experience nausea and/or vomiting with their attacks. This makes the absorption of oral drugs, such as triptans (Imitrex, Maxalt, Zomig, etc) so slow as to make them ineffective. In such patients we try to bypass the stomach, which until now was possible to do with a nasal spray, suppository, or an injection. Sumatriptan (Imitrex) is available in the US in tablets, nasal spray and self-administered injections. Nasal spray of sumatriptan is not very effective, but injections work better than tablets. Relief from an injection can occur in as quickly as 10 minutes, but injections can cause more side effects, which are mostly unpleasant rather than dangerous. Obviously, most people would rather not get a shot. One form of injectable sumatriptan delivers the medicine through the skin without a needle (Sumavel), but not without pain see this post.

One other triptan, zolmitriptan (Zomig) is available in a nasal spray and it is more effective than sumatriptan nasal spray, but it is not available in a generic form, making it less accessible because of the high cost and restricted insurance coverage.

The perfect patient for Zecuity is someone who experiences nausea and/or vomiting with their migraine attacks and who does not respond to tablets and has side effects from or aversion to injections. Zecuity provides good relief for such patients with the main side effect being skin irritation from the patch. The patch is fairly large, the size of a palm. It uses a miniature battery to generate an electric current, which helps drive the medicine through the skin. Iontopheresis is the name of this process. Iontopheresis has been known for decades, but Zecuity is the first product approved by the FDA to utilize this technology.

Disclosure – Teva Pharmaceuticals, manufacturer of Zecuity pays me to give lectures about Zecuity to doctors.

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Fluctuations in the female hormone estrogen have been proven to be involved in triggering menstrual and perimenopausal migraine headaches. Testosterone levels have been reported to be low in men and women with cluster headaches. Testosterone replacement therapy seems to help these patients, when other standard treatments for cluster headaches do not.

A study presented at the recent annual meeting of the American Headache Society reported on testosterone levels in men with chronic migraine headaches. A significant percentage of men with chronic migraines also have low testosterone levels. This study did not look at the effect of testosterone replacement therapy, but it is possible that it may help chronic migraine sufferers as it does those with cluster headaches. It seems prudent to check testosterone level in men with chronic migraine headaches who do not respond to standard approaches such as medications, Botox injections, magnesium, and other treatments. And if the level is low, replacement therapy should be tried.

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For years researchers have tried to find ways to block various chemicals (neurotransmitters) released during a migraine attack, including serotonin, CGRP, nitric oxide, substance P, glutamate, and other. Triptans (such as IMitrex or sumatriptan), the first “designer” drugs for migraine, which were developed over 20 years ago, bind to a very specific subtype of serotonin receptor and are very effective in stopping a migraine attack.

A very promising new type of migraine medications is being developed by at least four different companies – Alder, Amgen, Eli Lily, and Teva. These drugs are monoclonal antibodies against the CGRP molecule or the CGRP receptor. CGRP (calcitonin gene-related peptide) is widely distributed in the body and is involved in regulating blood vessel opening and in the function of the nervous system. All four companies developing these drugs recently presented the results of their phase II clinical trials and the data looks very promising. The antibody tightly binds to its target (CGRP molecule or receptor) with the effect lasting a month, or in case of the Alder drug, up to 6 months. The Alder drug is given every six months intravenously, while the other three, are given every month by an injection into the muscle.

All four drugs appear to be very effective in preventing migraine attacks when compared to a placebo injection. And fortunately, at least so far, they all look very safe. However, in phase II trials only a couple of hundred patients are treated and we need to await the results of the larger and more definitive phase III trials to confirm the safety and efficacy of this new group of medications. This means that the earliest we will see these drugs approved by the FDA is in about 3 years.

It is possible that these drugs will be effective not only for the prevention of migraines, but also for stopping an acute migraine attack.

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An opening between the left and the right side of the heart, called patent foramen ovale (PFO), is found in 25% of the general population. It has been found to be more common in people who suffer from migraines. A large PFOs can cause shortness of breath, heart failure, and strokes and they are usually closed surgically. Several companies developed a device to close this opening without open heart surgery, but rather by inserting an umbrella-like device through a vein in the groin.

The manufacturers of these devices have conducted clinical trials in the hope of preventing migraines by closing the PFO. The results so far have been mixed with some studies showing improvement in migraines and some showing no benefit. A study just presented at the annual meeting of the American Headache Society by Dr. Andrew Charles of UCLA and his colleagues reported on one such trial. This study was blinded, with 107 patients having a sham procedure (the catheter was inserted into the groin vein, but the PFO was not closed) and 123 having their PFO closed. Overall, there was a significant reduction in headache days in the closure group (-3.4 days) compared with the sham group (-2.0 days), however there was no difference in the primary efficacy endpoint of the number of patients with 50% or more reduction in migraine attacks.

A subset of patients did particularly well compared to the sham group – patients who had migraine aura with the majority of their migraine attacks. A significant reduction in migraine days was present in half of patients with aura compared with a quarter in the control group. About 11% (8 out of 74 patients) of those who had migraine with aura had complete elimination of migraine attacks, while this happened to only 1.5% (1 out of 68 patients) in the sham group with auras.

This study suggests that patients who have auras with the majority of their migraine attacks and whose migraines are difficult to control should undergo an echocardiogram to test for the possible presence of a PFO. If PFO is present, it may be reasonable to consider seeing an interventional cardiologist to close the PFO. This is a relatively safe procedure if done by an experienced doctor and that is a very important if. Pick a doctor who has done a hundred or more of these procedures.

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A topical cream seems to be effective in treating migraine headaches. Achelios Therapeutics announced results from a Phase IIa placebo-controlled clinical trial in moderate and severe migraine sufferers treated with Topofen, the company’s proprietary topical anti-migraine therapy. This is a well-known non-steroidal anti-inflammatory drug (NSAID) ketoprofen, which is applied to the face and seems to provide relief for patients suffering from acute migraine.

The results of the clinical trial were presented at the American Academy of Neurology annual meeting in Washington, D.C. Surprisingly, this study showed that it may be possible to relieve severe migraine with a topical application to facial nerve endings. Topical application avoids potentially serious side effects of NSAIDs, such as stomach bleeding and ulcers. The randomized, crossover, double-blind, placebo-controlled study involved only 48 adults with a history of episodic migraine with and without aura. Of the severe migraine patients, 77 percent experienced relief of pain and migraine-associated symptoms and 45 percent had sustained pain relief from two to 24 hours compared to 15 percent on placebo. Also, 50 percent of patients who treated their severe pain with Topofen were pain free at 24 hours compared to 25 percent of placebo-treated patients. Some patients experienced application-site irritation, which was mild or moderate in severity. That was the only reported side effect, which resolved quickly.

Such a small study does not prove that this treatment is in fact effective. A typical drug trial required for an FDA approval usually involves hundreds of patients. However, you do not need to wait for this cream to appear on the market because there are creams containing an NSAID already available by prescription (Voltaren Gel) and over-the-counter (Aspercreme). It is possible that the cream tested in the study may be better because it is a different NSAID, but Voltaren Gel is already approved and you can ask your doctor for a prescription. It is possible that insurance companies will not pay for it since it is not approved for migraines. A tube of Voltaren Gel will cost you about $55 (go to GoodRx.com to get the lowest price).

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Cost is the only major issue with Botox injections, which is the only FDA-approved treatment for chronic migraines and which is now covered by almost all insurance companies. It is very safe and highly effective, relieving headaches in 70% of migraine sufferers. A study just published in the journal Headache suggests that Botox may be not only clinically effective, but also cost-effective.

Researchers from the Renown Neurosciences Institute in Reno, Nevada analyzed data from 230 chronic migraine sufferers who did not respond to two or more prophylactic drugs and were given Botox injections. Botox was given twice, three months apart. Compared with the 6 months before Botox, there were 55% fewer emergency room visits, 59% fewer urgent care visits, and 57% fewer admissions to the hospital. In those 6 months the savings amounted to half of the cost of Botox treatments. Considering that improvement tends to get more pronounced with each subsequent Botox treatment, it is very likely that the costs savings would grow with additional treatments.

Obviously, besides saving money, Botox provides a significant improvement in the quality of people’s lives, which is much harder to measure. At our Center we give Botox to more than a quarter of our patients and see a dramatic improvement in the majority. Botox is not only much more effective for chronic migraines, but it is also much safer than any oral medication.

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A new report by Drs. Gfrerer, Maman and their colleagues at the Massachusetts General Hospital in Boston entitled Non-Endoscopic Deactivation of Nerve Triggers in Migraine Headache Patients: Surgical Technique and Outcomes was recently published in the journal Plastic & Reconstructive Surgery. Surgery for refractory migraine headaches was developed by Dr. Bahman Guyuron and others and was reported to benefit between 68 and 95% patients. This surgery involves cutting or freeing up nerves in the scalp that appear to be responsible for triggering migraines. Some surgeons use a laparascopic technique, which involves making only a few small incisions while others do this surgery through conventional incisions. The authors of this new study argue that endoscopic techniques may not be appropriate in many cases since some surgeons have little experience or limited access to the endoscope and in some patients this technique is not practical because the nerves could run in an unusual pattern, which would make them hard to find through a small incision.

This study involved 43 consecutive procedures in 35 patients. All patients completed questionnaires before and 12 months after surgery. The overall positive response rate was 91%. Total elimination of migraine headaches was reported in 51%, greater than 80% resolution of symptoms in 21%, and 28% had resolution between 50-80%. No improvement was reported after 9% of procedures. There were no major adverse events.

The authors concluded that non-endoscopic surgery was safe and effective treatment in select migraine headache patients.

Most headache experts agree that until proven effective in large controlled studies, surgery should be done only as a part of such a large controlled trial. Just like with previous studies of surgery for migraines, this was a small and not a rigorously controlled trial. Placebo response to surgical procedures is usually very high, however it is rarely 90% and the effect rarely lasts 12 months, as it did in this study. Considering these facts, as well as that this study was done at a reputable institution and that this group consisted of refractory patients (those who did not respond to conventional therapy, including Botox), surgery may in fact offer some real benefits to a small group of patients. We need larger and better controlled trials to figure out if that is indeed the case and what type of patients are the best candidates for surgery.

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The first time I heard of the potential benefit of stem cells for migraine headaches was last year from one of my patients. This 55-year-old woman had been having some improvement from intravenous magnesium and nerve blocks, while Botox was ineffective. However, she reported a dramatic improvement in her headaches after receiving an intravenous infusion of stem cells in Panama. The stem cells were obtained from a donated umbilical cord.

Stem cell research has been controversial because most of the early research used stem cells obtained from an aborted fetus. Since then, stem cells have been obtained from the bone marrow, umbilical cord, placenta, and artificial fertilization. Another rich source of stem cells is body’s fat tissue. Most of the stem cell procedures are not yet approved in the US. The main concern is that when you obtain stem cells from another person’s umbilical cord or placenta, there is a risk of transmitting an infection. There are relatively few stem cells in the bone marrow, placenta or the umbilical cord, which means that after isolating them, they need to be grown in a petri dish. This process involves adding various chemicals, which may not be safe, according to the FDA.

A group of doctors in Australia recently reported relief of migraines using stem cells from patients’ own fat. These doctors did not grow these cells, but infused them intravenously right after separating them from fat. The infused cells were not only stem cells, but so called stromal vascular fraction, which also includes cells that surround blood vessels. These four patients were given stem cell treatment for osteoarthritis and not migraines, but they noticed that their migraines and tension-type headaches improved.

Four women with long histories of chronic migraine or chronic tension-type headaches were given an infusion of cells isolated from fat, which was obtained by liposuction. Two of the four patients, aged 40 and 36 years, stopped having migraines after 1 month, for a period of 12 to 18 months. The third patient, aged 43 years, had a significant decrease in the frequency and severity of migraines with only seven migraines over 18 months. The fourth patient, aged 44 years, obtained a temporary decrease for a period of a month and was retreated 18 months later and was still free of migraines at the time the report was submitted one month later.

This case series is the first published evidence of the possible efficacy of stromal vascular fraction in the treatment of migraine and tension-type headaches.

It is not very surprising that stem cells can improve migraine headaches because stem cells are tested as a treatment for a variety of inflammatory diseases, such as multiple sclerosis, arthritis, and colitis. Inflammation is proven to be present during a migraine attack and this inflammation may attract stem cells. Many experts believe that stem cells may work for MS or other neurological disorders not by becoming brain cells, but by stimulating body’s own repair mechanisms.

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Beta blockers (Inderal or propranolol and similar drugs) are used for the preventive treatment of migraine headaches. Over the years, a few patients have told me that they take a beta blocker only when they have an attack of migraine with very good results. A report published in Missouri Medicine describes seven patients whose acute migraine headache went away with eye drops containing a beta blocker. These eye drops are used for the treatment of glaucoma. The authors argue that having medicine go into the eye allows it to get absorbed quickly into the blood stream. This is certainly true, but my first thought was that there is too little medicine in eye drops to produce an effect outside the eye. However, beta blocker eye drops can worsen asthma, lower the blood pressure and slow the heart rate, suggesting that the amount of medicine in eye drops is sufficient to cause effects beyond the eye. Oral beta blockers used daily for the preventive treatment of migraines are also contraindicated in those medical conditions. Considering that eye drops are probably safer than many oral medications used to treat an acute migraine attack and that they most likely work faster, this treatment is worth trying.

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Peripheral nerve blocks can be very effective in stopping a severe migraine attack. We utilize them when a patient does not respond to oral or injected medications or when medications are contraindicated because of a coexisting disease or pregnancy.

Dr. Jessica Ailani and her colleagues at the Georgetown University in Washington, D.C. presented their experience with nerve blocks at the last annual meeting of the American Headache Society in Los Angeles. The study included 164 patients. Most patients received occipital and trigeminal nerve blocks using lidocaine or a similar local anesthetic.

Most patients were satisfied with the results, which lasted from several days up to 2 weeks. Only a small number of participants experienced side effects such as soreness at the site of injections, nausea and vomiting, and head and neck pain.

Dr. Ailani noted that more than 71% of patients rated their pain as 4 to 8 out of 10 before treatment with a nerve block. After a nerve block, nearly half (47.2%) said the pain had reduced to 1 out of 10.

“This is a very well-tolerated procedure and patients are very satisfied with the procedure,” said Dr. Ailani.

Nerve blocks can help keeps headache sufferers out of the emergency room and provide an alternative to systemic drugs, that is drugs that are injected or ingested. Systemic drugs affect the entire body while nerve blocks exert only local effects (unless one is allergic to local anesthetics).

Dr. Robert Kaniecki, a headache specialist in Pittsburgh uses nerve blocks for the prevention of chronic migraine headaches. He administers them into the same areas where Botox is injected. He finds that for some of his patients nerve blocks given every 12 weeks can be as effective as Botox. It is possible that such patients have milder migraines since the effect of nerve blocks lasts a very short time (lidocaine leaves the body after 4 hours or so) compared with the effect of Botox which lasts 3 months. Unlike Botox injections, nerve blocks have not been subjected to a rigorous scientific study comparing them to placebo (saline) injections.

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Botox is a very effective treatment for chronic migraines and possibly other types of headaches and pain. However, Botox is an expensive and somewhat unpleasant treatment. Even though Botox helps a high percentage of patients (about 70%) it would be useful if we could predict who is going to respond and who is not.

One of the predictors seems to be the directionality of pain. That is, if patients with migraine who have constricting (imploding) pain or pain localized to the eye seem to respond better than those who have pain that seems to be pushing from inside out (exploding). This is not a very reliable predictor because some people have difficulty categorizing their pain in that way and because even if they do describe it clearly one way or another, this predictor is far from 100% accurate.

In a study just published in the journal Headache a group of Spanish neurologists claim that they have found a predictor with 95% accuracy. They measured blood levels of calcitonin gene-related peptide (CGRP) and found that those with levels of CGRP above a certain number were 28 times more likely to respond to Botox than those with levels below that level.

CGRP has been shown to be very involved in the process of migraine and several drugs and antibodies which block the CGRP receptor appear to be very promising (see my recent blog post on such antibodies). So, it is not very surprising that this correlation between the response to Botox and blood level of CGRP was found. However, this finding needs to be confirmed in a larger group of patients (this study involved 81 patients) and this test needs to become available commercially since now it can be done only in research laboratories.

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The introduction of Levadex has been delayed again, this time for a year. It seems like deja vu all over again – I wrote the same thing on this blog in April of last year. Levadex, which the manufacturer (Allergan) just renamed as Semprana, is an inhaler containing DHE. DHE, or dihydroergotamine is one of the most effective injectable drugs for migraine. It should be even better in an inhaled form because it works faster and causes much less nausea than the injection. The FDA is again delaying the launch because of manufacturing problems. Apparently, the particle size of the drug when it comes out of the inhaler is not uniform enough. Many patients are unhappy, but I am sure that the Allergan is very unhappy too since they spent almost a billion dollars to acquire this drug from a small company that developed it.

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Cluster headache patients have been coming to our office in increasing numbers in the past few weeks. We seem to be in a cluster season – many patients with cluster headaches come within the same month or two and then, for several months we see very few cluster patients. Many cluster headache sufferers ask about the efficacy of LSD, hallucinogenic mushrooms and seeds.

The use of hallucinogens for cluster headaches was first reported by a Scottish man in 1998. He started using LSD for recreation and for the first time in many years had a year without cluster headaches. The first report in scientific literature appeared in 2006 in the journal Neurology. Dr. Sewell and his colleagues surveyed 53 cluster headache sufferers, of whom 21 had chronic cluster headaches. Half of those who tried LSD reported complete relief.

Researchers are trying to study a version of LSD (brominated LSD) that does not cause hallucinations. This form of LSD was reported in the journal Cephalalgia to stop cluster attacks in all five patients it was given to. It is not clear if any additional studies are underway, but one American doctor, John Halpern is trying to bring this product to the market in the US.

Trying to obtain LSD or hallucinogenic mushrooms carries legal risks, including incarceration. According to Dr. McGeeney, who is an Assistant Professor at Boston University School of Medicine, it is legal to buy, cultivate, and sell seeds of certain hallucinogenic plants, such as Rivea Corymbosa, Hawaiian baby woodrose, and certain strains of morning glory seeds. However, it is not legal to ingest them.

The bottom line is that I urge my patients not to try hallucinogens because their safety has not been established. This is especially true for illicit products, which may contain additional toxic substances.

Fortunately, we do not need to resort to these agent because we have such a variety of safer and legal products. These include preventive medications, such as verapamil in high doses, topiramate, lithium, and for chronic cluster headaches, Botox injections. None of these drugs are approved by the FDA and are not likely to be approved because this is a relatively rare condition, which makes performing large studies very difficult. The only FDA-approved drug for cluster headaches is an abortive drug, injectable sumatriptan (Imitrex).

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Two new migraine drugs are about to be released on the market. They were mentioned in this blog in their earlier stages of development. Another two drugs are more interesting, but are several years away from becoming available (if at all).

Zecuity is a patch that delivers sumatriptan (active ingredient in Imitrex) through the skin. The patch contains a small battery and the electric current it generates helps the medicine penetrate through the skin. The patch is particularly useful when migraine is accompanied by nausea and vomiting. The main side effect of the patch, compared to the tablet, is that it causes irritation of the skin in one third of patients. This product was already approved by the FDA and will be soon available in pharmacies from its manufacturer, Teva Pharmaceuticals.

Levadex is a drug inhaled into the lungs using a device similar to those used for asthma drugs. It contains dihydroergotamine – a very old and very effective injectable drug. Dihydroergotamine does not work well in a nasal spray (Migranal) or when taken by mouth. Levadex causes less side effects, such as nausea, than the injection of this drug. The main target population for this drug is also migraine sufferers who experience nausea and vomiting and for whom tablets do not work. Because it works very fast it may be also very effective for those whose headache starts and escalates to a severe intensity very quickly, which includes not only migraine, but also cluster headache sufferers. Levadex is manufactured by Allergan, the company that also makes Botox. It should be available in the next few months.

Lasmitidan is a new drug being developed by CoLucid. It is in phase III trials, which is the final phase, which if successful, can lead to the FDA approval. Lasmitidan is a new type of drug – it targets a specific serotonin receptor subtype – 1F, while triptans (sumatriptan, rizatriptan, and other) target 1B and 1D serotonin receptors. It may have the advantage of not constricting arteries at all and may be allowed in patients with coronary artery disease. Triptans are contraidicated in such patients.

Merck is developing a drug, which does not have a name yet, only a number – MK-1602. It is a CGRP receptor antagonist – a blocker of a neurotransmitter in the brain that is involved in migraine origination. It is in phase II trials. MK-1602 also has the advantage of not constricting arteries. At least two other companies are developing CGRP antibodies (different from CGRP antagonists) and they were mentioned in a recent post here.

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The versatility of botulinum toxin continues to amaze. The use of botulinum toxin (Botox) for the treatment of migraine headaches (pioneered at the New York Headache Center) is becoming widespread in the US. The original FDA-approved indications for botulinum toxin was a rare eye condition, blepharospasm as well as strabismus. The number of indications (not all of them yet FDA-approved) for botulinum toxin has increased very quickly – from cosmetic use for wrinkles to gastrointestinal disorders (narrowing of the esophagus, rectal fissures), excessive sweating, muscle spasticity of cerebral palsy and following a stroke, neuropathic pain (neuropathy, trigeminal neuralgia, shingles), spastic bladder (which causes frequent urination), and other.

Injecting botulinum toxin into the fat pads around the heart after coronary bypass surgery seems to reduce the incidence of atrial fibrillation, an irregular hear beat. This is the conclusion of a randomized and blinded study of 60 patients, half of whom were injected with saline water and the other half with botulinum toxin (not Botox, but one of the other 3 botulinum toxin products, Xeomin).

Patients who received injections of botulinum toxin instead of saline water had a significantly lower rate of irregular heart beats in the first 30 days (30% versus 7%), according to Evgeny Pokushalov, MD, PhD, of the State Research Institute of Circulation Pathology in Novosibirsk, Russia. Injections of botulinum toxin around the heart did not cause any complications or side effects. These irregularities of heart rhythm can be dangerous and if these findings are confirmed, botulinum toxin injections may become standard during coronary bypass surgery. If these injections are indeed effective they would also save money by reducing the duration of hospital stay and preventing the need for additional treatments of irregular heart beat.

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Triptans, such as Imitrex or sumatriptan and similar drugs are “designer” drugs which were developed to specifically treat migraine headaches. They are highly effective and, after more than 20 years on the market, proven safe. Four out of the seven drugs in this category (Imitrex, Maxalt, Zomig, Amerge) are available in a generic form, which significantly lowers their cost, which was one of the obstacles for their widespread use. So, it would appear that now there is no reason for doctors not to prescribe triptans to migraine sufferers.

In 1998, emergency department doctors gave more than half of the patients suffering from migraine headaches opioids (narcotics) to relieve pain and, according to a new study, 12 years later, this hasn’t changed.

Despite the fact that triptans are widely considered to be the best drugs for acute migraine, the use of these drugs in the emergency department has remained at 10%, according to a study led by Benjamin Friedman, an emergency medicine doctor at the Montefiore Medical Center in the Bronx.

In 1998, about 51% of patients presenting with migraine at the emergency department were treated with an injection of a narcotic and in 2010, narcotics were given to 53% of the patients.

Other than narcotics (opioids) emergency department doctors often give injections of an NSAID (non-steroidal anti-inflammatory drug) Toradol (ketorolac) or a nausea drug, such as Reglan (metoclopramide). These two drugs are more effective (especially if given together) and have fewer potential side effects than narcotics. They also do not cause addiction and rebound (medication overuse) headaches, which narcotics do.

Dr. Friedman and his colleagues looked at the national data for 2010 and found that there were 1.2 million visits to the emergency departments for the treatment of migraine. Migraine was the 5th most common reason people come to the emergency room.

They also discovered that people who were given a triptan in the emergency department had an average length of stay in the ER of 90 minutes, while those given Dilaudid (hydromorphone) – the most popular narcotic, stayed in the ER for an average of 178 minutes.

Opioids should be used only occasionally – when triptans, ketorolac, and metoclopramide are ineffective or are contraindicated. This should be the case in maybe 5% of these patients, according to Dr. Friedman

One possible reason why ER doctors do not follow recommended treatments and use narcotics instead, is that they do not recognize a severe headache as migraine and misdiagnose it as sinus, tension-type or just as a “severe headache”. Many doctors still believe that migraine has to be a one-sided headache, or a visual aura must precede a migraine, or that the pain has to be throbbing. It is well established that none of these features are required for the diagnosis of migraine.

Another possible reason for the widespread use of opioid drugs in the ER is that doctors are very accustomed to using them, while triptans may be unfamiliar and require thinking about potential contraindications, what dose to give, what side effects to expect, etc.

In summary, if you or someone you know has to go to an ER with a severe migraine, ask for injectable sumatriptan (which you should have at home to avoid such visits to the ER) or ketorolac.

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Antibodies blocking a specific neurotransmitter involved in migraines appear to relieve migraine headaches. Two studies presented at the annual meeting of the American Academy of Neurology reported on the use of antibodies to CGRP (calcitonin gene-related peptide) for the treatment of migraine headaches. These were relatively small, but highly scientific (randomized, double-blind, and placebo-controlled) studies. The studies was conducted in patients with frequent migraines.

The two studies used two different antibodies developed by different companies. The results of the trials suggest that this approach is both effective and safe in preventing migraine, at least according to these preliminary studies.

If these antibodies are proven to be indeed safe and effective, they will be the first specific migraine therapy since the introduction of triptans over 20 years ago. Triptans (sumatriptan and other) are abortive drugs, meaning that abort a migraine attack, while CGRP antibodies are used for the preventive (prophylactic) treatment. While Botox was approved three years ago for the preventive treatment of chronic migraines it was not specifically developed for the treatment of migraines. Instead, Botox was found to have this effect accidentally.

One phase II proof-of-concept trial enrolled 218 people with 4 to 14 migraine headache days per month and randomly assigned them to get the antibody or a placebo. The study medication was given every 2 weeks by subcutaneous injection. Active treatment resulted in reduction of an average of 4.2 migraine days per month in the third month for those on the active drug and a drop of 3.0 days for those on placebo.

The side effects were similar between the groups and most were mild and resolved on their own.

In the other study the antibody was given intravenously at the start of the trial, with an hour-long infusion, but was not repeated. This study enrolled 163 patients, with 82 assigned to the drug and 81 to placebo. The average change from baseline in migraine days per month was a decline of 5.6 for the active treatment compared with a drop of 4.6 for placebo patients. Side effects in this study were also mild and occurred with the same frequency in the active and placebo groups.

While the difference between the active treatment and placebo does not seem to be significant, it was statistically significant and it is possible that some patients will respond very well while others not at all.

The next step is much larger phase III studies, which typically involve over 1,000 patients for each compound. If phase III studies also show safety and efficacy of these antibodies, then the FDA might approve them. This means that the earliest one or both of these drugs will become available is about 3 years.

The companies that sponsored these studies were Arteaus and Alder Biopharmaceuticals.

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Epidural steroid injections are popular for persistent neck and back pains. Patients with migraine and other headaches often have neck pain as well and if they happen to visit an anesthesiologist/pain specialist instead of a neurologist, there is a good chance they will be offered a cervical epidural steroid injection. If you or someone you know are offered such injections, just say no.

Despite the widespread use of this procedure, there is no good scientific evidence that these injections help. Not only they probably do not help, they can cause serious side effects. The US Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.

The FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks.

The FDA said that “Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and the FDA has not approved corticosteroids for such use.”

The FDA reviewed cases of serious neurological adverse events associated with epidural corticosteroid injections. Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema.

Some doctors perform these injections under X-ray guidance, but even then serious neurological complications can occur. X-ray guidance also exposes patients to harmful radiation and increases the cost of the procedure, which is significant even without the X-ray.

This FDA warning is unrelated to a recent disastrous contamination of corticosteroids used for epidural injections. This contamination occurred at a compounding pharmacy in Massachusetts and resulted in 749 patients contracting fungal meningitis with 61 patients dying from it. This is another reason to avoid epidurals.

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An oral tablet is the most convenient way to take medicine. However, many migraine sufferers wake up with a headache that is in full bloom and severe nausea or vomiting makes it difficult to take oral medications. Others find that tablets are ineffective or take too long to work.

Sumatriptan (Imitrex), the miracle migraine drug which has changed lives of millions of migraine and cluster headache sufferers, was first released in an injection. The injection is still available and is the most effective way to stop a migraine. The injection comes in a variety of pre-filled syringes and cartridges, which are very easy to self-inject. The problem with injections is that some people don’t like the idea of injecting themselves, which is surprising, considering how much pain and suffering they endure from migraine. Another problem is the cost – even in a generic form a shot costs $35 (see GoodRx.com for cheapest prices). The biggest reason why injections are underutilized is that doctors fail to offer this option to patients, many of whom would be happy to use it.

Nasal sprays offer a middle ground option – not as fast or effective as an injection, but faster and sometimes more effective than a tablet. There are several medications available in a nasal spray. The same triptan medication, sumatriptan comes in a nasal spray. However, another triptan, zolmitriptan (Zomig NS) in my experience is more effective. The disadvantage of Zomig is that it is very expensive if not covered by insurance (over $200 a spray) because it is not available in a generic form.

Another nasal spray approved for migraine headaches is Migranal. It contains dihydroergotamine, which is one of the strongest injectable migraine drugs. However, it is much less effective in a nasal spray form. It is also very expensive – $200 a dose. Dihydroergotamine is about to be released in an inhaler. It will be called Levadex and will deliver the medicine into the lungs. Its efficacy should be as good as that of an injection, but with fewer side effects. Hopefully, it will not be more expensive than the generic sumatriptan injection. Otherwise, just like with Migranal, insurance companies will not cover it.

Sprix is a nasal spray containing ketorolac. In a tablet form (Toradol) ketorolac is no more effective than aspirin and is more irritating to the stomach. But it is a very effective drug for migraines when it is injected and to a lesser extent, when sprayed into the nose. It is very popular as an injection in the ERs and at our New York Headache Center. Sprix can sometimes irritate the nasal passages. It costs about $35 a dose.

Stadol (butorphanol) is a narcotic (opioid) pain killer, which costs about $30 a dose in a generic form. It does relieve pain well and is approved for migraine headaches. However, just like other narcotics, it is potentially addictive. Also, many migraine sufferers find that narcotics do not help their migraine and often makes them feel sicker. It also costs over $30 a dose.

There are several over-the-counter nasal sprays containing hot pepper extract, capsaicin. There is no good scientific evidence that these capsaicin products sprayed into the nose relieve migraines or cluster headaches. On the other hand, besides burning and irritation of the nasal passages, they have few side effects and are inexpensive.

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A good predictor of response to Botox injections in chronic migraine patients has been found by Spanish researchers.

While Botox is a very effective treatment for chronic migraines and possibly other types of headaches and pain, it does not help everyone. Approximately 30% of patients with chronic migraine headaches do not respond to Botox. We usually try at least two sets of injections three months apart before considering the patient to be a non-responder. Considering that Botox is an expensive treatment, it would be very useful to know beforehand which patients will respond and which will not. Besides the cost, it would also save patients time, during which they could be trying other treatments.

Some studies show that having a constricting headache or pain in the eye is usually a positive predictor of response to Botox. On the other hand, exploding headache (that is when the pain is felt pushing from the inside out), is less likely to respond to Botox injections. However, these are very subjective descriptions and predictions based on them are not that reliable.

A new study by Spanish researchers just published in the journal Headache reported that the levels of CGRP (calcitonin gene-related peptide) and VIP (vasoactive intestinal peptide) in patients’ blood are good predictors of response to Botox in chronic migraine sufferers. These two chemicals, which circulate in the blood and perform various important functions in the brain have long been the subject of scientific research. Actually, we think that Botox works by blocking the release of CGRP from the peripheral nerve endings. Dr. Julio Pascual and his colleagues measured the levels of these two chemicals in chronic migraine patients before they were treated with Botox. Botox was administered according to the standard protocol every 12 weeks for at least two treatment cycles. A patient was considered a moderate responder when both: 1) moderate-severe headache episodes were reduced by between 33 and 66%; and 2) subjective benefit on a visual scale from 0 to 100 was recorded by the patient of between 33-66%. Patients were considered to be excellent responders when both items improved by more than 66%. Those without improvement of at least one-third in the two items were considered as nonresponders.

The study involved 81 patients with chronic migraine and 33 healthy controls. CGRP and VIP levels were significantly increased in the chronic migraine population vs controls. CGRP and, to a lesser degree, VIP levels were significantly increased in responders vs nonresponders. The probability of being a responder to Botox was 28 times higher in patients with a CGRP level above the threshold.

The measurement of CGRP and VIP is done only by research institutions and is not yet offered by commercial laboratories. However, considering how much money can be saved by not giving Botox to those who are unlikely to respond, these tests should become widely available once these findings are confirmed by other researchers.

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Yesterday, the FDA approved the first preventive (prophylactic) treatment for migraines in adolescents – kids between the ages of 12 and 17. Topamax (topiramate) was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.
As the FDA stated in its announcement, “Migraine headaches can impact school performance, social interactions, and family life. Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices.”
The announcement also stated that “About 12 percent of the U.S. population experiences migraine headaches. Migraine headaches are characterized by episodes of throbbing and pulsating pain in the head, and may occur several times per month. Other common symptoms include increased sensitivity to light, noise, and odors, as well as nausea and vomiting. Many patients experience their first migraine attack before reaching adulthood, and migraine can be just as disabling in teens as it is in adults.

The safety and effectiveness of Topamax in preventing migraine headaches in adolescents ages 12 to 17 was established in a clinical trial that enrolled 103 participants. Those treated with Topamax experienced a decrease in the frequency of migraine of approximately 72 percent compared to 44 percent in participants that took an inactive drug (placebo).

The most common adverse reactions with the approved dose of Topamax (100 milligrams) were paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain.

Topamax increases the risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women who take the drug during pregnancy. The benefits and risks of Topamax should be carefully weighed before using it in women of childbearing age. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used.”

It is a little surprising that the FDA based its approval on such as small study – 103 patients. I should add that topiramate can also cause cognitive side effects, such as memory and word retrieval problems in a significant percentage of children and adults. Approximately 20% of adults taking topiramate for more than a year or two develop kidney stones. This most likely can also happen in children. As you can tell from this and my previous posts, I am not a big fan of Topamax. In kids particularly we begin with life style and dietary changes, biofeedback, magnesium, CoQ10 and other supplements and even Botox injections, which are very safe, before resorting to prophylactic drugs such as topiramate.
Julie Mauskop
Art credit: JulieMauskop.com

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The beneficial effect of Botox on mood has been reported for years. I mentioned this in one of my blog posts in 2011. Now, a new and highly scientific study (double-blind, placebo-controlled) which is about to be published in the Journal of Psychiatric Research confirms that Botox relieves depression. The study is described in today’s New York Times.

I have also heard from many of my own patients who receive Botox for chronic migraines that their mood improves, although in their case it could be to a great extent because their headaches improve.

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A severe migraine attack can sometimes land you in an emergency room. With its bright lights, noise, and long waits, it is the last place you want to be in. To add insult to the injury, some doctors will think that you are looking for narcotic drugs and treat you with suspicion, while others will offer ibuprofen tablets. It is hard to think clearly when you are in the throes of a migraine, so you need to be prepared and have a list of treatments you may want to ask for, just in case the ER doctor is not good at treating migraines.

If you are vomiting, first ask for intravenous hydration and insist on having at least 1 gram of magnesium added to the intravenous fluids. Everyone with severe migraines should have sumatriptan (Imitrex) injection at home since it often eliminates the need to go to an ER in the first place. If you haven’t taken a shot at home, ask for one in the ER. The next best drug is a non-narcotic pain medicine, ketorolac (Toradol) and if you are nauseous, metoclopramide (Reglan). Do not let the doctor start your treatment with divalproex sodium (Depakene, drug similar to an oral drug for migraine prophylaxis, Depakote) or opioid (narcotic drugs) such as demerol, morphine, hydromorphone and other.

This post was prompted by an article just published in the journal Neurology by emergency room doctors at the Montefiore Hospital in the Bronx. It was a double-blind trial which compared intravenous infusion of 1,000 mg of sodium valproate with 10 mg metoclopramide, and with 30 mg ketorolac. They looked at relief of headache by 1 hour, measured on a verbal 0 to 10 scale. They also recorded how many patients needed another rescue medication and how many had sustained headache freedom.

Three hundred thirty patients were enrolled in the study. Those on divalproex improved by a mean of 2.8 points, those receiving IV metoclopramide improved by 4.7 points, and those receiving IV ketorolac improved by 3.9 points. 69% of those given valproate required rescue medication, compared with 33% of metoclopramide patients and 52% of those assigned to ketorolac. Sustained headache freedom was achieved in 4% of those randomized to valproate, 11% of metoclopramide patients, and 16% receiving ketorolac. In the metoclopramide arm, 6% of patients reported feeling “very restless”, which can be a very unpleasant side effect of this drug.

The authors concluded that the valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide was somewhat better than ketorolac but it also had more side effects.

To summarize, ask the doctor to start with hydration and magnesium, then sumatriptan injection, followed by metoclopramide and ketorolac, if needed. If the above treatments do not help, we also give dexamethasone (Decadron, a steroid medication) and DHE-45 (dihydroergotamine). All these medications can be administered in the office and we always tell our patients not to go to an ER and to come into the office if the attack occurs during our office hours.

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Trigeminal neuralgia (TN) is an excruciatingly painful disorder which affects about one in a thousand people. Patients describe the pain of TN as an electric shock going through the face. Eating and talking often triggers the pain, so some patients become malnourished and depressed. The pain is brief, but can be so frequent and severe that it causes severe disability, weight loss, severe anxiety, and depression. The good news is that most people can obtain relief by taking drugs, such as Tegretol (carbamazepine), Trileptal (oxcarbazepine), Dilantin (phenytoin), or Lioresal (baclofen). I have successfully treated several patients who did not respond to these medications with Botox injections.

Patients who do not respond to medications or Botox injections have several surgical options available. According to a new Dutch “Nationwide study of three invasive treatments for trigeminal neuralgia” published in journal Pain shows that every year about 1% of those suffering from TN undergo surgery. Of the three most common types of surgery, percutaneous radiofrequency thermocoagulation (PRT) is by far most popular – in a three year period in Holland, 672 patients underwent PRT, 87 underwent microvascular decompression (MVD), and 39 underwent partial sensory rhizotomy (PSR). The latter two procedures a performed by neurosurgeons (MVD requires opening of the skull), while PRT is usually done by anesthesiologists (a probe is inserted through the cheek to the nerve ganglion under X-ray guidance). MVD was most effective, but caused more complications than PRT, although fewer than with PSR. More patients having PRT had to have a repeat procedure, but it was still safer than the other two. Very often the physician under-treats during the first treatment of PRT in order to avoid complications. Overall, the best initial procedure for those suffering with TN is PRT and if repeated PRTs fail, MVD can often cure this condition.

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Transcranial magnetic stimulation (stimulation of the brain with a magnetic field) has been researched for over 30 years. It has been used to study the brain and to treat a variety of conditions, such as depression, Parkinson’s, strokes, pain, and other. The U.S. Food and Drug Administration has “allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.”

Here is an excerpt from the FDA News Release:

“The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.

The FDA reviewed a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present. Analysis of these 113 subjects was used to support marketing authorization of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.

The study showed that nearly 38 percent of subjects who used the Cerena TMS when they had migraine pain were pain-free two hours after using the device compared to about 17 percent of patients in the control group. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free compared to 10 percent in the control group.”

The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in people 18 years of age and older. The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.

Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). Dizziness may be associated with the use of the device.

Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.”

After 30 years of research we know that the risks of TMS are minimal, although theoretically, TMS induces an electric current in the brain, similarly to what happens with electric shock therapy, but to a much milder degree. TMS treatment of migraines does not appear to cause memory or any other problems seen with electric shock therapy for depression.

The main problem with this device is that it is bulky and inconvenient to carry around. It will probably will be reserved for people who have severe migraines that do not respond to preventive and abortive medications and Botox injections and cause disability. Considering its inconvenience, cost, and the fact that only 15% to 20% of migraine sufferers have auras (most of whom can be treated with medications or Botox), this device is not likely to be used widely. But for those for whom it works, it could be life changing.

Photo credit: www.eneura.com

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Botox injections are currently approved for the treatment of chronic migraines but not cluster headaches. However, my experience at the New York Headache Center suggests that Botox injections may also help relieve cluster headaches, which some call suicide headaches. We inject Botox for cluster headaches in a similar way we do for chronic migraines, that is the injections are given in the forehead, temple and back of the head and neck. One difference is that since cluster headaches are strictly one-sided we inject only one side with the exception of the forehead because injecting only one side of the forehead will result in a lopsided appearance.

Researchers at the Norwegian University of Science and Technology in Oslo came up with an idea of injecting Botox into the sphenopalatine ganglion. This ganglion is a bundle of nerve cells that sits behind the back of the throat and has been a target for all kinds of procedures to relieve various pain problems. Doctors have attempted numbing those cells with cocaine and lidocaine, destroying it with heat, and stimulating it with electric current in an attempt to relieve not only cluster and migraine headaches but a range of painful conditions, including low back pain. Unfortunately, we do not have any good scientific studies proving that any of these procedures on the sphenopalatine ganglion work for any condition it’s been tried for. We have many so called anecdotal reports describing successful cases, but no large controlled trials have ever been performed.

It is not clear why the Norwegian doctors think that injecting Botox into the ganglion will be effective, beyond the fact that Botox “can stops the flow of impulses along the nerves”. A report in StudyNordic.com says that “The researchers strongly believe in their treatment method, in part because a new study unrelated to their work has shown an effect by using an electric current to paralyse the nerve bundle.” So far it does not seem that they’ve treated any patients, but did start recruiting patients for a study.

They hope to enroll 30-40 cluster headache patients and then another 80 with migraine headaches. ScienceNordic.com also reports that the treatment uses an MRI of the patient’s head to make certain that the surgeon knows exactly where the nerve bundle is. A navigation tool, composed of three small spheres on the pistol, and a plate with three spheres mounted on the patient’s head, enables the surgeon to find the nerve bundle using the MRI image. “A computer sends light signals to all the spheres to form precise points. We don’t miss, but anyone who wants to participate in the study must accept the risk that it could happen, because this has never been done before. If the Botox hits an area near the nerve bundle, it could cause temporary double vision, or weaken the ability of the patient to chew,” says the lead researcher, Dr. Tronvik.

Until we have some evidence that this treatment works we have to work with the standard approaches to cluster headaches, which include, occipital nerve blocks, oxygen, a course of steroid medications, sumatriptan (imitrex) injections, verapamil, lithium, and other drugs. Two of my patients for whom none of these approaches and Botox injections worked did respond to vagus nerve stimulation, or VNS. This procedure involves wrapping a wire around the vagus nerve in the neck and connecting it to a pacemaker-like device which is implanted under the skin in the upper chest. This is also a totally unproven method with only anecdotal evidence. However, VNS has been approved by the FDA for difficult to treat epilepsy and depression. Considering that antidepressants and epilepsy drugs help migraine and cluster headaches, it is logical to conduct studies of VNS before going for a more invasive procedures.

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Botox injections is the only FDA-approved treatment for chronic migraine headaches. This is a very effective (works in 70% of chronic migraine patients) and very safe treatment. The only major drawback is its cost. However, there is a great variation in the cost from doctor to doctor and hospital to hospital. This post was prompted by an email I received from a former patient. Here are some excerpts from our exchange (with her permission):

“You’ve been my doctor now for many years, and I was just in your office over the summer for Botox treatment, but I live now in Charlottesville, VA and UVA’s hospital down here charges around $6000 for the same procedure that your office can do for $2250. With my insurance, I’m still responsible for 20% of the bill, and I can’t afford to have the procedure done here in Charlottesville.

They tell me it’s because they’re paying for facilities and staff, but even the drug is more than twice as much…THAT doesn’t make sense at all! This treatment has changed my life quite dramatically for the better. I’m so much healthier, more productive, creative, and all around a better citizen and human being as a result of not having constant headaches.”

Part of my response to her: “I am not surprised about the $6,000 price tag – I recently gave a lecture at Harvard and they also charge $6,000 and so do Mayo and Cleveland Clinics. They all also charge $2,000 for IV magnesium, while we charge $250.”

Our out-of-pocket fee for Botox injections is often only $1,700 and sometimes less, depending on the amount of Botox injected. However, the majority of our patients are covered by insurance and they have to pay only their usual copay. Almost all insurance plans now pay for Botox injections for chronic migraines, although they often require trials of prophylactic medications before they approve Botox.


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Surprisingly, Botox appears to relieve hemiplegic migraines, according to a report by two neurologists from the Mayo Clinic.

They describe 5 female patients who suffered from very frequent and severe migraine headaches with four of them having chronic migraines, that is had headaches on 15 or more days each month. The headaches were preceded and/or accompanied by weakness of one side of their body. The weakness lasted only 20 minutes in one patients, but for hours and days in others. All five patients were first treated with prophylactic medications, which either did not help or caused unacceptable side effects. Botox injections were given every 3 months into the usual sites around the scalp, neck and shoulders. A total dose of 150 units was injected. Three of the patients had three sets of injections by the time of this report and they continued to respond well.

Migraine with typical visual auras has been reported to respond well to Botox injections, which is also somewhat surprising since Botox appears to work on the sensory nerves. This effect on sensory nerve endings leads to the relief of pain. It is likely that reducing painful episodes in turn leads to a calming effect on the brain in general and the brain stops generating migraines as well as symptoms associated with migraines.

I have also seen many patients with visual, sensory and motor aura respond well to Botox injections, often when prophylactic drugs had been ineffective.


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Stimulation of the sphenopalatine ganglion seems to relieve cluster headaches according to a study by European neurologists. The study examined the efficacy of the on-demand sphenopalatine(SPG) stimulation in chronic cluster headache patients. 43 patients in this randomized controlled study were implanted with the ATI Neurostimulator System. Chronic cluster headache is a disabling neurological disorder that often does not respond to medical therapy. A previous study showed that this stimulator was effective for acute cluster headache pain relief and in some patients made their attacks less frequent. These patients also had clinically and statistically significant improvement in quality of life and reduction in headache disability.

The 43 patients in the current study were dissatisfied with their cluster headache treatment and 32 of them completed the one-year study with 23 continuing to use the stimulator beyond one year. At enrollment, 18 (78%) of patients indicated their overall evaluation of the ATI Neurostimulation System for treating their chronic cluster headaches as good or very good. 18 (78%) found SPG stimulation a useful therapy in treating their cluster headaches. 19 (83%) found surgical effects tolerable and the implanted neurostimulator comfortable or did not notice it and 23 (100%) found the stimulation sensation tolerable. 15 (65%) did not have significant side effects after stimulation. 21 (91%) would make the same decision again to treat their CH with the ATI Neurostimulation System, and 22 (96%) would recommend the ATI Neurostimulation System to someone else. 13 (57%) of patients experienced clinically significant improvement in headache disability and quality of life compared to baseline.

These results suggest that SPG stimulation with the ATI Neurostimulator is an effective therapy with sustained benefits and a high level of
patient satisfaction. This is an experimental device and is not available in the US. Even when it becomes available it would be more reasonable to try less invasive, even if not proven treatments, such as Botox injections. My experience treating chronic cluster headaches with Botox is only “anecdotal” (as opposed to that from large clinical trials) and involves a small number of patients, but nevertheless it has been very positive.


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Botox is approved by the FDA for the prophylactic treatment of chronic migraine headaches. Chronic migraine was arbitrarily defined by headache researchers as headache occurring on more than 14 days each month. Epidemiological research by Dr. Richard Lipton and his colleagues at the Albert Einstein School of Medicine suggests that there is no biological difference between frequent migraines that occur on 10 or more days each month and chronic migraines.

They compared clinical features and the incidence of other chronic medical conditions in three groups of patients with migraine: low frequency (0-9 days/month), high frequency (10-14 d/mo) and chronic migraine (15-30 d/mo). The American Migraine Prevalence and Prevention Study is a US-population-based study with 16,573 people with migraine who responded to a 2005 survey. Of these, 10,609 had low frequency, 640 had high frequency and 655 had chronic migraines. Rates of pulmonary and respiratory conditions including asthma, bronchitis, chronic bronchitis, emphysema/COPD, allergies/hay fever, and sinusitis increased across headache frequency groups and were significantly different for chronic migraine vs. low frequency, but not for chronic migraine vs. high frequency. A similar finding was seen for cardiac conditions and strokes. Depression, nervousness or anxiety, bipolar disorder/mania, and chronic pain were also much more common and similar in those with frequent or chronic migraine compared to those with low frequency migraines (around 30% vs 15%-18%).

These findings suggest that patients with frequent migraines resemble those with chronic migraines much more than they do those with low frequency migraines. One practical implication of this research is that Botox is very likely to be as effective for patients with frequent migraines (those with 10-14 headache days a month) as it is for patients with chronic migraines. And indeed, I’ve observed an excellent response in patients with frequent migraines in my almost 20 years of giving Botox injections for headaches. The response for both patients with frequent migraines and chronic migraines is about 70%, which significantly exceeds the efficacy of any prophylactic drug with no potentially serious side effects seen with most drugs.

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Many migraine sufferers suffer from nausea and vomiting and cannot swallow pills or even if they can swallow them, it takes too long for them to work. Injections is one way to overcome this problem, but nasal spray is a much more pleasant alternative. There are several migraine medications available in a nasal spray form, including Zomig (zolmitriptan), Imitrex (sumatriptan), Migranal (dihydroergotamine), Sprix (ketorolac), and Stadol (butorphanol). Unfortunately, they don’t always work or work inconsistently. Having nasal congestion due to allergies, a cold, or migraine itself often makes these medicines ineffective. Stadol is a narcotic, which can be addictive, while Imitrex and Migranal require delivery into the nose a large volume of fluid, which tends to leak out or gets swallowed, thus reducing their efficacy.

Seattle-based Impel Neuropharma has been working for five years to show it can quickly deliver drugs through the nose, directly to the brain, rather than what happens with the currently available sprays – absorption into the blood stream first and then carried to the brain. Impel, a University of Washington spinoff, recently presented a study of seven patients who used the company’s nose-to-brain drug delivery device, which was able to propel a test protein deep into the upper nasal passages and to the brain stem at an “order of magnitude” greater concentration than a conventional nasal spray. Researchers saw it get delivered to the destination within 10 to 20 minutes. Most nasal sprays don’t propel drugs anywhere close to the upper nasal passages, which is the only place in the body where nerve cells (neurons) are possibly accessible to the outside environment. This device delivers a pressurized, rotational flow of aerosol to reach those neurons.

The company stated that a nose-to-brain delivery device could, in theory, get an effective pain reliever to work more quickly for patients in need of something fast, and do it safely by minimizing the amount that gets absorbed into the bloodstream. It also could be convenient for patients, especially when compared with injectable treatment options.

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Botox appears to be effective for the treatment of chronic post-traumatic headaches in service Members with a history of mild traumatic brain injury according to a recent report by Dr. Juanita Yerry and her colleagues at Ft. Bragg, NC. The researchers assessed the safety of onabotulinum toxin type A (Botox) in the preventive care of post traumatic headache. Headache is a common complication of mild traumatic brain injury in active duty service members. Migraine and chronic migraine type are the most common headache types. The approved use of Botox in chronic migraine made the doctors think that Botox might be safe and possibly effective in post-traumatic headaches with features of chronic migraines. They examined records of all patients treated with Botox for post-traumatic headache in the Concussion Care Clinic at Womack Army Medical Center, Ft. Bragg, NC between 2008 and 2012. They recorded patient demographics, prior history of headache, injury type, current headache type, time from injury to first injection, treatment techniques, number of treatments/treatment interval, side effects, reasons for discontinuation and Patient Global Evaluation of Change (PGEC). Out of 67 patients (66 male) who were treated 10% had prior history of headaches. Most common injuries were blast (46.3%), parachute jumps (14.9%) and motor vehicle accidents (11.9%). About 56% reported more than one headache type. Headache types included: chronic migraine (22.4%), episodic migraine (7.5%), chronic tension type (7.5%), hemicrania continua (7.5%), nummular (1.5%); mixed tension/chronic migraine (41.8%), and tension/migraine (7.5%). A very large percentage (75%) had a continuous headache. Reasons for discontinuing Botox treatment included ineffectiveness (44.8%), side effects (2.9%), or reinjury (1.5%). They were not able to follow-up with 22% patients of whom 73.3% reported being “much better”. Overall, 60% were better or much better, 4.5% were worse or much worse, and 33% reported no change. The researchers concluded that Botox appears to be safe and well tolerated in active duty service members treated for post-traumatic headaches.

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A new treatment for pseudotumour cerebri was reported by a team of interventional neuroradiologists and neurosurgeons. Pseudotumour cerebri is a rare condition, which manifests itself by increased pressure in the head, leading to severe headaches, vision impairment and even complete loss of vision and brain damage. It affects more women than men and usually occurs without an obvious trigger, although pregnancy, obesity, and certain medications increase the risk of developing this condition. The diagnosis is made by performing a spinal tap (lumbar puncture) and measuring cerebrospinal fluid pressure. Typical MRI scan findings (narrowing of the ventricles – cerebrospinal fluid filled spaces in the brain) and finding of swollen optic nerves (papilledema)on eye exam confirm this diagnosis.

The new treatment is based on the theory that narrowing of a vein located at the back of the brain is the underlying cause, although this theory remains controversial. Narrowing of this vein is thought to reduce drainage of the cerebrospinal fluid from inside the brain, leading to build up of this fluid and increased pressure inside the skull. The usual treatments for pseudotumor include weight loss, medications that reduce pressure, such as acetazolamide (Diamox), and the surgical placement of a shunt to continuously drain spinal fluid from the brain, thus reducing the pressure.

The study, published in the online edition of the Journal of Neuro-Ophthalmology, shows that lowering pressure inside the vein alleviates the condition and improves vision. The doctors at Johns Hopkins used an advanced ultrasound scanner to thread an expandable metal stent through a vein in the groin, all the way to the transverse sinus, one of the main veins inside the skull draining fluid from the brain.

The study involved only 12 patients, but all of them had immediate relief of their headaches and 10 had lasting improvement. The researchers admitted that the efficacy of this treatment needs to be confirmed in a larger group of patients.


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Approval of the inhaled dihydroergotamine or DHE to be sold under the name of Levadex has been delayed again by the FDA. We expected approval last year because the FDA did consider the product to be safe and effective, but they were not happy with the manufacturing process. The application for approval was resubmitted and we all expected the product to become available in the middle of this year, but apparently the FDA still has the some concerns about the manufacturing. If all goes well Levadex may come to the market at the end of 2013. In the past few months the small company that developed Levadex, MAP Pharmacueticals sold itself to the maker of Botox, Allergan. Allergan hopes to find synergy between Botox, which is approved for the prevention of chronic migraines and Levadex, which is indicated for the treatment of an acute migraine attack. It will be much more efficient for Allergan’s sales force to sell two complementary drugs to neurologists rather than just one. Both are excellent drugs with high efficacy (70% for Botox and 60% – 70% for Levadex), excellent safety for Botox and relatively good safety for Levadex (comparable to triptans, such as Imitrex).

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Melatonin does seem to help prevent migraine headaches according to a new study by Brazilian researchers just presented at the annual scientific meeting of the American Academy of Neurology. In my previous post over two years ago I wrote about a negative study that showed no benefit from 2 mg of extended release melatonin given to 46 migraine sufferers. This new study was also blinded and it compared 3 mg of immediate release melatonin with placebo and with 25 mg of amitriptyline, which is one of the oldest preventive drugs for migraines.
This was a larger study – it involved 196 patients who suffered from 2-8 attacks of migraine with or without aura each month. The number of headache days dropped by 2.7 days in the melatonin group, 2.18 for amitriptyline, and 1.18 for placebo. Melatonin significantly reduced headache frequency compared to placebo, but not to amitriptyline. Not surprisingly, melatonin was better tolerated then amitriptyline. Considering its safety and very low cost, it is worth considering a trial of 3 mg of melatonin for the prevention of migraine headaches. Some studies have suggested that taking a much smaller dose of 0.3 mg (300 mcg) of melatonin may be more effective for insomnia than taking a much larger dose. It would be interesting to see if this also applies to the treatment of migraine headaches.


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Vagus nerve stimulation (VNS) seems to be effective for the treatment of migraine headaches. In my post over a year ago I mentioned our study of a device that stimulates vagus nerve with an external portable device. The results of this study were just presented at the annual scientific meeting of the American Academy of Neurology. The device was developed by scientists at ElectroCore, a small company following my publication of a study of implantable VNS in 6 patients. In the current study we included patients with migraine with or without aura. Participants acutely treated up to 4 migraine attacks with this portable VNS within 6 weeks. Treatment consisted of two, 90-second doses, at 15-minute intervals. Patients were asked to self-treat once pain became moderate or severe, or after 20 minutes of mild pain. Of 30 enrolled patients, 26 treated 79 migraine headaches. At two hours, 46 of 79 headaches (58%) responded, and in 22 out of 79 (28%) pain was completely gone. At two hours, 76 of 79 (96%) were improved or did not worsen. Of 26 patients 20 (77%) reported mild or nor pain at 2 hours, for at least one treated headache. Side effects were limited to muscle or skin irritation and two reports of lightheadedness, most of which resolved immediately after treatment, and all within two hours of treatment. These are very preliminary results, but they suggest that VNS may be an effective and well-tolerated acute treatment for migraine. Additional large clinical trials are needed to confirm these findings.

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A recently published study by neurologists at the Military Medical Center in San Antonio led by Dr. Grogan tried to find predictors of response to botulinum toxin injections in chronic migraine sufferers. They looked at the records of 128 patients who received injections of botulinum toxin, although they did not receive Botox (onabotulinumtoxinA), but a similar product, Myobloc (rimabotulinumtoxinB). It has been previously reported (and mentioned in this blog) that patients with headaches who experience constricting pain or pain in the eye are more likely to respond than those who have an “exploding” headache or pain with pressure felt going from inside out. This new study confirmed this observation, originally made by Dr. Rami Burstein and his colleagues at Harvard Medical School. Dr. Grogan and his colleagues’ patients received an average of 7 and a half treatments over a period of 22 months. Treatment results showed that 80% of their patients who received injections of Myobloc had at least a 50% improvement and 57% had a greater than 75% reduction in their headache frequency. This is similar to the 70% response rate we see with Botox injections. Patients who had migraine with aura were more likely to respond to Myobloc injections. Just like with Botox side effects were few and mild and only 4% of patients decided to stop this treatment due to side effects. More patients who received Myobloc (82%) complained of pain during injections. I have also observed this and the reason is that Myobloc is very acidic, while Botox is non-acidic.
There are two other botulinum toxin products on the market, but only Botox is approved by the FDA for the treatment of chronic migraine headaches. These other two products are Dysport (abobotulinumtoxinA) and Xeomin (incobotulinumtoxinA) and they are more similar to Botox than Myobloc because they are also type A botulinum toxins, while Myobloc is type B. Only Botox is approved by the FDA for the treatment of chronic migraine headaches, while the other three are approved for movement disorders such as dystonia as well as for cosmetic use.


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A typical visual aura which precedes the headache in about 20% of migraine sufferers usually lasts 20 to 60 minutes. A small number of patients suffer prolonged auras, which can last for hours. While we have many medications to treat the pain of migraine, we have no effective way to stop a prolonged aura. The only possible exception is intravenous magnesium, which I have found to help some patients for prolonged visual and other types of aura. Researchers at UCSF led by Dr. Peter Goadsby conducted a rigorous blinded study of intranasal ketamine for prolonged auras. They compared ketamine to a strong tranquilizer, midazolam. The results of the study published in Neurology showed that ketamine but not midazolam can make aura milder, but it did not shorten it. Ketamine is a drug given intravenously for anesthesia, but it has been also widely tested for the treatment of pain, albeit with mixed results.

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I failed to mention in my two previous posts that there is a difference in the type of electrical current used in transcutaneous electrical nerve stimulation (TENS) and transcranial direct current stimulation. The former uses alternating current, while the latter is a direct current (AC vs DC). Cefaly device uses AC, while tDCS devices use DC. It is possible that both types of stimulation are equally effective for chronic migraine headaches and other conditions. We would need to have a blinded trial comparing these two types of stimulation to see if one is superior to the other.

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An article in today’s New York Times reported on the efficacy of electrical brain stimulation for the treatment of depression. It described a study published last week in the journal JAMA Psychiatry, in which a commonly used antidepressant, sertraline (Zoloft) was compared with transcranial direct current stimulation, or tDCS. This blinded study showed that Zoloft and the electrical stimulation of the brain were equally effective, but the electrical stimulation lacked the side effects of the drug. Combining electrical stimulation with Zoloft produced even better results. This type of electrical stimulation is very safe and is somewhat similar to the transcutaneous electrical stimulation mentioned in my previous post. tDCS was also tried in patients with chronic migraines. A study published in Headache last year showed that pain intensity and migraine duration was reduced after 10 sessions of tDCS given over a period of 4 weeks. Even though the study involved only 13 patients, the active treatment was compared to sham stimulation, which makes the findings more likely to be true, rather than due to the placebo effect. It is too early to recommend tDCS for the treatment of chronic migraines. However, this is a very safe and inexpensive treatment that may be worth trying before other unproven, more expensive, and more invasive treatments, such as occipital or supraorbital nerve stimulation or migraine surgery.

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Electrical stimulation of the nervous system is widely used for a variety of conditions and in a variety of ways. The nervous system can be electrically stimulated at the level of the brain, by implanting electrodes into the brain, at the level of spinal cord, also with implanted electrodes or at the level of peripheral nerves in the skin by attaching an adhesive electrode or with an implanted wires. The conditions that can be helped by electrical stimulation range from Parkinsons disease and depression to chronic low back pain and post-herpetic neuralgia (shingles). Stimulation of the nerves through adhesive electrodes temporarily attached to the skin is called transcutaneous electrical stimulation, or TENS. TENS has been proven to help a variety of musculo-skeletal conditions, such as back pain and arthritis pain.
There have been some studies of the use of TENS for headaches, but none of them have been as rigorous and scientific as the one just published in Neurology. The lead author, a Belgian neurologist and a headache specialist Dr. Jean Schoenen and his colleagues conducted a study on 67 patients with a proprietary TENS device called Cefaly. The device is put on the forehead like eyeglasses and it contains electrodes which stimulate the nerves above the eyes. The study showed that by using this stimulator for 20 minutes daily for 3 months patients reduced the number of their migraine headaches from an average of 7 to 5 a month. Those patients who put on the device but were not given electrical stimulation (the sham, or placebo group) did not improve.
The device costs about $368 on Amazon and $240 at Costco in Canada. It is not clear if this device offers any advantages over a TENS unit that costs about $50 and is widely available in this country. Perhaps, Cefaly is much more convenient in that it does not require adhesive electrodes with wires attached to a little box. Another possible advantage is the stimulating current may have specific frequency, strength and wave shape, which provides better relief. However, an electrical engineer could easily hook up the Cefaly unit to a monitor and figure out and publicize these settings. I do not suggest that the people who developed this device and did all the testing do not deserve to be financially rewarded. They may, in fact be rewarded because their device is significantly more convenient and simple to use and many people will prefer it to a more cumbersome device.
Cefaly
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Botox (anabotulinumtoxinA) is the only treatment approved by the FDA for the treatment of chronic migraine headaches. The FDA based its approval on the results of two clinical trials with 700 patients in each (I participated in one of them). In these studies half of the patients were given placebo injections and the other half, Botox for the first six months and then everyone was getting Botox. Even after 4 weeks following the first treatment those who received Botox were doing better than those who received placebo. After the first Botox treatment 49% of participants had a 50% reduction in the number of headache days, after the second treatment this number was 60% and after the thurs, 70%. After 56 weeks, 70% of patients treated with Botox continued to have at least a 50% improvement in headache days per month. This means that by that time 70% of patients were no longer were having chronic migraine, which is defined as having a headache on more than half of the days. So, even in those chronic migraine sufferers who were having daily headaches, a 51% improvement meant that they no longer had headaches on more than half of the days. This also means that Botox converts chronic migraine into episodic. My observation over 18 years of injecting Botox for headaches also indicates that with continued treatment some people stop having migraines altogether. Of course, this observation does not mean that Botox was definitely the reason why headaches stopped since migraines often subside with age and at times can stop without an obvious reason on their own. However, the fact that improvement occurs gradually and continuously with repeated Botox injections suggests that Botox does contribute to this complete resolution of headaches.
Another point I would like to emphasize that some patients who did not a significant improvement after the first treatment did improve after the second or even third. Most of my colleagues and I will not do a third treatment if the first two were completely ineffective. However, if even mild improvement occurs, it may be worth repeating the treatment.
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Migraine surgery continues to be promoted by an ever increasing number of plastic surgeons. In my previous post in 2007 I mentioned the reasons to avoid such surgery and five years later all those reasons remain. Some of the leading objections are lack of proof, existence of a safer alternative (Botox injections), and most importantly, the risk of potentially serious side effects. Several of my colleagues have seen patients who suffered complications of surgery and we decided to ask other patients who underwent migraine surgery to come forward and share their experience. We understand that this will not be a highly scientific study and it will not tell us what percent of people suffer negative outcomes since those who suffered complications and side effects are more likely to come forward than those who had none. However, we think that because doctors who perform surgery are unlikely to report side effects and complications, it is important for people to know what can go wrong. So, please post your experience in response to this blog or if you prefer to remain anonymous, email me at DrMauskop@nyheadache.com.
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Botox relieved severe pain of SUNCT, a rare and very painful condition, according to a report recently published in journal Cephalalgia. SUNCT stands for short-lasting, neuralgiform headache attacks with conjuctival injection and tearing. The pain of SUNCT is very sudden and brief, lasting 5 to 240 seconds and occurring 20-30 or more times a day. The pain usually occurs around the eye and is accompanied by tearing and redness of the eye. It can be a very debilitating condition because it is difficult to treat. Medications, such as lamotrigine (Lamictal), gabapentin (Neurontin), carbamazepine (Tegretol), and other have been reported to help. The report in Cephalalgia by a Spanish neurologist describes a patient with SUNCT who did not respond to a variety of medication and nerve destruction (thermocoagulation of the trigeminal ganglion), but had an excellent response to Botox injections given every three months. He has received 10 Botox injections over a period of 2 and 1/2 years with sustained relief. He was still having 6-8 attacks per week, but before Botox he was having 20-30 a day. His functioning has also significantly improved. Botox is approved by the FDA only for chronic migraines, although it also seems to work for cluster headaches, which cause pain similar to SUNCT, although it lasts for 1-3 hours and occurs once or twice a day. SUNCT is a very rare condition and it is very unlikely that a blinded clinical trial of Botox for SUNCT will ever be conducted, but this report suggests that Botox may be worth trying in patients with SUNCT.
SUNCT

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Zecuity was just approved by the FDA for the treatment of acute migraines. Zecuity is a skin patch containing sumatriptan. Delivering sumatriptan through the skin is an appealing option for patients who have severe nausea or vomiting and have difficulty swallowing tablets. NuPath is a company that has been working on such a delivery system for several years and I mentioned their research in one of the posts on this blog over three years ago. Recently, they completed another clinical trial which confirmed that the idea is valid and their product (it was first named Zelrix, but now is to be called Zecuity) is effective in treating migraine attacks. The patch containing sumatriptan delivers medicine through the skin with the help of an electrical current derived from a miniature battery embedded within the patch. The patch is used once and then is discarded. The results of this trial were published in the journal Headache. This study involved 469 patients half of whom treated their migraine with an active patch and the other half with an inactive (placebo) patch. A significantly higher proportion of patients given sumatriptan were completely pain-free compared to those who were given placebo – 18% vs 9%. Pain relief after two hours was observed in 53% patients receiving sumatriptan compared to 29% of those receiving placebo and this difference persisted. Side effects were mostly local due to the patch – 23% had pain at the site of patch, 20% had either burning of tingling, and 7% had other types of skin reaction, but only 2% had a reaction severe enough that they took the patch off. Zecuity (transdermal sumatriptan) appears to offer a good option for migraine sufferers who cannot take oral medications and do not want to inject themselves with sumatriptan.
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Transcranial magnetic stimulation (TMS) seems to be effective for the treatment of migraines with aura. “Spring TMS” device which delivers a jolt of such stimulation has been on the market in Europe since 2011. The American company that manufactures this device, eNeura Therapeutics hopes to obtain approval to sell it in the US in the near future. The approval of this device in Europe was based on a multi-center study results of which were published in Lancet Neurology. Unfortunately, the device is fairly bulky and needs to be carried around constantly because it seems to work only if used during the aura phase of the migraine. Auras usually begin unpredictably and last 20-60 minutes. Migraine with aura affects only 15-20% of all migraine sufferers, further limiting the potential market for this device.

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Aspirin is by far the most effective drug for the prevention of migraine with aura, according to Italian researchers from Turin. They reported on 194 consecutive patients who had migraine with aura and who were placed on a prophylactic medication. Ninety of these patients were on 300 mg of aspirin daily and the rest were given propranolol (Inderal), topiramate (Topamax), and other daily medications. At the end of 32 weeks of observation 86% of those on aspirin had at least a 50% reduction in the frequency of attacks of migraine with aura compared with their baseline frequency, while 41% had even better results – at least a 75% reduction. In contrast, only 46% of patients on other drugs had a 50% improvement in frequency. The probability of success with aspirin was six times greater than with any other prophylactic medication, according to the lead author, Dr. Lidia Savi.
Aspirin is not only effective for the prevention of migraines with aura but also for acute therapy of migraine attacks. In previous posts I mentioned that a rigorous analysis of large numbers of patients showed that 1,000 mg of aspirin is better than 500 mg of naproxen (2 tablets of Aleve) and that 1,000 mg of aspirin was as good as 100 mg of sumatriptan (Imitrex) with fewer side effects.
Many health benefits of aspirin, which was originally derived from the willow bark, are becoming widely known. In addition to helping prevent heart attacks and strokes, aspirin has cancer-fighting properties. You may want to read a very interesting article about aspirin, The 2,000-Year-Old Wonder Drug, just published in the New York Times.
Willow
Aspirin formula

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Occipital nerve stimulation (ONS) has been reported to relieve refractory (difficult to treat) migraine headaches. Results of a clinical trial of ONS for patients with refractory migraine was just published in the journal Cephalalgia. This study was sponsored by St. Jude Medical, company that manufactures occipital nerve stimulators. This was a large (157 patients) and very scientific (randomized, controlled) study.?Patients were considered refractory if they failed two prophylactic migraine medications, such as blood pressure medications, anti-epilepsy drugs, or anti-depressants. Of the 157 patients, 105 patients had real stimulation and 52 had sham stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a ?50% reduction in pain scores after 12 weeks). The researchers found no significant difference in the percentage of responders in the Active compared with the Control group. The authors of the report suggest that had they used different measures of efficacy, the results would have been positive and they are calling for more studies. The most common adverse event was persistent implant site pain, which occurred in 15% of patients. The editorial by Hans-Christoph Diener, one of the leading headache experts suggested that the efficacy of this treatment appears to be very low, while side effects and costs are quite significant. The cost of the stimulator and of the surgery to implant it ranges from $20,000 to $40,000. Another problem with the study is that it did not require that patients fail Botox injections before they were enrolled in this trial. Botox is known to be effective for the treatment of migraine headaches in many patients who fail prophylactic medications. Botox is not only very effective, but is also significantly cheaper and much safer.
Occipital nerve stimulatorOccipital nerve stimulatorOccipital nerve stimulator

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I just saw a man with chronic cluster headaches whom I’ve been treating for the past 5 years. He had tried various treatments and still remains on verapamil which provides partial relief, but he finds excellent relief from monthly intravenous infusions of magnesium and Botox injections given every 2 to 4 months. He sometimes needs a magnesium infusion every three weeks. He occasionally takes sumatriptan (Imitrex) injections as needed for breakthrough headaches, but many of his remaining attacks are mild and are relieved by rizatriptan (Maxalt) tablets or zolmitriptan (Zomig) nasal spray. Botox is not approved by the FDA for the treatment of cluster headaches, only for chronic migraines. However, there are several case reports of successful use of Botox in patients similar to mine. I’ve treated several other cluster headache patients with Botox with good results, but this is the only one who has been receiving Botox for three years (he has had 15 treatments to date). As far as the use of intravenous magnesium, we’ve published an article showing that 40% of patients with cluster headaches are deficient in magnesium and respond to intravenous infusions.
Cluster headache
Photo credit: IHS-Classification.org

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A small number of my patients take triptan medications daily. Many doctors, including neurologists and headache specialists think that taking these drugs daily makes headaches worse, resulting in rebound, or medication overuse headaches (MOH). However, there is no evidence to support this view. Sumatriptan (Imitrex, Treximet), rizatriptan (Maxalt), zolmitriptan (Zomig), naratriptan (Amerge), eletriptan (Relpax), almotriptan (Axert), and frovatriptan (Frova) have revolutionized the treatment of migraines. I started my career in 1986, five years before the introduction of sumatriptan when treatment options were limited to ergots with and without caffeine (Cafergot), barbiturates with caffeine and acetaminophen (Fioricet), and narcotic or opioid drugs (codeine, Vicodin, Percocet). These drugs were not only ineffective for many migraine sufferers, but they also made headaches worse. Dr. Richard Lipton and his colleagues followed over 8,000 patients with migraine headaches for one year. Results of their study showed that taking barbiturates (Fioricet, Fiorinal) and narcotic pain killers increased the risk of migraines become more frequent and even daily and resulting in chronic migraines. We know from many other studies that withdrawal from caffeine and narcotics can result in headaches. However, taking triptans and non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin (Migralex), naproxen (Aleve), ibuprofen (Advil, Motrin) does not lead to worsening of headaches. Only those patients who were taking NSAIDs very frequently to begin with were more likely to develop even more frequent headaches at the end of the year. Aspirin, in fact, was found to have preventive properties – if you were taking aspirin for your migraines at the beginning of the year you were less likely to have worsening of your headaches by the end of the year.
There are also studies showing that NSAIDs taken daily can be effective for the prophylactic (preventive) treatment of migraine headaches. Unfortunately, no studies have been done to show that taking triptans daily can also prevent headaches.
Over the years, I have treated dozens patients with daily triptans. Prescribing sumatriptan or another triptan for daily use was never my original intent. However, most of these patients failed multiple preventive medications, Botox injections, various supplements, biofeedback and acupuncture. Because of the widespread belief that triptans cause rebound headaches most of them tried to stop taking these drugs. After a week or even several weeks, their headaches did not improve, as should be the case with rebound or MOH. In fact, most of them became unable to function and I would resume prescribing 30 and up to 60 tablets of a triptan each month. Sometimes I would prescribe 6 of one, 9 of another, and 18 tablets of the third triptan, depending on what the insurance company would allow. For some patients all triptans work equally well, for some several do, and for others only one out of seven would provide good relief without causing side effects.
The cost of these drugs, even after sumatriptan going generic, has been very high and is now the main obstacle for most patients. The original main concern we had early after the introduction of triptans was the potential serious side effects. But now, 20 years of experience strongly suggests that taking triptans daily does not cause any serious long-term side effects. I do not suggest that they cannot or do not cause serious side effects – they can and do and are contraindicated in patients with coronary artery disease and strokes, but in healthy people they are very safe. For the past several years, triptans have been available in Europe without a prescription.
In conclusion, daily triptans can be a highly effective and safe treatment for a small group of patients with chronic migraine headaches. They should not be prescribed for the prevention of migraines or for daily abortive use, unless other options (excluding barbiturate, caffeine, or narcotics) have been tried.

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We are conducting a trial of a very novel treatment for migraine headaches. ElectroCore is a company that developed a small hand-held device which is placed at the front of the neck during a migraine and which painlessly stimulates the vagus nerve. The idea for this device came from my study of 6 patients who had a vagus nerve stimulator implanted in the neck. The results of this study was published in 2005 in the journal Cephalalgia. All six patients had very debilitating headache which did not respond to dozens of drugs, Botox injections, nerve blocks, acupuncture and a variety of other treatments. Two of them had cluster headaches and both improved. Four had chronic migraines and two of these also improved.
Implanting a device to stimulate the vagus nerve is an invasive and expensive procedure, so having a small portable and non-invasive device offers great advantages. This device is approved in Europe and id currently in clinical trials in the US.

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Botox, or onabotulinumtoxinA was recently approved by the FDA for treatment of chronic migraine based on the results of two large studies. Botox is the only prophylactic therapy specifically approved for chronic migraine. Many patients and doctors alike wonder about the mechanism of action of Botox. We originally thought that Botox works by relaxing tight muscles around the scalp. Studies have shown that during a migraine attack, the muscles in the forehead, temples and the back of the head are in fact contracted. It is also typical for a person with a migraine to rub their temples or the neck, which provides some temporary relief. However, I have seen some patients who would report that injecting muscles around the head eliminated pain in the injected areas, but that they still had pain on the top of the head. There are no muscles on the top of the head and we usually do not inject Botox there, but in those patients who do have residual pain on the top, injecting Botox stops the pain. Recent research has shown that Botox in fact also exerts a direct analgesic (pain-relieving) effect. This is supported by my and other doctors’ observation that Botox also helps other types of pain, such as that of shingles or trigeminal neuralgia. These are so called anecdotal reports and cannot be relied on to make definitive conclusions – we need large trials can prove this. It appears that Botox helps by reducing pain messages sent to the brain from both muscles and peripheral sensory nerves. This explains why migraine, which is a brain disorder, can be helped by a procedure directed only at the peripheral nerves – with the reduction of the barrage of pain messages reaching the brain, the brain does not become more and more excitable, or “wound-up” and a migraine attack does not occur. Some patients tell me that after Botox treatment they sometimes feel that a migraine is about to start, but it does not.

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Intravenous infusion of magnesium for the treatment of an acute migraine is receiving more attention and is mentioned in the recent issue of journal Headache. In the first of three articles Drs. Nancy Kelley and Deborah Tepper of the Cleveland Clinic describe the use of triptans (such as sumatriptan, or Imitrex), DHE (dihydroergotamine), and magnesium for the emergency treatment of migraines. In their article they included seven reports of the use of magnesium infusion, all with positive results. We published the very first article on the use of intravenous magnesium for migraines in 1995. In the same year we published our results of the use of this treatment for cluster headaches, also a first and since that time have been promoting the use of this safe and effective treatment in many articles, lectures, and symposia. We’ve found that 50% of patients with migraines and 40% of those with cluster headaches responded to magnesium infusion. Unfortunately, many patients seen in the emergency room still do not receive magnesium, but in the best case sumatriptan or ketorolac injection, in the worse, narcotic drugs. An infusion of magnesium should be always tried first. We actually discourage our patients from going to the emergency room during office hours – instead they come to our office and are given an infusion of magnesium. If it is ineffective, then we proceed with sumatriptan, ketorolac, dexamethasone, other drugs, and sometimes nerve blocks.
Oral magnesium is not suitable for the acute treatment of a severe headache because it is absorbed too slowly. However, Migralex, a drug containing magnesium and aspirin was developed to dissolve and absorb quickly, so it can deliver magnesium (along with aspirin) to the brain within 15 – 30 minutes. Another article in the same issue of Headache recommends the use of aspirin as the first line treatment for migraine and tension-type headaches, regardless of their severity. Many doctors use “stratified” approach, which means that they recommend aspirin for milder headaches and a prescription drug, such as sumatriptan, for more severe attacks. However, the authors reviewed results of studies involving thousands of patients and concluded that aspirin can be very effective for many patients with a severe headache and should be tried first. If it is ineffective, then the patient is advised to take the prescription drug.

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The FDA approved Botox for the treatment of chronic migraine because of the two large double-blind and placebo controlled trials which involved close to 1,400 patients (in which we, at the NYHC also participated). These studies showed that Botox reduced the number of days with headaches and it also improved many other related aspects. A study just published in Neurology looked at the effect of Botox on the quality of life of patients that participated in these trials. It is possible to have a treatment that reduces the number and even the severity of migraines without improving patients’ quality of life because of its side effects. This is seen with some patients who take topiramate (Topamax) – their headaches may be much better but the quality of life is not because of memory impairment or fatigue, which makes them unable to function. The same is true with other medications, such as antidepressants. However, the quality of life of patients receiving Botox in these two studies was significantly better than in those receiving placebo injections. This is because their headaches improved dramatically and because Botox rarely caused any side effects. Unfortunately, many insurance companies will pay for Botox only after the patient fails to improve on 2 or 3 prophylactic medications, even though these medications are not approved by the FDA for chronic migraines.

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Cluster headaches are relieved by steroid injections in the back of the head, according to a study by French doctors, published in The Lancet. 43 patients with chronic and episodic cluster headaches were recruited into this blinded study where some patients received a steroid (cortisone) injection and some received saline water. The injections were given in the back of the head under the skull, on the side of headache. Injections were repeated every 2 – 3 days for a total of 3 injections. There was a significant improvement in patients who received cortisone. This study supports the wide use of a similar procedure, an occipital nerve block to relieve cluster headaches. In this study patients were allowed to take oxygen and sumatriptan (Imitrex) as needed. They were also started on verapamil for the prevention of cluster headaches and the injections were used for short-term relief while awaiting for the effect of verapamil to kick in. In my experience, some patients, especially those with episodic cluster headaches, may have complete resolution of their headaches just from the nerve block. Sometimes a single block is sufficient, but occasionally it helps for only a few days and needs to be repeated. It is likely that the injection technique and doctor’s experience can make a difference. Another option to stop cluster headaches is to take an oral steroid medication, such as prednisone, but taking it by mouth is more likely to cause side effects. Verapamil is an effective preventive drug, but it usually needs to be taken at a high dose – starting with 240 mg and going up to 480, 720 mg, and even higher. Verapamil is a blood pressure medication and before starting it and before increasing the dose an EKG is usually taken as it is contraindicated in people with some heart problems. In addition to verapamil, topiramate (Topamax), lithium, other drugs, and even possibly Botox injections can prevent attacks.

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Merck discontinued the development of telcagepant, a promising new drug which represents a new class of migraine drugs, so-called CGRP antagonists. These drugs appear to be as effective as sumatriptan (Imitrex) and other triptans in aborting a migraine attack, but do not carry an increased risk of strokes and heart attacks which can occur, albeit very rarely, with triptans. Telcagepant was also tested as a daily preventive drug for migraines and in those trials some patients developed minor liver abnormalities. At first, Merck continued to pursue the development of telcagepant for abortive treatment, but recently decided that the risk of not getting it approved by the FDA because of the liver problems was to high. This again demonstrates that part of the reason why new drugs are so expensive – for every one that makes it to the market there are many that after an investment of hundreds of millions of dollars do not. It is likely that Merck and other companies will continue to do research to find a CGRP antagonist without serious side effects.

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Chronic cluster sufferers may benefit from sodium oxybate (Xyrem), according to a report in the leading neurology journal,Neurology. Xyrem is a drug approved for the treatment of narcolepsy but it is also being evaluated for the treatment of pain of fibromyalgia, chronic fatigue, and other conditions. It is well established that patients with cluster headaches often suffer from sleep disorders and cluster attacks often wake patients from sound sleep in the middle of the night. It is logical to consider drugs that affect sleep in the treatment of cluster headaches. However, traditional sleeping medications do not help cluster sufferers. Approximately 10% of patients with cluster headaches suffer from chronic clusters, which means that they have headaches for years without a break, while the other 90% have cluster periods lasting a few weeks to a few months every year or every several years. The article in Neurology describes 4 patients with chronic clusters who were treated with Xyrem with excellent long-term results. In one patient relief lasted 8 months while in the other three for up to two years. Side effects consisted mostly of dizziness, some memory difficulties, vomiting, and weight loss, however they were not severe enough to stop taking this medication. Xyrem is a controlled drug with potential for abuse and is dispensed only through a single centralized pharmacy.

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Botox has been shown to relieve headaches of low spinal fluid pressure in a case reported at the last annual scientific meeting of the American Headache Society in Washington DC. Low spinal fluid headache usually occurs after a spinal tap (lumbar puncture) or rarely without an obvious cause. The diagnosis is made by doing a spinal tap which normally shows low pressure and by a characteristic appearance of the MRI scan of the brain. The woman who was treated by doctors from the Mayo Clinic had a spontaneous leak of the spinal fluid and did not respond to blood patches which is the first-line treatment for this condition and consists of injections of person’s own blood into the area around the leak. She also did not respond to a variety of medications. Botox injections provided her with relief for the first time in 20 years. She has continued to receive Botox injections for three years now with sustained results. It somewhat surprising that Botox would help because the cause of low pressure headaches is thought to be tugging on the nerves due to sagging of the brain, which normally is floating in the spinal fluid. It is possible that Botox just stops pain sensations regardless of the cause, whether it is due to migraine, shingles or other nerve disturbance.

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Trigeminal neuralgia is an excruciatingly painful disorder which affects about one in a thousand people. Patients describe the pain of TN as an electric shock going through the face. The pain is brief, but can be so frequent as to become incapacitating. Eating and talking often triggers the pain, so some patients become malnourished and depressed. The good news is that most people can obtain relief from this condition by taking medications, such as Tegretol (carbamazepine), Trileptal (oxcarbazepine), Dilantin (phenytoin), or Lioresal (baclofen). Patients who do not respond to medications have several surgical options available. According to a new Dutch nationwide study of three invasive treatments for trigeminal neuralgia published in journal Pain shows that every year about 1% of those suffering from TN undergo surgery. Of the three most common types of surgery, percutaneous radiofrequency thermocoagulation (PRT) is by far most popular – in  a three year period in Holland, 672 patients underwent PRT, 87 underwent microvascular decompression (MVD), and 39 underwent partial sensory rhizotomy (PSR). The latter two procedures a performed by neurosurgeons (MVD requires opening of the skull), while PRT is usually done by anesthesiologists (a probe is inserted through the cheek to the nerve ganglion under X-ray guidance). MVD was most effective, but caused more complications than PRT, although fewer than with PSR. More patients having PRT had to have a repeat procedure, but it was still safer than the other two. Very often the physician under-treats during the first treatment of PRT in order to avoid complications. Overall, the best initial procedure for those suffering with TN is PRT and if repeated PRTs fail, MVD can sure this condition.

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Obese people are more likely to suffer from more frequent and severe migraine headaches. The question that remained unanswered was whether losing weight helps relieve headaches. A new study just published in the leading neurology journal, Neurology suggests that this may be the case. Researchers from Brown University in Providence, RI examined 24 severely obese patients before and after bariatric (weight reduction) surgery. Their mean body mass index (BMI) was 46 and their mean age was 39. A direct correlation between the amount of weight loss and the reduction in the number of headache days was observed. Weight loss was also associate with reduced disability. This study gives scientific support to the idea that weight loss may improve migraine headaches.

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Taking two different triptans (drugs such as Imitrex, or sumatriptan, Maxalt, or rizatriptan and other) within 24 hours of each other is contraindicated according to the FDA. However, there is no scientific reason for such prohibition. You are allowed to take a second dose of the same triptan 2 hours after the first dose, so it makes no sense why you could not take a different one. Most of the triptans (five out of seven) get washed out from the body within 2 – 3 hours, so even if there was an interaction between different triptans (and there is absolutely no evidence for that) it would be safe to give a different one 3 hours later. A report in the latest issue of the journal Headache by Dr. Rothrock studied 200 patients who “mixed triptans”, that is took a shot of sumatriptan and two hours before or after a tablet of either rizatriptan (Maxalt, zolmitriptan (Zomig), almotriptan (Axert), or eletriptan (Relpax). He found that not only there were no problems, patients were highly satisfied with this approach. I also hear from my patients that sometimes they know that one tablet of a triptan will not be enough for their severe attack and they will take two at once. Many doctors strongly advise their patients against it, but there is no evidence of any great danger from a higher dose. These dosages were arrived at by looking for an optimal dose which provides good relief and few side effects and for most people the standard dose will suffice. But some people need higher amounts. In case of eletriptan (Relpax), 20 mg and 40 mg are available in the US, but in some European countries it is available in 80 mg. It is clear that some patients benefit from a higher than recommended dose without an increase in side effects.

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Botox is now approved for chronic migraine headaches. However, it may help you feel happier not only because your headaches improved. Several studies suggest that the inability to frown caused by Botox makes people happier too. Psychologists at the University of Cardiff in Wales showed that healthy people (not headache sufferers) who had cosmetic Botox injections were happier and less anxious than those who hadn’t. Another study published in the Journal of Pain showed that people who grimaced during a painful procedure felt more pain than people who did not. In an experiment by German researchers, healthy people were asked to make an angry face while their brains were being scanned by a functional MRI. Those who received Botox injections had much less activation in areas of the brain that process emotions than those who had no injections. My patients who receive Botox for headaches also report that because they cannot make an angry face they feel less angry. We need a large study of the effect of Botox injections on the mood, so that if this finding is confirmed, Botox can be recommend for the treatment of mood disorders.

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Melatonin does not seem to be effective for the prevention of migraine headaches, according to a study published in Neurology. The researchers from Norway gave 2 mg of extended release melatonin every night for 8 weeks to 46 migraine sufferers. All 46 received also received 8 weeks of placebo and neither the doctors nor the patients knew whether the first treatment was with melatonin or placebo (so called double-blind crossover trial). Migraine frequency did improve from an average of 4.2 a month to 2.8, but the same results were observed while on melatonin as on placebo. This study confirms a well established observation that taking a placebo helps, or perhaps that what helps is just keeping track of your headaches and seeing a medical provider on a regular basis.
One argument against the validity of the study is that the dose of melatonin might have been too low because one small trial of 10 mg of melatonin in cluster headache sufferers did show benefit. Another possibility is that the dose was too high. There is a study that suggests that taking 0.3 mg (or 300 mcg) helps insomnia, while 3 mg does not. Anecdotally, I find that for me and many of my patients 0.3 mg works better for insomnia and jet lag than 3 mg.

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Botox, which was recently approved for the treatment of chronic migraine headaches, was originally thought to relieve migraine headaches by relaxing tight muscles around the scalp.  However, several recent studies determined that besides relaxing muscles, Botox also stops the release of several neurotransmitters from the nerve endings.  These neurotransmitters are released by messages sent from the brain centers that trigger a migraine attack.  In turn the released neurotransmitters send pain messages back to the brain completing a vicious self-sustaining cycle.  A meticulous study just published in the journal Pain by Danish researcher confirmed that injections of Botox stop the release of neurotransmitters and reduce sensitivity of rat’s chewing muscles.  Not knowing the exact way how Botox works makes many doctors skeptical about its efficacy.  However, we have no idea how preventive medications, such as beta blockers, antidepressants and epilepsy drugs prevent headaches either.  These drugs, like Botox, were also discovered to help headaches by accident.  This does not and should not stop us from using them.  Botox is more effective and safer than medications taken by mouth and is an excellent option for over 3 million Americans who suffer from chronic migraines.

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Intranasal sumatriptan powder seems to be a new and very promising way to deliver a migraine drug.  Sumatriptan (Imitrex) nasal spray has been available for many years, however it is not very effective or at least is not consistently effective.  The liquid tends to leak out of the nose, get swallowed, or just not get absorbed.  Nasal spray of Zomig (zolmitriptan) appears to be more effective, perhaps because of the smaller volume of the liquid and a finer spray particles.  The new product, OptiNose nasal powder seems to be even more effective.  It is a sophisticated device which does not allow for the powder to enter the lungs and deposits the medicine only in the nasal cavity.  In a study of 117 patients, 57% were pain-free and 80% had pain relief 2 hours after receiving 20 mg of sumatriptan powder, which was very significantly better than with placebo.  The nasal powder seems to be three times more effective than the nasal spray and almost as effective as an injection.  We hope that the FDA will approve this product in the near future.

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Botox was just approved by the FDA for the treatment of chronic migraine headaches.  This is great news to the more than 3 million chronic headache sufferers in the US (people who have more than 15 days with headaches each month).  In Dr. Mauskop’s opinion Botox is one of the most effective treatments for frequent and severe headaches and it is the first treatment approved FDA for chronic migraines. Dr. Mauskop was one of the first headache specialists to begin using this treatment more than 15 years ago. He has published several scientific articles and book chapters on the use of Botox for headaches. His most recent chapter on Botox for headaches was just published a month ago in the 97th volume of the Handbook of Neurology (Elsevier).  Dr. Mauskop has trained over 200 doctors from all across the US, Canada and Europe who traveled to the New York Headache Center to learn this technique.  Initial reports of the use of Botox for headaches were met with disbelief, while strong skepticism about the efficacy of this treatment persisted for many years. The main reason for this skepticism was the fact that migraine headaches are known to originate in the brain, while Botox affects only muscles and nerves on the outside of the skull. A large amount of research led to our current understanding of how Botox works: while the brain begins the headache process, it requires feedback from nerves and muscles on the surface of the head. By blocking activation of the nerves and muscles the feedback loop remains open and the headache does not occur. After the first few treatments some patients still develop a migraine aura or just a sensation that the headache is about to start, but it does not. After repeated treatments even the auras and this sensation stops occurring. Botox seems to be effective in 70% of patients, which is a rate significantly higher than with any preventive migraine medications, such as Topamax (topiramate), Depakote (divalproex sodium), Inderal (propranolol), or Neurontin (gabapentin). These drugs are effective in less than 50% of patients who try them. The other 50% do not respond or develop unacceptable side effects. Lack of serious side effects is another big advantage of Botox over medications. Botox can cause cosmetic side effects, such as a surprised look, droopy eyelids, or one eyebrow being higher than the other. These and other side effects become less common as the doctor who performs them becomes more experienced. Occasionally, patients develop a headache from being stuck with a needle. This is also uncommon because the needle is very thin and if done correctly, the procedure usually causes very little pain. The effect of Botox begins about 5-6 days after the injections, but the improvement continues to occur for 3 months, at which point the second treatment is given. Some patient require Botox injections at 2 month intervals. Published studies have shown that the second treatment is usually more effective than the first and the third one is better than the second. After several treatments some people improve completely (a small percentage of patients stop having all of their headaches after the first treatment). Dr. Mauskop’s experience suggests that children as young as 10 who suffer from daily headaches also respond well to Botox injections. The major drawback of Botox is its cost. However, several insurance companies have been paying for this treatment and with the FDA approval most of them will have to cover this treatment for patients with chronic (more than 15 days a month) headaches.

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A new treatment for motion sickness in patients with migraines was reported by a group of doctors from Pittsburgh.  Giving migraine sufferers who are prone to motion sickness a migraine drug, rizatriptan (Maxalt) prevented motion sickness . There were 25 subjects in the study and 15 of them developed motion sickness after being rotated in the darkness. Of these 15 patients, 13 showed decreased motion sickness after being pretreated with rizatriptan. This was a small study and not all patients benefited, but this is an option that should be considered in patients who suffer from severe motion sickness.  It is likely that the effect is not specific to rizatriptan, but that sumatriptan (Imitrex), eletriptan (Relpax) and other triptans are also effective.  However, just like when treating migraine attacks, it is possible that some patients will respond better to one triptan and others to another.

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Medication overuse (rebound) headache (MOH) has been the subject of many studies and reports.  Another review of this subject appeared in the latest issue of journal Pain by Italian neurologists. This review addressed possible causes, predisposing factors, and possible treatments. The list of possible drugs which can lead to overuse headaches included in this article includes every possible headache medicine. However, the authors do not mention that for some drugs there is more scientific evidence than for other. For example, only caffeine and opioid (narcotic) analgesics have been proven to cause MOH, while drugs such as aspirin may actually prevent the development of MOH. There is only anecdotal (case reports) evidence for triptans (sumatriptan, or Imitrex, rizatriptan, or Maxalt, and other). The authors suggest that both environmental and genetic factors may contribute to patient’s vulnerability to substance overuse, dependence, and withdrawal in MOH. They also think that psychological comorbidities such as depression, anxiety and poor pain coping abilities may contribute to chronification of headaches.
The authors report on different detox strategies, including the need for hospital admission for patients taking large doses of narcotics or barbiturates (such as butalbital, found in Fioricet, Fiorinal, Esgic). However, almost all patients seen at the New York Headache Center are successfully withdrawn on an out-patient basis. Many patients fear worsening of pain from medication withdrawal, but several treatments can make the process less painful. Botox injections, intravenous infusions of magnesium, topiramate (Topamax), gabapentin (Neurontin) and a short course of steroids are some of the most commonly used strategies. Elimination of dietary caffeine, regular aerobic exercise, biofeedback, and acupuncture are also very useful adjunctive therapies.

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Many, but not all epilepsy drugs are also effective in preventing migraine headaches.   For example, divalproex sodium (Depakote), topiramate (Topamax), and to a lesser degree gabapentin (Neurontin), pregabalin (Lyrica), and levetiracetam (Keppra) relieve migraine headaches, while other epilepsy drugs, such as phenytoin (Dilantin) and carbamazepine (Tegretol)  do not.  A report by Drs. Krusz at the annual meeting of the American Headache Society held last month suggests that a new epilepsy drug, lacosamide (Vimpat) may also be effective for the treatment of headaches.  Dr. Krusz treated 22 patients with chronic migraines  (patients who had more than 15 headache days each month) with this medication and discovered that on average the monthly number of headaches dropped from 21 to 13.  Side effects, such as drowsiness, nausea, and cognitive impairment lead 4 patients to stop the drug.  Despite very impressive results it is premature to declare lacosamide an effective headache treatment because the study was very small and not placebo-controlled.

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Aspirin and similar anti-inflammatory drugs have been proven to be effective for many migraine sufferers.  In a recent report 1,000 mg of aspirin was found to be as effective as 100 mg of sumatriptan (Imitrex) with fewer side effects.  Cambia is a new prescription drug, which was recently approved by the FDA specifically for the treatment of migraine headaches.  The active ingredient in this drug is diclofenac, which is also sold under Voltaren and Cataflam names.  But unlike other forms of diclofenac, Cambia is a powder which patients are supposed to dissolve in a glass of water and drink it.  Drinking a solution rather than swallowing a pill speeds absorption of the drug, which can make a difference for those migraine sufferers who need to catch their attacks early, or drugs don’t help.  The drug has a “black box” warning, which cautions about possible cardiovascular side effects, as well as gastro-intestinal side effects, including bleeding and ulcers.  The cardiovascular side effects of diclofenac are similar to those of Vioxx which was taken off the market.  Other NSAIDs also carry risk of cardiovascular (and GI) side effects, but their risk is lower.  The only NSAID without cardiovascular risks is aspirin.  In fact it is used to prevent strokes and heart attacks.  Aspirin is also the only drug which prevents the development of rebound headaches – worsening of headaches from frequent intake of a headache medicines or caffeine.

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Medication overuse headaches are usually treated by withdrawing the offending drug (usually Excedrin, Fioricet or narcotics, such as codeine, Vicodin and Percocet) or dietary caffeine.  About half of the people who stop taking these drugs improve, while the other half does not.  A recent study by Dr. Andrew Hershey and his colleagues at the University of Cincinnati suggests that by doing genomic analysis of the blood we may be able to predict who is going to improve by withdrawing overused medication and who is not. This does not mean that the latter group is going to be left to suffer. However, this test could save a major effort that is involved in getting someone off medications. Instead these patients can be maintained on their medication while other preventive treatments are tried. These treatments can include biofeedback, magnesium infusions, Botox injections, prophylactic drugs, acupuncture, CoQ10, butterbur, and other treatments.

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Severe migraines are often accompanied by nausea and vomiting, making oral medications ineffective.  Sumatriptan (Imitrex) and Zomig (zolmitriptan) are available in a nasal spray and Imitrex also as an injection (a needleless injection, Sumavel was launched recently).  Nasal spray is not well absorbed and does not work well for many (in my experience, Zomig spray is somewhat better than Imitrex).  Injections work fast, but are painful (even the needleless injection hurts) and expensive.  Another way to get medicine into the body is rectally.  Rectal suppositories are absorbed very quickly and more consistently than nasal sprays.  Europeans are much more receptive to this route of administration than the Americans.  A group of Italian researchers compared  the effect of a suppository containing 25 mg of sumatriptan with a 50 mg tablet.  The suppository was slightly more effective than the tablet.  Imitrex suppositories are not available, but so called compounding pharmacies can prepare a suppository of any medication, if doctor writes an order.  With Imitrex going generic, the price should be more affordable.

There are two other products in development (not yet available), which will bypass oral route – a sumatriptan skin patch and an inhaler of dihydroergotamine (Levadex).  The patch is somewhat large and may be awkward to use, while the inhaler is much more promising.  Inhaling a drug into the lungs provides very fast onset of action, faster than subcutaneous injection of Imitrex.  According to the published data the efficacy of Levadex is very good with few side effects.

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Occipital nerve blocks can stop a migraine attack when other treatments fail.  This is a relatively simple procedure (although not many physicians are trained in it), and it consists of an injection of lidocaine or a similar local anesthetic drug into an area at the back of the head on one or both sides.  There are two branches of the nerve – greater and lesser occipital nerves and I usually inject both.  The block can help even if the headache is not strictly localized to the back of the head.  In some people headache returns after a few hours, once the effect of the local anesthetic wears off.  However, a recent study presented at the American Academy of Neurology suggested that up to 60% of patients with an acute migraine may respond without return of the headache.   Adding steroid medication to the local anesthetic does not seem to improve outcome.  However, occipital nerve block with steroid medication (Depo-Medrol, Celestone, and other) is effective in aborting cluster headaches.

Obviously, occipital nerve block is not practical or necessary treatment for people who respond to oral or self-injected medications, but if these treatments fail such a block is an excellent option. However, even if other treatments fail, we usually start office treatment of severe migraines with intravenous magnesium, which is more effective than any other treatment in those 50% of patients who are magnesium deficient.

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Review of 16 published scientific articles on the efficacy of naproxen sodium as a treatment of acute migraine indicates that it is effective in the treatment of moderate to severe migraines. Naproxen sodium, 500 mg (2 tablets of Aleve) provided some relief after 2 hours to 45% of patients, complete pain relief to 17% and complete relief after 24 hours to 11%. Aspirin, 1,000 mg (2 extra-strength tablets) has been shown to do better, providing 52%, 27% and 24% of relief, respectively. Both naproxen sodium and aspirin relieve all of the migraine symptoms, including pain, nausea, sensitivity to light and noise.

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Anxiety and depression occur in migraine patients 2 to 3 times more often than in those without headaches.  The opposite is also true, those with anxiety and depression are more likely to develop migraines.  Certain antidepressants, such as amitriptyline (Elavil), nortriptyline (Pamelor), venlafaxine (Effexor), and duloxetine (Cymbalta) have been shown to help prevent headaches.  However, when an antidepressant (or any other drug) is being tested for the prevention of headaches, patients with depression and anxiety are usually excluded.  This is done to clearly establish if a drug works to prevent headaches directly, rather than indirectly through relieving anxiety and depression.  There have been no studies of drugs to treat people who have both conditions.  A report by Dr. Morris Meizels published in the current issue of Headache presents cases of three patients with severe migraines and anxiety who did not respond to the usual preventive medications.  They did respond very well when he prescribed clonazepam (Klonopin), which is a tranquilizer in the family of benzodiazepines.  Diazepam (Valium) and alprazolam (Xanax) are two other well-known members of that family, but they all have somewhat different clinical properties.  Dr. Meizels stresses the fact that these drugs are potentially addictive and habituating and should be used in carefully selected patients and under close supervision.

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Occipital nerve stimulation has been under investigation for the treatment of difficult to treat migraine headaches for the past several years with promising results.  A recent study at the Mayo Clinic in Scottsdale, AZ suggests that this treatment may also help relieve chronic cluster headaches.  It is less surprising that the occipital nerve stimulation works for cluster headaches than for migraines.  It is not unusual for cluster headache patients to complain of pain not only in the eye, but also in the back of the head on the same side.  Also, occipital nerve block with steroids has been shown to abort an episode of episodic cluster headaches and is widely used by headache specialists.  In chronic cluster patients this block may provide temporary relief and these patients may be good candidates for an occipital nerve stimulation.  The stimulator is usually implanted by a neurosurgeon in an out-patient procedure.  The wire electrode and the battery are embedded under the skin.  Another miniature stimulator which has been in development contains both the electrode and the battery in a very small capsule-size device.  This miniature stimulator is much easier to implant and it is less bothersome.          

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It is very exciting to finally have two published studies (PREEMPT 1 and PREEMPT 2) which provide definitive proof that Botox is effective for chronic migraine headaches.  More than 15 years ago a plastic surgeon in California, Bill Binder reported that many of his patients treated with Botox for wrinkles found relief from headaches.  Everyone was very skeptical, but having many patients who failed every other treatment and having learned that Botox is very safe if used properly, I decided to try it.  To my great surprise Botox worked exceptionally well.  My most dramatic experience was in a 76-year-old woman who suffered from daily headaches for 60 years.  She had failed a long list of medications, nerve blocks, acupuncture and other treatments.  After the first Botox treatment, for the first time in 60 years she went for three months without a single headache.  Her neurologist came to my office to learn the technique I developed and has been using Botox in his practice ever since.  More than 200 doctors from around the world came to our Center to learn how to use Botox for headaches.  They were all searching for new treatments for their desperate patients.  At the same time most of the medical community had remained very skeptical and dismissive of this approach.  They could not believe that Botox could help headaches and wanted to see double-blind, placebo-controlled trials before using it in their patients.  Well, now they have it, but over the past 15 years many of their patients could have benefited from this safe and effective treatment.  Yes, we do need proof that any new treatment works, but when this treatment is safe and there are no better alternative, it is appropriate to try it before definitive proof is available.  We hope that these two studies will lead to the FDA approval of Botox for the treatment of chronic migraines before the end of 2010, which will make it easier for patients to obtain insurance reimbursement.

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Some headaches, usually migraines, do not respond to the usual over-the-counter and even prescription headache medications.  Once it is clear that there is no serious underlying cause, such as an aneurysm, several injectable medications can be given in an emergency room (during office hours at the New York Headache Center we also give injections in the office). These medicines may include intravenous injections of: magnesium sulfate (which is not a medication, but a mineral), sumatriptan (Imitrex, which can be self-injected by patients at home), ketorolac (or it is also called Toradol, which is a drug in the aspirin family), dexamethasone (Decadron, a steroid drug, which can help pain of almost any type, but cannot be given for long periods of time), prochlorperazine (or Compazine, which is a nausea medication but can help pain as well), valproate sodium (Depacon), and several other drugs.

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There are several effective preventive medications for migraine headaches, however they are prescribed to only a small number of people who could benefit from them.  A study by Dr. Richard Lipton in the journal Cephalagia and his colleagues discovered that only 13% of migraine sufferers are taking preventive medications, but those who do have significantly less disability than those who don’t. Among possible reasons, doctors who don’t realize how disabling migraines are, patients how think that medications are dangerous or will cause side effects. Cost does not seem to be a factor because all patients in this study had insurance and most of these medications are inexpensive. Patients are often reluctant to take medications, but would rather find and remove the cause. Unfortunately, in most cases migraine is a genetic disorder and true cure is not possible. However, for most migraine sufferers it is possible to find and remove triggers which make headaches worse. If this is not sufficient, magnesium, CoQ10, other supplements, biofeedback, Botox injections, and regular exercise can provide relief without drugs. If all this still does not provide relief, medications, such as anti-depressants, epilepsy drugs, and high blood pressure drugs can be very effective and improve the quality of life.

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Large clinical trials are required to prove that a new drug or treatment is effective.  Without such proof doctors will not (and should not) believe that any particular medicine or device is effective.  The FDA also approves drugs by evaluating results of large trials, usually involving hundreds if not thousands of participants.  If you want to help these new treatments to become available you should consider participating in such study.  In addition to feeling good about helping science and possibly your descendants, you may also benefit from a free evaluation and treatment.  Of course, there are risks associated with new treatments and the researchers are required to explain them to you in great detail.

One of the reasons for this post is to let you know about a new website which makes finding a clinical trial very easy.   You can search these trials by disease, location, and other criteria.  The site is http://www.medpedia.com/clinical-trials.  Check it out.

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One of the oldest preventive headache medications for migraines is propranolol (Inderal), which belongs to the family of blood pressure medications called beta-blockers.  There are newer and better beta-blockers, such as nebivolol (Bystolic), which have fewer side effects than propranolol.  We also use other types of blood pressure medications, such as calcium channel blockers (verapamil or Calan, and other) and ACE inhibitors (lisinopril, or Zestril/Prinivil is one example).  The newest category of blood pressure medications is ACE receptor blockers (ARBs) which are at least as effective and have fewer side effects than ACE inhibitors.  The best scientific evidence (from a single double-blind study) for the efficacy of ARBs in migraines is for candesartan (Atacand).

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Migralex is finally available to all headache sufferers.  This is the first new brand of headache medicine in 15 years.  After years of painstaking research, complicated development work, and manufacturing setup it is very gratifying to see Migralex available at www.Migralex.com and independent pharmacies.  If you know someone who suffers from headaches, please tell them about Dr. Mauskop’s Migralex.  Migralex works quickly, has few side effects, and works for many different types of headaches.  Please go to www.Migralex.com for more information.

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A blinded study comparing Botox with Topamax for the prevention of migraine headaches was conducted by Drs. Jaffri and Mathew and published in the current issue of Headache.  They enrolled 60 patients and divided them into two groups – one group received real Botox and placebo tablets, while the second group received saline water injections instead of Botox, but were given tablets of Topamax.  At the end of 9 months and after 2 Botox treatments the efficacy of these two treatments was the same, but many more patients in the Topamax group developed side effects and dropped out of the study.

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Botox appears to be effective for peripheral nerve pain according to a study by French researchers.  This finding is consistent with my observation that injecting Botox into the skin of the top of the head in patients with headaches relieves pain in that area.  When I started injecting botulinum toxin (Botox) for headaches about 15 years ago the assumption was that Botox works by relieving spasm of muscles in the forehead, temples, back of the head, and neck.  However, some patients would come back and report that their headache was gone in the injected areas, but not on the top of the head.  When gave additional injections the top of the head pain also stopped.  I also see patients who get Botox injections for their headaches from dermatologists or plastic surgeons and do not obtain adequate relief.  This is usually because only the front of the head is injected, rather then all areas of pain.   There have been other reports of Botox relieving pain of diabetic as well as trigeminal neuralgia, however the French group conducted a very rigorous double-blind study which provides scientific proof of pain-relieving properties of Botox.

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Botox can relieve pain of occipital neuralgia, according to a pilot study by neurologists in Ohio, published in Headache.  Occipital neuralgia is a painful condition that manifests itself by pain in the back of the head, usually on one side.  Pain can be burning, but also sharp,or throbbing in character.  It is often the result of a spasm of occipital and suboccipital muscles, so it is not surprising that Botox would relieve this pain by relaxing these muscles.  In addition to relaxing muscles Botox also reduces activation of the sensory nerve that send pain messages to the brain.  Other treatments for occipital neuralgia include isometric neck exercise, acupuncture, medications, and occipital nerve block with corticosteroids and lidocaine.

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Some migraine patients are more disturbed and disabled by migraine aura symptoms than by the headache itself.  Some people do not even have pain but only auras.  In the majority the aura is visual and consists of squiggly lines, flashing lights, distorted vision, or partial loss of vision on one side of each eye.  Less often people experience numbness of one side of the body, dizziness, or vertigo.  These symptoms are sometimes more difficult to treat than the pain.  Anecdotal reports suggest that a blood pressure drug belonging to the family of calcium channel blockers can help.  Another medication that has been reported to be effective (also only in case series and not double-blind trials) is an epilepsy drug, lamotrigine (Lamictal).  The effective dose of lamotrigine varies from 100 to 500 mg day, while verapamil is usually effective at 12-240 mg, although in some patients only much higher doses are effective.

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Two large trials of Botox provide unequivocal proof of its efficacy in the treatment of chronic migraine headaches.  The results of these two double-blind, placebo-controlled studies (I participated in one of the two trials) of onabotulinumtoxinA (Botox) in chronic migraines were presented at the International Headache Congress in Philadelphia last week.  Botox was proven to reduce the number of days with headaches, improve multiple headache symptoms, and improve the quality of life.  The treatment was extremely well tolerated with very few side effects overall and no serious side effects.   Having used Botox for the treatment of various headache types for over 15 years in several thousand patients it is very gratifying to finally have well-designed trials which confirm my and my colleagues’ experience.   The manufacturer is submitting the results of these trials to the FDA and we expect to have approval of Botox for the treatment of chronic migraines by the end of 2010.  FDA approval will force insurance companies to pay for this highly effective treatment and will make it affordable for people who desperately need it.

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Vitamin B12 (cyanocobalamine) deficiency is known to cause a wide variety of neurological symptoms.   It also seems to produce facial neuralgia, according to a report presented at the International Headache Congress in Philadelphia a week ago.  Two physicians from Milwaukee described 17 patients who had facial pain that was not typical of trigeminal neuralgia because they had no trigger area and had numbness on the affected side.  They all had vitamin B12 deficiency and they pain improved with injections of vitamin B12.  In a previous post I mentioned another study that found an association between migraine headaches and high homocysteine levels, which can also be caused by vitamin B12 deficiency.  Oral absorption of vitamin B12 supplements is often inadequate and a nasal spray (which is expensive) or an injection are the best ways to correct this deficiency.

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Migrainous vertigo seems to respond to intravenous infusion of a high dose of corticosteroids, according to a report in the latest issue of Headache by a group of Indian doctors.  Two of their patients had intermittent episodes of severe vertigo and two had chronic vertigo.  All four respond to infusions of 1 gram of methylprednisolone.  One require 3 infusions, one needed 2 and in another 2 vertigo stopped after a single infusion.  We routinely use corticosteroids for severe migraine attacks when other medications fail.  While occasional (once or twice a month) use of corticosteroids is relatively safe, frequent or daily intake of corticosteroids (besides methylprednisolone, these drugs include prednisone, prednisolone, and dexamethasone) can lead to dangerous side effects.  It is possible that oral corticosteroids will produce a similar effect as an infusion and may be worth trying when nothing else helps relieve the vertigo.

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A blood pressure medication telmisartan (Micardis) was shown to be effective in the prevention of migraine headaches by a group of German researchers led by H-C Diener.  Several blood pressure medications have been proven to prevent migraine headaches.  The oldest category of blood pressure drugs, beta-blockers have the most evidence to support their use and two of them (propranolol and timolol) are approved by the FDA for the preventive treatment of migraines.  However, beta-blockers are not high on my list because they tend to cause more side effects than other blood pressure medications.  The most common side effects are due to excessive lowering of blood pressure – lightheadedness, fatigue, and fainting.  They also slow down the heart rate, which can make it difficult to exercise, while regular aerobic exercise is the first treatment I recommend to my headache patients.  Calcium channel blockers, such as verapamil, are not as effective for migraine prevention as they are for the prevention of cluster headaches and can cause constipation, swelling and irregular heart beats.  Another blood pressure medication, lisinopril which belong to the family of ACE inhibitors has also been shown to prevent migraine headaches.  The most common limiting side effect of ACE inhibitors is coughing.  A newer group of medications, which are similar in action to ACE inhibitors is ACE receptor blockers, or ARBs.  ARBs do not cause coughing and telmisartan which is one of the ARBs caused as few side effects as the placebo.

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In my post 2 years ago I wrote about surgery for migraines and the many reasons why Botox injections is a better option than surgery to permanently cut nerves and muscles.  I also wrote that there were no controlled studies to show that surgery actually works.  Now we do have one study.  The study was blinded, which means that some patients had nerves and muscles cut, while others had only a skin incision.  The results were much better in patients who had real surgery.  The plastic surgeons who performed the study tried their best to produce a blinded study, but they admit that blinding is far from perfect since patients who had real surgery can see their muscles shrink or not move.  But even if we accept that blinding was achieved and surgery indeed provides relief of headaches, all of my other arguments stand.  These include surgical risks (bleeding, infection, scarring, and persistent nerve pain) and high cost.  Yes, Botox is expensive too, but migraine usually is not a life-long illness and migraine attacks often stop for long periods of time or permanently with or even without treatment.  I have seen many patients whom I treated with Botox every 3 months and whose headaches stop after a year or two.  Two years of Botox treatments is significantly cheaper than surgery and it does not carry all of the surgical risks.

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Medications used for the preventive treatment of migraine headaches can cause weight loss, but more often cause weight gain.  An interesting study by Dr. Bigal and his colleagues, just published in Cephalalgia looked at this effect of drugs in 331 patients.  They found that 16% of them gained weight (5% or more of their baseline weight) and 17% lost weight.  The various treatments given to these patients were equally effective in both groups.  However, not surprisingly, those who gained weight had elevation of their cholesterol, blood glucose, blood pressure and pulse.  Patients who have migraine headaches with aura (about 15-20% of migraine sufferers) already have an increased risk of strokes, so adding additional risk factors for both strokes and heart attacks should be especially avoided in this group.  The only preventive migraine drug which consistently lowers weight in many patients is topiramate (Topamax).  This drug is now available in a generic form, making it much less expensive.  While topiramate does lower weight and helps prevent migraine headaches only half of the patients stay on it.  For the other half it causes unpleasant side effects (memory impairment and other) or it does not work.

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Trigeminal neuralgia is an extremely painful condition which causes severe electric shock-like pain in one or more branches of the trigeminal nerve.  The 3 branches are mandibular, in the lower jaw, maxillary, in the upper jaw, and ophthalmic in the upper face.  It is more common in the elderly and is caused by compression of the trigeminal nerve by a hardened blood vessel inside the skull, near the brainstem.   Treatment consists of trials of different medications, which work for most patients, but a small percentage require a partial destruction of the nerve (with radiofrequency heat) or surgery.  Surgery consists of opening the skull and placing Teflon insulation between the nerve and the blood vessel.  Medications that are used for trigeminal neuralgia inlcude epilepsy drugs, such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and a muscle relaxant, baclofen (Lioresal).  A recent report suggests that a newer epilepsy drug, pregabalin (Lyrica) is also effective.  However, carbamazepine, phenytoin, and baclofen are available in a generic form, which makes them much less expensive than the other, branded products.

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In addition to an injection, tablet and a nasal spray, sumatriptan is being tested in two other formulations.  No, it is not an inhaled form, which I just posted in my previous blog (dihydroergotamine inhaler), but through a skin patch and by a “lingual spray”, that is a spray into the mouth.  The skin patch may work fast and will deliver medicine through the skin, bypassing the stomach, which would be very useful for people who get very nauseous and have difficulty swallowing medications.   However, it is quite a large patch and will probably cost significantly more than a tablet, particularly in the generic form.  The second new formulation, a spray into the mouth, appears to partially absorb in the mouth and partially in the stomach, making it also work faster, although so far it looks to be only as effective as a 50 mg tablet.  The usual dose is 100 mg.  Also, hopefully the company that is developing this product has been able to mask the taste of sumatriptan.  Patients who have tried the nasal spray often complain of a very unpleasant taste, which can make nausea worse.

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Trials of an inhaled version of an old migraine drug show surprisingly good results.  The drug is dihydroergotamine and in injectable from is considered to be one of the strongest migraine medications.  It is often used intravenously to treat severe migraines that do not respond to other therapies and for medication overuse headaches.  It can be also injected into the muscle, under the skin or sprayed into the nose.  The main problem with this drug is that it often makes nausea worse or even causes severe nausea in patient who do not have it.  What is surprising about the new product being developed by MAP Pharmaceuticals (to be called Levadex if and when FDA approves it) is not that is is very effective, but that it causes significantly less nausea than the same drug in an injectable form.  Another advantage is that inhaling the medicine into the lungs results in a very quick delivery of the drug into the circulation – as quick as an injection but without a needle.  A similar product, Ergotamine Medihaler was available until about 15 years ago, but was withdrawn because of manufacturing difficulties and limited demand.  The demand for this new product will also be limited because it will be more expensive than a tablet of any migriane drug, it will be more bulky to carry around, and will be mostly utilized by patients who cannot take oral medications due to nausea or by those who need very quick onset of action to abort an attack.

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Imitrex and Topamax are two migraine medications that recently lost their patent protection and became available in a generic form, under the names of sumatriptan and topiramate.  Many patients are concerned about the quality of generic products.  A recent study published in Neurology looked at 948 patients with epilepsy who were treated with generic Topamax (it is approved for the treatment of both migraines and epilepsy).  Compared to patients who used the branded Topamax, those on generic substitutions needed to have more of other medications, were admitted to the hospital more frequently and stayed in the hospital longer.  The risk of head injury or fracture (presumably due to seizures) was almost three times higher after the switch to a generic drug.

Clearly, migraine patients do not run the same risk as epilepsy patients of having a seizure or being admitted to the hospital, however a small number of patients can have worsening of their migraines.  The main reason is the legally permitted variation in the amount of medicine in each tablet.  Taking a higher dose of the generic drug can help.

The same applies to Imitrex – a small number of patients will find that the generic sumatriptan is slightly less effective.  The only, albeit significant, advantage of the generic drugs is cost savings.  At this point we have only one generic substitution for Imitrex and the price difference is only 20%, but in a few months more generics will appear and the price should drop significantly, which is a very welcome development for patients with frequent migraines.

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Occipital nerve stimulation appears to be a promising new treatment for migraine and cluster headaches.  Phase II trials performed by Medtronics, the manufacturer of one type of  stimulator, have been positive.  This stimulator requires implantation of a stimulator wire next to the occipital nerves and a separate incision to implant a stimulator device with a battery in the upper chest.  A recent report suggests that the same effect can be achieved by implanting a small self-contained device without the need for wires, large battery, or a separate incision.  This “Bion Microstimulator” has not been subjected to any extensive studies similar to ones  performed by Medtronics, but the preliminary data looks promising.

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Dr. Rami Burstein of Harvard University and his colleagues discovered the way to predict who is going to respond to Botox injections.   Patients who have pain that is constricting, crushing, or “imploding” with pressure going from outside in and those with pain in the eye respond much better than those whose pain is “exploding” or with a sensation of pressure building up from inside the head.  This was true for patients with episodic, as well as chronic migraine headaches.  About 83% of non-responders had “exploding” headaches and 84 of responders had “imploding” headaches.  Fortunately, many more patients suffer from imploding headaches or headaches with pain in the eye than with “exploding”headaches.

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Cluster headaches, which arguably cause the worst pain of any headache, are not likely to be cured by trigger point injections, according to a group of Spanish doctors.  They treated 12 patients with trigger point injections and some of the patients reported some relief, but they all needed medications as well.  This is a small study without placebo control, which means that no conclusions can be made about usefulness of this treatment.  We do have better evidence that occipital nerve blocks can be helpful in aborting cluster headaches.  This is a procedure similar to trigger point injections, but it involves injection not only of a local anesthetic, but also a long-acting steroid into an area of the occipital nerve on the side of the headaches.  It is a simple and safe procedure and it should be tried in most patients, particularly those who in addition to pain around the eye have pain or tenderness in the back of the head or upper neck.

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Treatment of menstrual migraines often is more difficult than of non-menstrual attacks.  A double-blind study by Marcelo Bigal and his collaborators just published in Headache shows that a combination of 10 mg of rizatriptan (Maxalt) and 4 mg of a steroid medication, dexamethasone (Decadron) is more effective than either drug alone.  Both drugs are effective in treating many refractory migraine attacks (although I usually use 8 mg of dexamethasone), this is the first trial of two drugs together.  While the results are not very surprising, the study may lead to wider acceptance of combination therapy and better relief for many women.  While in the past the emphasis was placed on finding a single drug to treat a disease, in recent years combination therapy has become a standard approach in many conditions.  Treximet, a combination of sumatriptan (Imitrex) and naproxen (Aleve) was also shown to be better than either of the two ingredients alone.

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Refractory migraines may respond to occipital nerve stimulation, according to Dr. Joel Saper who led a multicenter trial of this treatment.  An electrode was surgically implanted in the back of the head, where the occipital nerve is located, and a pacemaker-size device was implanted under the skin.  The trial looked at 110 patients who had more than 15 days with migraines each month and who did not respond to a variety of medications.  66 patients completed the diary information for three months following the start of treatment.  The results were encouraging – 39% of patients improved, compared with 6% in the control group.  None of the patients had any adverse events.

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Botox is effective for chronic migraines, according to a statement released by Allergan, maker of Botox.  The company reported that a large multi-center trial (the New York Headache Center was one of the trial sites) yielded positive results.  This report did not surprise us or our colleagues who routinely use Botox in treating patients with chronic migraines.  The excitement we feel is due to the fact that many of our colleagues have been skeptical about the efficacy of Botox.  Much more importantly, we hope that this definitive study will compel insurance companies to pay for this treatment.

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Cluster headaches cause the worst pain imaginable, leading some patients to thoughts of suicide.  They occur in about 0.1% of the population, while  migraine headaches afflict 12%, which may explain why so much less research has been conducted on cluster than on migraine headaches.  Injectable sumatriptan (Imitrex) is the only drug approved by the FDA for cluster headaches.  We do use many other medications “off-label” for both acute and prophylactic treatment, but none have been subjected to rigorous research.  That is none, until recently – zolmitriptan nasal spray (Zomig NS) has been shown to be effective in relieving cluster headaches within 30 minutes.  While the dose of Zomig NS for migraines is 5 mg, in this latest trial both 5 and 10 mg dose was studied.  The 10 mg dose was better than 5 mg dose in patients with episodic cluster headaches (74% vs 52%), but these two doses were equally effective in patients with chronic cluster headaches (41% vs 42%).  The advantage of Zomig NS over Imitrex injection is that it is easier to use and does not involve a painful injection, while the advantage of Imitrex is that it works faster.  Zomig NS is now approved for acute treatment of cluster headaches in Germany, Netherlands and Denmark.

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Women with menstrual migraines who also have chronic migraines can be successfully treated with hormonal therapy, according to a study by Drs. Calhoun and Ford published in journal Headache.  Surprisingly, controlling menstrual migraines led to improvement in chronic migraines as well.  Chronic migraine is defined as a headache with migraine features that occurs on more than 15 days each month and it affects a staggering 4%-5% of the population.   Hormonal therapy usually consists of taking an oral contraceptive continuously for many months, thus eliminating menstrual periods and often headaches and PMS symptoms.  Oral contraceptives should not be taken by patients who have visual aura – visual disturbance that usually lasts 30 minutes and precedes the headache.

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Treating migraines in adolescents presents some unique challenges.  Besides difficulties, such as getting them to bed before midnight and getting them to improve their diets, we face the problem of not having any FDA-approved drugs to treat migraine attacks.  And it is not for lack of trying on the part of makers of triptans, which are drugs that work miracles for many adult headache sufferers.  The problem has been proving to the FDA that these drugs work in kids.  Because children tend to have shorter attacks, by the time we try to assess the efficacy of a particular drug two and four hours after the pill is taken, the headache is gone even if the pill was a placebo.  Many studies have shown that the triptans are safe and effective (as was observed in kids who have longer duration of attacks).   Many, but far from all headache specialists use triptans, such as Imitrex and Maxalt in adolescents.  A study just published in Headache proved that Axert, another drug in the triptan family and that was tested in 866 children, is effective in children 15 to 17 years of age.  The bottom line is that triptans can be safely used in kids who suffer from severe migraine headaches.  I am often asked by other physicians, what is the youngest age I would prescribe a triptan?  Because of a shortage of pediatric neurologists I feel compelled to see children as young as 10 and this is the youngest age at which I will prescribe triptans.

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Menstrual migraines are at times very difficult to treat.  Triptans, such as Maxalt, Imitrex and other are usually very effective, but in some patients do not provide sufficient relief.  Corticosteroid drugs, such as prednisone and dexamethasone can help some patients.  Marcelo Bigal and his colleagues compared treatment of menstrual migraines with Maxalt alone, dexamethasone alone, and combination of the two.  Maxalt was much better than dexamethasone, providing sustained 24-hour relief in 63% of patients vs 33%, but the combination was better than Maxalt alone, giving relief to 82% of women.  We would always try Maxalt or a similar drug alone, but if one drug is insufficient a combination with dexamethasone should be tried.  Corticosteroids should not be used for more than a few days a month because frequent and prolonged use can lead to serious side effects.

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Treximet, a new migraine treatment was approved today by the FDA.  Treximet is a combination of two old drugs – sumatriptan (Imitrex), 85 mg and naproxen (Aleve), 500 mg.  The combination is more effective than Imitrex alone because naproxen provides additional relief through its anti-inflammatory and pain relieving effects.  Imitrex is losing its patent protection and is going to be available as a generic drug in 2009.  The maker of Treximet, GlaxoSmithKline is hoping to switch most of the patients currently taking Imitrex to Treximet before patent expiration, in order to reduce its losses to generic competition.  However, it is likely that insurance companies will force physicians to prescribe generic Imitrex and generic naproxen rather than pay for Treximet.  GSK argues that the combination drug, just like Imitrex are fast-dissolving and therefore faster acting drugs than the generic naproxen is and the generic Imitrex is going to be.

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Botulinum toxin injections relieve tension headaches, according to a study just published in the European Journal of Neurology .  Most of the previous studies had been conducted in patients with migraines or chronic migraines (more than 15 days of headaches a month).  There is much less evidence that Botox also helps tension headaches.  Our experience at the NYHC treating patients with tension headaches with Botox injections has been also very positive.  In this European study doctors used Dysport – a version of botulinum toxin type A that is not available in the US.  However, Dysport is very similar to Botox.  On the other hand, Myobloc, which is botulinum toxin type B,  is a very different version of botulinum toxin and in several aspects is inferior to Botox.

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Migraine and cluster headaches that do not respond to the usual treatments, may improve with injections of histamine.  Dr. Seymour Diamond of the Diamond Headache Clinic in Chicago has pioneered the use of histamine in cluster headaches.  We have found that in cluster headache patients for whom nothing else works histamine often provides excellent relief.  A recent study published in the journal European Neurology suggests that histamine injections may also help migraine patients. 

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A new drug may be better for the prevention of migraines than the old ones in the same category.  A study just published in Headache suggests that nebivolol, a beta-blocker just approved in the US for the treatment of high blood pressure may be as effective as old beta-blockers, but with significantly fewer side effects.  Beta-blockers, such as propranolol (Inderal), timolol (Blocadren) metoprolol (Toprol), atenolol (Tenormin) and nadolol (Corgard) have been used for the prevention of migraines for many years.  However, many patients could not tolerate them because of side effects, mostly fatigue, slow heart beat and low blood pressure.  Nebivolol appears to cause these side effects 50% less often, while preventing migraine attacks with equal efficacy. 

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Anti-epilepsy drugs such as Neurontin (gabapentin), Topamax (topiramate) and Depakote (divalproex) have been proven to prevent migraine headaches.  Each drug works for about half of the patients who try it.  The other half either does not get any benefits or develops side effects.  This does not seem to be that effective, but these drugs do beat placebo in blinded trials.  We also know that not all anti-epilepsy drugs work for headaches.  Tegretol (carbamazepine) was never shown to help and a study just published in Neurology confirms our impression that its cousin, Trileptal (oxcarbazepine) does not work either.  We do occasionally see good results with two other epilepsy drugs, Keppra (levetiracetam) or Lamictal (lamotrigine), but large  clinical trials proving their efficacy are lacking.

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Memantine is an old medication which has been available in Europe for over 30 years, but was only recently introduced in this country for the treatment of Alzheimer’s disease.  Memantine blocks a specific receptor in the brain cells.  Activation of this so called NMDA receptor is responsible for many negative effects, including pain and nerve cell damage.  As soon as the drug was introduced in the US pain and headache specialists tried using it for pain, but probably because it is a weak blocker of the NMDA receptor our experience with this drug has not been very impressive.  However, in the recent issue of journal Headache Greek doctors report that one patient with chronic migraines obtained complete relief due to memantine.  One case report clearly does not prove that memantine is going to work for any significant percentage of patients.  However, this drug has relatively few side effects and if the usual treatments fail it may be worth trying.

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Topamax is a popular drug for the prevention of migraine headaches.  IT works for about half of the patients who try it.  The main problem that makes people stop taking the drug is cognitive side effects.  Patients tell us that they feel “stupid” on this drug.  An article just published in the European Journal of Neurology pinpoints the main cognitive problem, which turns out to be word fluency.  This means having trouble coming up with the right word. 

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Clopidogrel, which is also known as Plavix, is a drug used to prevent strokes and heart attacks.  It works by preventing platelets from sticking together and causing a blood clot which can block a vessel in the heart or brain.  Platelets also tend to become sticky in patients during a migraine attack, which is how this drug might help migraine sufferers.  A British physician reported that a small number of patients given this drug stopped having migraine headaches after many years of unsuccessful treatments.  A large study is currently under way to prove that this drug in fact works better than a placebo. 

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Botox has been shown to relieve migraine headaches in another two studies published in Headache.  One study compared the efficacy of Botox and an epilepsy drug, Depakote and found them to be equally effective.  However, Depakote caused more side effects, which resulted in more patients taking Depakote dropping out of the study.  The second study was done in patients who had difficulty complying with daily preventive medications.  Half of them were injected with Botox and the other half with saline water.  Neither the doctor nor the patient knew who received which treatment (double-blind study).  The impact of migraines on patients’ lives was significantly improved by Botox.  These two studies by leading headache specialists provides additional proof that Botox is effective for the relief of migraine headaches.

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Botox relieves migraine headaches and other painful conditions, such as sciatica, neuralgias and neck pain.  A recent study of 43 patients with arthritis of the shoulder suggests that Botox may relieve arthritis pain as well.  This was a double-blind study where half of the patients were given Botox and the other half saline injections.  Neither the doctor nor the patient knew what was being injected.  The results clearly favored Botox and the difference was statistically significant.  This adds another possible indication to a long list of conditions that Botox might relieve.  The safety of Botox in this study was as remarkble as in all previous studies, which now number in hundreds.  

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This is a common question people ask when we suggest that they start taking a daily preventive medication.  A groundbreaking study just published by Hans-Christoph Diener and his colleagues answers this question.  Over 800 patients were placed on topiramate (Topamax), a popular epilepsy drug used to treat headaches.  After 26 weeks half of the patients were switched to placebo and the other half contined on Topamax for another 26 weeks without doctors or patients knowing who was taking what.  It turns out that stopping Topamax did worsen headaches, but not that much – in a 28-day period those on Topamax had one fewer day with migraine than those on placebo.  This suggests that what most headache specialists have suspected from their experience all along is correct.  That is many patients can stop taking their daily medication after about six months without significant worsening.  However, there are some patients who may need to stay on a medication for longerer periods of time.

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Postpartum headaches are very common and are usually benign. A study presented at the meeting of the Society for Maternal-Fetal Medicine by Dr. Caroline Stella and her colleagues looked at 95 women with severe headaches that started 25 hours to 32 days after delivery and were not responsive to usual doses of pain medicines. Half of these women eventually were diagnosed to have migraine or tension-type headaches and they all responded to higher doses of pain drugs. In one quarter of patients headaches were due to preeclampsia or eclampsia and were relieved by intravenous magnesium or magnesium and high blood pressure medications. Fifteen women had spinal headaches due to complication of epidural analgesia and they responded to a “blood patch” procedure. Only one woman had a brain hemorrhage and one had thrombosis (occlusion) of a vein in the brain. The authors suggested that all these conditions should be considered when evaluating women with postpartum headaches and appropriate testing needs to be performed.

In another study presented at this meeting Dutch researchers found that women who suffered from an episode of eclampsia had persistent cognitive dysfunction 6-8 years later. This contradicts the widely held belief that women with eclampsia can expect full recovery. This study suggests that eclampsia needs to be treated early and aggressively (magnesium infusion is one of the main treatments) to prevent permanent brain injury. It is also important to understand that persistent cognitive dysfunction is not psychological in nature and that it should be treated with cognitive rehabilitation.

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Results of a phase II study of a new headache medicine was published in journal Neurology. Merck and Co. is starting phase III trials of this drug, which works by blocking the release of a neurotransmitter CGRP. Previous migraine medicines, such as sumatriptan (Imitrex), rizatriptan (Maxalt), eletriptan (Relpax) and other in the triptan family worked on serotonin receptors. While the triptans are very safe they very rarely can constrict blood vessels in the heart and cause a heart attack. The new medicine, which is known as MK-0974 does not constrict blood vessels. In the published trial it was at least as effective as Merck’s older drug, Maxalt. If phase III studies go well we could see this medicine on the market in a couple of years.

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The United States Food and Drug Administration (FDA) has approved a new formulation of Imitrex Injection that allows a convenient way for patients to take a 4mg dose using the Imitrex STATdose System®. Imitrex Injection is indicated for the acute treatment of migraines with and without aura in adults. The United States Food and Drug Administration (FDA) has approved a new formulation of Imitrex Injection that allows a convenient way for patients to take a 4mg dose using the Imitrex STATdose System®. Imitrex Injection is indicated for the acute treatment of migraines with and without aura in adults. We find that Imitrex injections are very underutilized, mostly because doctors don’t offer them as an option to their patients. Surprisingly, surveys indicate high acceptance of injections by patients. This should not be so surprising at all considering how disabling migraines can be. The ideal candidates for injectable Imitrex include patients who have severe nausea, those who wake up with a severe attack and need prompt relief, patients for whom oral triptans do not provide adequate relief and those with cluster headaches. We typically prescribe 6 mg injections and use 4 mg ones for patients who are very sensitive to drugs, have small weight or have side effects from 6 mg.

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It is not clear how Botox relieves migraine headaches.

Oliver Dolly, an Irish researcher who devoted many years of his work to the study of botulinum toxin, has just published results of a new study which may help explain this question. Twelve years ago when I started using Botox for the treatment of headaches the only possible explanation for the way it worked was that it relaxed tight muscles. It is true that during a migraine attack muscles go into a contraction and many patients find some relief by massaging their temples, back of their head and neck. However, some people reported to me that injecting Botox relieved their headaches in the temples, forehead and back of the head, but not on the top of the head. I did not inject the top of the head because there are no muscles there. When I did inject those areas to my surprise pain on the top of the head improved as well. This has been also observed by many of my colleagues around the country. Dr. Dolly’s experiment showed that in addition to relaxing muscles, Botox prevents the release of CGRP (a chemical messenger – neurotransmitter) from nerve endings and stops painful messages from being transmitted along the nerves. It appears that relaxing muscles may be less important than stopping nerves from sending pain messages to the brain.

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A study just published by Dr. Mathew and his colleagues in the journal Headache reports that patients with chronic migraine headaches responded to Botox better than patients with chronic tension headaches. Patients who had headaches predominantly on one side and those with scalp tenderness had a better response to Botox. Scalp muscle tenderness was also a predictor of response in chronic tension headaches. Overall, Botox was highly effective in patients with chronic migraine – 76%, (54 out of 71 patients) obtained relief. Of those 54 patients 37 or 69% had one-sided headaches. Having headaches on both sides does not preclude success with Botox – 17 patients with bilateral headaches also responded. This study confirms what I have observed in my 12 years of treating thousands of patients with Botox – it is a highly effective and safe treatment for frequent migraine headaches.

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Prolapse or herniation of the upper cervical disc is known to cause not only neck pain but also so called cervicogenic headaches. Dr. Diener and his German colleagues reported (in journal Cephalalgia) on 50 patients who had prolapse of lower cervical disks and used as controls 50 patients with lumbar disk herniations. They found that 12 out of 50 patients with lower cervical disk herniations developed a headache and in 8 out of 12 headache stopped within a week following surgery. Only two of the patients with lumbar disk herniations developed a headache. Three months after surgery seven of 12 had no headaches and three were improved. It is not very surprising that these patients had headaches – neck muscles overlap all along the neck and form a supporting collar for the cervical spine. Muscle spasm in the lower neck that accompanies a herniated disk will often cause this spasm spread up the neck and cause a headache. Even patients with migraines at times develop a migraine attack from spasm of muscles in the neck or even shoulders. When treating these patients, both with migraines and cervicogenic with Botox injections are usually given not only into the muscles around the head, but also in the neck and shoulders. This makes Botox treatment significantly more effective.

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Hemiplegic migraine can be safely treated with triptans (drugs like Imitrex, Maxalt and other).

This is the conclusion of a study published in the September issue of journal Cephalalgia. A group of Finnish doctors gave triptans to 76 patients who suffered from hereditary and non-hereditary forms of hemiplegic migraine – migraine that is accompanied by temporary paralysis of one side of the body. They found that triptans worked well and none of the patients had strokes or any other serious reactions. According to the FDA, triptans are not to be given to patients suffering from hemiplegic migraine because they potentially could cause a stroke. No strokes have ever been reported, but it was thought that constriction of blood vessels in the brain during hemiplegic migraine is responsible for the weakness and giving triptans could worsen this constriction and cause a stroke. In the past several years we have learned that weakness is caused by a disturbance of brain neurons rather than constriction of blood vessels. Many headache specialists use Imitrex and similar drugs in patients with hemiplegic migraine and several years ago Drs. Klapper and Mathew have already reported on their positive experience in a small group of patients.

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I just received an announcement for the “2nd Annual Surgical Treatment of Migraine Headaches.” The event is sponsored by Case Western Reserve University and presented by its Department of Plastic Surgery. Ten of the 12 speakers on the program are plastic surgeons. Their premise is that since Botox injections relieve migraines, why not go a step further and cut those muscles in the forehead for permanent relief.

When I asked my friend Ken Rothaus, a plastic surgeon at the New York Hospital, about this approach, he was not excited—despite the potential new pool of patients. Here is what he said: “I think that when there exists a relatively non-invasive procedure such as Botox that works so well and costs less than the corresponding surgical procedure, it represents the better first line choice for the patient. All surgery has risks and complications, Botox can be injected in all the involved areas not just the glabellar, and the cumulative cost of 3-5 years of Botox may be less than that one surgical procedure.”

Another strong argument against surgery is the very nature of migraines. They come and go for long periods of time, and on their own improve with age in most patients.

An additional reason, and perhaps the most compelling: Plastic surgeons lack training in diagnosing and treating headaches. They do not know how to properly diagnose different types of headaches, how to detect potential triggers, and how to combine different treatments into a comprehensive plan.

A case can be made that if a neurologist is also involved in the care of a patient receiving surgical migraine relief, it may be a reasonable approach. However, injecting Botox only into the forehead is ineffective for most patients. We usually also inject the temples, the back of the head and, at times, the jaw and neck muscles. Surgery cannot be done in these areas, and cutting only forehead muscles is not likely to have a significant effect.

Finally, while we have about 100 scientific articles published on the use of Botox for headaches, there has been only one small, uncontrolled study published on the use of plastic surgery for migraines.

So, surgery for migraines? In my opinion, this is a treatment that’s not quite ready for prime time.

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Restless leg syndrome (RLS) affects 10% of the population with 3% suffering from severe symptoms. Patients suffering from RLS complain of difficulty falling asleep because of uncomfortable sensation in their legs which is temporarily improved by moving their legs or getting up and walking around. The movement of the legs persists in sleep and interferes with the deep restful stages of sleep leading to tiredness during the day. Many patient do not realize they have a problem because they’ve had it all their lives and because one of their parents also had it.Researchers reporting in the recent issue of journal Nature Genetics say they have found proof of the genetic nature of RLS. However, not all patients with these symptoms have RLS. Iron deficiency, peripheral nerve damage and antidepressant medications can cause symptoms of RLS. Another sleep disorder, such as sleep apnea can at times mimic RILS and a sleep study may be needed to establish the diagnosis.Treatment of RLS involves the use of medications such as Requip, Mirapex, which belong to a category of drugs called dopamine agonists (they are also used to treat Parkinson’s disease, but these two conditions are not related). Some epilepsy drugs, including Neurontin and Topamax and particularly opioid analgesics, such as hydrocodone and oxycodone can be effective.Sleep deprivation or poor quality of sleep can be a major trigger for migraine headaches. We see many patients with RLS at the NYHC and treating their RLS will often improve their headaches.

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A recent small study suggests that wearing red colored contact lenses can relieve pain of a migraine attack. A recent small study suggests that wearing red colored contact lenses can relieve pain of a migraine attack. At the NYHC we have tried this approach and in a several patients it made a dramatic difference. One woman has found that she no longer has to be confined to a dark room and is able to go outside wearing these lenses without developing a migraine from bright daylight. Some patients wear these lenses all the time, while others only when they have a headache. Sunglasses do not offer the same level of light filtering,uinless they are of wraparound type and fit tightly around the eyes.

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Medication overuse headache (MOH) does not respond to steroids according to a new study published in the July 3 issue of journal Neurology. Patients who take Fioricet, Fiorinal, Esgic, Excedrin and other, mostly caffeine-containing drugs often have a headache that is perpetuated by the constant intake of these drugs. This is less likely to happen from triptans, such as Imitrex, Maxalt and Relpax or ibuprofen and acetaminophen. When we try to stop these medications headache usually worsens for several days or weeks before it gets better. We do use corticosteroids (prednisone, dexamethasone, methylprednisolone) to treat not only headaches that result from medication withdrawal but also severe migraines that do not respond to the usual migraine drugs. Corticosteroids are safe when taken occasionally, but can cause many different and often dangerous side effects if taken for long periods of time (weeks and months). We limit the use of corticosteroids to a few days a month.
The editorial which accompanies this report comments on the fact that a previous, larger but less rigorous study found that steroids are beneficial for MOH. The possible reasons for this discrepancy are: 1. the dose of prednsione used in the study was not high enough; 2. corticosteroids are only effective for MOH in patients who suffer from migraines and not tension-type headaches (both were included in this study); and 3. the older and larger study was not blinded and placebo might have played a bigger role.
The bottom line is that because of our positive experience and in the absence of a definitive negative study, we at the NYHC will continue using corticosteroids both for MOH and for other refractory migraine attacks when other treatments (triptans, intravenous magnesium, Botox, etc) fail.

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Chronic migraine headaches can be helped by topiramate (Topamax) even in those patients who are having rebound headaches from daily intake of pain or migraine medications, according to a report in the latest issue of Cephalalgia. Chronic migraine headaches can be helped by topiramate (Topamax) even in those patients who are having rebound headaches from daily intake of pain or migraine medications, according to a report in the latest issue of Cephalalgia. Common thinking is that in order for a preventive drug, like topiramate to work the patient first has to stop drugs that cause rebound headaches. This study suggests that patients can obtain relief even without stopping the drug that causes rebound. We find that the same is true for Botox – it can also help relieve chronic migraines without the patient having to first get off drugs such as Fioricet and Excedrin.

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Women with migraine have a higher frequency of excessive and/or prolonged menstrual bleeding and endometriosis, according to a study published recently in Headache, the journal of the American Headache Society. While as many as 60% of women experience migraine in conjunction with their menstrual periods, there is little information regarding the relationship between migraine and menstrual disorders.(1,2). A study published in 2004 found an increased prevalence of migraine in women with endometriosis (a condition in which the endometrial tissue is outside of the uterus) (3), but the reason for this association is unknown. Menstrual problems are common, and unusually heavy bleeding over several cycles in a row occurs in about 30% of women.4 Endometriosis affects 0.5% to 5% of fertile women and 25% to 40% of infertile women.(5-7)

To understand more about the association between menstrual disorders and migraine, Dr. Gretchen Tietjen of the Medical College of Ohio in Toledo, and colleagues, enrolled 50 female migraineurs (diagnosed according to the International Headache Society criteria) of childbearing age and 52 age-matched women. They were asked to complete a questionnaire regarding migraine and migraine-related disability, menstrual history, other bleeding history, vascular event history, and vascular risk factors.

The frequency of smoking, oral contraceptive use, and hormone replacement therapy was similar between the two groups of women. Twenty-three of the 50 migraineurs reported that migraine was associated with their menstrual period, and 36% suffered from chronic headache (15 or more days/month).

More migraineurs reported unusually heavy periods (63% vs. 37%), and endometriosis was more commonly diagnosed in migraineurs (30% vs. 4%). More migraineurs (24% vs. 14%) had undergone a hysterectomy, and endometriosis was identified as the reason in over half of the cases. Interference in life activities and mood from menstrual periods was three times more likely to be reported in migraineurs compared to controls.

A greater prevalence of hypertension (25% vs. 10%) and Raynaud’s disease (10% vs. 2%) and the trend to report transient ischemic attacks/stroke (10% vs. 2%) in the migraine group suggest an altered vascular response,8 but the researchers say the study is too small to make any definitive conclusions.

They say the findings support further research to study the factors influencing endometriosis and menstrual blood flow, such as hormonal influences and blood clotting disorders.

References

1. Kelman L. Women’s issues of migraine in tertiary care. Headache 2004;44:2-7.
2. Epstein MT, et al. Migraine and reproductive hormones throughout the menstrual cycle. Lancet 1975;1:543-548.
3. Ferrero S, et al. Increased frequency of migraine among women with endometriosis. Hum Reprod 2004;19:2927-2932.
4. Oehler MK, Rees MC. Menorrhagia: an update. Acta Obstet Gynecol Scand 2003;82:405-422.
5. Houston DE, et al. Incidence of pelvic endometriosis in Rochester, Minnesota, 1970-79. Am J Epidemiol 1987;125:959-969.
6. Strathy JH, et al. Endometriosis and infertility: a laparoscopic study of endometriosis among fertile and infertile women. Fertil Steril 1982;38:667-672.
7. Haupt BJ. Utilization of short-stay hospitals: annual summary for the United States, 1980. Vital Health Stat 1982;13:1-60.
8. Planchon B, et al. A quantitative test for measuring reactivity to cold by the digital plethysmograph technique: application to 66 control subjects and 65 patients with Raynaud’s phenomenon. Angiology 1986;37:433-439.

Source:

Tietjen GE, et al. Migraine is associated with menorrhagia and endometriosis. Headache 2006; doi:10.1111/j.1526-4610.2006.00290.x

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Curtis Schreiber and Roger Cady reported their study at the recent annual meeting of the American Academy of Neurology. This was a randomized, double-blind, placebo controlled study Another study of Botox for migraines. Curtis Schreiber and Roger Cady reported their study at the recent annual meeting of the American Academy of Neurology. This was a randomized, double-blind, placebo controlled study (that is the most reliable kind of a study) of patients who had disabling headaches and had difficulty complying with their previous prophylactic treatment. 60 received Botox and 21 received placebo injections. There was a significant improvement in headache frequency, headache impact (so called HIT-6 measure) and treatment satisfaction in patients who received Botox compared to those who received placebo. There are about 100 published reports on the use of Botox for migraine headaches and the experience of most headache experts in the US is very positive. However, many insurance companies will not cover Botox because the FDA has not yet approved it for migraines. Allergan, the company that manufactures Botox is conducting the FDA-required trials (we at NYHC are participating in one of the two trials), but the earliest possible time for approval is 2009.

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Patients who suffer from chronic migraines say they would do anything to rid themselves of the
pain-but heart surgery?

Click here to download the full article ( .pdf )

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Medtronic Begins Study of Occipital Nerve Stimulation for Chronic, Refractory Migraine Headaches; Implanted Device Delivers Electrical Impulses to Occipital Nerves. Medtronic Begins Study of Occipital Nerve Stimulation for Chronic, Refractory Migraine Headaches; Implanted Device Delivers Electrical Impulses to Occipital Nerves

Medtronic, Inc. today announced the first patient implant in a preliminary study to evaluate if an implanted device might help some of the thousands of Americans who suffer the agony of chronic migraine headaches that have not responded to other treatments.

More on occipital nerve block: The current issue of journal Headache presents a report of two patients whose prolonged hemiplegic migraine aura resolved with greater occipital nerve block. It is hard to explain how blocking a nerve would stop this brain dysfunction, but Botox which we routinely use to treat migraines, also seems to affect brain processes through peripheral nerves. I might try occipital nerve block for my next patient with a prolonged aura, but only if an intravenous infusion of one gram of magnesium sulfate fails.

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