Sumatriptan is now available in a nasal powder form. We already have sumatriptan in a tablet, injection, nasal spray, and a skin patch. I mentioned this product over 5 years ago and finally it was just approved by the FDA. This does not mean it will be available right away as it often takes many months for the company to ramp up production. In some cases, such as with inhaled migraine drug Semprana (formerly called Levadex), it takes years before the manufacturer achieves FDA quality standards of production.

OptiNose is the company that developed Xsail Breath Powered Delivery Device which is used to deliver sumatriptan nasal powder. OptiNose licensed the product to Avanir Pharmaceuticals and they named it Onzetra. Onzetra is a fast-acting dry powder that is delivered into the nasal cavity. The patient exhales into the device, which seals the nasal cavity, and this carries the medication from the device directly into one side of the nose.

Nasal powder should be much more effective and more consistently effective than the nasal spray. The problem with the nasal spray is that the liquid tends to leak out of the nose or into the mouth, while the powder sticks to the nasal mucosa and all of it gets absorbed. And while the nasal spray contains 20 mg of sumatriptan and Onzetra only 11 mg, Onzetra should be more effective. Similarly, only 6 mg of injected sumatriptan is much more effective than 100 mg of sumatriptan in a tablet. But do we need another form of sumatriptan? Actually this may be a very good product for people who have a sudden onset of a severe migraine or those who vomit with their attacks. The injection works well for these patients, but many would rather avoid the pain of a shot. Zecuity, a new transdermal form of sumatriptan would seem to be a good choice, except for the fact that it works much slower than Onzentra.

The approval of Onzetra Xsal was based on the data from Phase 2 and 3 clinical trials, safety data from over 300 patients, and the historical data from various other formulations of sumatriptan, which have been on the market for over 20 years. One of the studies showed a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes (42% vs. 27%) and at every time point up to 2 hours post-dose vs. placebo patients (68% vs. 45%).

Onzetra Xsail will be supplied as a disposable nosepiece containing a capsule and a reusable device. Each capsule contains 11 mg of sumatriptan and each kit contains 8 doses.

onzetratm-xsailtm-photo-1-5-HR

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Headache is usually the main presenting symptom of temporal arteritis (also known as giant cell arteritis, or GCA), which is caused by inflammation of blood vessels. This condition happens almost exclusively in the elderly. It presents with a severe headache, which is often one-sided. Some, but not all patients have swelling and tenderness of their temporal artery at the temple. This is a serious condition because it damages blood vessels and can cause strokes, loss of vision, and other complications. The diagnosis is made by blood tests (C-reactive protein, or CRP and erythrocyte sedimentation rate, or ESR) and temporal artery biopsy. However, even the biopsy sometimes does not show the inflammation. The treatment consists of steroid medications, such as prednisone. Prednisone is usually very effective. Unfortunately, prednisone needs to be taken for years if not for the rest of the person’s life and when it is used for long periods, it has many potentially dangerous side effects.

A recent study published in JAMA Neurology showed that many patients with biopsy-proven giant cell arteritis have an infection with varicella-zoster virus. This virus is also responsible for shingles and chickenpox

The researchers reviewed samples of temporal arteries for the presence of varicella-zoster virus. It was found in 68 of 93 (73%) of temporal arteries of patients with the disease, compared with 11 of 49 (22%) normals.

The authors concluded that in patients with clinically suspected GCA, prevalence of the virus in their temporal arteries is similar independent of whether biopsy results are negative or positive. They also felt that “Antiviral treatment may confer additional benefit to patients with biopsy-negative GCA treated with corticosteroids, although the optimal antiviral regimen remains to be determined”, and that “Considering that antiviral medications such as Acyclovir are very safe, it is reasonable to give them to all patients with temporal arteritis.”

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Trigeminal neuralgia is an extremely painful condition which causes jolts of very intense electric-like pains in the face. Fortunately, many trigeminal neuralgia sufferers respond to medications or Botox injections.

Several surgical procedures have also been used to treat this condition. One of these procedures is destruction of the trigeminal ganglion. The most effective treatment involves opening the skull and placing a teflon pad between the trigeminal nerve and the blood vessel which compresses the nerve (this procedure is called microvascular decompression). This pressure on the trigeminal nerve by an artery is the cause of pain in the majority of patients. While surgery can be truly curative, it carries a risk of serious complications and should be done only if medications and Botox injections fail. Ideally, it should be performed by a surgeon who has performed hundreds of these operations.

Besides medications, Botox, and injections to destroy the trigeminal ganglion, stereotactic radiosurgery, or gamma knife, offers another alternative to brain surgery. This treatment appears to be very effective and a new study published in Neurology suggests that this procedure is more effective if it is done early. If gamma knife radiosurgery is done within a year of the onset of pain, patients remained pain free for an average of 68 months, while if it was done more than 3 years after the onset, the relief lasted only 10 months.

Although microvascular decompression is curative, two groups of patients may opt for radiosurgery. One group consists of patients who are poor surgical candidates because they have other medical conditions which may increase the risk of complications or death. Another group include those who are afraid to have open brain surgery and who prefer to have stereotactic radiosurgery.

As a side note I should mention that gamma knife, or stereotactic radiosurgery is the treatment of choice for most cases of acoustic neuroma, a benign tumor of the vestibular nerve, a nerve going from the inner ear to the brain. Open surgery almost always leads to facial paralysis and complete loss of hearing, while gamma knife can shrink the tumor without any damage to healthy tissues.

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The little white spots seen on brain MRI scans have long been thought to be benign. A nagging concern has always persisted since their meaning has remained unclear. A recent study by researchers at several medical centers across the US established that even very small brain lesions seen on MRI scans are associated with an increased risk of stroke and death.

This is a very credible study since it involved 1,900 people, who were followed for 15 years. Previous studies of these white matter lesions (WML), which are also called white matter hyperintensities (WMH) involved fewer people and lasted shorter periods of time (these are my previous 4 posts on this topic).

Migraine sufferers, especially those who have migraines with aura are more likely to have WMLs. One Chinese study showed that female migraine sufferers who were frequently taking (“overusing”) NSAIDs, such as aspirin and ibuprofen actually had fewer WMLs than women who did not overuse these medications. Even though most neurologists and headache specialists believe that NSAIDs worsen headaches and cause medication overuse headaches, this is not supported by rigorous scientific evidence (the same applies to triptan family of drugs, such as sumatriptan). Another interesting and worrying finding is that the brain lesions were often very small, less than 3 mm in diameter, which are often dismissed both by radiologists who may not report them and neurologists, even if they personally review the MRI images.

The risk of stroke and dying from a stroke in people with small lesions was three times greater compared with people with no lesions. People with both very small and larger lesions had seven to eight times higher risk of these poor outcomes.

This discovery may help warn people about the increased risk of stroke and death as early as middle age, long before they show any signs of underlying blood vessel disease. The most important question is what can be done to prevent future strokes.

An older discovery pointing to a potential way to prevent strokes is that people who have migraines with aura are more likely to have a mutation of the MTHFR gene, which leads to an elevated level of homocysteine. High levels of this amino acid is thought to damage the lining of blood vessels. This abnormality can be easily corrected with vitamin B12, folic acid and other B vitamins.

More than 800,000 strokes occur each year in the United States, according to the National Institute of Neurological Disorders and Strokes. Strokes are a leading cause of death in the country and cause more serious long-term disabilities than any other disease. Routine MRI scans should not be performed, even in migraine sufferers, but if an MRI is done and it shows these WMLs, it is important to warn the patient to take preventive measures.

There are several known ways to prevent or reduce the risk of strokes. These include controlling weight, hypertension, cholesterol, diabetes, reducing excessive alcohol intake, stopping smoking, and engaging in regular aerobic exercise.

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Asthma is more common in migraine sufferers and migraine is more common in those who suffer from asthma (the medical term is co-morbid conditions). A new study published in Headache examines a possible connection between asthma and chronic migraine. Migraine is considered chronic if headache occurs on 15 or more days each month.

This co-morbidity between migraine and asthma is thought to be due to the fact that both conditions involve inflammation, disturbance of the autonomic nervous system, and possibly shared genetic and environmental factors. What is not mentioned in the report is the fact that intravenous magnesium can relieve both an acute migraine (in up to 50% of migraine sufferers who are deficient in magnesium) and a severe asthma attack. This suggests another possible explanation for the co-morbidity. Magnesium deficiency may also explain, at least in part, co-morbidity between migraine and fibromyalgia and vascular disorders.

The Headache report was one of many based on the outcomes of the large and long-term American Migraine Prevalence and Prevention study (AMPP). Study participants had to meet criteria for episodic migraine in 2008, complete an asthma questionnaire in 2008, and provide follow-up information in 2009. The researchers counted the number of these patients who developed chronic migraine a year later. The sample for this study included 4446 individuals with episodic migraine in 2008 of whom 17% had asthma. The mean age was 50 and 81% were female. In 2009, of the patients who had episodic migraines and asthma, 5.4% developed chronic migraine, compared to only 2.5% of those without asthma. So, having asthma doubles the risk of episodic migraine becoming chronic within a year. There was also a correlation between the severity of asthma and the risk of developing chronic migraine.

What we don’t know is whether aggressive treatment of asthma and migraines will reduce the risk of chronification of migraines. It is also possible that simple magnesium supplementation may have a protective effect.

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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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Magnesium deficiency is a regular topic on this blog. Up to half of migraine sufferers are deficient in magnesium, but magnesium levels are rarely checked by doctors. Even when magnesium level is checked, it is usually the serum level, which is totally unreliable. The more accurate test is RBC magnesium or red blood cell magnesium because 98% of body’s magnesium resides inside cells or in bones. At the New York Headache Center we often don’t bother checking even the RBC magnesium level, especially if other signs of magnesium deficiency besides migraines are present. These include coldness of hands and feet or just always feeling cold, leg muscle cramps, palpitations, anxiety, brain fog, and in women, premenstrual syndrome or PMS (bloating, breast tenderness, irritability). For these patients we recommend daily magnesium supplementation and sometimes monthly magnesium infusions.

About 20 to 30 million women suffer from moderate or severe PMS, and a recent study published in the American Journal of Epidemiology indicates that having PMS increases the risk for hypertension (high blood pressure) later in life.

This study was done at the University of Massachusetts, Amherst and it involved 1,260 women who suffered from moderate or severe PMS as well as more than 2,400 women with mild or no PMS. Women with moderate or severe PMS were 40 percent more likely to develop high blood pressure than those with mild or no PMS symptoms. The researchers adjusted the risk for other risk for hypertension, such as being overweight, smoking, drinking, inactivity, use of birth control pills, postmenopausal hormone use, and family history of high blood pressure.

The association between moderate or severe PMS and high blood pressure was most pronounced among women younger than 40, who were three times more likely to develop hypertension.

Interestingly, the risk of high blood pressure was not increased in women with moderate or severe PMS who were taking thiamine (vitamin B1) and riboflavin (vitamin B2). Other researchers found that women who consumed high levels of those vitamins were 25 to 35 percent less likely to develop PMS.

Unfortunately, the researchers did not look at magnesium levels or magnesium consumption in these women. A strong association exists between magnesium deficiency and high blood pressure. There is also an association between an increased magnesium (and potassium) intake and reduced risk of strokes. Supplementation with magnesium during pregnancy decreases the risk of hypertension during pregnancy. There is also a strong association between magnesium and depression.

There are literally hundreds of scientific articles on beneficial effects of magnesium, but unfortunately magnesium remains ignored by mainstream physicians. However, consumers are ahead of most doctors and many do take magnesium supplements. This is helped by many print and online articles and many books. Some of these books include Magnificent Magnesium, Magnesium Miracle, Magnesium – The Miraculous Mineral of Calm, and my two books – The Headache Alternative: A Neurologist’s Guide to Drug-Free Relief and What Your Doctor May Not Tell You About Migraines.

Migralex is a product I patented and developed for the treatment of headaches. It contains an extra-strength dose of aspirin and magnesium. Magnesium in Migralex acts as a buffering agent and reduces the risk of stomach irritation by aspirin. Migralex is available at CVS stores, Amazon.com, and Migralex.com.

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Meditation is growing in popularity and deservedly so. Several of my previous posts mentioned the benefit of meditation in migraine headaches. Scientists are conducting rigorous studies that repeatedly show the profound effect meditation has on the brain. The most recent study was done at the Wake Forest Baptist Medical Center and it compared the effect of meditation and placebo on pain.

The study was published in the recent issue of the Journal of Neuroscience. It showed that mindfulness meditation not only provided greater pain relief than placebo, but the brain scans could differentiate patterns of brain activity during meditation from that induced by placebo.

The study involved seventy five healthy, pain-free volunteers who were randomly assigned to one of four groups: mindfulness meditation, placebo meditation (“sham” meditation), placebo analgesic cream or control.

Pain was induced by heat applied to the skin. The mindfulness meditation group reported that pain intensity was reduced by 27 percent and the emotional aspect of pain (how unpleasant it was) by 44 percent. In contrast, the placebo cream reduced the sensation of pain by 11 percent and emotional aspect of pain by 13 percent.

Mindfulness meditation reduced pain by activating brain regions associated with the self-control of pain while the placebo cream lowered pain by reducing brain activity in pain-processing areas.

Another brain region, the thalamus, was deactivated during mindfulness meditation, but was activated during all other conditions. This brain region serves as a gateway that determines if sensory information is allowed to reach higher brain centers. By deactivating this area, mindfulness meditation may have caused signals about pain to simply fade away, said Dr. Zeidan, one of the researchers.

Mindfulness meditation also was significantly better at reducing pain intensity and pain unpleasantness than the placebo meditation. The placebo-meditation group had relatively small decreases in pain intensity (9 percent) and pain unpleasantness (24 percent). The study findings suggest that placebo meditation may have reduced pain through a relaxation effect that was associated with slower breathing.

This study is the first to show that mindfulness meditation does not relieve pain the way placebo does. This study confirms previous observations that as little as four 20-minute daily sessions of mindfulness meditation could enhance pain treatment. Another study has shown that an 8-week course of mindfulness meditation not only relieved pain but also made certain parts of the brain cortex measurably thicker.

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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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23andMe offers direct-to-consumer genetic testing by analyzing a saliva sample. It provides information on predisposition for more than 90 traits and conditions ranging from acne to Alzheimer’s. Health-related results were suspended by the FDA because of the concern was that consumers may not be able to correctly interpret the health data, particularly regarding conditions such as Alzheimer’s Parkinson’s, various cancers, and other. What is available is genealogical data and information on several conditions which did receive FDA approval. As of June 2015, 23andMe has genotyped over 1,000,000 individuals.

After submitting a saliva sample, consumers are asked to complete a number of surveys about their medical conditions, including migraines, personal habits, and other information. This has led to some important discoveries, which have been published in scientific journals. Here are some results related to migraines.

23andme discovered three genes which make migraines more likely. This discovery is not as important as it seems because these genes increase the risk of migraines by a very small amount and because dozens of other migraine susceptibility genes are being continuously identified.

In 2012 23andme acquired CureTogether, a “health research project that brings patients and researchers together to find cures for chronic conditions”, where some of the following information comes from.

Here is interesting, but also not very surprising information on most commonly reported migraine triggers:

stress (85%)
insufficient sleep (72%)
dehydration (64%)
looking at bright sunlight (61%)
inhaling smoke/strong odors (57%)
staring at a computer screen (56%)
flashing or flickering lights (56%)
weather changes (50%)
low blood sugar (49%)
loud environments (48%)
heat (47%)
caffeine withdrawal (43%)
alcoholic beverages (42%)
large groups of people (28%)
bananas (6%)

More than 65% of migraine sufferers have tried acetaminophen (Tylenol®), but it doesn’t work very well for most people. Over 20% of people have tried an alcoholic beverage, even though it typically makes migraines much worse. In contrast, less than 20% of people have tried wrapping a cold towel around their head, and yet it is one of the more effective treatments listed by migraine sufferers on CureTogether.

Treatments rated as most effective for patients with migraine
1. Dark, quiet room
2. Sleep
3. Eliminate red wine
4. Passage of time
5. Eliminate MSG
6. Avoid smoke
7. Wear sunglasses
8. Intravenous DHE
9. Imitrex injection
10. Ice packs

According to 23andme, “When symptom data and treatment data come together, powerful things happen. Data from nearly 3,500 CureTogether members tell us that those who experience vertigo or dizziness with their migraines are three times more likely (18% vs 6%) to have a negative reaction to Imitrex®, a sumatriptan medication that is often prescribed for migraine sufferers”.

A word of caution about 23andme. I personally submitted my saliva for testing and completed many questionnaires to help with their research. However, some feel that 23andme’s promises of not sharing personal genetic information with anyone else could be undermined in the future, as it happened with Google. Here is an interesting blog post from the Scientific American on this topic entitled, 23andMe Is Terrifying, but Not for the Reasons the FDA Thinks
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