FDA Approves New Inhaler for Migraine

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new type of inhaler for the treatment of acute migraine in adult patients with or without aura.

Onzetra Xsail delivers a low dose of a dry powder formulation of sumatriptan, the most commonly prescribed medication for migraine.

"Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people," said Roger Cady, MD, director of the Headache Care Center and associate executive chairman of the National Headache Foundation.

"The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat."

The inhaler is activated when a user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. The medication is dispersed deep into the nasal cavity, reaching areas where it can be rapidly absorbed.

As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduces gastrointestinal absorption.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth.

The FDA approved Onzetra after clinical trials showed the inhaler provided headache relief to about 40% of users within 30 minutes. About two-thirds of users reported pain relief after two hours. Side effects include abnormal product taste, nasal discomfort, rhinorrhea and rhinitis.

Medical Marijuana May Reduce Migraine Headaches

By Pat Anson, Editor

New research is adding to the growing body of evidence that medical marijuana can be used to treat migraine headaches.

In a small study of 121 migraine patients by researchers at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado, 103 patients reported a significant decrease in the number of migraine headaches they had every month. The frequency of headaches dropped from an average of 10.4 to 4.6 per month. Most patients used more than one form of marijuana and used it daily. The study was published in the journal Pharmacotherapy.

"There was a substantial improvement for patients in their ability to function and feel better," said senior author Professor Laura Borgelt, PharmD. "Like any drug, marijuana has potential benefits and potential risks. It's important for people to be aware that using medical marijuana can also have adverse effects."

Fifteen of the patients reported marijuana use had no impact on their headaches, while three said they had more headaches.

The study looked at patients treated at Gedde Whole Health, a private medical practice in Colorado that utilizes medical marijuana for a variety of conditions. Inhaled marijuana appeared to be the favorite method for treating acute migraines, while edible cannabis, which takes longer to be absorbed into the body, helped prevent headaches.

Exactly how cannabis relieves migraines is not fully understood. Natural cannabinoid receptors in the brain, connective tissues, and the immune system appear to have anti-inflammatory and pain-relieving properties. These cannabinoids also seem to affect neurotransmitters like serotonin and dopamine.

"We believe serotonin plays a role in migraine headaches, but we are still working to discover the exact role of cannabinoids in this condition," Borgelt said.

“We have had numerous patients finding results with migraines and the use of cannabis,” said Ellen Lenox Smith, a Pain News Network columnist who is a caregiver to medical marijuana patients in Rhode Island.

“We just had a woman out at the house a few days ago that was suffering will full body Reflex Sympathetic Dystrophy (RSD) and when she took one hit on a vaporizer of day meds, you could actually see the forehead relax and had headache relief immediately. When it is right for you, the results are amazing.” 

A 2013 study on rodents published in The Journal of Neuroscience found that triptans – a drug widely prescribed to treat migraine – appear to activate cannabinoid receptors just as marijuana does.

A 2007 study published in the European Journal of Critical Pharmacology found that migraine patients possessed significantly lower levels of endogenous cannabinoids than healthy control subjects.

Imaging Identified as Most Wasteful Medical Test

By Pat Anson, Editor

Should you get an MRI for your headache?

What about a CT scan for low back pain?

Or a bone-density scan for someone under the age of 65?

In most cases, the answer to all of those questions is no, according to the Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce the use of hundreds of unnecessary and costly medical tests. Experts say an MRI or CT scan of the lower back can cost over $1,200 and does nothing to relieve your back pain.

Since Choosing Wisely was launched in 2012, over 370 wasteful procedures have been identified by over 70 medical societies, such as the American Academy of Sleep Medicine and the American Academy of Neurological Surgeons. Each organization was asked to identify an initial list of five medical services that may be unnecessary. Many societies went far beyond that, returning with two or even three lists.

A neurologist at the University of Michigan says the list of recommendations from the American Academy of Neurology (AAN) only scratches the surface. Brian Callaghan, MD, has identified 74 tests and procedures related to neurology that are often unnecessary. Many involve the use of imaging.

“The two biggest areas that might be done more than they should are imaging for low back pain and imaging for headaches,” Callaghan said. “It’s a big problem and it costs a lot of money – we’re talking a billion dollars a year on just headache imaging.”

According to a recent study at the University of Michigan, one in eight visits to a doctor for a headache or migraine end up with the patient going for a brain scan. Often a doctor will order a CT or MRI scan to ease a patient’s fear that they may have a brain tumor or some other serious issue causing their pain. Physicians could also order a scan to protect themselves legally in case of a future lawsuit.

In most cases, however, the brain scan will be useless. Previous research found that only 1 to 3 percent of brain scans of patients with repeated headaches identify a cancerous growth or aneurysm that's causing the problem. Many of the issues that a scan might identify don’t pose a serious threat or may not require treatment right away. There is also the risk of a false positive that could generate unnecessary fear and alarm.

“These are all areas where lots of physicians agree that you’re more likely to get harmed by doing the procedures,” said Callaghan, whose study was recently published in the journal Neurology.

Callaghan isn’t encouraging you to say no if your doctor wants to image your brain or lower back, but he hopes his research will inspire a thoughtful discussion between doctors and patients about the purpose of the test and its value

“Ordering an MRI for a headache is very quick, and it actually takes longer to describe to the patient why that’s not the best route,” Callaghan said. “These guidelines are meant for physicians and patients both, to trigger a conversation.”

Besides imaging, another treatment that is widely questioned is the use of opioid pain medication to treat headaches and migraine. The Choosing Wisely campaign recommends that opioids only be used as a last resort for severe headaches, including migraine. Overuse of any pain reliever – even over-the-counter medications -- are known to make headaches worse.

My Life with Migraines

By Sara Batchelder, Guest Columnist

I have had migraine disease since I was 22. My first migraine was in 1992, the year I graduated from college. 

I am now 45, and my migraines have become chronic and daily.  I have lost two jobs, many friendships, my social life, and my relationship of eleven years.  This year, I also lost my ability to work full-time at a regular job.  The only reason I can still work part-time is that my ex employs me and allows me to work whenever I am able.  Thank goodness for that. Working gives me a purpose and makes me feel like a productive member of society.  It is an extreme struggle to work twenty hours a week though. 

I also have thyroid disease (my thyroid gland was removed when I was 29), celiac disease (I have been 100% gluten free for a year), depression, anxiety, infertility, and extreme allergies to many things, such as food, pollen, dust, cats, you name it. 

I now have a multi-pronged approach to my treatment.  For migraine, I have botox injections every three months, I see a “natural MD” for various treatments, and I take Relpax (a triptan) and opioids (Norco and morphine). 

I am still learning a lot about celiac disease, but I stay ever vigilant that I do not ingest any gluten whatsoever, even one molecule.  It’s a learning experience and constantly challenging.  For instance, I will visit a restaurant that I consider safe, get “glutened” and cross that restaurant off the list.  I am down to four restaurants that I can eat at. 

Since I am too sick to cook for myself most of the time, I graze on various packaged food - some good, some not so good.  I eat protein bars when traveling, although I do not travel often anymore.  It’s a lot of work to make sure all the food I eat is gluten-free and free of all of my other food allergies. 

sara met with sen. barbara boxer while advocating for migraine research

I’ve been dealing with allergies for all of my 45 years.  My “natural MD” (my voodoo doctor, as I jokingly call him) gives me small doses of LDA shots, which are helping a bit.  He also believes that I have a lyme-like disease called Bartonella, which he is treating me for.  I am on so many vitamins that I won’t even go there. I take Wellbutrin for depression, nothing for anxiety, and since I am now 45, the infertility has played itself out. 

Deep breath. That’s a lot of illness and treatment.

Even with all of this, my scariest problem today is the government’s war on pain patients who take opioids.  After the DEA stormed one of my doctors’ offices in bulletproof vests with guns drawn (to request appointments with two doctors -- couldn't that have been done by phone?), all of my doctors, but one, have withdrawn ALL narcotic treatments for ALL migraineurs. 

It baffles me why this policy exists.  This is discrimination plain and simple.  I want to sue, but no lawyer will take the case.  I know that many addicts lie and tell doctors that they are migraine patients, since migraine is an invisible disease that cannot be diagnosed with blood tests, MRI’s, or anything else, but these are doctors whom I have a 10 year relationship with! 

They are either petrified of the DEA or always thought that I was an addict, and didn’t care enough to deal with that.  Either way, what the heck I am supposed to do?  Without my weekly pain shots, I can no longer work full-time.  If I still didn’t have one doctor on my side, I’m pretty sure I would have committed suicide. 

My private disability was denied due to some technicality.  SSI pays less than I can make part-time and SSI doesn’t allow the disabled to work part-time anyway (don’t get me started on that). 

I am very, very fortunate to work in California, where I have been on part-time disability.  But it will only last for one year, so I will be on my own again soon anyway.  I don’t know about other people, but there is no way I can survive in California on half-pay.  I was barely making ends meet while working full-time.  Now that I am single again, I cannot rely on someone else to support me. It is terrifying!!!

I have met and will soon meet again with members of Congress to discuss more funding for migraine and headache research through an organization called Headache on the Hill. That organization does not support opioid treatment for migraine at this time, but I still want to address the opioid issue with other pain patients.  Who will join me?
 

Sara Batchelder lives in California, where she received an MBA with honors from the University of San Francisco and works as a controller for small architecture firm. Sara volunteers at her local credit union and tries to advocate for migraineurs as much as she can.

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study Finds Doctors Order Too Many Imaging Tests

By Pat Anson, Editor

Doctors are still ordering too many imaging tests for low back pain and headache, according to an early study of the effectiveness of the Choosing Wisely campaign, a national effort to reduce the number of unnecessary medical treatments and procedures.

In an analysis of seven clinical services with questionable benefit to patients, published in JAMA Internal Medicine, researchers found that the use of five procedures either increased or stayed the same; while there were only slight declines in the use of two others.

CT and MRI imaging tests for simple headache decreased from 14.9 percent to 13.4 percent, while cardiac imaging for patients with no history of heart problems dropped from 10.8 percent to 9.7 percent.

The prescribing of nonsteroidal anti-inflammatory drugs (NSAIDs) increased from 14.4% to 16.2% for hypertension, heart failure or chronic kidney disease. Testing for human papillomavirus (HPV) in young women also rose, from 4.8% to 6%.

Imaging tests for low back pain (53.7%), pre-operative chest x-rays (91.5%), and antibiotics for sinusitis (91.5%) remained stubbornly high.

The study was based on a database of insurance claims from 2013 for about 25 million members of Blue Cross and Blue Shield health plans.

“It remains an open question whether clinicians or consumers at large are aware of specific Choosing Wisely recommendations or have changed their attitude toward unnecessary tests and procedures,” wrote Ralph Gonzalez, MD, in a commentary published in JAMA Internal Medicine.

“In a fee-for services system, most delivery systems continue to get paid for tests and drugs. Payers are able to pass on these costs to employers and patients, creating a vicious cycle.”

The Choosing Wisely campaign was launched in 2012 by the ABIM Foundation (American Board of Internal Medicine) with the goal of reducing waste and unnecessary medical tests and treatments. It has grown to include a list of hundreds of frequently used procedures that have little value or may, in fact, be risky.

“Most people with lower-back pain feel better in about a month whether they get an imaging test or not. In fact, those tests can lead to additional procedures that complicate recovery,” Choosing Wisely states on its website.

“A study that looked at 1,800 people with back pain found that those who had imaging tests soon after reporting the problem fared no better and sometimes did worse than people who took simple steps like applying heat, staying active, and taking an OTC pain reliever. Another study found that back-pain sufferers who had an MRI in the first month were eight times more likely to have surgery, and had a five-fold increase in medical expenses.”

The Choosing Wisely campaign also discourages doctors from performing epidural steroid injections if a patient doesn’t show signs of improvement after one injection. A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Blood Test Identifies Women Prone to Migraine

By Pat Anson, Editor

Researchers may have discovered a new marker for episodic migraine – lipids in the blood that regulate inflammation in the brain.

In a small study involving 88 women, researchers found that total levels of the lipids -- called ceramides or sphingolipids -- were significantly decreased in women with episodic migraine when compared to women without migraine. Episodic migraine is defined as less than 15 headaches per month. The women in this study had an average of 5.6 headache days a month.

"While more research is needed to confirm these initial findings, the possibility of discovering a new biomarker for migraine is exciting," said study author B. Lee Peterlin, DO, with the Johns Hopkins University School of Medicine. The study is published in Neurology,  the medical journal of the American Academy of Neurology.

Ceremides are bioactive lipids that may be involved in other neurological disorders, such as dementia and multiple sclerosis.

Women with migraine had approximately 6,000 nanograms per milliliter of ceramides in their blood; while women without headache had about 10,500 nanograms. Every standard deviation increase in total ceramide levels was associated with over a 92% lower risk of having migraine. Two other types of lipids, called sphingomyelin, were associated with a 2.5 times greater risk of migraine.

The researchers tested their theory by analyzing the blood of a random sample of 14 of the women. They were able to correctly identify those who had migraine and those who did not based on their lipid levels.

"This study is a very important contribution to our understanding of the underpinnings of migraine and may have wide-ranging effects in diagnosing and treating migraine if the results are replicated in further studies," said Karl Ekbom, MD, with the Karolinska Institute in Stockholm, Sweden, who wrote an accompanying editorial.

Ekbom noted there were limitations in the study. Only women were included, chronic migraine was not studiedm and an unusually high number of participants had migraine with aura

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

Migraine Device Reduces Headache Pain

By Pat Anson, Editor

A device that looks like a space age tiara not only helps prevent migraine attacks, but also relieves headache pain once a migraine starts, according to the results of a small clinical trial.

In a study of 20 migraine sufferers, published in The Journal of Headache and Pain, the Cefaly device provided "statistically significant" pain relief, as well as an 81 percent reduction in the number of migraine attacks. Patients in the study also said they used less migraine medication.

Cefaly was approved last year by the U.S. Food and Drug Administration as the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of migraine pain.  Previous studies of the device only focused on migraine prevention.

"This is great confirmation on what we thought about the high efficacy of Cefaly," said Dr. Pierre Rigaux, chief executive officer of Cefaly Technology, a company based in Belgium. "We knew Cefaly to be very safe and with minimal side effects, but now we learn that it's not just the frequency of migraine days that's reduced for every four out of five patients, but the intensity of pain during a migraine attack is reduced as well."

IMAGE COURTESY OF CEFALY TECHNOLOGY

The battery-powered device, which is worn over the forehead like a headband, uses tiny electrical impulses to stimulate the trigeminal nerve, which has been associated with migraine headaches. Cefaly requires a prescription and costs about $349. The device is only available through the company’s website and is not covered by insurance. It’s been available in Europe and Canada for several years.

It was on a trip to Canada that Maria Coder learned about Cefaly and – at the urging of her boyfriend Jay– reluctantly agreed to buy one.

“At the time my boyfriend and I got into a big fight because he wanted me to use it right away and I didn’t really like the idea. I’d never heard of it and I was nervous about using it,” said Coder, who has suffered from migraine for nearly two decades.  

The device sat in its box for about a week before she finally tried it.

“I was alone in the apartment and put on the headband and loved it. I fell in love with it. I started to feel better, but I thought beginner’s luck,” Coder told Pain News Network. “I tried it a few more times and then it took on a life of its own. Now I feel like a wimp when I get a migraine because I don’t get them hardly ever compared to before. It’s down to maybe 3 to 5 a month, whereas for almost ten years it was chronic, almost daily.”

Coder, who works in public relations, wrote a letter to Cefaly Technology that eventually turned into a job as a publicist for the company. She also recently married her boyfriend – wearing the Cefaly device for her daily 20-minute session during a break after the ceremony and before her reception.

“I really love and I really believe in it. I didn’t believe in it at first, when I got it. And then the more that I used it, the more I couldn’t deny the results,” she said.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

maria coder

In 2013, the FDA approved the marketing of another device -- the first transcranial magnetic stimulation (TMS) device approved for the relief of migraine pain. The Cerena TMS is placed at the back of the head to release a pulse of magnetic energy to the brain’s occipital cortex, which may stop or lessen pain caused by migraine headaches.

Researchers Say Back to School Headaches Often Real

By Pat Anson, Editor

With summer nearly over and millions of children heading back to school, many parents will hear a familiar refrain:

“I’ve got a headache. Can I stay home from school?”

While parents may be tempted to think their child dreads going back to school and just wants to prolong summer a little longer, kids now have research to back them up.

In a study of emergency room visits by children, researchers at Nationwide Children’s Hospital in Columbus, Ohio found that pediatric headaches do indeed increase in the fall – often because children are stressed out by abrupt changes in their summer routines, nutrition and sleep patterns.

“When we saw many of our families and patients in clinic, the families would report that their child or teenager’s headaches would increase during the school year,” said lead researcher Ann Pakalnis, MD, a neurologist and Director of the Comprehensive Headache Clinic at Nationwide Children’s Hospital.

“So, we decided to go back and look at emergency department visits for that time period and see if there were more visits here at certain seasonal variations during the year.”

Pakalnis and her colleagues analyzed about 1,300 emergency room visits to the hospital by children from 2010 to 2014. The number of pediatric headaches was stable throughout the year, except for the fall – when headaches in school aged children surged by nearly a third.

"We see a lot of headaches in young boys, from five to nine years of age, and in boys they tend to get better in later adolescence,” said Pakalnis, who is also a professor of Clinical Pediatrics and Neurology at The Ohio State University College of Medicine. “In teenage girls, migraines oftentimes make their first presentation around the time of puberty and unfortunately tend to persist into adulthood.”

The two types of headaches seen most often by physicians are tension headaches and migraines. About 20 percent of all pediatric patients 11 years and older suffer from migraine, which are often associated with nausea and vomiting, as well as sensitivity to light, sound and smell. Tension headaches tend to feel more like a painful tightening around the head.

The increase in fall headaches may be attributed to a number of factors, including academic and social stress, schedule changes and an increase in extracurricular activity. Other common headache triggers include lack of sleep, too much caffeine, lack of exercise and too much time on a computer or mobile device.

Researchers say headaches can often be prevented, just by getting three meals a day, drinking enough liquids, and getting adequate sleep.

“Your brain is like your cell phone,” said Howard Jacobs, MD, a headache specialist at Nationwide Children’s. “If you don’t plug your cell phone in, it doesn’t have energy, it doesn’t work well. If you don’t plug your brain in by providing energy, it doesn’t work well and that causes headaches.”

If headaches persist or get worse, Jacobs says a doctor should be seen.

“A sudden, severe headache or a change in the headache sensation from previous, what we call ‘first or worst’ headaches should be evaluated,” said Jacobs. “Another good rule of thumb is that if the headaches are interfering with a child’s normal routine, then it is time to get them evaluated, so therapy can be instituted to return your child’s life to normal.”

Nationwide Children’s Hospital produced this video about the headache study:

Findings from Nationwide Children's Hospital physicians demonstrate that headaches increase in fall in children, a trend that may be due to back-to-school changes in stress, routines and sleep.

For tension headaches, doctors say over-the-counter pain relievers such as acetaminophen, ibuprofen or naproxen can be helpful, but they can make headaches worse if taken too often.

Until recently, treatment options have been limited for children with migraine.

In May, the U.S. Food and Drug Administration approved Treximet for pediatric migraine patients 12 years of age and older. Treximet is the first approved prescription drug for migraine to contain both sumatriptan and naproxen. Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. Treximet was approved by the FDA for use by adults in 2008.

In June, the FDA also approved Zomig nasal spray for the treatment of migraine in pediatric patients 12 and older. Zomig provides pain relief in as little as 15 minutes, with most patients obtaining some relief in about two hours. Zomig was approved for use by adults in 2003.

Childhood Trauma Linked to Adult Migraine

By Pat Anson, Editor

Children who witness domestic violence between their parents are significantly more likely to experience migraine headaches as adults, according to a large new study published in the journal Headache.

Researchers at the University of Toronto examined a nationally representative sample of over 12,000 women and 10,000 men who participated in the 2012 Canadian Community Health Survey-Mental Health. About 6.5% of the men and 14.2% of the women experienced migraine, which is consistent with prior research.

Participants were asked if they had experienced three types of childhood trauma: physical abuse, sexual abuse or if they witnessed parental domestic violence.

"We found the more types of violence the individual had been exposed to during their childhood, the greater the odds of migraine. For those who reported all three types of adversities -- parental domestic violence, childhood physical and sexual abuse -- the odds of migraine were a little over three times higher for men and just under three times higher for women" said Sarah Brennenstuhl, PhD, first author of the study.

Researchers said the most surprising finding was the link between migraines and parental domestic violence. Even after accounting for variables such as age, race, and socioeconomic status, men and women who had witnessed parental domestic violence had 52% and 64% higher odds of migraine compared to those who did not see their parents fighting.

"The cross-sectional design of our study does not allow us to determine if the association between early adversities and migraines is causative, but our findings do underline the importance of future prospective studies investigating the long-term physical health of children exposed to parental domestic violence,” said co-author Esme Fuller-Thomson, professor and Sandra Rotman Endowed Chair at University of Toronto's Factor-Inwentash Faculty of Social Work.

Previous research by Fuller-Thomson has found that depression and thoughts of suicide are more likely among individuals with migraine.

The risk of depression and suicide ideation is about twice as high for those who experience migraine. Individuals with migraine who are under the age of 30 had six times the odds of depression compared to migraineurs aged 65 and over.

Migraine is thought to affect a billion people and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

The month of June is Migraine Awareness Month.

Doctors Prescribing Opioids for Migraine Despite Risks

By Pat Anson, Editor

Physicians are still prescribing opioid painkillers or barbiturates to treat migraine, even though frequent use of the drugs can make headaches worse and raise the risk of addiction.

Over half the patients who visited a headache center in New York City said they had been prescribed opioids and/or barbiturates, according to a new study presented at the annual scientific meeting of the American Headache Society. About 20 percent of the 218 patients surveyed, most of whom had a migraine diagnosis, said they were still taking the drugs.

"Headache specialists are often in a difficult position when patients request opioids or increasing quantities of barbiturates," said lead author Mia Minen, MD, Director of Headache Services at NYU's Langone Medical Center. "Although many patients find these effective, they are known to contribute to headaches related to medication overuse."

Minen and her research team identified which physicians were prescribing the drugs and found the most frequent first prescribers of opioids were emergency room physicians, while general neurologists were the most frequent first prescribers of barbiturates. Primary care physicians were also identified as first prescribers.

"Taken as a whole, these data provide a useful snapshot of the wide variety of physician specialties that might benefit from additional education on the appropriate use of opioids and barbiturate-containing medications in patients with headaches," said Minen.

Opioids and barbiturates should only be used as a last resort to treat migraine, according to the American Board of Internal Medicine's "Choosing Wisely" campaign. The campaign recommends the first medications for migraine should be either over-the-counter pain relievers or a class of prescription drugs called triptans that are made specifically for migraine.

"This study underscores the fact that prescribers may not be aware of best practices in migraine care,” said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“Problems arise when ‘crisis solutions’ are applied as the de facto treatment for daily management of pain. Patients may believe that opioids are beneficial but they lead to worse migraine and headache pain, and are not considered appropriate first-line treatment for these conditions. If possible, patients should seek a specialized evaluation with a board certified specialist to ensure they receive medications that will help them in the long run.”

Darnall called opioids and benzodiazepines “a dangerous combination of medications,” and said they should be avoided or combined only under close medical supervision.

The problem extends far beyond the borders of the United States. According to the recently released Global Burden of Disease Study, the number of headaches caused by medication overuse has risen by 120% since 1990. Medication overuse headache is the 18th leading cause of disability worldwide.

New “Landmark” Class of Migraine Drugs Being Developed

Meanwhile, clinicians and researchers at the American Headache Society’s annual meeting are reportedly excited about a new class of drugs called Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which are showing promise in treating high-frequency episodic migraine and chronic migraine. Research studies on CGRP are being presented at the meeting, which draws more than 1,000 migraine specialists from around the world.

"This development is a transformative moment in migraine treatment," said Peter Goadsby, MD, who is chief of the UC San Francisco Headache Center and one of the world's leading headache treatment experts. "Up till now, migraine patients have had limited choices for preventive treatment. Now four pharmaceutical companies are showing positive results in human trials targeting CGRP mechanisms."

The new drugs appear to reduce elevated levels of the peptide known as calcitonin gene-related peptide, which is a key driver of migraine pain. Versions of anti-CGRP therapies are being tested by Alder Pharmaceuticals, Amgen, Eli Lilly and Teva Pharmaceuticals.

Teva reported that in a Phase II clinical study its CGRP therapy achieved a significant reduction in the number of headache hours after one week, with more than half of patients experiencing a 50% or greater reduction in headache frequency.

Amgen’s research showed showed that its anti-CGRP product also reduced the number of migraine days by 50% in about half the treated patients after 12 weeks.

"The potential of these new compounds is enormous and gives us real hope that effective specific treatments for migraine may be on the near horizon," said Goadsby. "The development of CGRP antibodies offers the simple, yet elegant and long awaited option for migraine patients to finally be treated with migraine preventives; it's a truly landmark development."

There has not been a new class of anti-migraine drugs since the development of triptans in the early 1990s.

Migraine is thought to affect a billion people and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

The month of June is Migraine Awareness Month.

Nasal Spray Approved for Migraine in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a nasal spray for the treatment of migraine in pediatric patients, the second migraine drug the agency has approved in the last month for patients 12 years of age and older.

About one in five teens suffer from migraine, but treatment options for them have been very limited compared to adults.

Zomig nasal spray was first approved by the FDA in 2003 for the treatment of migraine in adults. It provides pain relief in as little as 15 minutes, with most patients obtaining some relief in about two hours.

The FDA’s approval came after the agency reviewed safety and efficacy data from clinical trials demonstrating that Zomig was significantly more effective than placebo in relieving headache pain and other migraine symptoms in pediatric patients. It also had a safety profile similar to that in adults.

Zonig is the first prescription nasal spray approved for migraine in children. The most common adverse reaction to Zomig in pediatric patients during clinical trials was an unusual taste.

"Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making Zomig Nasal Spray available to this 'school age' patient population," said Fred Wilkinson, President and CEO of Impax Laboratories, which obtained the U.S. commercial rights to Zomig products from AstraZeneca in 2012. Impax has since lost exclusive rights to Zonig tablets and is focused on the nasal spray.

The recommended starting dose for Zomig in pediatric patients is 2.5 mg. The dosage can be adjusted on an individual basis, but should not exceed 5 mg in a single dose or a maximum daily dose of 10 mg in any 24 hour period.

Last month the FDA approved the migraine drug Treximet for pediatric patients 12 years of age and older.. Treximet is the first approved combination drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

Like Zomig, Treximet had already been on the market for several years to treat migraine in adults.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

The month of June is Migraine Awareness Month.

Back Pain World's Leading Cause of Disability

By Pat Anson, Editor

Lower back pain remains the world's leading cause of disability, according to an extensive new study of health data that also warns that the number of people living in poor health is set to rise rapidly over coming decades.

Using a statistical analysis known as "years lived with disability" (YLD),  the Global Burden of Disease Study ranks lower back pain as the leading cause of disability worldwide, followed by major depression.  

Low back pain was the leading cause of YLDs in 86 countries and the second or third leading cause in 67 countries. It also caused more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined.

Several other painful conditions also ranked high, including neck pain (#4), migraine (#7),  musculoskeletal disorders (#10), osteoarthritis (#13) and medication overuse headache (#18).

The study, which is published online in The Lancet, is the first to examine the extent, pattern, and trends in disabilities worldwide. An international consortium of researchers led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington studied 301 diseases and injuries in 188 countries.

They found that while people around the world are living longer, they are spending more time in ill health as rates of diseases and injuries decline more slowly than death rates.

Just one in 20 people worldwide had no health problems in 2013, with a third of the world’s population -- 2.3 billion people -- experiencing more than five ailments. Of those, 81% were younger than 65 years old.

The disease burdens for low back pain and depression both increased more than 50% since 1990. There was also a startling increase in disability caused by diabetes (up 136%), Alzheimer’s disease (up 92%), medication overuse headache (up 120%), and osteoarthritis (up 75%).

"What ails you isn't necessarily what kills you," said IHME Director Dr. Christopher Murray. "As nonfatal illnesses and related ailments affect more people of all ages, countries must look closely at health policies and spending to target these conditions."

Between 1990 and 2013, YLDs increased from 537.6 million to 764.8 million for both sexes. The leading causes of YLD remained largely stable during this period, but they took an increased toll on health due to population growth and aging.

Musculoskeletal disorders, combined with fractures and soft tissue injuries, accounted for one-fifth of YLDs globally in 2013, ranging from a low of 11% for Mali's population to a high of 30% in South Korea.

"Many countries around the world have made great progress in addressing fatal diseases, but nonfatal illnesses pose the next major threat in terms of disease burden," said Professor Theo Vos of IHME, the study's lead author. "This need to meet the challenge of nonfatal diseases and injuries only becomes more urgent as the population increases and people live longer."

Leading Causes of YLDs in 2013:

1.  Low back pain
2.  Major depressive disorder
3.  Iron-deficiency anemia
4.  Neck pain
5.  Hearing loss
6.  Diabetes
7.  Migraine
8.  Chronic obstructive pulmonary disease
9.  Anxiety disorders
10.  Other musculoskeletal disorders

“Large, preventable causes of health loss, particularly serious musculoskeletal disorders and mental and behavioral disorders, have not received the attention that they deserve. Addressing these issues will require a shift in health priorities around the world, not just to keep people alive into old age, but also to keep them healthy,” said Vos.

This study was funded by the Bill & Melinda Gates Foundation.

Fatigue Often Stops RA Patients from Working

By Pat Anson, Editor

Fatigue and pain are the top reasons rheumatoid arthritis (RA) patients in the U.S. stop working, according to a new survey that found only about a third of RA patients are still employed full-time.

The “RA in America” survey of over 3,500 patients was conducted online by Health Union, a healthcare research and marketing company. It found that RA had a severe impact on patients’ quality of life, employment, and ability to afford treatment.

RA is a chronic and disabling autoimmune disease that causes pain and stiffness in joints. It affects about 1.3 million Americans and about one percent of the global population.

Ninety-four percent of respondents said they cannot do as much as they were able before acquiring the disease. Only 37% said they were still working full time.

Although fatigue is often overlooked as a symptom of RA, it had the greatest impact on the respondents’ ability to work – with 92% reporting they were tired while on the job. Pain, physical limitations, and a lack of understanding by colleagues also presented challenges.

“My biggest complaint is fatigue,” wrote one poster on a Health Union Facebook page.  “I am an invalid due to RA. I am in bed 24/7, I can't even sit up. I sleep a lot, not much else to do, but no matter how much I sleep, when I wake I'm exhausted. It's so crazy. I can sleep for 20 hours, and I'm exhausted the minute I open my eyes.”

“I was forced from my job because of exhaustion,” wrote another woman. “The meds contributed to the sleepiness, so I am careful about which I take. (I have) developed Lupus, OA and several related syndrome in addition to the RA.”

Many people who were surveyed said they were diagnosed with other conditions, including depression and anxiety (39%), high blood pressure (33%), fibromyalgia (32%) and migraine (25%).

Survey respondents also reported they needed help with daily activities, such as cleaning (75%) and other household chores (52%). Over a third (41%) needed assistance from a caregiver, which was typically a spouse, to help manage their RA.

"Many people do not know rheumatoid arthritis is a progressive, autoimmune disease and not the result of aging and wear on the body, like osteoarthritis the most common form of arthritis," said Andrew Lumpe, PhD, an RA patient. "Treatment can help slow the damage, but rheumatoid arthritis frequently alters the lives of both patients and their families."

The survey found some good news to report. Over a third (34%) of respondents said their RA had gone into remission at some point, usually for less than a year. Nearly three-fourths (74%) said the remission occurred after they began taking medication.

About half the survey respondents reported satisfaction with their treatments and only 21% were dissatisfied. Those on biologics, a newer and more expensive medication that can cost over $20,000 a year, had a slightly higher satisfaction rate. Over a third of respondents (38%) have avoided medications because of cost.

"The affordability of effective rheumatoid arthritis treatments is a serious concern," said Mariah Leach, an RA patient. "When you consider the burden this disease places on patients in terms of quality of life and employment, it is clear that supporting these individuals with treatment options can yield many benefits."

FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.