New Hope for Hard-to-Treat Migraine Patients

Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).

In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.

"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.

"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”

Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.

"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.

“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."

Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of world.

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. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.

Researchers Question Value of Brain Imaging

By Pat Anson, Editor

An international team of researchers is recommending against the use of brain imaging as a diagnostic test for chronic pain, saying the tests are “inappropriate and unethical.”

"It's not possible at this point in time to say with any degree of certainty that a person does or does not have chronic pain based on brain imaging," said Karen Davis, PhD, senior scientist at the Krembil Research Institute and a professor at the University of Toronto.

"The only way to truly know if someone is in pain is if they tell you because pain is subjective and it is a complex experience. No brain scan can do that."

In recent years, technological advances in brain imaging have led to an increased use of functional magnetic resonance imaging (fMRI) to search for brain-based biomarkers for chronic pain.

Demand for brain imaging is also growing for legal purposes, including the development of a potential “lie detector” test for chronic pain.

"Use of such tools would be inappropriate and unethical," said Davis. "This technology is not foolproof. There are vast issues of variability between people and even within a person at different times. As a result, brain imaging must not be used as a lie detector for chronic pain."

Davis and her colleagues say brain-based biomarkers should only be used to supplement -- not replace -- a patient’s own reports of pain, even if testing is improved and valid protocols developed. Their recommendations were published in the journal Nature Review: Neurology.

"We are working towards biomarkers for chronic pain, but the goal is not as a lie detector test but rather to help provide personalized pain treatment options for patients," Davis. “People outside of the field of imaging might be disappointed, but the fact of the matter is the technology cannot be used to support or dispute a claim of chronic pain."

According to a 2015 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 an fMRI to ease a patient’s fear that they may have a brain tumor or some other serious health problem. Doctors may also order a test to protect themselves in case of a lawsuit. About 1 to 3 percent of brain scans of patients with repeated headaches identify a cancerous growth or aneurysm.

University of Michigan researcher Brian Callaghan, MD, identified 74 neurological tests and procedures 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.”

Other researchers believe brain imaging can be used as a valuable diagnostic tool. In a small study at the University of Colorado Boulder, researchers used fMRIs to discover a “brain signature” that identifies fibromyalgia with 93 percent accuracy. They found three neurological patterns in the brain that correlate with the pain hypersensitivity typically experienced with fibromyalgia.

Noah the Narwhal: A Children’s Book About Migraines

By Jennifer Kilgore, Columnist

It’s not often that children’s books and chronic pain cross paths, but that is exactly what has happened in Noah the Narwhal, a new book from author Judith Klausner and illustrator Sarah Gould.

I was introduced to Judith by my old law school roommate, who was teaching a course at Boston University on anthropology and disability. She knew the author, who suffers from chronic migraines.

“Does anyone have any media contacts in the chronic pain circuit?” Judith asked. Well, my roommate certainly knew someone. Me!

Judith is a 31-year-old artist who lives in Somerville, Massachusetts, and this is her first book -- ever. You’d never know that by looking at it. The book is well written, slick, colorful and filled with friendly underwater characters who are brought to life in surprisingly little time. 

The story follows Noah, a narwhal whale who suffers from migraines (and who also wears a cute little sweater). I asked Judith why she chose narwhals.

“A couple reasons. One is that I kind of like the idea of a creature that unfortunately some people don’t realize is real,” she told me. (Embarrassing truth: I didn’t know narwhals were real until last year. My husband won’t let me forget this.) 

“Also, some people don’t think migraines are real,” Judith explained. “‘Eh, you have a headache. Get over it.’ I liked that analogy. Then, there’s the visual idea of the pain of a migraine. Noah wakes up with the feeling of a horn growing into his head. So that seems convenient! You just have to turn the horn inside out!”  She laughed.

“That, and narwhals are cool. They’re the unicorns of the sea.”

The story is fairly simple: Noah lives a great life and has wonderful friends, but he also has to deal with terrible migraines that drill into his head at unexpected moments. He tries to keep up with his family commitments, his job, and his social obligations, but his pain flares keep setting him back. At first, his loved ones don’t believe the pain can be all that bad, and they say, “But you were fine yesterday!”

“Today is not yesterday,” Noah keeps telling them. (I want to get that tattooed on my wrist.)

He also has adorable metaphors like, “My head feels like it’s full of sea urchins.”

Noah frets over leaving his friends and family in the lurch, but then they remember all the times that he was there when they needed him, and all the good that Noah has brought into their lives. They realize it doesn’t matter if Noah has to deal with migraines -- they love him, no matter what.

I cried when I read it.

Noah’s story parallels the points in Judith’s life that come out so strongly in the book. “It’s definitely pretty autobiographical,” she said. “I’ve had them (migraines) pretty much my whole life.”

In elementary school, Judith’s parents noticed a pattern and had the foresight to take her to a doctor when the migraines became more frequent and were accompanied by nausea. Eventually they were popping up multiple times a week, and auras started in high school.

The migraines kept a very strict pattern, arriving promptly in the evening at 5 o’clock. They never showed up more than three days in a row, so the fourth day was always clear. Then, in college, everything went off the rails. With no daily schedule, her migraines had no schedule, either -- they decided to strike whenever they wanted, lasting days in a row. Her doctors tried her on preventatives, which caused a host of side effects.

When asked how she dealt with college (she was a studio art major at Wesleyan College), Judith replied, “Not well.” She would let one class suffer each semester, in the hopes of just getting through with her degree.

After graduating, she fell into a depression and her friendships withered, because chronic migraines (having one a day for almost three years) interfered with any work or social schedule.

“With something like a chronic pain condition, you can’t schedule around it,” Judith said. “I was finding myself not able to do these things that everyone around me was doing. I thought I wasn’t strong enough, or smart enough, or I was too lazy, that there was something wrong with me, that I was the problem. And I had a lot of self-hatred around that time.”

Then she saw a migraine specialist who told her, “You know, you’re doing really well with what you have.”

“That was a really important thing for me to hear, at a really important time for me to hear it. Someone gave me permission to stop beating myself up so much,” Judith recalled.

It was out of these experiences that Noah was created. Judith always loved sculpting, writing and picture books. As she told me, “Picture books are not just for kids, and children’s books are a medium that have the opportunity to reach people at a formative age.”

Working from her couch, Judith put long hours into Noah the Narwhal, odds and ends that equaled a full-time job, though only when her body allowed. As those of us with chronic pain know, sometimes the demands of a full-time 9-5 job are impossible, a claim to which Judith can attest. 

For the artwork, she turned to her longtime friend, Sarah Gould. Their relationship goes back more than a decade. She works as a computer programmer on the west coast and earned a master’s degree in landscape architecture, but always wanted to work as an illustrator. The two of them thought that some sort of collaboration would be a fun long-distance project.

Sarah’s soft, precious, approachable artwork is the perfect complement to Judith’s words. Even when she was writing, Judith said she was imagining Sarah’s illustrations. 

Noah the Narwhal works because it is a simple story distilled into even simpler parts. Pain isn’t complicated. Doctors, medications, lab visits, insurance bills and prognoses -- those are complicated. At its core, though, pain is a feeling, a reaction, a response to stimuli. It’s a horn drilling into your head.

Judith understood this perfectly when writing the story. That’s why it works. As she said, “The more we can do to help people realize they aren’t alone, by understanding (chronic pain), the better.”

And it would do us all well to remember, today isn’t yesterday.

Noah the Narwhal is featured on PNN"s Suggested Reading list.

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer on her blog, Wear, Tear, & Care.  

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

Cannabis Formula Just as Effective as Migraine Drug

By Pat Anson, Editor

An experimental medication made from marijuana is just as effective as a widely used pharmaceutical drug in the treatment and prevention of migraine, according to two new studies by Italian researchers.

In the first study, a research team led by Dr. Maria Nicolodi found that combining two cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD), in a 200mg dose reduced acute pain by 55 percent in a group of 48 migraine sufferers. The medication, which was taken orally, contained 19% THC and 9% CBD.

In a second phase of the study, researchers then gave a group of 79 chronic migraine patients either the 200 mg THC-CBD combination or a 25mg dose of amitriptyline – a tricyclic antidepressant commonly used to treat migraine.

After three months of daily treatment, researchers found that the group taking the THC-CBD combination had a 40.4% reduction in migraine attacks, which was slightly better than the amitriptyline group (40.1%). 

The cannabinoids reduced migraine pain intensity by an average of 43.5 percent. Female patients also reported a decline in stomach ache, colitis and musculoskeletal pain.

"We were able to demonstrate that cannabinoids are an alternative to established treatments in migraine prevention,” said Nicoldi, who recently presented her findings at the 3rd Congress of the European Academy of Neurology in Amsterdam.

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.

Previous research has also found that cannabis is effective in treating migraines. A 2016 study by the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado found that inhaled and ingested cannabis significantly reduced the number of headaches in a group of migraine sufferers. Inhalation appeared to provide the fastest results, while the edible cannabis took longer to provide pain relief.

Hormone Changes Trigger Migraines in Girls

By Pat Anson, Editor

Changes in female hormones may trigger migraines in adolescent girls, but the frequency and severity of headaches depends on a girl's age and stage of puberty, according to a new study.

Researchers at the University of Cincinnati's College of Medicine and Cincinnati Children's Hospital Medical Center evaluated 34 girls between the ages of 8 and 17 who suffered from migraine.

They found that higher levels of the hormone progesterone were associated with fewer headaches in older teenagers, while lower levels of the hormone resulted in more headaches. In younger girls, the opposite appears to be true.

The findings are published online in Cephalalgia, the journal of the International Headache Society.

"Ours is the first study to show that migraine headaches might also be influenced by female hormones in girls with migraine," says Vincent Martin, MD, a professor and co-director of the Headache and Facial Pain Center at the University of Cincinnati’s Gardner Neuroscience Institute.

"While low and declining estrogen levels are thought to precipitate migraine in adult women, we found that progesterone (appeared) to be the most important trigger factor in these young girls. However, this effect seemed to differ depending on the age of the girls and their pubertal development."

Migraine affects about three times as many women as men. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.  

About 10 percent of school age children in the U.S. suffer from migraine, according to the Migraine Research Foundation (MRF). As adolescence approaches, the incidence of migraine increases rapidly in girls and by age 17 about 23 percent of girls have experienced migraine.

About two thirds of adult women will develop "menstrual migraine" -- migraine attacks that occur shortly before or during menstrual bleeding. Low and declining levels of estrogen are thought to trigger menstrual migraines. Prior to this new study the contribution of female hormones to migraine was unknown in girls and at what age they begin.

"There is a dramatic change in the way that female hormones affect migraine that occurs during puberty," said Martin. "Prior to puberty, progesterone has little effect on migraine, but after puberty high progesterone levels are associated with fewer headaches and low progesterone levels have more headache."

Girls aged 16 to 17 in the study had a 42 percent chance of having a headache when their progesterone levels were low, but when levels of the hormone were high the chance of headache dropped to 24 percent.

In the 8 to 11 age group, there was 15 percent chance of suffering from migraine or headache when levels of progesterone were low, but a 20 percent chance when high levels of progesterone

"Our study suggests that female hormones play an important role in triggering headaches in young girls and that their response to hormones seems to change at the time of puberty," says Martin. "Since migraine commonly begins during puberty in girls one might ask whether a change in response to hormones might represent the initiating factor for migraine in some girls -- kind of like the ‘big bang’ theory of migraine."

Common Medical Conditions Linked to Fibromyalgia

By Lana Barhum, Columnist

People with fibromyalgia are more likely than others in the general population to have other chronic conditions. But doctors have yet to figure out why fibromyalgia often coexists with other diseases – what’s known as “comorbidity.”

Fibromyalgia sufferers often have migraines, autoimmune diseases, irritable bowel syndrome, depression, anxiety and sleep disturbances. Having multiple overlapping conditions isn’t easy, and increases physical pain and suffering. 

It is important for all of us with fibromyalgia to learn about these conditions and their symptoms.  Being knowledgeable about them will help us and our medical providers better control our symptoms, pain and overall health. 

Here are several common medical conditions faced by people who also have fibromyalgia:

Migraines:  Research indicates migraine sufferers are more likely to have fibromyalgia. One study from 2011, published in The Journal of Headache and Pain, suggests migraine headaches may even trigger fibromyalgia. Researchers believe preventing migraine headaches could potentially stop or slow down the development of fibromyalgia in some people, or minimize symptoms in fibromyalgia sufferers.

"These results suggest different levels of central sensitization in patients with migraine, fibromyalgia or both conditions and a role for migraine as a triggering factor for FMS. Prevention of headache chronification in migraine patients would thus appear crucial also for preventing the development of fibromyalgia in predisposed individuals or its worsening in co-morbid patients,” Italian researchers reported.

Autoimmune Diseases:  In about 25% of cases, fibromyalgia co-exists with an autoimmune condition, according to the Centers for Disease Control and Prevention.  Two serious autoimmune diseases that may accompany fibromyalgia are rheumatoid arthritis (RA) and lupus. 

Other studies show at least 20% of RA patients also have fibromyalgia, but researchers have yet to understand the connection. The pain of RA can trigger fibromyalgia flares, worsen pain and symptoms, and vice versa. 

In 2016, researchers in the UK tried to determine whether RA patients who also had fibromyalgia had lower levels of joint inflammation.  The results of their study, published in BMC Musculoskeletal Disorders, determined RA patients with fibromyalgia had "widespread soft tissue tenderness but fewer clinically inflamed joints, have higher disease activity scores but may have lower levels of synovial [joint] inflammation."

The researchers suggested that different approaches to treatment may benefit these patients.

"These patients are less likely to respond to escalation of inflammation-suppressing therapy and may be more suitable for other forms of treatment including alternative means of pain control and psychological support,” they wrote.

It is also not uncommon for lupus and fibromyalgia to co-occur.  However, fibromyalgia is no more common in lupus than other autoimmune diseases, according to researchers out of the National Data Bank for Rheumatic Diseases. 

Depression and Anxiety: People with fibromyalgia frequently experience depression and anxiety.

According to a 2011 report published in the journal Pain Research and Treatment, 90% of fibromyalgia patients have depressive symptoms at least once, and 86% of those people may suffer from a major depressive disorder. Depression and fibromyalgia occur at the same time in at least 40% cases -- a connection that researchers are still trying to understand.

The prevalence of anxiety symptoms in fibromyalgia patients ranges from 13% to about 71%,  according to Portuguese researchers. 

Irritable Bowel Syndrome: A majority of fibromyalgia patients – up to 70% - also suffer from irritable bowel syndrome (IBS), a digestive disorder characterized by abdominal pain, cramping, bloating, diarrhea and constipation.

Sleep Disturbances:  Most people with fibromyalgia report problems sleeping.  No matter how long they sleep, theyrarely feel rested. Restless leg syndrome, non-restorative sleep, and sleep apnea are all sleep issues associated with fibromyalgia.

People with fibromyalgia are more likely to have restless leg syndrome (RLS) than others in the general population, according to a study from the American Academy of Sleep Medicine (AASM). RLS is a disorder that causes uncomfortable feelings in the legs and/or the urge to keep moving the legs. The AASM study, published in the Journal of Clinical Sleep Medicine, finds 33% of people with fibromyalgia also have RLS.  

Up to 90% of fibromyalgia patients experience non-restorative sleep, a feeling of not getting refreshing sleep, despite appearing to have slept.

A 2013 study published in Clinical and Experimental Rheumatology reports that 61% of men with fibromyalgia suffer from sleep apnea, as well as 32% of women. Sleep apnea is a serious sleep disorder where breathing is interrupted during sleep.  

Living with Fibromyalgia and Co-Existing Conditions                 

In addition to suffering from fibromyalgia, I also suffer from three co-existing conditions -- rheumatoid arthritis, depression, and anxiety.  Having both RA and fibromyalgia, I have struggled with more severe symptoms, including muscle and joint pain and cognitive issues.  I know dealing with this debilitating pain results in both depression and anxiety, and both have been frequent visitors to my life.   

I am aware of the effect multiple conditions have on my well-being, and work hard at improving my overall health. I know I can still have a good quality of life, despite the many obstacles that fibromyalgia and its multiple co-occurring conditions present. 

There are other conditions linked to fibromyalgia that I have not mentioned, but they are still significant. Understanding how fibromyalgia and these conditions coexist may someday help researchers develop better treatments for fibromyalgia. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

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.

Would This Meal Give You a Migraine?

By Pat Anson, Editor

The dinner on the right looks inviting – but to some people prone to migraines it could leave them with a bad headache.

Many migraine sufferers have learned to avoid or limit their consumption of foods and beverages that can cause a migraine attack. Wine, chocolate, coffee, nuts, and milk are often named as likely triggers, but did you know that some diets can actually help prevent migraines?

The role of diet in the treatment and prevention of migraine is poorly understood and somewhat controversial in the field of headache medicine because few rigorous studies have been performed.

In an effort to bring some clarity to the issue, two professors at the University of Cincinnati College of Medicine performed a comprehensive review of over 180 research studies on the subject of migraine and diet. Their two-part review, "Diet and Headache" is being published online in Headache: The Journal of Head and Face Pain. You can also see it by clicking here and here.

"One of the most important triggers for headache is the withdrawal of caffeine," says Vincent Martin, MD, a professor in the Department of Internal Medicine at the University of Cincinnati (UC) College of Medicine. “Let's say you regularly pound down three or four cups of coffee every morning and you decide to skip your morning routine one day, you will likely have full-fledged caffeine withdrawal headache that day."

Martin and co-author Brinder Vij, MD, an associate professor in the UC Department of Neurology and Rehabilitation Medicine, say there are two different approaches to preventing headaches with diet. The first is an elimination diet that avoids foods and beverages known to trigger headaches. The second approach is to adopt low fat and low carbohydrate diets that may actually help prevent headaches.

"The beauty of these diets is that they not only reduce headaches, but may produce weight loss and prevent heart disease," says Vij.

One of the most promising diets for those with frequent migraine attacks is one that boosts omega-3 fats while reducing omega-6 fatty acids. That means avoiding polyunsaturated vegetable oils (corn, sunflower, safflower, canola and soy) in favor of flaxseed oil. Foods that are rich in omega-3 fats include flaxseed, salmon, halibut, cod and scallops, while foods to avoid would be peanuts and cashews.

Martin and Vij say gluten-free diets are only helpful in lessening headaches if someone suffers from celiac disease, which can be established through a blood test or intestinal biopsy.

Other foods to avoid include anything with monosodium glutamate (MSG), a flavor enhancer used in many processed foods, including frozen or canned foods, soups, snack foods, salad dressing, seasoning salt, ketchup, barbecue sauce, and in some Chinese cooking.

"You eliminate it by eating fewer processed foods," explains Martin. "You eat more natural things such as fresh vegetables, fresh fruits and fresh meats. MSG is most provocative when consumed in liquids such as soups."

About 5 percent migraine suffers are likely to have an attack on days they consume nitrites, a preservative often used in processed meats such as bacon, sausage, ham and lunch meat. The use of both nitrites and MSG has declined, but Martin says checking food labels is a good idea.

Alcohol is another headache trigger for about a third of migraine sufferers, and studies suggest that red wines, especially those with high histamine content, are the worst. Interestingly, one study found that beer was associated with fewer headaches and migraines.

"Persons with headache and migraine have more dietary options than ever. Ultimately a healthy headache diet excludes processed foods, minimizes caffeine and includes a lot of fruits, vegetables, fish and lean meats,” Martin says.

Martin and Vij say identifying dietary triggers is challenging because there are so many different foods and ingredients that migraine sufferers are exposed to. They recommend keeping a food diary to help determine which foods to eliminate.

“It is not reasonable for persons with headache to avoid all know dietary triggers, as individuals may only be susceptible to a small number of foods or beverages,” they wrote. “The triggers could be identified by simple observation if the association is strong or through the use of a food diary if it is less obvious. The ideal would be to use a food diary as part of an app that would then determine statistically if a given food or beverage was associated with headache.”

Migraine affects about three times as many women as men. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

Migraine Drugs No More Effective Than Placebo for Kids

By Pat Anson, Editor

Two medications commonly prescribed to prevent migraines in adults are no more effective than a placebo when given to children and teenagers, according to a new study published in The New England Journal of Medicine.

Researchers affiliated with the Childhood and Adolescent Migraine Prevention (CHAMP) study randomly assigned 328 children and adolescents into three groups. One group received a daily dose of amitriptyline (Elavil), the second group received topiramate (Topamax), and the third group was given an ordinary sugar pill.

After 24 weeks, 52 percent of those taking amitriptyline and 55 percent of those taking topiramate had a 50 percent or more reduction in the number of headache days.

But the sugar pill was more effective, with 61% of the placebo group reporting their number of headache days reduced by 50 percent or more.

Researchers say the expectation of responding to a medication may have surpassed the pharmacological effects of taking a drug.

"The study was intended to demonstrate which of the commonly used preventive medications in migraine was the most effective. What we found is that we could prevent these headaches with either a medication or a placebo," says Andrew Hershey, MD, co-director of the Cincinnati Children's Headache Center and senior author of the study. "This study suggests that a multi-disciplinary approach and the expectation of response is the most important, not necessarily the prescription provided."

The children taking amitriptyline or topiramate had a significantly higher rate of side effects, including fatigue, dry mouth and, in three cases, mood alteration. About a third of those taking topiramate had paresthesia, a "pins and needles" tingling sensation in their hands, arms, legs or feet.

"The interpretation of these results is very challenging. In most situations, trials that fail to show benefit of an intervention do so because study participants do not improve. That was not the situation here. A majority of all study participants improved, regardless of their assigned treatment group," says Chris Coffey, PhD, a professor of biostatistics in the University of Iowa's College of Public Health, who was lead statistician for the study.

Researchers say further studies are needed identify the best ways to treat pediatric migraines. Simply prescribing sugar pill would be unethical without the patient’s knowledge.

"Our national team was hoping to develop evidence to drive the choice by medical providers of the first line prevention medication for helping youth with migraine, but the data showed otherwise, says Scott Powers, PhD, a pediatric psychologist and co-director of the headache center at Cincinnati Children's.

"We see this as an important opportunity for health care providers, scientists, children, and families because our findings suggest a paradigm shift. First line prevention treatment will involve a multidisciplinary team approach and focus on non-pharmacological aspects of care."

One of the non-pharmacological therapies being used is cognitive behavior therapy (CBT). While CBT has not been directly compared to a placebo for pediatric migraines, neurologists and psychologists say it can be a helpful component in pain care.

As many as one out of five teens suffers from migraines, but treatment options are limited compared to adults.  Last year the Food and Drug Administration approved two new treatments for pediatric migraine. Zonig is a nasal spray that provides pain relief in as little as 15 minutes, while Treximet is a medication that contains sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Both Zonig and Treximet have been available for years to treat adult migraine.

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. 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.

Do Scents Make You Sick?

By Pat Anson, Editor

One in three Americans suffers adverse health effects – such as migraines and asthma attacks – when exposed to air fresheners, cleaning supplies, perfume and other scented consumer products, according to a new study.

Researchers at the University of Melbourne polled over 1,100 Americans in an online survey and found that nearly all were exposed to fragranced products at least once a week at home, work, or in public places such as stores or hospitals.

Almost 35% reported adverse health effects such as breathing difficulties, migraine headaches, asthma attacks, skin rashes, dizziness, nausea, and other medical problems. For half of these individuals, the problems are so severe they are potentially disabling, as defined by the Americans with Disabilities Act.

"This is a huge problem; it's an epidemic," said Professor Anne Steinemann of the University of Melbourne School of Engineering, who is an expert on the health effects of environmental pollutants.

"Basically, if it contained a fragrance, it posed problems for people."

The study found that fragranced products may affect the bottom lines of many businesses. Over 20 percent of respondents said if they entered a store or business and smelled an air freshener or some fragranced product, they would leave as quickly as possible. And more than twice as many customers would choose hotels and airplanes without fragranced air than with fragranced air.

In the workplace, over 15% of respondents said they became sick, lost workdays or even lost a job due to exposure to fragranced products. Over half said they would prefer fragrance-free workplaces and health care facilities.

Even hygiene is impacted by fragrances. Nearly one in five said they are unable or reluctant to use toilets in public places because of the presence of an air freshener, deodorizer or scented product. And 14 percent said they would be reluctant to wash their hands in a public restroom because the soap might be scented.

“Adverse effects resulting from exposure to fragranced products, such as in workplaces and public places, raise concerns about liability,” said Steinemann. “For instance, individuals can suffer acute health effects, such as an asthma attack, if they enter a restroom that uses air fresheners. If they are unable to access a restroom due to the presence of an air freshener, then that poses a potential violation of the Americans with Disabilities Act.”

Two out of three survey respondents were not aware that fragranced products often emit hazardous air pollutants such as formaldehyde, and 72% were not aware that even so-called natural, green, and organic fragranced products emit hazardous air pollutants.

“Fragranced product manufacturers are not required to disclose all ingredients in their formulations. This lack of disclosure can impede efforts to understand and reduce adverse effects associated with potentially harmful compounds,” Steinemann wrote. “Further, we lack knowledge on which specific chemicals or mixtures of chemicals are associated with the adverse effects, and this is an important area for research.”

The study findings are published in the journal Air Quality, Atmosphere & Health.

Experimental Drug Reduces Migraine Days by Half

Pat Anson, Editor

An experimental injectable drug reduces the number of migraine days by 50 percent or more in patients who suffer from chronic migraine, according to the results of a new study released by drug makers Amgen and Novartis.

The Phase II study of AMG 334 -- also known as erenumab – involved 667 patients who suffered an average of about 18 migraine days per month.  A reduction of 50% or more in monthly migraine days was observed in four out of ten patients taking a 140 mg dose of erenumab. Patients taking a 70 mg dose had a 40% reduction in migraine days compared to a placebo drug. 

Significant improvements were also noted in quality of life, headache impact, disability, and pain interference compared to the placebo.

“Chronic migraine patients lose more than half of their life to migraines with 15 or more headache days a month, facing intolerable pain and physical impairment,” said Stewart Tepper, MD, a professor of neurology at the Geisel School of Medicine at Dartmouth. “As a neurologist, these findings are exciting because they demonstrate that erenumab could serve as an important new therapy option for reducing the burden of this often-disabling disease.”

Erenumab is not an opiate and falls under a newer class of medications – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate.

“Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine,” said Sean Harper, MD, executive vice president of Research and Development at Amgen, which is co-developing the drug with Novartis.

“The results from this global chronic migraine study are exciting because they support the efficacy of erenumab for a patient population that has had few therapeutic options.”

Results from two Phase III studies of erenumab for episodic migraine are expected later this year. If positive results are achieved, that could lead to a new drug application with the Food and Drug Administration.

"This is an exciting time in the treatment of chronic migraine, which has a profound impact on the lives of those who suffer from the disease," said Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options."

Under its agreement with Novartis, Amgen holds sales rights for erenumab in the United States, Canada and Japan, while Novartis would sell the drug in Europe and the rest of the world.

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.

Many Multiple Sclerosis Patients Misdiagnosed

By Pat Anson, Editor

Multiple Sclerosis (MS) is a chronic disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue. Patients diagnosed with MS face enormous physical, emotional and financial challenges coping with a disease that cannot be cured.

Many also discover that they don’t actually have MS.

A new study published in the journal Neurology looks at 110 patients who were incorrectly diagnosed with MS when they actually suffered from more common and treatable conditions such as migraine and fibromyalgia.   

One third of the patients were misdiagnosed for a decade or longer, most took unnecessary and potentially harmful medication to treat a disease they didn't have, and some even participated in clinical trials for experimental MS therapies.

About a third suffered from “unnecessary morbidity” – morbid thoughts of death.

"Misdiagnosis of MS is common; patients may experience common MS symptoms, such as numbness and weakness with a variety of different conditions, many that are more common and less serious than multiple sclerosis," says the study's senior author Brian Weinshenker, MD, a neurologist at Mayo Clinic.

"With the advent of treatments for MS, many physicians feel pushed to reach an early diagnosis, and may be less strict than they should in requiring more specific symptoms or objective neurological findings before making a diagnosis of MS.”

Unlike other chronic illnesses, there is no specific biomarker or blood test for MS. The nerve damage caused by MS is also associated with a wide range of symptoms, many of which are also caused by other conditions such as Lyme disease, lupus, fibromyalgia, and Vitamin B12 deficiency.

Some diagnostic tests for MS, such as magnetic resonance imaging (MRI), can also be misinterpreted.

“Nonspecific MRI abnormalities that can mimic those of MS are very common in healthy individuals, and widespread use of MRI as a diagnostic tool increases the rate of misdiagnosis," said Weinshenker.

The 110 patients included in the study were identified by MS subspecialist neurologists at Mayo Clinic, University of Vermont, Washington University and Oregon Health & Science University.

Twenty two percent of the misdiagnosed patients actually had migraine; 15% had fibromyalgia; 12% had a nonspecific condition flagged by an abnormal MRI; 11% had a conversion or psychogenic disorder; and 6% had neuromyelitis optica spectrum disorder.

"This study suggests significant and long-term unnecessary risks for these patients," said lead author Andrew Solomon, MD, a neurologist at the University of Vermont College of Medicine. "While there may be different reasons for misdiagnoses by subspecialists and nonspecialists, this study suggests that we all make mistakes, and I think we can all do better.”

A previous survey of MS specialists found that more than 95% had seen at least one patient in the past year that was misdiagnosed with MS by another provider.

Some treatments for MS carry serious side effects. One drug, taken by 13 percent of the misdiagnosed patients in the current study, can cause a potentially fatal brain infection. Other patients suffered from the discomfort and inconvenience of daily injections; others experienced side effects from medications or lacked treatment for the conditions they actually had.

There are also enormous financial costs involved. The cost of medications to treat MS in the United States now exceeds $50,000 a year.

"Premature diagnosis of MS should be avoided," says Weinshenker. "When in doubt, physicians often can defer a diagnosis if it is not clear that there is a serious neurological problem or if a patient is stable. Physicians should request a second opinion when they are unsure but concerned that it might be harmful to delay a definitive diagnosis of MS."

Weinshenker and Solomon hope their study will encourage better education of clinicians on the proper use of MS diagnostic criteria and to further studies on how to recognize patients incorrectly diagnosed with MS.

Updated Device Helps Prevent Migraines

By Pat Anson, Editor

A new pocket-sized wearable device is available to help treat and prevent migraine headaches.

Cefaly Technology has released the Cefaly II, an updated version of the Cefaly I, which is worn over the forehead like a headband and uses small electrical impulses to stimulate the trigeminal nerve, which has been associated with migraine headaches.

The Cefaly II is much smaller and fits in the palm of a hand. Like its predecessor, the device is worn on the forehead, but is held more securely in place by a magnet. Because of its smaller size, the manufacturer believes the Cefaly II will be more accessible and easier to use.

“This compact device is so easy to tuck in a pocket or purse and I am hopeful it will further increase compliance and bring an even larger reduction in migraine attacks to patients,” said Dr. Pierre Rigaux, Chief Executive Officer of Belgium-based Cefaly Technology.

“Now that the device is so small, it’s a big deal because patients can have their Cefaly II with them wherever they go, which means they’ll be able to use it more readily, at their most convenient time.”

cefaly technology image

The Cefaly II uses a magnet to attach itself to a self-adhesive electrode worn directly on the forehead. The rechargeable, battery powered device sends tiny electrical impulses through the skin to desensitize the upper branches of the trigeminal nerve and reduce the frequency of migraine attacks. Patients have full control of their daily 20-minute session and can ramp up the intensity to their own comfort level.

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

The electrode and output of the Cefaly II is identical to the Cefaly I, according to the company.

Here’s a company produced video of how the Cefaly II works:

The Cefaly II is only available by prescription and costs $349, with a 60-day money back guarantee. The device can be ordered online by clicking here. The Cefaly I will no longer be offered, but the electrodes for it will be available for another 5 years. Cefaly Technology has sold about 20,000 of the devices in United States and 80,000 outside the U.S.

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.

My 50 Years with Chronic Pain

By Carol Hansen, Guest Columnist

I am a 71 year old woman living with chronic pain.  When I was in my 20’s I started having severe migraine headaches, at least two per month.  It was hard to do anything. They lasted at least 3 days, leaving me wiped out!

I also cared for my grandparents in my home until they died. My grandmother also had migraines when she was younger.  She shared with me that when I got older my headaches would go away and she was correct.

I had some aunts that had fibromyalgia, which at that time no one knew what it was.  I knew my grandmother’s pain level was high, because she was on opiates.  Her doctor gave her a high dose so she was hooked on these medications. 

Doctors used to prescribe a lot of pain medication, thinking that was all they could do for pain patients. Even then they did not want to deal with us. I was always afraid of pain medication because I observed my grandmother’s life.  After my grandparents passed away our lives naturally changed.

We enjoyed time with our young family.  Still my migraines were very hard on me and fibromyalgia slowed me down.  Yet I still had bluebirds and was a Sunday school teacher, along with a full schedule helping teachers and caring for my children.

In 1981, I was trying to start the heater in our camper when the camper blew up, leaving me with third degree burns. The company that repaired our camper had left all the gas lines disconnected.  More stress, and we filed a lawsuit.  This added to my migraines and my fibromyalgia was very painful.

In 1983, my wonderful husband died leaving me with teenagers.  My body reacted in what I thought was an unusual way.  I felt as if I couldn’t stay still. I had to be moving all the time and at night sleep didn’t come.  This went on for at least two years, while increasing fibromyalgia pain. 

After my husband died I felt that if I had a business it might help me through the grief.   After much thought I started a small business, it is now 30 years old with multi-layered experiences.  Because of my unique business I was asked by two magazines to write a monthly article which I did. 

My church asked me to lead a group and host a family of 7 immigrants (boat people from Vietnam). I was in charge of them for several years.  As much as I loved the family, I had to use tough love and slowly stopped helping them to let me go and begin their own lives, as families should.  Knowing this family is a wonderful story that added happiness to our lives. I did all this through my pain.

My neck was so bad I was losing the use of my left arm. There was more pain and it was getting harder to deal with my business.  During this time I met a second wonderful man.  We saw each other for 6 years before we married. 

I saw a doctor about my neck pain.  When the camper exploded, I hit the back of my neck on the counter edge.  I didn’t know at first that I had hurt my neck because the burns were so bad.  My neck had a dent in the vertebrae’s and was collecting calcium deposits. Over time I ended up having three surgeries on my neck.  They couldn’t get all the calcium out because it was too close to the spinal cord and I could have been paralyzed.

Right after one of the surgeries I ended up back in the hospital with mononucleosis and hepatitis.  It made healing much harder and the pain became chronic along with fibromyalgia.  I saw a rheumatologist in Seattle.  We tried Lyrica and Cymbalta, but I had terrible side effects. 

I was asked to take part in a University of Washington fibromyalgia study that lasted several months.  I roller skated 4 miles around Green Lake every day. I was in great shape and was doing this through all the pain. I tried biofeedback and swimming twice a week.  I also have a TENS machine, but that only helps while you’re on it. 

I tried everything to help the pain.  My rheumatologist recommended I take oxycodone three times a day.  They helped me but it was not a time release so it would not decrease pain evenly.  When OxyContin became available, my doctor suggested I try it. I now take OxyContin three times a day.  He also gave me the oxycodone for breakthrough pain.  I started this program in the early 1990’s and have been on the same dose ever since, never asking for more or stronger medication.  It helps control about 75% of my pain.  Sometimes I forget to take the medication and I hurt a lot.  This medication is not addicting like the pills my grandmother took.  I am not addicted, I am dependent!

I have had several other surgeries, including two that failed.  One surgery was on my left foot and the doctor left my foot deformed; he is no longer practicing.  In 2013 I had a total knee replacement and it was a complete failure. I have problems going up and down stairs, and it is now my biggest pain area.  I am also diabetic and have osteoarthritis in my hands and hips. 

My pain is very chronic, there is no way to exercise or do other things recommended by the CDC. I’ve already tried them. The pain medication is the only relief I will ever have.

In 2001, we moved from Seattle to northern Idaho.  No doctor there wanted to deal with a new pain patient, so we were traveling 800 miles round trip back to Seattle every 3 months. Then my doctor retired. The doctor that replaced him left for another clinic because he didn’t want to deal with my doctor’s patients.  The doctor that took his place said she would not prescribe pain medication.  I got a letter saying they did not want me as a patient – even though I was a great patient staying with the same doctor for many years. In fact, they kicked out ALL pain patients from that clinic!

I did eventually find a pain clinic near us. So far they are keeping me on the same program as my retired doctor had me on.

The CDC, FDA and the Obama administration are telling doctors to take pain medication away from us. They are lumping pain patients in with addicts and causing horrible problems.  Doctors don't want to deal with us. Whatever happened to "Do No Harm"? 

Carol Hansen lived in Idaho. She invites people to learn more about chronic pain by reading "Opioid Epidemic Myths" and this Petition2Congress.

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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Migraines Linked to Low Levels of Vitamin D

By Pat Anson, Editor

Low levels of Vitamin D have been associated with fibromyalgia, rheumatoid arthritis, multiple sclerosis and other chronic pain conditions. And new research suggests the “sunshine vitamin” may play a role in preventing migraines.

Researchers at Cincinnati Children's Hospital Medical Center found that a high percentage of children, teens and young adults with migraines appear to have mild deficiencies in vitamin D, riboflavin and coenzyme Q10. The latter is a vitamin-like substance found in cells that is used to produce energy for cell growth and maintenance.

"Further studies are needed to elucidate whether vitamin supplementation is effective in migraine patients in general, and whether patients with mild deficiency are more likely to benefit from supplementation," says Suzanne Hagler, MD, a Headache Medicine fellow in the division of Neurology at Cincinnati Children's Hospital Medical Center. She presented her findings at the annual meeting of the American Headache Society in San Diego.

Hagler studied a database of patients with migraines who had their blood levels checked for vitamin D, riboflavin, coenzyme Q10 and folate, all of which have been linked to migraines in previous and sometimes conflicting studies.

Many of the patients were put on migraine medications and received vitamin supplementation, if their blood levels were low. Because few received vitamins alone, the researchers were unable to determine if vitamin supplements by themselves were effective in preventing migraines.

Hagler found that girls and young woman were more likely than boys and young men to have coenzyme Q10 deficiencies. Boys and young men were more likely to have vitamin D deficiency. Patients with chronic migraines were more likely to have coenzyme Q10 and riboflavin deficiencies than those with episodic migraines.

Vitamin D helps control levels of calcium and phosphate in the blood and is essential for the formation of strong bones and teeth. Vitamin D also modulates cell growth, improves neuromuscular and immune function, and reduces inflammation

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Danish researchers found that exposure to sunlight may delay the onset of multiple sclerosis (MS). Patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors.

Low levels of serum vitamin D were found in over 1,800 fibromyalgia patients in a recent meta-analysis (a study of studies) published in the journal Pain Physician. Researchers at National Taiwan University Hospital found a “positive crude association” between chronic widespread pain and hypovitaminosis D.

Pain News Network columnist Crystal Lindell began taking Vitamin D supplements when her blood levels were found to be very low. Within a few months she was feeling better, exercising more, and losing weight. You can read Crystal’s story by clicking here.

New Treatments Offer Hope to Migraine Sufferers

By Pat Anson, Editor

Findings from several new clinical studies could pave the way for new treatments that could someday prevent and lessen the severity of migraines.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. Although there are many treatment options available, most migraine sufferers are not fully satisfied with their effectiveness.

Teva Pharmaceuticals (NYSE: TEVA) is developing a new injectable drug – called TEV-48125 – that is designed to be injected monthly in chronic migraine sufferers who have headaches at least 15 days per month.

"Chronic migraine affects about 1 percent of all adults, yet less than 5 percent of those people receive a correct diagnosis and appropriate treatment," said study author Marcelo Bigal, MD, of Teva Pharmaceuticals. "Most people who receive preventive medication for chronic migraine stop using them, and one reason for that is the drugs can take a long time to become effective.”

In findings published online in the journal Neurology, Bigal reported that TEV-48125 was effective in reducing the length of headaches three to seven days after the first injection. The drug contains an antibody that blocks the calcitonin gene-related peptide that plays a role in migraine pain.

Teva’s Phase II study involved 261 people with chronic migraine who were divided into three groups; one group received a monthly shot for three months with a low dose of TEV-48125, the second group received a high dose and the third group received a placebo shot. Participants then used an electronic diary to record the number and length of their headaches.

After one week, the average number of headache hours went down by 2.9 hours for people taking the placebo, 9.1 hours for people taking the low dose of TEV-48125 and 11.4 hours for those taking the high dose.

After two weeks, the number of days with moderate or severe headaches, fell by 0.8 days for patients getting the placebo, 1.3 days for the low dose and 1.5 days for the high dose of TEV-48125.

“If these results can be confirmed with larger studies, this could be exciting for people with migraine," said Bigal.

Amgen Injectable Migraine Drug

Amgen (NASDAQ: AMGN) and Novaratis (NYSE: NVS) are also developing a monthly injectable drug --- called erenumab – which contains an antibody that blocks a peptide receptor that is believed to transmit migraine pain signals.

In a Phase II study, 667 chronic migraine patients were injected with a placebo or two different doses (70 mg or 140 mg) of erenumab. At the start of the study, patients were experiencing about 18 migraine days per month.

Patients who received erenumab at either dose experienced an average 6.6-day reduction in migraine days, compared to a 4.2-day reduction in those who receive a placebo. Less than five percent of the  patients treated with erenumab had a side effect, such as injection site pain, upper respiratory tract infection and nausea.

Erenumab is currently under evaluation in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention. Amgen expects results from a Phase III study of erenumab in the second half of 2016. Depending on the findings, that could result in an early new drug application to the Food and Drug Administration.  

Clinical studies presented this week at the annual meeting of the American Headache Society also highlighted some promising new migraine treatments.

Alder BioPharmaceuticals presented data showing that a single injection of a drug called ALD403 reduces migraine for up to six months. In a recent Phase II study of patients with chronic migraine, ALD403 significantly reduced migraines by 75 percent in up to a third of patients. 

“A 75 percent reduction in migraine days for these patients means a reduction of 12 or more migraine days each month,” said Jeffrey T.L. Smith, MD, Senior Vice President at Alder. “This equates to giving patients back roughly two weeks of their lives after a single administration.”

Researchers at Montefiore Medical Center and Albert Einstein College of Medicine reported results from a placebo controlled study on the efficacy of ubrogepant in treating a single migraine attack. Patients who received ubrogepant reported a reduction in headache severity from severe or moderate to mild or none within two hours.

Ubrogepant is free of known cardiovascular risk and may provide an important treatment option for patients who suffer from cardiovascular disease. 

Migraine affect 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.