New Study Finds Images Placed In Front Of Smartphone Screen Increase Visual Discomfort

Several reports indicate that prolonged viewing of mobile devices and other stereo 3D devices leads to visual discomfort, fatigue and even headaches. According to a new Journal of Vision study, the root cause may be the demand on our eyes to focus on the screen and simultaneously adjust to the distance of the content.

Scientifically referred to as vergence-accommodation, this conflict and its effect on viewers of stereo 3D displays are detailed in a recent Journal of Vision article, The Zone of Comfort: Predicting Visual Discomfort with Stereo Displays.

"When watching stereo 3D displays, the eyes must focus - that is, accommodate - to the distance of the screen because that's where the light comes from. At the same time, the eyes must converge to the distance of the stereo content, which may be in front of or behind the screen," explains author Martin S. Banks, professor of optometry and vision science, University of California, Berkeley.

Through a series of experiments on 24 adults, the research team observed the interaction between the viewing distance and the direction of the conflict, examining whether placing the content in front of or behind the screen affects viewer discomfort. The results demonstrated that with devices like mobile phones and desktop displays that are viewed at a short distance, stereo content placed in front of the screen - appearing closer to the viewer and into the space of viewer's room - was less comfortable than content placed behind the screen. Conversely, when viewing at a longer distance such as a movie theater screen, stereo content placed behind the screen - appearing as though the viewer is looking through a window scene behind the screen - was less comfortable.

"Discomfort associated with viewing Stereo 3D is a major problem that may limit the use of technology," says Banks. "We hope that our findings will inspire more research in this area."

The team of investigators suggests future studies focus on a larger sample in order to develop population-based statistics that include children. With the explosion of stereo 3D imagery in entertainment, communication and medical technology, the authors also propose guidelines be established for the range of disparities presented on such displays and the positioning of viewers relative to the display.

"This is an area of research where basic science meets application and we hope that the science can proceed quickly enough to keep up with the increasingly widespread use of the technology," adds Banks.

Source:
Katrina Norfleet
Association for Research in Vision and Ophthalmology

Behavioral Treatment For Migraines A Cost-Effective Alternative To Meds

Treating chronic migraines with behavioral approaches - such as relaxation training, hypnosis and biofeedback - can make financial sense compared to prescription-drug treatment, especially after a year or more, a new study found.

Longtime behavioral therapy researcher and practitioner Dr. Donald Penzien, University of Mississippi Medical Center professor of psychiatry, coauthored the study. He said the costs of prescription prophylactic drugs - the kind chronic migraine sufferers take every day to prevent onset - may not seem much even at several dollars a day.

"But those costs keep adding up with additional doctor visits and more prescriptions," Penzien said. "The cost of behavioral treatment is front-loaded. You go to a number of treatment sessions but then that's it. And the benefits last for years."

Published in the June issue of the journal Headache, the study compared the costs over time of several types of behavioral treatments with prescription-drug treatments. The research team included investigators from Wake Forest University, UMMC and the University of Mississippi.

The researchers found that after six months, the cost of minimal-contact behavioral treatment was competitive with pharmacologic treatments using drugs costing 50 cents or less a day. Minimal-contact treatment is when a patient sees a therapist a few times but largely practices the behavioral techniques at home, aided by literature or audio recordings.

After one year, the minimal-contact method was nearly $500 cheaper than pharmacologic treatment.

"We have a whole armamentarium of behavioral treatments and their efficacy has been proven. But headache sufferers are only getting a tip of these options," said Dr. Timothy Houle, associate professor of anesthesiology and neurology at Wake Forest University, and the study's principal investigator.

"One reason is people think behavioral treatment costs a lot. Now with this study, we know that the costs are actually comparable, if not cheaper, in the long run."

At a time when health-care costs are under national scrutiny, the study offers a framework for comparing costs that researchers can update and use for years to come.

"We thought, 'Wouldn't it be fun to model this and see how it comes out over time?'" Penzien said. "All the figures are there so if someone disagrees with it, they can plug in their own numbers."

The researchers didn't compare the effectiveness of methods, nor did they calculate the costs over time of individual drugs, since dosages and prices vary widely. Rather, they figured the per-day costs of each method based on fees of physicians and psychologists. For the physician group, they added in the cost of prescription beta-blocker drugs at various prices.

For instance, among the psychologists surveyed, one-on-one behavioral sessions cost between $70 and $250 for the intake visit and $65 and $200 for follow-up visits. That put the median intake cost at $175 and median follow-up cost at $125 for a median 10 visits.

The researchers calculated the median cost of pharmacologic approaches at $250 for the intake session and a professional fee of $140 per session. Median time to the first follow-up was 52.2 days, rising to 60 for the second with a median five visits per year.

To get information on behavioral treatments, the researchers surveyed members of the Behavioral Issues Group of the American Headache Society. For figures on pharmacologic treatments, the researchers surveyed a group of Headache Society-member physicians they knew treated substantial numbers of headache sufferers.

The most expensive behavioral treatment method - individual sessions with a psychologist in clinic - cost more than pharmacologic treatment with $6-a-day drugs in the first months. But at about five months, individual sessions become competitive. After a year, they are cheaper than all methods except treatment with drugs costing 50 cents or less a day.

Overall, group therapy and minimal-contact behavioral treatment were cost-competitive with even the cheapest medication treatment in the initial months. At one year, they become the least-expensive headache treatment choice.

Grant funding from the National Institute of Neurological Disorders and Stroke supported the research.

Source:
Jack Mazurak
University of Mississippi Medical Center

Migraine Rates Up For No Apparent Reason

Migraine rates in a comprehensive Norwegian health study have climbed by 1% in a decade -- that may not sound like much, but in the Norwegian context, it means 45,000 more migraine sufferers -- and if the trend were to hold for the European Union, that would be an additional 5 million more people plagued by migraines. Researchers at the Norwegian University of Science and Technology (NTNU) are baffled by the cause of this trend.

The findings, in which researchers compared data from a survey conducted in the mid-1990s to data collected in 2006-2008, shows that people aged 20-50 years are more prone to migraines now than in the mid 1990s.

The numbers are derived from the second and third phases of the Nord-Trøndelag Health Study, called HUNT 2 and 3 after their Norwegian acronyms, which represents one of the largest comprehensive health studies in the world. HUNT 2 involved the collection of a health history during 1995-1997 from 74,000 people, with the collection of blood samples from 65,000 people. The follow-up in 2006-2008, called HUNT 3, involved 48,289 people, many of whom were represented in the earlier study.

The findings showed that while 12 per cent of the population met the medical criteria for having migraine headaches in the HUNT 2 survey, 13 per cent of the HUNT 3 respondents 11 years later met the medical criteria for having migraines.

While that 1 per cent increase "may not sound dramatic, in the context of the population as a whole, that represents an increase of roughly 45 000 Norwegians," says Professor Knut Hagen, one of the NTNU researchers working with the data. "Those are real numbers and give some cause for concern. The increase has also occurred over a relatively short period of time."

The increase is most marked in the age group 20-50 years, but is also found in older age groups. Hagen does not have data for people younger than 20.

The most puzzling aspect of the finding is that it has no obvious scientific explanation, Hagen says. Diagnostic criteria were the same in the 1990s as they are today, and the level of self-reported migraine did not increase. The number of migraines caused by medicines has also not increased between the HUNT 2 and HUNT 3 databases, he said.

"This last finding is really good news because the use of pain relievers has risen sharply since these drugs have been available for sale in stores without a prescription," says Hagen.

A more likely explanation for the increase in migraines is a change in the external environment, Hagen says.

"From experience we know that visual impacts, such as flickering screens, can trigger migraines. Measurements of the neurophysiological activity in the brain with EEG shows that migraine patients are more susceptible to light stimulation. It is tempting to believe that the increase in migraines is due to the increase in these kinds of stimuli during the 11 years between the two HUNT surveys," Hagen says. "But this is speculation that we have no scientific evidence for."

But Hagen was clear that one possible candidate radiation from mobile devices was not a cause of the increase, based on the results of a previous NTNU study, which found no evidence that radiation from mobile phones contributed to an increase in headaches.

Sources: The Norwegian University of Science and Technology (NTNU), AlphaGalileo Foundation.

Nautilus Neurosciences And Tribute Pharmaceuticals Announce Exclusive Canadian License For CAMBIA™

 (diclofenac Potassium For Oral Solution)

Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Tribute Pharmaceuticals, a privately-held Canadian specialty pharmaceutical company, announced today their exclusive license agreement for the commercialization of CAMBIA™ (diclofenac potassium for oral solution) in Canada. CAMBIA™ is approved in the United States for the acute treatment of migraine with or without aura and was launched in the United States in June 2010.

"Canada is an important pharmaceutical market and opportunity for CAMBIA," said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada. This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA™ to the broader North American market and reach more people suffering from acute migraine headaches. We look forward to completing the expansion of our efforts through the addition of a partner for the family practice market in the United States in 2011."

Rob Harris, President & CEO of Tribute Pharmaceuticals points out that, "According to IMS, the prescription drug market in Canada for treating migraine headaches is valued at approximately one hundred and fifty million dollars." Many Canadians who suffer from migraines are dissatisfied with their current medication and hope for a better treatment. "Tribute Pharmaceuticals is very excited about the potential for CAMBIA™ in Canada and we look forward to building a strong partnership with Nautilus Neurosciences."

According to a survey published in the Journal of the American Board of Family Medicine, many people still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of people who suffer migraines describing themselves as "very satisfied" with their treatment.

A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA™ is the only prescription non - steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine. Engineered using Dynamic Buffering Technology™ (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., CAMBIA™ is specifically designed for fast, effective relief from the symptoms of migraine. CAMBIA™ enters the bloodstream quickly and readily achieves peak plasma concentrations, providing pain relief in fifteen minutes for some patients.

Unites States Indication

CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.

CAMBIA is not indicated for prophylactic therapy or for cluster headache.

Important Safety Information (United States)

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS NSAIDs, including CAMBIA, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery. NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.

Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.

CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with preexisting asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactic reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactic reaction occurs.

Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.

Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (eg, acetaminophen, certain antibiotics, antiepileptics). Warn patients to avoid acetaminophen containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac, and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.

NSAIDs can lead to new onset or worsening of preexisting hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.

Using CAMBIA with other NSAIDs (eg, aspirin) or with anticoagulants (eg, warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.

NSAIDs, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.

CAMBIA can harm fetuses. Starting at 30 weeks' gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.

The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.

Source: Nautilus Neurosciences, Inc

Blood Pressure, Glaucoma Links In Migraine Patients; Eye Care Goes Digital And Mobile

Data on glaucoma risk in people with migraine and on innovative uses of mobile, digital technology were featured in the Scientific Program yesterday (Oct.17), presented at the 2010 American Academy of Ophthalmology (AAO) - Middle East-Africa Council of Ophthalmology (MEACO) Joint Meeting. The AAO-MEACO meeting is in session October 16 through 19 at McCormick Place, Chicago. It is the largest, most comprehensive ophthalmic education conference in the world.

The Blood Pressure-Glaucoma Connection in People with Migraine

Yury S Astakhov, MD, PhD, of Pavlov Medical University, St. Petersburg, Russian Federation, studied how day- and at night-time blood pressure levels may be related to the development of glaucoma in people with migraine. Understanding such effects is important for doctors in determining how to treat patients with multiple diseases.

Migraine is a known risk factor for open-angle glaucoma, a disease that can cause blindness due to damage to the optic nerve. The association between the two is stronger for people with "normal tension" glaucoma (NTG), in which the pressure within the eye is normal but optic nerve damage occurs nonetheless. It is also known that glaucoma patients who have low blood pressure at night are more likely to develop visual field loss (reduction of the full range of vision, which occurs first in the peripheral vision).

Dr. Astakhov's team compared day- and night-time systolic and diastolic blood pressures in 12 patients who had migraine and glaucoma (8 with NTG) against 16 patients with migraine but no glaucoma. The only significant difference between the groups was in night time diastolic pressure: migraine patients with glaucoma had excessive decreases - more than 20 percent - in their diastolic pressure levels.

"We conclude that low diastolic blood pressure at night is a possible risk factor for glaucoma in patients with migraine," Dr. Astakhov said.

iPhone Images: Good Enough for Medical Use?

Like the rest of society, medicine increasingly relies on digital systems and mobile devices to manage work flow and enhance communications. Eye M.D.s (ophthalmologists) routinely evaluate internet-transmitted images of patients' eyes as part of diagnosis and treatment. Usually images are viewed at computer workstations with standard display screens. University of Pittsburg School of Medicine researchers wondered whether handheld devices like the iPhone would work equally well.

In the study, Eye M.D.s from the University of Pittsburg Eye Center evaluated three aspects of diabetic retinopathy, a potentially blinding disease that affects many people with diabetes, by reviewing both the standard computer monitor and iPhone images for 55 patients (110 eyes). The doctors then made recommendations for follow up treatment.

"We found high consistency - more than 85 percent agreement - between evaluations based on the standard computer monitor and on the iPhone for all image sections tested," said Dr. Michael J. Pokabla. "There were no significant differences between evaluations and recommendations using the two systems, and the doctors rated the iPhone images as excellent. We conclude that mobile devices like the iPhone can be used to evaluate ophthalmic images," he added.

No Eye M.D. in the House? Videoconferencing Brings the Expert to the Outback When no ophthalmologist is available on site, some emergency rooms (ERs) in remote medical centers in rural Australia now use videoconferencing to receive diagnosis and treatment advice for their eye injury and ophthalmic illness patients.

A telecommunication link at a major metropolitan teaching eye hospital, the Royal Victorian Eye and Ear Hospital (RVEEH), is connected with four ERs that serve large regions of rural Australia. Dr. Christolyn Raj and her team studied the effectiveness of this approach by reviewing the initial six months of RVEEH videoconference interactions with the regional ERs.

Diagnoses were altered in approximately 60 percent of cases and management plans were changed in about 70 percent of cases following videoconference consultations, study results show. The average consultation time was 10 minutes.

"Videoconferencing is a sustainable, effective way of providing prompt eye management advice to rural emergency doctors," Dr. Raj said. "Although it can never replace face to face clinical care, it is a useful tool to have at one's fingertips and its use will undoubtedly increase in coming years," she added.

Source:
Mary Wade
American Academy of Ophthalmology

Painful Summer: Migraine Triggers Bring a Season of Misery for Many

By KIM CAROLLO (@kimcarollo)

July 5, 2011

It's a difficult time of year for frequent migraine sufferer Nancy Scuri. Certain weather and atmospheric factors affect her sinuses, which, in turn, trigger her debilitating headaches. "If a storm comes in where barometric pressure changes, that can affect me and set off a migraine," she said. "I also have an allergy to tree pollen, which affects my sinuses and breathing." The tree pollen season has nearly ended but summer still brings plenty of storms that can come at any time. "I constantly watch the Weather Channel," Scuri, 43, said.

Scuri of Hauppauge, N.Y., isn't the only one who gets more frequent migraines during the summer. Experts say there are numerous triggers that can make summer an especially painful time of year for many people prone to migraines. Some research has suggested that summer is the worst time of year, but experts say it really depends on what factors set off migraines.

"Some people do experience more migraines in the summer but, for others, the winter is worse," said Dr. Joel Saper, founder and director of the Michigan Headache and Neurological Institute in Ann Arbor.
Those who suffer in the summer might experience a migraine when exposed to some of these common triggers:

Dehydration
Losing a lot of water and sodium through sweating can trigger migraines. "If a lot of sodium is lost when sweating, it can dilute the bloodstream a bit and when sodium goes down to a certain point, it can be very headache-provoking," Saper said.

 

A similar effect can happen if people drink too much water. Over-hydration can also throw off the balance of electrolytes, which can lead to a migraine.

Dehydration often occurs during extended periods of exercise, but physical exertion on its own can also trigger migraines.

Lazy Days of Summer
"Migraines can happen at a time of a let down from stress. When a person has a chance to relax, it may be the time for headaches to happen," said Dr. Andrew Charles, director of the Headache Research and Treatment Program at UCLA's Geffen School of Medicine in Los Angeles. "The first days of vacation or the start of the weekend are common times for migraines to occur."

Changes in sleep patterns can also cause migraines in some people. The longer days often cause people to go to sleep later than usual.

"People stay out later and sleeping patterns tend to change," Saper said. "People with migraines don't shift time zones well on vacation or tolerate different sleeping patterns well."
Migraines can also be caused when people don't eat at their normal times, which tends to happen in the summer. Maintaining consistent sleeping and eating patterns is key, he said.

Environmental Factors
Summer allergens, such as grass pollen, can also trigger migraines.
"There are also some studies suggesting that differences in the levels of pollutants may be correlated with frequences in migraines," Charles said. Humidity can increase the levels of some allergens in the environment and can also cause migraines in other ways. "Humidity can trigger migraines because when it's humid, you can pick up odors you wouldn't smell on a less humid day," Saper said.

Other summer migraine triggers include the heat, which can cause changes in body temperature; alcoholic beverages and higher altitudes some people might experience when they go camping.

Experts recommend that migraine sufferers know what their triggers are and avoid them if possible, but say even when all precautions are followed, migraines might still strike.

That's a painful reality Scuri experiences on a regular basis.
"As long as I stay on top of things, I'm OK," she said. "But I still get migraines one or two times a month."

Common Forms Of Neck Pain Not Cured By Botulinum Toxin

There is no evidence that Botulinum toxin injections reduce chronic neck pain or associated headaches, says a group of scientists who reviewed nine trials involving a total of 503 participants. Their findings are published in the latest update of The Cochrane Library.

The Botulinum toxin (BoNT) operates by temporarily stopping muscles contracting. This reduces muscle tightness or spasm. It is best known for its use in cosmetic treatments where commercially available products such as Botox, Dysport, Xeomin, Myobloc or Neurobloc are used to reduce wrinkles. Effects begin within three to eight days of an injection and may last up to four months. When the effect wears off, it can be repeated.

Having an injection of a very small volume of BoNT is not risk free, and patients may experience muscle tenderness or pain, weakness, or a general sense of being unwell. A few have anaphylactic reactions and there are reports that some have died.

"It's always important to look carefully at evidence from clinical trials to see whether a treatment is more effective than a placebo, and this is particularly important when treatments have known adverse effects," says the study's spokesperson, Dr Paul Michael Peloso, who works as a director of clinical research at Merck, in New Jersey, USA.

Some of the trials specifically compared the effects of either giving the toxin or a placebo injection of saline to two different groups of people with neck pain. The researchers could see no difference between the two groups either at 4 weeks or 6 months. Similarly adding BoNT to physiotherapy was no more effective than adding either an anaesthetic or saline.

"It is possible that BoNT did give some benefits that were not measured in the trials, or that it could help highly particular types of neck pain, but we would need some much more carefully conducted trials to reveal this," says Peloso.

"Based on current evidence we have no reason for supporting the use of BoNT as a stand-alone therapy for neck pain, but we do suggest that researchers consider further study to clarify whether the dose can be optimized for neck pain" says Peloso. The researchers also believe that trials should be run that look at other symptoms than pain, such as function, to see if there is any reason for believing that BoNT can provide some benefit.

Source:
Jennifer Beal
Wiley-Blackwell

View drug information on Botox; Myobloc; Xeomin.

Behavioral Treatment For Migraines A Cost-Effective Alternative To Meds

06 Jul 2011  

Treating chronic migraines with behavioral approaches - such as relaxation training, hypnosis and biofeedback - can make financial sense compared to prescription-drug treatment, especially after a year or more, a new study found.

Longtime behavioral therapy researcher and practitioner Dr. Donald Penzien, University of Mississippi Medical Center professor of psychiatry, coauthored the study. He said the costs of prescription prophylactic drugs - the kind chronic migraine sufferers take every day to prevent onset - may not seem much even at several dollars a day.

"But those costs keep adding up with additional doctor visits and more prescriptions," Penzien said. "The cost of behavioral treatment is front-loaded. You go to a number of treatment sessions but then that's it. And the benefits last for years."

Published in the June issue of the journal Headache, the study compared the costs over time of several types of behavioral treatments with prescription-drug treatments. The research team included investigators from Wake Forest University, UMMC and the University of Mississippi.

The researchers found that after six months, the cost of minimal-contact behavioral treatment was competitive with pharmacologic treatments using drugs costing 50 cents or less a day. Minimal-contact treatment is when a patient sees a therapist a few times but largely practices the behavioral techniques at home, aided by literature or audio recordings.

After one year, the minimal-contact method was nearly $500 cheaper than pharmacologic treatment.

"We have a whole armamentarium of behavioral treatments and their efficacy has been proven. But headache sufferers are only getting a tip of these options," said Dr. Timothy Houle, associate professor of anesthesiology and neurology at Wake Forest University, and the study's principal investigator.

"One reason is people think behavioral treatment costs a lot. Now with this study, we know that the costs are actually comparable, if not cheaper, in the long run."

At a time when health-care costs are under national scrutiny, the study offers a framework for comparing costs that researchers can update and use for years to come.

"We thought, 'Wouldn't it be fun to model this and see how it comes out over time?'" Penzien said. "All the figures are there so if someone disagrees with it, they can plug in their own numbers."

The researchers didn't compare the effectiveness of methods, nor did they calculate the costs over time of individual drugs, since dosages and prices vary widely. Rather, they figured the per-day costs of each method based on fees of physicians and psychologists. For the physician group, they added in the cost of prescription beta-blocker drugs at various prices.

For instance, among the psychologists surveyed, one-on-one behavioral sessions cost between $70 and $250 for the intake visit and $65 and $200 for follow-up visits. That put the median intake cost at $175 and median follow-up cost at $125 for a median 10 visits.

The researchers calculated the median cost of pharmacologic approaches at $250 for the intake session and a professional fee of $140 per session. Median time to the first follow-up was 52.2 days, rising to 60 for the second with a median five visits per year.

To get information on behavioral treatments, the researchers surveyed members of the Behavioral Issues Group of the American Headache Society. For figures on pharmacologic treatments, the researchers surveyed a group of Headache Society-member physicians they knew treated substantial numbers of headache sufferers.

The most expensive behavioral treatment method - individual sessions with a psychologist in clinic - cost more than pharmacologic treatment with $6-a-day drugs in the first months. But at about five months, individual sessions become competitive. After a year, they are cheaper than all methods except treatment with drugs costing 50 cents or less a day.

Overall, group therapy and minimal-contact behavioral treatment were cost-competitive with even the cheapest medication treatment in the initial months. At one year, they become the least-expensive headache treatment choice.

Grant funding from the National Institute of Neurological Disorders and Stroke supported the research.

Source:
Jack Mazurak
University of Mississippi Medical Center

"Not tonight, dear, I have a headache"

Types of Headaches

by Dr. Nor Ashikin Mokhtar

There's a reason why the clichéd phrase, "Not tonight, dear, I have a headache", always appears in the speech bubble above a woman's head, instead of a man's.

It is not sexist to say that women suffer from headaches more often than men. It's simply a biological truth. Women's fluctuating hormone levels are the main reason for this, as the hormone levels can cause chemicals in the brain to rise and fall, leading to headaches during certain times.

This is not to say that all women constantly suffer headaches and men do not. Environmental and social factors like stress can contribute to headaches in both men and women.

Not all headaches are the same. Different types of headaches have different causative factors. If you know what type of headache you are prone to, you can learn how to prevent or treat them when they occur.

In this article, six common types of headaches will be described.


1. Tension Headaches

This type of headache is the most common in both women and men. It results in a dull ache on both sides of your head, triggered by stress, fatigue, or hunger.

A tension headache is different from a migraine because it does not cause nausea or sensitivity to light, sound or smells, neither does it get worse with regular activities like walking.

The triggers of tension headaches are sometimes unavoidable, but fortunately, this type of headache can be treated with over-the-counter painkillers.


2. Migraines

Women are believed to be more prone to migraines than men because hormonal changes are one of the triggers of migraines, which is why it can occur more frequently during menstruation.

The vast range of other triggers includes certain types of food and drink (e.g. aged cheeses, red wine, and coffee), nicotine and cigarette smoke, sudden changes in weather, over-sleeping, strong smells and, for some, even sex.

Like tension headaches, migraines can also be triggered by stress, lack of sleep, and emotional upsets. But the difference with migraines lies in the symptoms – the pain is sometimes only on one side of the head, it causes nausea and/or vomiting, and there is sensitivity to light, sounds, and motion.

Some people with migraines notice a warning 'aura' before the migraine occurs, while others don't. The aura takes the form of flashing lights, or spots and lines floating in front of the eyes.

As the migraine triggers are very specific for each person, you can prevent them or reduce the severity by identifying the triggers and avoiding them. You can also see your doctor for specific pain-prevention medications.


3. Sinus Headaches

The sinuses are air-filled cavities in the skull that help insulate the skull. A sinus infection can cause a headache or pressure in the eyes, nose, cheek area, or on one side of the head.

Sinus headaches are treated with decongestants that contain painkillers. Sometimes, your doctor may prescribe antibiotics if there is an infection present.

Sometimes, sinus headaches can be mistaken for migraines, and vice versa. One way to distinguish it is to see whether the headache is accompanied by a fever and thick greenish or yellow mucous. This distinction is important because if you take decongestants for what is actually a migraine, you could make your headache worse.


4. Cluster Headaches

This type of headache is actually more common in men than in women. It is called a cluster headache because it occurs in cluster periods, such as for several days, weeks, or months at a time, followed by a remission where the attacks stop completely.

Cluster headaches cause a sharp, penetrating or burning pain, generally located in or around the eye, that may radiate to other areas of the face, head, neck and shoulders, and is usually one-sided.

Unlike migraines, cluster headaches lead to restlessness, because the person may feel that lying down makes the pain worse.

Unfortunately, over-the-counter painkillers often do not work for cluster headaches. You should see a doctor for prescription medications, such as triptans, or other specific medications.


5. Rebound Headaches

Ironically, popping too many painkillers can set you up for a never-ending cycle of headaches. These are called rebound or medication-overuse headaches.

You may be getting rebound headaches if you're taking over-the-counter painkillers or sinus headache formulas with a decongestant at least 15 days a month, or prescription painkillers at least 10 days a month.

What happens is that your threshold for pain is lowered as your body's pain receptors become overly sensitive when the dose of painkiller wears off.

It won't be easy to wean yourself off the pain medications. But you have to, because the vicious cycle could go on and on, with no relief. Ask for your doctor for help, and explore other remedies for relieving pain, such as acupuncture, yoga, or medication.

Most importantly, do not self-medicate rebound headaches by trying other medications on your own.


6. Exercise Headaches

Some women suffer from headaches right after physical activity, particularly strenuous exercise. These are actually called exertional headaches, which are a group of headaches associated with some form of physical strain, such as exercise or even sex.

This type of headache is closely related to migraines, as it often occurs in those who have inherited a tendency for migraines. Most exercise or exertion headaches are harmless and can be treated with simple painkillers.

However, if it's a new, severe headache that occurs after exercise, especially if you're not prone to migraines, it could be a sign of something more serious, such as abnormalities in the brain or other diseases. It is better to be safe by seeing your doctor immediately.

This is no reason to stop exercising completely. Exercise reduces stress, helps you sleep, and increases endorphins (chemicals in your brain that act as natural painkillers).

What you can do is avoid activities that make your head bob up and down, such as jogging, and switch to cycling or swimming instead. Drink plenty of water before, during, and after your workout, warm up gradually, and exercise in a cool environment.

In Control

Headaches are no joking matter. They can make you want to curl up in bed and avoid the rest of the world. Learning to recognise the different types and their causes can help you to be in control of the pain.

National Migraine Awareness Month: More Than Just a Headache

by  Teri Robert

Each day, approximately 430,000 people are unable to go to work because of a Migraine. In a year, that adds up to 157 million lost work days and industry losses of $31 billion.

There are more than 37 million Migraineurs in America, yet Migraine disease remains misunderstood, under-diagnosed, and under-treated. The stigma that remains attached is so strong that participants in a study about Migraine and stigma scored higher on the Stigma Scale for Chronic Illness than a mixed panel of patients with chronic neurologic diseases - stroke, epilepsy, multiple sclerosis, Alzheimer’s, ALS and Parkinson’s disease.¹

June is National Migraine Awareness Month (NMAW), and the National Headache Foundation (NHF) has launched an awareness campaign - More Than Just a Headache - to educate the public on the personal and societal costs of Migraine and to provide resources for Migraineurs and their families. Bob Dalton, executive director of the NHF, commented:

“National Migraine Awareness Month is long overdue for the attention it deserves. The tens of millions of people in this country who battle this devastating disease merit the same kind of support and understanding that others receive for conditions generally thought of as ‘more serious.’ This past week in Washington DC, we heard the testimony of a Migraineur who is also a breast cancer survivor; she considers Migraine to be the greater challenge by far. Until the public as a whole recognizes what people with  Migraine achieve each day just by carrying on a normal life, NHF and other advocates for  Migraineurs have their work cut out for them.”² 

Serene Branson, the CBS reporter whose on-air Migraine earlier this year demonstrated how frightening and debilitating a Migraine can be, has partnered with the NHF to raise awareness and drive the More Than Just a Headache campaign. I spoke with Miss Branson last week about her Migraines and awareness month. You can read more about that interview in Serene Branson on Migraines and Awareness Month.

Each of us needs to be diligent in working to educate ourselves and others about Migraine and to become active in building awareness. National Migraine Awareness Month is the perfect time to do so.

• Visit the NHF site and submit your "Migraine Moment." The NHF will select stories to feature in upcoming issues of their quarterly magazine, "Head Wise." You can enter your "moment" from their awareness month page.
• Visit the NHF site and check out the information on their regional educational conferences. These conferences are great. The morning is for physician education, and the afternoon is for patients and their families and friends. Keep an eye on that page of their site to watch for new locations and dates to be added.
• Make a donation to your favorite Migraine and headache organization. Some fund research; some fund educational opportunities; all serve us well and need our support.
• Sign up for the email mailing list of the Alliance for Headache Disorders Advocacy. That mailing list is used to notify us when there are emails we can send to Congress about issues important to Migraine awareness and research. Just visit the AHDA subscription page.
• Are you on Facebook or Twitter? When you see good Migraine information online, share the link on Facebook and Twitter.

For more information about National Migraine Awareness Month, visit our Awareness Month Special.

____________
Resources:

¹ Park J.E.; Kempner J.; Young W.B. "The Stigma of Migraine." Poster presentation. 52nd annual meeting of the American Headache Society. Los Angeles. June, 2010.

² Interview. Teri Robert with Robert Dalton, Executive Director of the National Headache Foundation. June 9, 2011.

AHRQ News And Numbers: Over 3 Million Look To Hospitals For Headache Relief, Particularly For Migraines

May 2011  

More than 3 million Americans went to hospital emergency rooms seeking relief from headaches and there were 81,000 hospitals admissions, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. One-third of the emergency visits and two thirds of the hospital stays were for migraine headaches.

AHRQ also found in 2008 that:

Women accounted for nearly 3 out of 4 emergency department visits and hospital admissions for headaches.

- Migraines were about 4 times more common among women than men in both the emergency department and the hospital.

- People from the lowest-income communities were 2.3 times more likely than those from the highest-income communities to go to the emergency room for headaches - 1,300 versus 565 visits per 100,000 people, respectively.

- Rural residents were 1.6 times more likely than their urban counterparts to make emergency department visits for headaches (1,425 vs. 896 visits per 100,000 people).

- By age, the most likely to make emergency departments visits for headache was 18-to-44 year-olds (1,626 visits per 100,000 people) and the least likely were those 18 and younger (345 visits per 100,000 people).

- The Midwest and South led the country in emergency department visit rates for headache (1,158 and 1,131 per 100,000 people), compared to the Northeast's 809 visits per 100,000 and people and the West's 744 visits per 100,000 people.

This AHRQ News and Numbers is based on data in Headaches in U.S. Hospitals and Emergency Departments, 2008.

The report uses data from the 2008 Nationwide Inpatient Sample and from the 2008 Nationwide Emergency Department Sample -- databases of hospital inpatient stays and emergency departments visits in all short-term, non-Federal hospitals. The data are drawn from hospitals that comprise 95 percent of all discharges in the United States and include patients, regardless of insurance type, as well as the uninsured.

Source:
Agency for Healthcare Research and Quality

St. Jude Medical Reveals Randomized Clinical Trial Data Demonstrating Benefit of Neuromodulation for Chronic Migraine

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine, a debilitating condition that affects millions worldwide. Presented at the 15^th International Headache Congress in Berlin, Germany, the study shows statistically significant improvement across multiple measures including a reduction in the number of headache days per month and improvement in quality of life. This is the largest clinical study to date evaluating the use of PNS via an implanted medical device for the treatment of chronic migraine.

The study followed 157 participants who, on average, suffered from headache 26 days per month. Study participants were implanted with the St. Jude Medical Genesis(TM) neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implant, while patients in the control group did not receive stimulation until after the first 12 weeks. All patients were followed for one year. At one year, 66 percent of patients reported excellent or good pain relief.
At 12 weeks, the study demonstrated the following statistically significant results:

• Patients who received stimulation reported a 28-percent decrease in their number of headache days (seven less days a month) compared to the placebo group which reported a 4-percent decrease (one less day per month).
• Overall disability as measured by the Migraine Disability Assessment questionnaire (MIDAS) indicated participants in the active group had a 41-percent improvement compared to a 13-percent improvement in the placebo group.
• Zung Pain and Disability Index (PAD) scores improved in the active group by 20 percent compared to an 8-percent improvement in the placebo group.
• In addition to the standardized scales (MIDAS and PAD), patients were asked to subjectively assess their pain relief. The active group reported 42-percent pain relief compared to 17 percent in the placebo group.
• Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12-week end point, 53 percent of patients in the active group ranked their relief as excellent or good compared to 17 percent in the placebo group.
• When asked to rate the effect on their quality of life, 67 percent of the active group reported improvement compared to 17 percent in the placebo group.
• The active group reported 51-percent satisfaction with headache relief compared to 19 percent in the placebo group.

Statistical significance was demonstrated across most measures. It was not however observed in the primary endpoint as established by the U.S. Food and Drug Administration. This was defined as a significant difference between active and placebo groups who reported a 50-percent reduction in pain as measured on a visual analog scale and a minimum 10-percent point difference between the 95-percent confidence intervals comparing the active and placebo groups. A statistically significant difference between the active and placebo groups was observed at the 40-percent reduction in pain level.

"Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks," said Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center, and the principal investigator in the study. "Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone. This research demonstrates that peripheral nerve stimulation can ease the suffering of chronic migraine patients."

St. Jude Medical has filed for CE Mark approval of the Genesis neurostimulation system for the management of pain and disability associated with chronic migraine and expects to begin a limited launch in Europe later this year. It is not yet clear when this neuromodulation system will be approved for the treatment of chronic migraine in the U.S. This system delivers mild electrical pulses from an implanted device to leads placed under the skin at the back of the head, stimulating the occipital nerves.

About Migraine
According to the World Health Organization (WHO), 10 percent of adults worldwide suffer from migraine, a disabling condition that can last for hours or days at a time. WHO also estimates 1.7 to 4 percent of adults have headaches on more than 15 days per month. In the U.S. alone, it is estimated that almost 28 million Americans suffer from migraine - or roughly 13 percent of the population, according to the National Headache Foundation. The severity of each migraine attack can vary widely, with typical symptoms ranging from sensitivity to light, noise and motion, to nausea and vomiting in addition to headache.

Three Decades of Leading-Edge Neurostimulation Technology
For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.
Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Additional clinical studies are currently underway for Parkinson's disease, essential tremor, major depressive disorder, and other significant indications.

About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit www.sjm.com.


SOURCE: St. Jude Medical, Inc.

Autonomic Technologies Announces Positive Preliminary Findings For A Novel Device For The Treatment Of Severe Headache

27 Jun 2011  

Autonomic Technologies, Inc. (ATI), the developer of a novel miniaturized implantable system for severe headaches, today announced positive preliminary findings from a study evaluating the safety and efficacy of the company's investigational neurostimulation system for the treatment of cluster headache. Jean Schoenen, M.D., coordinator of the Headache Research Unit at University of Liege in Liege, Belgium, presented the findings at a late breaking session today at the 15th Congress of the International Headache Society in Berlin, Germany.

Cluster headache is a highly disabling neurologic condition characterized by intense stabbing pain in the area of one eye, often accompanied by swelling, tears and nasal congestion. Often called 'suicide headache,' the pain inflicted by the condition is recognized as amongst the most severe known to man. Sufferers can have headache attacks multiple times per day, each lasting 15 minutes to three hours. Approximately one in one thousand people suffer from cluster headaches.1

Twenty-two of approximately 40 planned patients have been enrolled in the Pathway CH-1 study. Of those, stimulation data from the therapy 'titration' period are available for seven patients. The primary endpoint of Pain Relief within 15 minutes was met in 67 percent of headaches treated (n=48).

Importantly, more than 70 percent of patients experienced a reduction in the frequency of their headaches by 50 percent or more as compared to the four-week period prior to study enrollment. This effect was only seen once patients began using stimulation.

"These results are extremely encouraging," said Prof. Dr. Schoenen. "Chronic cluster headache sufferers are highly disabled by their condition, which causes immense pain and often prevents patients from leading a normal life. The investigators and I look forward to continuing to study this novel therapy in cluster headache, as well as future research in severe migraine."

"There are few treatment options today that serve cluster headache patients well," said Prof. Dr. Arne May, a neuroscientist at the University Hospital Hamburg-Eppendorf and president of the German Migraine and Headache Society. "Current treatments include preventive and acute abortive drugs, including expensive injectable medications and inhaled oxygen. Some patients are not candidates for these medications, and others experience significant side effects or have cardiovascular risk factors that place them at risk for taking them. I am hopeful that this novel approach might offer promise for many cluster headache patients."

"We are extremely pleased with these promising early results," said Ben Pless, president and chief executive officer of Autonomic Technologies. "We look forward to continued studies of our technology for cluster headache as well as for migraine, with the hope that our work may one day offer relief to millions of people."

About the ATI Neurostimulation System

The investigational ATI Neurostimulation System is a novel, miniaturized implantable stimulator approximately the size of an almond that is designed for the treatment of severe headache, including cluster headache and migraine. The neurostimulator is delivered through a surgical incision in the gum, leaving no external scars or cosmetic effects. The lead tip of the implant is placed at the sphenopalatine ganglion (SPG) nerve bundle behind the cheekbone. For years clinicians have targeted the SPG to relieve severe headache, primarily by applying lidocaine and other agents to the SPG to achieve a nerve block.

Using an external remote controller similar in size to a large cell phone, patients deliver stimulation as needed to relieve the headache. When the headache is treated, the remote controller is simply removed from the cheek, turning off stimulation therapy.

About the Pathway CH-1 Study

The multi-center Pathway CH-1 study includes seven leading headache centers from six countries across Europe and will ultimately include up to 40 patients. An initial 'titration' period of stimulation allows the stimulation settings to be set and refined for the patient. This is followed by an experimental period in which patients' headaches are randomized to one of three 'doses' of stimulation, including a placebo - a rigorous trial design used in headache studies. Prof. Dr. Schoenen presented the initial results on seven patients from the titration phase; results from the randomized phase have not yet been presented.

1 Fischera M, Marziniak M, Gralow I, Evers S. The incidence and prevalence of cluster headache: a meta-analysis of population-based studies. Cephalalgia. 2008 Jun ;28(6):614-8. Epub 2008 Apr 16.

Source:
Autonomic Technologies

Implantable Device May Help Ease Tough Migraines

By Denise Mann
HealthDay Reporter

Latest Migraine News

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• Want More News? Sign Up for MedicineNet Newsletters!

THURSDAY, June 23 (HealthDay News) -- An implantable device hidden in the nape of the neck may mean more headache-free days for people with severe migraines that don't respond to other treatments, a new study suggests.

More than 36 million Americans get migraine headaches, which are marked by intense pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not everyone improves with these measures.
The St. Jude Medical Genesis neurostimulator is a short, thin strip that is implanted behind the neck. A battery pack is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can dim the pain of migraine headache.

"There are a large number of patients for whom nothing works and whose lives are ruined by the daily pain of their migraine headache, and this device has the potential to help some of them," said study author Dr. Stephen D. Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by device manufacturer St. Jude Medical Inc., is slated for presentation on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The company is now seeking approval for the device in Europe and then plans to submit their data to the U.S. Food and Drug Administration for approval in the United States.

Researchers tested the new device in 157 people who had severe migraines about 26 days out of each month. After 12 weeks, those who received the new device had seven more headache-free days per month, compared to one more headache-free day per month seen among people in the control group. Individuals in the control arm did not receive stimulation until after the first 12 weeks.

Study participants who received the stimulator also reported less severe headaches and improvements in their quality of life. After one year, 66% of people in the study said they had excellent or good pain relief. The pain reduction seen in the study did fall short of FDA standards, which call for a 50% reduction in pain.
"The device is invisible to the eye, but not to the touch," said Silberstein. The implantation procedure involves local anesthesia along with conscious sedation so you are awake, but not fully aware. There may be some mild pain associated with this surgery, he said.

Study co-author Dr. Joel Saper, founder and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a member of the advisory board for the Migraine Research Foundation, said this therapy could be an important option for some people with migraines.

"There were numerous patients who did benefit in terms of pain control and quality of life," Saper said. "We don't have any universally effective therapies for migraine, so we don't ever expect everyone to have dramatic results, but for those few that it works in, it's life-changing."

But, he said, "it is surgical and there are risks to surgery, and there are unknowns such as how long the effects will last." Risks of the new neurostimulation procedure may include infection and the device can sometimes dislodge. Saper has not received any compensation from the device manufacturer.
"Occipital nerve stimulation is a treatment of great promise for patients with intractable chronic migraine," said Dr. Richard B. Lipton, director of the Headache Center at Albert Einstein College of Medicine/Montefiore Medical Center in the Bronx and a board member of the Migraine Research Foundation. He is not affiliated with the new study.

"Eliminating a full week per month of headaches is a huge gain for chronic migraine sufferers and translates into big improvements in treatment satisfaction and quality of life," he said. "This treatment will make a huge difference for millions of migraine sufferers with chronic migraine."
The results do mirror what Lipton has seen in his practice. "This shows that [the treatment] can give chronic migraine sufferers their lives back."

Dr. Robert Duarte, director of the Pain Center at North Shore-Long Island Jewish Health System in Manhasset, N.Y., said that the new device should not be considered a first-line treatment for migraine, however.
"You need to be evaluated by a headache specialist, and make sure all treatment options are tried before installing a stimulator, but it is an option and there is definitely evidence that it works," he said. Duarte is not affiliated with the new study.

"It is not a cure, but a treatment option that can reduce frequency and intensity of headaches in some people," Duarte added. Doctors can also do a trial run using an external stimulator to see if it will work before implanting the device, he said.

Copyright © 2011 HealthDay. All rights reserved. 

SOURCES: Stephen D. Silberstein, M.D., director, Jefferson Headache Center, Philadelphia; Joel Saper, founder and director, Michigan Head Pain and Neurological Institute, Ann Arbor, Mich.; Richard B. Lipton, director, Headache Center, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, N.Y.; Robert Duarte, M.D., director, Pain Center, North Shore-Long Island Jewish Health System, Manhasset, N.Y.; June 23, 2011, presentation, International Headache Congress, Berlin

St. Jude Medical Reveals Randomized Clinical Trial Data Demonstrating Benefit Of Neuromodulation For Chronic Migraine

23 Jun 2011  

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced study results on the safety and efficacy of peripheral nerve stimulation (PNS) of the occipital nerve for the management of pain and disability associated with chronic migraine, a debilitating condition that affects millions worldwide. Presented at the 15th International Headache Congress in Berlin, Germany, the study shows statistically significant improvement across multiple measures including a reduction in the number of headache days per month and improvement in quality of life. This is the largest clinical study to date evaluating the use of PNS via an implanted medical device for the treatment of chronic migraine.

The study followed 157 participants who, on average, suffered from headache 26 days per month. Study participants were implanted with the St. Jude Medical Genesis(TM) neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implant, while patients in the control group did not receive stimulation until after the first 12 weeks. All patients were followed for one year. At one year, 66 percent of patients reported excellent or good pain relief.

At 12 weeks, the study demonstrated the following statistically significant results:

- Patients who received stimulation reported a 28-percent decrease in their number of headache days (seven less days a month) compared to the placebo group which reported a 4-percent decrease (one less day per month).

- Overall disability as measured by the Migraine Disability Assessment questionnaire (MIDAS) indicated participants in the active group had a 41-percent improvement compared to a 13-percent improvement in the placebo group.

- Zung Pain and Disability Index (PAD) scores improved in the active group by 20 percent compared to an 8-percent improvement in the placebo group.

- In addition to the standardized scales (MIDAS and PAD), patients were asked to subjectively assess their pain relief. The active group reported 42-percent pain relief compared to 17 percent in the placebo group.

- Patients in the study were asked to define their headache relief as excellent, good, fair, uncertain, or poor. At the 12-week end point, 53 percent of patients in the active group ranked their relief as excellent or good compared to 17 percent in the placebo group.

- When asked to rate the effect on their quality of life, 67 percent of the active group reported improvement compared to 17 percent in the placebo group.

- The active group reported 51-percent satisfaction with headache relief compared to 19 percent in the placebo group.

Statistical significance was demonstrated across most measures. It was not however observed in the primary endpoint as established by the U.S. Food and Drug Administration. This was defined as a significant difference between active and placebo groups who reported a 50-percent reduction in pain as measured on a visual analog scale and a minimum 10-percent point difference between the 95-percent confidence intervals comparing the active and placebo groups. A statistically significant difference between the active and placebo groups was observed at the 40-percent reduction in pain level.

"Many migraine patients have exhausted all current treatment options and often are disabled by the pain and frequency of migraine attacks," said Stephen D. Silberstein, M.D., past president of the American Headache Society, director of the Jefferson Headache Center, and the principal investigator in the study. "Achieving a reduction in the number of days they suffer from headache and a significant improvement in their quality of life may be even more important than pain reduction alone. This research demonstrates that peripheral nerve stimulation can ease the suffering of chronic migraine patients."

St. Jude Medical has filed for CE Mark approval of the Genesis neurostimulation system for the management of pain and disability associated with chronic migraine and expects to begin a limited launch in Europe later this year. It is not yet clear when this neuromodulation system will be approved for the treatment of chronic migraine in the U.S. This system delivers mild electrical pulses from an implanted device to leads placed under the skin at the back of the head, stimulating the occipital nerves.

About Migraine

According to the World Health Organization (WHO), 10 percent of adults worldwide suffer from migraine, a disabling condition that can last for hours or days at a time. WHO also estimates 1.7 to 4 percent of adults have headaches on more than 15 days per month. In the U.S. alone, it is estimated that almost 28 million Americans suffer from migraine - or roughly 13 percent of the population, according to the National Headache Foundation. The severity of each migraine attack can vary widely, with typical symptoms ranging from sensitivity to light, noise and motion, to nausea and vomiting in addition to headache.

Three Decades of Leading-Edge Neurostimulation Technology

For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.

Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Additional clinical studies are currently underway for Parkinson's disease, essential tremor, major depressive disorder, and other significant indications.

Source:
St. Jude Medical

Decreasing Brain Excitability with Migraine Therapy: Targeting Glutamate

By Andrew Charles, M.D.

 

Key Points:

1. Uncontrolled brain activity may contribute to lack of migraine control.
2. Glutamate, one of the most important brain pain chemicals causes increased brain activity.
3. Blocking excessive brain activity without interfering with normal function could help control migraine.
4. A drug, not currently approved for migraine, may decrease excess brain activity and control migraine.

Although multiple preventatives for migraine are currently available, many sufferers haven’t been able to find one that effectively reduces the frequency and severity of their migraine attacks. This may, at least in part, be due to excess brain activity, referred to as excitation, not adequately controlled by therapy. One promising area of research on new migraine treatments involves the chemical glutamate, one of the main neurotransmitters in the brain. A substance released by one nerve cell that allows it to communicate with another is a neurotransmitter. This communication or interaction occurs through a structure on the surface of the cell (or inside the cell), known as a receptor. Receptors selectively receive and lock onto specific substances, such as glutamate. Glutamate functions as an “excitatory” neurotransmitter, because when released it causes neighboring cells to become more active (excited).  

 

Increasing evidence supports that excessive activation of cells in specific areas of the brain causes migraine. Special brain scans show that patients having migraine attacks may have waves of abnormal activity that spread across the surface of the brain (the cortex), as well as excitation of nerve centers deep within the brain (the brainstem). Both of these patterns of abnormal activity may involve the neurotransmitter glutamate.

 

Medications that stop glutamate nerve cell activity block waves of activity traveling across the brain surface in mice and rats that are very similar to those seen in migraine sufferers. Experimental studies also show glutamate receptors play a key role in the sensation of head pain, which occurs in brainstem nerve centers.  These studies provide support for the use of glutamate receptor blockers for migraine therapy.

 

The challenge is to block excessive glutamate activity without interfering with normal cell function.  Memantine (brand name in the US is Namenda) may accomplish this. Memantine inhibits excessive activity of glutamate receptors, but does not have significant effects on the normal function of these receptors. In rodent experiments memantine blocks the waves of brain activity that may be a trigger for migraine.

 

Memantine is used for the treatment of Alzheimer’s disease and therefore available for migraine prevention only “off-label.” “Off-label” refers to the use of a medication for treatment of a condition that is different than the one for which it is FDA approved.  Initial studies of the experiences of patients with memantine as a migraine preventive treatment are encouraging. Two preventative studies of memantine for migraine have been published – both showed promising results. Our group reviewed by survey the experience of patients with frequent migraine who had not had a satisfactory response to other therapies. 36 out of 54 treated with memantine for at least 2 months reported a significant reduction in estimated headache frequency, and improved function. Side effects were uncommon and generally mild.  The most recently published study is an open-label study by Bigal, et al. In an open-label study both patient and practitioner know what the drug is being used. In 28 patients treated, monthly headache frequency was reduced from 21.8 days at baseline to 16.1 at 3 months. The mean number of days with severe pain was reduced from 7.8 to 3.2 at 3 months. However, neither study was the kind of formal clinical trial that is required to definitively prove that a treatment is effective. Such a trial is known as a randomized controlled trial (RCT). This kind of formal study is clearly needed in order to establish whether or not memantine can be widely recommended as a treatment for prevention of migraine. Two successful migraine RCTs are required in the United States for the FDA to consider labeling any drug as “indicated for migraine.” Until such time many insurance plans refuse coverage of such therapy “as not indicated,” but not all, given input from you and your practitioner. In the meantime, considering these issues and the early studies this may be a treatment worth discussing with your practitioner if other standard or conventional treatments have failed for prevention of migraine.

 

Memantine is generally very well tolerated --- a minority of patients experience side effects that may include drowsiness, dizziness, or anxiety. Most, however, experience no adverse effects from the drug. At this time we do not know whether memantine will be proven to be effective in formal clinical trials and eventually approved for prevention of migraine. Regardless, however, initial laboratory and clinical studies indicate that targeting glutamate receptors represent a potential new approach to migraine therapy, and that this is an important topic for further investigation.

 

Andrew Charles, MD, Professor and Vice Chair, Director, Headache Research and Treatment Program, Department of Neurology, David Geffen School of Medicine at UCLA

Migraine: Current Treatment Methods (part 2 of 3)

Non-drug Alternatives to Preventative Treatment of Migraines

Gut Brain Therapy  MAGNUM looks into the exciting work that ForeverWell is doing in Migraine research & the gut brain. An intriguing possibility is beginning to develop. The growing evidence supporting our long term belief that Migraine is a brain disorder coupled with the work showing a second brain in the gut might cause some to look at proper neuropeptide/neurotransmitter production by the digestive system as a root cause of the factors leading to Migraine.

One company doing just that has recently published an outcome based study in which they focus primarily on healing and improving digestive dysfunction that they believe on some level is occurring in most Migraine sufferers. Synergistically, they provide nutritional support to the liver and kidney believing that these organs are critical in balancing internal function.

This natural Migraine prevention approach has shown very positive results in their initial study. Interestingly, some of the comments from study participants included that while on the nutritional supplements they found that the Migraines they did get were less severe and a lower dose of various pain treatments seemed to be more effective.

80% of the 40 study participants reported good to dramatic benefit from this approach. 20% had no benefit. In 60% of the cases the participants quality of life rating was in the 80 to 100 range indicating a virtually Migraine free condition. To learn more about Gut Brain Therapy and to read the entire study visit, www.foreverwell.com. 

Michael Gershon, MD of Columbia University is the recognized father of the growing field of neurogastroenterology and author of The Second Brain. His book is fascinating and may explain why ForeverWell is getting great results with Migraine by focusing on the digestive system. For a FREE, chapter by chapter, description of the book you can send an email request to gutbrain@verizon.net. 

There is a book called The Second Brain by Michael Gershon, MD. He is at Columbia University in New York and seems to be the leading authority in neurogastroenterology. The book is quite fascinating and perhaps does explain why ForeverWell has been getting great results with Migraine by treating the gut.

For more information:

• Take a look at Michael Gershon, MDs book The Second Brain and how it supports and points to the possibilities that healing the gut could help the brain.
• Review Gary Zaloga, MDs book Nutrition in Critical Care and how small chain peptides may provide an explanation of ForeverWells preliminary success.
• Visit the ForeverWell website, www.foreverwell.com and read the details and explanation of their work and approach to treating Migraine.

Contact Information:
Tom Staverosky, President
ForeverWell
PO Box 14653
Reading, PA 19612
www.foreverwell.com
tstaverosky@verizon.net
1-800-619-5969
610-374-5258

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Petasites Hybridus (Butterbur root) is a new non-drug preventive treatment available in the United States. It is available under the name of Petadolex™ from the well respected German firm of Weber & Weber. In recent double blind studies it was shown 77% effective as a Migraine prophylaxis. Dose is one 50mg capsule twice a day.

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Feverfew Leaf is a good non-drug preventitive treatment you may want to explore. Its main uses are for migraines and arthritis. Studies at the London Migraine Clinic have increased interest in this herb. This herb continues to undergo extensive scientific investigation of the parthenolide content, and how it normalizes the funtion of platelets in the blood system by inhibiting platelet aggregation, reducing serotonin release from platelets and blocking the formation of pro-inflamatory mediators. Seventy percent of the patients in these studies report fewer attacks of migraines and less painful attacks. Researchers believe that Feverfew prevents the spasms of blood vessels in the head that trigger migraines. This herb also relieves the inflammation associated with arthritis. Other benefits include: relief from nausea and vomiting; improvement of digestion; more restful sleep; and, relief of dizziness, brain, and nerve pressure.

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Vitamin B2 supplements is another preventative non-drug treatment you may want to consider taking. A study in Belgium found that people who took 400 milligrams of vitamin B2 daily had about one-third fewer migraines than did those taking a placebo. The study, published in the February issue of the journal Neurology, included 55 patients in Belgium and Luxembourg who normally had two to eight migraine attacks each month.

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Magnesium as an alternative preventive treatment has mixed support in the medical community. The most current position on this alternative over the counter preventive approach is best summarized by the Migraine and headache expert Ninan T. Mathew, M.D., which he noted the following at the 1998 AASH (American Association for the Study of Headache) Scottsdale Symposium-"Even though magnesium deficiency in the brain is implicated in the pathophysiology of Migraine, there is still no proof that magnesium replacement is of any benefit in Migraine prophylaxis. The only double-blind placebo controlled study in patients with Migraine without aura (69 patients) reported negative results, even though a previous small study in menstrual Migraine reported magnesium to be effective. Mauskop et al emphasized the importance of serum ionized magnesium measurements in determining the magnesium state in Migraine patients and have used intravenous magnesium in patients found to have low ionized magnesium level. These observations have not been confirmed yet." 

 

Perhaps oral magnesium supplementation should be a part of treatment for migraine as a preventive. Taking a 100% of the USDA recommended DV (daily value) would be safe and prudent. That would be 400mg of magnesium (from magnesium oxide or magnesium sulphate) a day. 

 

A Canadian approach suggested that physicians advise migraine patients to consume at least 6 mg magnesium per day for each kilogram of body weight. An even higher intake of 10 mg/day per Kg of body weight may be desirable provided that it does not trigger a laxative effect. Breaking the dosage into three or four parts taken at different times of day helps prevent laxative effect. Magnesium hydroxide is NOT recommended because of poor bioavailability and because they know of no instance of it having any beneficial use other than as a laxative. Other Magnesium compounds appear to be better, including Magnesium oxide, Magnesium sulphate, and Magnesium citrate. Natural magnesium in water (magnesium carbonate dissolved in CO2-rich water) is 30% more bio-available than Magnesium in food or pill, and offers much greater cardio-protection. If pills are used, they suggest chelated, Krebs cycle, with several Magnesium compounds; this gives greater bio- availability, and doesn't upset the stomach. 

(II) Trigger Management

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Second, trigger management is important in preventing Migraine attacks. Triggering factors can cause Migraine, and if recognized and/or avoided, may impede an impending attack. Triggers vary from person to person. 

 

Examples of what ARE triggers include changes in weather or air-pressure, bright sunlight, glare, fluorescent lights, chemical fumes, menstrual cycles, and certain foods such as processed meats, red wine, beer, dried fish, broad beans, fermented cheeses, aspartame, and MSG. 

 

Examples of what ARE NOT triggers include lifestyle, stress, anxiety, worry, emotion, excitement, depressions, and caffeine. Unlike many articles mistakenly state, caffeine, which constricts blood vessels, is not a trigger, and, in fact, may help relieve mild Migraine pain caused by vasodilatation.