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.

---

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.

---

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.

Migraine: Current Treatment Methods (part 1 of 3)

Many breakthroughs regarding the biological and genetic causes of Migraine have been made in recent years. And while certain of the exact biological mechanisms are still being studied, breakthroughs in treatment offer hope and relief for millions of people who suffer from the pain of Migraine. 
 
MAGNUM has noted that in the past, Migraine tended to be managed in a way that either prescribed drugs that helped prevent attacks OR prescribed drugs that treated pain during an attack, but not both. However, the best approach to Migraine management is what MAGNUM calls a MULTIFACTORAL approach, which involves addressing all four aspects of Migraine health care: preventive treatment, trigger management, abortive treatment, and general pain management.
 

MAGNUM's Multifactoral Approach
I	Preventative or Prophylactic
II	Trigger Management
III	Attack Aborting
IV	General Pain Management

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(I) Preventive or Prophylactic

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First, preventive, or prophylactic, medications are prescribed to prevent or reduce the number of attacks in patients who experience frequent Migraines, typically two or more per month. In general, these medications act over time to prevent blood-vessel swelling; however, they do not treat the Migraine-associated symptoms and are non-selective. Many sufferers using preventive treatments will still have to take attack-aborting medications to relieve pain and other symptoms.

Beta-blockers are the most commonly prescribed prophylactic treatment for Migraine and are considered to be an effective preventive treatment. Medication includes propranolol. Click here for more detailed information. 

 

Antidepressants are believed to have a possible effect on serotonin or possible analgesic effects. Click here for more detailed information. 

 

Calcium channel blockers are also used to decrease the frequency of Migraine attacks. It is thought that calcium channel blockers play a role in vessel constriction. Click here for more detailed information. 

 

Methysergide is thought to block the inflammatory and vessel-constricting effects of serotonin. Because of potential side-effects, methysergide is generally used only on select patients. This medication also requires a four to six week drug hiatus every six months. Click here for more detailed information. 

 

Divalproex Sodium (Depakote®) is probably the most promising of the preventive regiments currently available for Migraine. This drug was originally developed for Epilepsy; a disease often referred to as a sister disorder to Migraine, prescribed in much smaller doses when used to treat Migraine thus lessening the mild side effects. 

Source:

Information offered at this Web site by either a lay person or a health professional should not be interpreted as giving a diagnosis or a treatment recommendation. These can only be provided by a physician who has had an opportunity to interact with a patient in person and at length, with access to the patient's previous records and appropriate follow-up.