October 15th, 2010
|11:39 pm - Possible remedies for migraineurs|
PLEASE feel free to send this to any migraineur you might know, or to post it in your own journal--I don't need credit for it.
In case you haven't heard about risk factors for migraines, aside from genetics: 25% of migraineurs are bipolar, 25% of bipolars are migraineurs. Ain't that fun? That's part of how I was dx'd with bipolar disorder.
I heard about this use for botox earlier today on the radio, and looked it up online, for more info. These injections would be done by a neurologist rather than by a plastic surgeon, who normally give botox injections.
I can't find any information more current than 2004 on the dentist who developed a gel for calming some nerves back in your jaw area. He does seem to have received FDA approval for it, though.
BTW, feel free to pass this along to migraineurs you might know.
Here's an article from Bloomberg
Allergan Says U.S. FDA Approved Botox as Treatment for Chronic Migraines
By Molly Peterson - Oct 15, 2010 4:16 PM PT
Allergan Inc. won U.S. regulatory approval to sell its wrinkle smoother Botox as a treatment for chronic migraine headaches after pleading guilty 10 days ago to charges it marketed the drug for unapproved uses.
The Food and Drug Administration cleared Botox for people who suffer from migraines at least 15 days a month, the agency and company said today in separate statements. The drug, which blocks connections to nerves, is a purified form of the poison botulinum.
Botox, administered as an injection to relax facial wrinkles and treat neurological disorders, is the Irvine, California-based company’s top product with $1.3 billion in annual sales last year. The migraine indication may add $1 billion in annual revenue, Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, said in May. Allergan won clearance from U.K. regulators in July to sell Botox as a migraine treatment.
“Chronic migraine is one of the most disabling forms of headache,” Russell Katz, director of the FDA’s division of neurology products, said in the statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”
Allergan rose $4.54, or 6.6 percent, to $73.40 at 6:42 p.m. in extended trading on the New York Stock Exchange after closing at $68.86. The shares have gained 9.3 percent this year.
On Oct. 5 the company settled a 2 1/2-year investigation of its Botox marketing that analysts said held up FDA approval for the migraine treatment. Allergan pleaded guilty and was ordered by a judge to pay $375 million to resolve Justice Department allegations it promoted Botox for headache, pain and juvenile cerebral palsy from 2000 to 2005 without FDA approval. The plea, approved by U.S. District Judge Orinda Evans in Atlanta, includes a $350 million criminal fine and $25 million in forfeited assets, the Justice Department said.
The company also agreed to a five-year compliance plan requiring it to disclose payments to doctors on its website and provide annual certification by senior executives and board members that divisions meet federal health-care requirements.
About 12 percent of people in the U.S. experience migraines, according to the National Institutes of Health, in Bethesda, Maryland. The painful headaches last 4 to 72 hours, and symptoms include sensitivity to light, noise and odors.
Patients with chronic migraines who took Botox had 7.8 fewer days per month with any headaches, including migraines, compared with 6.4 fewer headache days on placebo, according to a company-funded study released last year. In a separate trial, patients getting Botox injections had 9 fewer days of headaches per month, compared with 6.7 fewer with a placebo.
To treat migraines, Botox is given every 12 weeks in multiple injections around the head and neck to reduce future symptoms, the FDA said. The drug hasn’t been shown to work for other types of headaches, or for migraines that occur less frequently than 15 days a month, the agency said.
The FDA last year ordered manufacturers of all botulinum products to strengthen warnings that the toxins may cause muscle weakness and life-threatening breathing or swallowing difficulties if the poison spreads beyond the injection site.
To contact the reporter on this story: Molly Peterson in Washington email@example.com
To contact the editor responsible for this story: Reg Gale at firstname.lastname@example.org.
An advert to the side of this article offered Migraine Surgery.
A plastic surgeon in SF, CA offers it--but I am sure there are others elsewhere!--and this is the website:
Migraine Surgery: Information for Health Care Professionals
Incidence of Migraine Headaches
• 8-12% of the U.S. population
• 112 million workdays lost.
• $14 Billion lost productivity
Migraine Headache Surgery Effectively Eliminates or Reduces Migraine Headaches
• Randomized double-blinded placebo (sham surgery) controlled clinical trial demonstrated surgical efficacy.
• 84% experienced at least a 50% reduction in migraine
• 57% experienced complete elimination of migraine headaches at 1 year after surgery.
• Surgery was effective in all trigger points tested:
Who is a candidate?
• Migraine headache diagnosed by a neurologist or pain specialist, and
• Not adequately treated by existing medications, or
• Migraine medications cause undesirable side-effects, or
• Frequency or severity of migraine headaches (even with effective medication) intereferes with daily life, and
• A trigger point is identifiable (e.g. frontal, temporal, occipital, nasal).
How Is Migraine Surgery Performed?
• Outpatient procedure (in most cases).
• The triggering nerve is decompressed (trigeminal, supra-orbital, supra-trochlear, and/or greater occipital) or divided (zygomatico-temporal).
• Decompression is conceptually similar to carpal tunnel surgery.
• Migraine Surgery can be minimally invasive:
• Can be done endoscopically for the supra-orbital, supra-trochlear and zygomatico-temporal.
• Can be performed endo-nasally for naso-septal trigger points.
• Migraine Operations are similar in approach to endoscopic brow lift and/or septoplasty.
• Open decompression via small access incisions hidden at the hairline for the occipital trigger point.
• Recovery is often 1-2 weeks with some improvement seen quickly in many cases.
Current Treatment Strategies Are Often Inadequate
• Triptans (e.g. sumatriptan, Imitrex) are often effective.
• Problems with triptans include delay (pain) from time of administration to time of medication effect.
• Side Effects:
• Weight Gain
• Hair Loss
• Contraindicated in:
• Coronary Artery Disease
• History of Stroke
A NYT article on the procedure:
Since getting to NYT online can often be a problem, here's the article
Plastic Surgery May Also Ease Migraines
By CATHERINE SAINT LOUIS
Published: September 2, 2009
MANY of the nearly 30 million Americans who suffer from migraines end up feeling like guinea pigs. Chronic patients — those who are laid low 15 or more days a month — often cycle through drug after drug in search of relief. They also contend with side effects like mental sluggishness and stomach upset. Treatment involves guesswork because doctors have not pinpointed what causes migraines, nor do they know which drugs will best help which patients.
“It can be a merry-go-round going from medication to medication in pursuit of control,” said Dr. Roger K. Cady, the vice president of the board for the National Headache Foundation, a nonprofit organization devoted to patient education.
No wonder that last month, news of a surgical “cure” that touts a high success rate ricocheted worldwide. The double-blind study,published in the journal Plastic and Reconstructive Surgery, found that more than 80 percent of patients who underwent surgery in one of three “trigger sites” significantly reduced their number of headaches compared with more than 55 percent of the group who had sham surgery. More than half of the patients with the real surgery reported a “complete elimination” of headaches compared with about 4 percent of the placebo group.
Forehead lifts are cosmetic procedures that plastic surgeons typically perform to smooth furrowed brows. But a decade ago, after some of his patients reported that their migraines improved post-operation, Dr. Bahman Guyuron, a plastic surgeon and the lead author of the study, began to search for a surgical solution that could address migraine trigger points — which he defines as where the headache begins and settles — in the forehead, temples and the back of the head.
Headache specialists tend to be neurologists or internists, so Dr. Guyuron’s work has not always been taken seriously. “If I had a neurologist tell me there’s a new way of doing a facelift, I would have been very skeptical about it also,” said Dr. Guyuron, the chairman of the plastic surgery department at University Hospitals Case Medical Center in Cleveland. “But honestly I would have had an open mind.”
In the last month, the press has made much of the fact that a single operation could relieve migraines and turn back the clock in one fell swoop. But it is the potential that surgery for migraines may offer a viable alternative to drugs that has migraine specialists intrigued. “A very large subset became headache-free and remained headache-free for a year — that is a fantastic result,” said Dr. Richard B. Lipton, the director of the Montefiore Headache Center in the Bronx.
Especially considering that in the field of migraines, success is defined “as a reduction of 50 percent of attacks,” Dr. Cady said. Going from 10 episodes monthly to 5 is a welcome change, he added, but “it’s still a lot of migraines.”
The theory behind the surgery is that because some migraines are caused when sensitive nerve branches are squeezed and irritated by muscles, deactivating those muscles could bring prolonged relief. In the off-label use of Botox for migraines, those same muscles — when paralyzed with Botox injections — have eased headaches in some patients for roughly three months. Forehead lifts, Dr. Guyuron reasoned, might result in a longer-lasting, perhaps permanent, alleviation of pain. Only study participants who responded positively to Botox were offered the surgery.
(Dr. Cady cautioned that the research on Botox as a treatment for chronic headaches is not yet ironclad. Allergan, Botox’s maker, is pursuing the approval of Botox as a treatment for chronic migraines by theFood and Drug Administration.)
Many headache specialists, Dr. Lipton and Dr. Cady included, emphasize that this migraine surgery isn’t applicable to most sufferers. “Folks who are appropriate for this procedure — they are the tip of the iceberg, not the vast majority,” said Dr. Jennifer S. Kriegler, a neurologist who is one of the study’s authors and who works at the Cleveland Clinic’s headache center.
At this stage, suitable candidates are those who endure frequent migraines and have failed more tried-and-true methods of controlling their headaches, several doctors said. The bottom line, Dr. Lipton explained, is if you can’t identify a point of irritation and “if you don’t respond to Botox, we don’t know if this treatment works for you.”
Some doctors fear that the surgery may be offered to inappropriate patients before further research confirms its efficacy for a broader group of patients. “I don’t want us to overshoot and start doing widespread surgeries in not very well selected patients until we are convinced this is broadly effective,” said Dr. F. Michael Cutrer, the chief of the headache division in the neurology department at the Mayo Clinic in Rochester, Minn. “You can always stop a medication but you can’t reverse a surgery.”
As word of the surgery spreads, Dr. Cutrer said that he anticipated pleas for referrals to the few plastic surgeons nationwide who offer the operations, but that “until we maybe have studies that are a bit larger, and some longer follow-up I’m going to be very cautious.”
So far, Dr. Guyuron has trained roughly 150 doctors, and other plastic surgeons are refining their own migraine operations, even though they barely advertise.
Two years ago, an aunt told Shannon Byrne, from Mayfield Heights, Ohio, about Dr. Guyuron’s migraine surgery. Ms. Byrne said that she had already spent a decade on “every single medication you can think of.” Still, pain hammered her head more days than not. “You’re willing to try anything,” she said. Dr. Guyuron’s surgery, which she had 18 months ago, was a godsend. The migraines that led to her dropping out of college and to a stroke at 20 are gone. “My dad told me not to worry about the money,” Ms. Byrne, now 22, said of the thousands paid out of pocket.
A classic forehead lift for cosmetic effect differs significantly from surgery for migraine sufferers. The latter removes frown muscles more thoroughly and entails padding nerves with fatty tissue, said Dr. David A. Branch, a plastic surgeon in Bangor, Me., who performs migraine operations.
Sometimes, migraine surgery doesn’t involve the forehead at all. It varies according to where the patient’s trigger sites are: forehead, temples or back of the head. If Dr. Guyuron operates on the temples, the eyebrows are rejuvenated, he said. It is only the surgery at the back of the head that has no added perk, he said.
It’s unclear whether or not the migraine sufferers whose pain had disappeared a year post-operation will remain headache-free for life.
“My goal is zero headaches,” said Dr. Jeffrey E. Janis, a plastic surgeon in Dallas, who has performed roughly 100 operations in the last five years after training with Dr. Guyuron. “I might be able to achieve that in some, not in all.”
Complete elimination is “a pretty strong claim after one year of follow-up,” Dr. Cutrer said.
As a way of dampening expectations, Dr. Kriegler, who has referred patients to Dr. Guyuron, frequently tells them: “Once a migraineur, always a migraineur.”
This article has been revised to reflect the following correction:
Correction: September 10, 2009
An article last Thursday about plastic surgery that helps relieve migraines misstated the month in which the success of such operations was first reported. It was August, not this month.
An article with not date appears in the Health division of the paper's archives
Until recently, abnormalities of blood vessel (vascular) systems in the head were thought to be mainly responsible for migraines. Now, however, doctors tend to believe that migraine starts with an underlying central nervous system disorder. When triggered by various stimuli, this disorder sets off a chain of neurologic and biochemical events, some of which subsequently affect the brain's vascular system. No experimental model fully explains the migraine process.
There is certainly a strong genetic component in migraine with or without auras. Researchers have located a single genetic mutation responsible for the very rare familial hemiplegic migraine, but several genes are likely to be involved in the great majority of migraine cases.
Numerous chemicals, structures, nerve pathways, and other players involved in the process are under investigation. These include:
• Peptides . Stress or some unknown factor triggers the release of certain protein fragments called peptides (Substance P, calcitonin gene-related peptide, and others). These peptides dilate blood vessels and produce an inflammatory response that triggers over-excitation of the nerve cells in the trigeminal pathway. [This nerve pathway runs from the brain stem to the head and face. These nerves spread to the meninges (the membrane covering of the brain.)]
• Abnormal Calcium Channels. Some migraines may be due to abnormalities in the channels within cells that transport the electrical ions calcium, magnesium, sodium, and potassium. Calcium channels appear to play a particularly critical role in migraine.
• Serotonin and Other Neurotransmitter Levels. Neurotransmitters are chemical messengers in the brain. Serotonin is a neurotransmitter (chemical messenger in the brain) that is important for sleep, well-being, and other factors that affect quality of life. Abnormalities in serotonin levels have been observed in both tension-type and migraine headache sufferers. Altered levels of other neurotransmitters, importantly dopamine and stress hormones, also occur with migraine and tension-type headaches, and could trigger the events in the brain leading to migraine.
• Reduced Magnesium Levels. Magnesium deficiencies have been observed in people with both tension-type and migraine headaches. Reduced levels could be a destabilizing factor, causing the nerves in the brain to misfire, possibly even accounting for the auras that many sufferers experience.
• Nitric Oxide. Other research suggests that nitric oxide may be important in triggering in most primary headaches (tension-type, cluster, and migraines).
• Estrogen Fluctuations in Women. Tension-type headaches and migraine headaches are slightly more common in females during adolescence and adulthood. Most likely hormone fluctuations , rather than whether levels are elevated or low, trigger headaches.
A wide range of events and conditions can alter conditions in the brain that bring on nerve excitation and trigger migraines. They include, but are not limited to:
• Emotional stress
• Intense physical exertion (such as exercise, lifting, or even bowel movements or sexual activity)
• Abrupt weather changes
• Bright or flickering lights
• High altitude
• Travel motion
• Lack of sleep
• Skipping meals
• Certain types of foods, and chemicals contained in them. More than 100 foods and beverages may potentially trigger migraine headache. Caffeine is one such trigger. Caffeine withdrawal can also trigger migraines in people who are accustomed to caffeine. Red wine and beer are also common triggers. Preservatives and additives (such as nitrates, nitrites, and MSG) can also trigger attacks. Doctors recommend that patients keep a headache diary to track which foods trigger migraine.
Current Mood: curious
My co-worker had a rather serious head injury a few years ago and started to get migraines. Her doc suggested the botox injections, which are the only thing that help her.