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New treatments

Some headaches, usually migraines, do not respond to the usual over-the-counter and even prescription headache medications.  Once it is clear that there is no serious underlying cause, such as an aneurysm, several injectable medications can be given in an emergency room (during office hours at the New York Headache Center we also give injections in the office). These medicines may include intravenous injections of: magnesium sulfate (which is not a medication, but a mineral), sumatriptan (Imitrex, which can be self-injected by patients at home), ketorolac (or it is also called Toradol, which is a drug in the aspirin family), dexamethasone (Decadron, a steroid drug, which can help pain of almost any type, but cannot be given for long periods of time), prochlorperazine (or Compazine, which is a nausea medication but can help pain as well), valproate sodium (Depacon), and several other drugs.

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There are several effective preventive medications for migraine headaches, however they are prescribed to only a small number of people who could benefit from them.  A study by Dr. Richard Lipton in the journal Cephalagia and his colleagues discovered that only 13% of migraine sufferers are taking preventive medications, but those who do have significantly less disability than those who don’t. Among possible reasons, doctors who don’t realize how disabling migraines are, patients how think that medications are dangerous or will cause side effects. Cost does not seem to be a factor because all patients in this study had insurance and most of these medications are inexpensive. Patients are often reluctant to take medications, but would rather find and remove the cause. Unfortunately, in most cases migraine is a genetic disorder and true cure is not possible. However, for most migraine sufferers it is possible to find and remove triggers which make headaches worse. If this is not sufficient, magnesium, CoQ10, other supplements, biofeedback, Botox injections, and regular exercise can provide relief without drugs. If all this still does not provide relief, medications, such as anti-depressants, epilepsy drugs, and high blood pressure drugs can be very effective and improve the quality of life.

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Large clinical trials are required to prove that a new drug or treatment is effective.  Without such proof doctors will not (and should not) believe that any particular medicine or device is effective.  The FDA also approves drugs by evaluating results of large trials, usually involving hundreds if not thousands of participants.  If you want to help these new treatments to become available you should consider participating in such study.  In addition to feeling good about helping science and possibly your descendants, you may also benefit from a free evaluation and treatment.  Of course, there are risks associated with new treatments and the researchers are required to explain them to you in great detail.

One of the reasons for this post is to let you know about a new website which makes finding a clinical trial very easy.   You can search these trials by disease, location, and other criteria.  The site is http://www.medpedia.com/clinical-trials.  Check it out.

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One of the oldest preventive headache medications for migraines is propranolol (Inderal), which belongs to the family of blood pressure medications called beta-blockers.  There are newer and better beta-blockers, such as nebivolol (Bystolic), which have fewer side effects than propranolol.  We also use other types of blood pressure medications, such as calcium channel blockers (verapamil or Calan, and other) and ACE inhibitors (lisinopril, or Zestril/Prinivil is one example).  The newest category of blood pressure medications is ACE receptor blockers (ARBs) which are at least as effective and have fewer side effects than ACE inhibitors.  The best scientific evidence (from a single double-blind study) for the efficacy of ARBs in migraines is for candesartan (Atacand).

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Migralex is finally available to all headache sufferers.  This is the first new brand of headache medicine in 15 years.  After years of painstaking research, complicated development work, and manufacturing setup it is very gratifying to see Migralex available at www.Migralex.com and independent pharmacies.  If you know someone who suffers from headaches, please tell them about Dr. Mauskop’s Migralex.  Migralex works quickly, has few side effects, and works for many different types of headaches.  Please go to www.Migralex.com for more information.

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A blinded study comparing Botox with Topamax for the prevention of migraine headaches was conducted by Drs. Jaffri and Mathew and published in the current issue of Headache.  They enrolled 60 patients and divided them into two groups – one group received real Botox and placebo tablets, while the second group received saline water injections instead of Botox, but were given tablets of Topamax.  At the end of 9 months and after 2 Botox treatments the efficacy of these two treatments was the same, but many more patients in the Topamax group developed side effects and dropped out of the study.

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Botox appears to be effective for peripheral nerve pain according to a study by French researchers.  This finding is consistent with my observation that injecting Botox into the skin of the top of the head in patients with headaches relieves pain in that area.  When I started injecting botulinum toxin (Botox) for headaches about 15 years ago the assumption was that Botox works by relieving spasm of muscles in the forehead, temples, back of the head, and neck.  However, some patients would come back and report that their headache was gone in the injected areas, but not on the top of the head.  When gave additional injections the top of the head pain also stopped.  I also see patients who get Botox injections for their headaches from dermatologists or plastic surgeons and do not obtain adequate relief.  This is usually because only the front of the head is injected, rather then all areas of pain.   There have been other reports of Botox relieving pain of diabetic as well as trigeminal neuralgia, however the French group conducted a very rigorous double-blind study which provides scientific proof of pain-relieving properties of Botox.

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Botox can relieve pain of occipital neuralgia, according to a pilot study by neurologists in Ohio, published in Headache.  Occipital neuralgia is a painful condition that manifests itself by pain in the back of the head, usually on one side.  Pain can be burning, but also sharp,or throbbing in character.  It is often the result of a spasm of occipital and suboccipital muscles, so it is not surprising that Botox would relieve this pain by relaxing these muscles.  In addition to relaxing muscles Botox also reduces activation of the sensory nerve that send pain messages to the brain.  Other treatments for occipital neuralgia include isometric neck exercise, acupuncture, medications, and occipital nerve block with corticosteroids and lidocaine.

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Some migraine patients are more disturbed and disabled by migraine aura symptoms than by the headache itself.  Some people do not even have pain but only auras.  In the majority the aura is visual and consists of squiggly lines, flashing lights, distorted vision, or partial loss of vision on one side of each eye.  Less often people experience numbness of one side of the body, dizziness, or vertigo.  These symptoms are sometimes more difficult to treat than the pain.  Anecdotal reports suggest that a blood pressure drug belonging to the family of calcium channel blockers can help.  Another medication that has been reported to be effective (also only in case series and not double-blind trials) is an epilepsy drug, lamotrigine (Lamictal).  The effective dose of lamotrigine varies from 100 to 500 mg day, while verapamil is usually effective at 12-240 mg, although in some patients only much higher doses are effective.

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Two large trials of Botox provide unequivocal proof of its efficacy in the treatment of chronic migraine headaches.  The results of these two double-blind, placebo-controlled studies (I participated in one of the two trials) of onabotulinumtoxinA (Botox) in chronic migraines were presented at the International Headache Congress in Philadelphia last week.  Botox was proven to reduce the number of days with headaches, improve multiple headache symptoms, and improve the quality of life.  The treatment was extremely well tolerated with very few side effects overall and no serious side effects.   Having used Botox for the treatment of various headache types for over 15 years in several thousand patients it is very gratifying to finally have well-designed trials which confirm my and my colleagues’ experience.   The manufacturer is submitting the results of these trials to the FDA and we expect to have approval of Botox for the treatment of chronic migraines by the end of 2010.  FDA approval will force insurance companies to pay for this highly effective treatment and will make it affordable for people who desperately need it.

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Vitamin B12 (cyanocobalamine) deficiency is known to cause a wide variety of neurological symptoms.   It also seems to produce facial neuralgia, according to a report presented at the International Headache Congress in Philadelphia a week ago.  Two physicians from Milwaukee described 17 patients who had facial pain that was not typical of trigeminal neuralgia because they had no trigger area and had numbness on the affected side.  They all had vitamin B12 deficiency and they pain improved with injections of vitamin B12.  In a previous post I mentioned another study that found an association between migraine headaches and high homocysteine levels, which can also be caused by vitamin B12 deficiency.  Oral absorption of vitamin B12 supplements is often inadequate and a nasal spray (which is expensive) or an injection are the best ways to correct this deficiency.

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Migrainous vertigo seems to respond to intravenous infusion of a high dose of corticosteroids, according to a report in the latest issue of Headache by a group of Indian doctors.  Two of their patients had intermittent episodes of severe vertigo and two had chronic vertigo.  All four respond to infusions of 1 gram of methylprednisolone.  One require 3 infusions, one needed 2 and in another 2 vertigo stopped after a single infusion.  We routinely use corticosteroids for severe migraine attacks when other medications fail.  While occasional (once or twice a month) use of corticosteroids is relatively safe, frequent or daily intake of corticosteroids (besides methylprednisolone, these drugs include prednisone, prednisolone, and dexamethasone) can lead to dangerous side effects.  It is possible that oral corticosteroids will produce a similar effect as an infusion and may be worth trying when nothing else helps relieve the vertigo.

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