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New treatments

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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A blood pressure medication telmisartan (Micardis) was shown to be effective in the prevention of migraine headaches by a group of German researchers led by H-C Diener.  Several blood pressure medications have been proven to prevent migraine headaches.  The oldest category of blood pressure drugs, beta-blockers have the most evidence to support their use and two of them (propranolol and timolol) are approved by the FDA for the preventive treatment of migraines.  However, beta-blockers are not high on my list because they tend to cause more side effects than other blood pressure medications.  The most common side effects are due to excessive lowering of blood pressure – lightheadedness, fatigue, and fainting.  They also slow down the heart rate, which can make it difficult to exercise, while regular aerobic exercise is the first treatment I recommend to my headache patients.  Calcium channel blockers, such as verapamil, are not as effective for migraine prevention as they are for the prevention of cluster headaches and can cause constipation, swelling and irregular heart beats.  Another blood pressure medication, lisinopril which belong to the family of ACE inhibitors has also been shown to prevent migraine headaches.  The most common limiting side effect of ACE inhibitors is coughing.  A newer group of medications, which are similar in action to ACE inhibitors is ACE receptor blockers, or ARBs.  ARBs do not cause coughing and telmisartan which is one of the ARBs caused as few side effects as the placebo.

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In my post 2 years ago I wrote about surgery for migraines and the many reasons why Botox injections is a better option than surgery to permanently cut nerves and muscles.  I also wrote that there were no controlled studies to show that surgery actually works.  Now we do have one study.  The study was blinded, which means that some patients had nerves and muscles cut, while others had only a skin incision.  The results were much better in patients who had real surgery.  The plastic surgeons who performed the study tried their best to produce a blinded study, but they admit that blinding is far from perfect since patients who had real surgery can see their muscles shrink or not move.  But even if we accept that blinding was achieved and surgery indeed provides relief of headaches, all of my other arguments stand.  These include surgical risks (bleeding, infection, scarring, and persistent nerve pain) and high cost.  Yes, Botox is expensive too, but migraine usually is not a life-long illness and migraine attacks often stop for long periods of time or permanently with or even without treatment.  I have seen many patients whom I treated with Botox every 3 months and whose headaches stop after a year or two.  Two years of Botox treatments is significantly cheaper than surgery and it does not carry all of the surgical risks.

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