Archive
Tag "Botox"

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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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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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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Botulinum toxin injections relieve tension headaches, according to a study just published in the European Journal of Neurology .  Most of the previous studies had been conducted in patients with migraines or chronic migraines (more than 15 days of headaches a month).  There is much less evidence that Botox also helps tension headaches.  Our experience at the NYHC treating patients with tension headaches with Botox injections has been also very positive.  In this European study doctors used Dysport – a version of botulinum toxin type A that is not available in the US.  However, Dysport is very similar to Botox.  On the other hand, Myobloc, which is botulinum toxin type B,  is a very different version of botulinum toxin and in several aspects is inferior to Botox.

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Botox has been shown to relieve migraine headaches in another two studies published in Headache.  One study compared the efficacy of Botox and an epilepsy drug, Depakote and found them to be equally effective.  However, Depakote caused more side effects, which resulted in more patients taking Depakote dropping out of the study.  The second study was done in patients who had difficulty complying with daily preventive medications.  Half of them were injected with Botox and the other half with saline water.  Neither the doctor nor the patient knew who received which treatment (double-blind study).  The impact of migraines on patients’ lives was significantly improved by Botox.  These two studies by leading headache specialists provides additional proof that Botox is effective for the relief of migraine headaches.

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Botox relieves migraine headaches and other painful conditions, such as sciatica, neuralgias and neck pain.  A recent study of 43 patients with arthritis of the shoulder suggests that Botox may relieve arthritis pain as well.  This was a double-blind study where half of the patients were given Botox and the other half saline injections.  Neither the doctor nor the patient knew what was being injected.  The results clearly favored Botox and the difference was statistically significant.  This adds another possible indication to a long list of conditions that Botox might relieve.  The safety of Botox in this study was as remarkble as in all previous studies, which now number in hundreds.  

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