Wednesday, November 3, 2010

Botox – How effective is it for migraines?


There has been a lot of talk lately about Botox for migraines. In spite of the recent FDA approval, the question still remains as to how well Botox works for migraines and is it safe.

Approval

Drug manufactures pay the FDA to approve their drugs and approval is not an indication that it works. The FDA's approval for use of Botox to fight migraines was based on the results of two studies involving 1,384 adults in North America and Europe. Since, half of those received the placebo; the approval was based on about 750 people in a population of 28 million migraineurs.

The studies used by the FDA showed that, "Onabotulinum toxin A [Botox]was proven in these trials to be moderately superior to placebo, and probably to natural outcome, in a population of chronic migraine patients of whom the majority was overusing acute medication and a substantial proportion had never received preventive drugs."

The report noted that the trials were not concerned about measuring the number of headaches, "Headache episodes, is clearly not an adequate outcome measure, nor clinically relevant in patients who have almost daily headaches and use symptomatic pain-relieving therapies."

It went on to say, "It is not known whether BOTOX [is] safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine)."

What does this mean? It appears to mean that there is more hype than reality to the claims. If the number of "headache episodes" is not a good measure of the outcome of something used to prevent migraines, than what is? Can you image getting a treatment for something where your expectations are not considered to be part of the measure of success?

Unfortunately, if one only listens to media, what doctors repeat from the drug reps, and drug advertisements, a person may never hear the complete story.

 (See FDA Report on Botox for Migraines)

How Botox Is Used to Treat Migraines

Botox to treat chronic migraines is given at intervals of about 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms, the FDA says in a statement. The company [Allergan] says that when treating chronic migraine, qualified medical specialists administer 31 Botox injections into seven specific head and neck sites.

Guidelines

The American Academy of Neurology Guidelines for Use of Botulinum Toxin states "botulinum toxin injections should not be offered to patients with episodic migraine and chronic tension-type headaches." Dr. Markus Naumann, head of the Department of Neurology at Augsburg Hospital in Germany also wrote in the report, "It is no better than placebo injections for these types of headaches."

Controversy and New Warnings

One of the alarming controversies in the use of Botox is whether or not it can enter the brain. Leading scientists including Matteo Caleo of Italy's Institute of Neuroscience found that botulinum toxin can travel down nerve fibers and into the brain within days. While the effects of this are unknown, it raises questions about the safety of the drug, especially the long term effects.

FDA Safety Warnings

The new FDA required black box warnings for Botox state the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. It should also be noted that so far there has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine which was only approved for last month (October 2010).

Side Effects

It is interesting that the FDA report shows the most common adverse reactions reported by patients being treated for chronic migraine were headache and neck pain. The FDA report recommends patients thoroughly discuss Botox with their doctor before any treatment especially noting the use of prescription drugs such as muscle relaxants, cold medicines, and sleep aids, and also any problems with breathing or swallowing.  See list of side effects.

Become Informed Before Treatment

Although it is common for patients to accept new treatments from their doctor without question, when it comes to using new methods such as Botox you should become informed before making any decision to try it. There are several good reports and sources for information listed on the Botox page on Tuliv Migraine Prevention site.

Looking for Results

From my own migraine research, including interviews with over 1,000 migraineurs, I can report that I have yet to find anyone who has had any long term success with using botox for migraine prevention.

If you have already tried Botox for migraines or plan to try it, I would like to know the results for a future follow-up report on this subject. Please email me at Botox@Tuliv.com.  

Do What is Best for You

At this point you may be asking, "Now that I know more about Botox, what is the best thing for me to do now?"

If safety and performance are important to you, consider the safe all-natural migraine prevention formula Tuliv Migraine Defense. Migraine Defense works naturally on the cause of migraines.

Questions: Call 1-866-367-5953 for real answers to your migraine questions. There is no cost or obligation.