Botox for Migraines   --  In-Depth Doctor's Interview
Reported November 28, 2005

Stephen Silberstein, M.D., professor of neurology at Thomas Jefferson University and Director of the Jefferson Headache Center in Philadelphia, explains how Botox can help people with chronic daily headaches. Ivanhoe Broadcast News Transcript with Stephen Silberstein, M.D., Professor of Neurology at Thomas Jefferson, University, and Director of the Jefferson Headache Center, Jefferson University Hospital, Philadelphia, TOPIC: Botox for Migraines

What is CDH?

Dr. Silberstein: CDH stands for chronic daily headaches, which means you have headaches more often than not. A person experiencing CDH has, on average, headaches 15 or more days a month.

How many people suffer from chronic daily headaches?

Dr. Silberstein: About 4 percent of the world's population has CDH. In the United States, about 2 percent of the population has migraines almost every day while 2 percent of the population has a tension headache every day.

Who does this study target?

Dr. Silberstein: We've targeted patients who have headaches more often than not. The characteristics of the headache are migraines, whether occurring often or not. We dealt with a population of patients with very frequent migraines occurring more than 15 days a month.

What did the study entail?

Dr. Silberstein: We took a population of patients with migraines more often than not and did a baseline period where we could actually measure their headache frequency. Then patients were either given saline injections or botulinum toxin (type A Botox) injections, every three months. During this time, we monitored what happened to their headaches.

What happened to their headaches?

Dr. Silberstein: Headache frequency went down in all patients, regardless of the type of injection. The people receiving botulinum toxin type A, however, responded much better compared to simply getting the saline injections.

Was the saline the placebo?

Dr. Silberstein: It's not a true placebo because simply injecting something into the skin and the nerves may have a benefit. In the study we showed the addition of botulinum toxin, or Botox, enhanced the benefit of simply giving an injection.

How does Botox work?

Dr. Silberstein: In the past, researchers believed Botox only worked to relax muscles, but that didn't explain some interesting things. People who get Botox are people with dystonia, an abnormal neck posture, who often have pain. More patients get relief of pain from the Botox than they do from their funny posture. We believe that the botulinum toxin works directly on the pain nerves to prevent the process that results in very frequent headaches. Dr. Oshinsky, from our laboratory at Thomas Jefferson Hospital, has shown in animals if botulinum toxin is injected in the skin, it can prevent the changes in the brain that occur as chronic migraines.

Does the Botox actually change what is happening in the brain?

Dr. Silberstein: Yes. Botulinum toxin changes the properties of the nerves so they don't become as active or sensitive, in turn reducing migraines.

There is previous research on Botox helping migraines, what is new about this study?

Dr. Silberstein: Previously when I looked at patients with migraines that came and go (episodic migraines) many drugs and treatments were available for episodic migraines. What's new and unique about this new study is that it is being done on a large study in patients with the most disabling headache, one that occurs all the time.

Does the patient need to get injections for the rest of their life or do these results become permanent?

Dr. Silberstein: Once their headaches become under control, whether it's botulinum toxin, or regular treatment, many patients no longer need treatment. These studies were only done for nine months but it's our experience that after the headaches get under control patients may no longer need treatment.

Can anyone with chronic daily headaches get Botox injections, or is there a segment of the population that would not be a good candidate for this?

Dr. Silberstein: One of the advantages of the botulinum toxin is that just about anybody except if they have some unusual disorders would be a candidate for Botox.

Compared to the saline injections, how did patients receiving Botox injections improve?

Dr. Silberstein: Compared to the saline, the Botox injections produced a greater than 50-percent reduction in patients.

How does this change the life of a patient suffering from CDH?

Dr. Silberstein: Patients with daily headaches are some of the most disabled patients known to mankind. Many of them can't work or go to school; if they do work and go to school their pain surrounds their life. Their social activity is limited; they can't have fun with their families, they can't do household chores. Getting these headaches under control would do wonders for these patients. Can you imagine what it's like to have a headache every day of your life, and never wake up pain free, then suddenly, for the first time, you're pain free, you can function, you can have a life, it's almost like being reborn.

Has FDA approved this treatment?

Dr. Silberstein: We made a preliminary report to the American Academy of Neurology so we could design the pivotal trial in attempt to get FDA approval for using botulinum toxin for headaches. Those studies are about ready to begin, we figure it will probably take about two years before the studies are finished and FDA approval occurs.

Will insurance pay for this?

Dr. Silberstein: In some parts of the country, insurance carriers are, actually paying for botulinum toxin. Whether the company pays depends on where you are in the country and what kind of insurance you have.

                                 END OF INTERVIEW