New Botox Trials – Encouraging News on the bumpy road to acceptance
If you want your insurance to pay for Botox treatment for migraine, you should be encouraged by the report at last month’s International Headache Congress. Botox migraine treatment is continuing on the road to acceptance, but there’s no doubt it’s still a bumpy road.
The President-elect of the American Headache Society, Dr. David Dodick, gave the report on two trials of onabotulinumtoxinA (Botox), and there’s a lot for proponents of Botox treatment to celebrate.
First, these trials were very professionally done, a serious step toward Botox’ acceptance by the USA’s FDA. They were randomized, placebo-controlled, well balanced trials, the kind of trials that we need more of.
 |
As you may guess, the results were positive. Patients that received Botox had fewer headache and migraine days, fewer attacks, and significantly fewer actual hours of headache and migraine attacks. Overall, those taking Botox had less disability and functioned better than the placebo group.
This is the kind of evidence we’re looking for – proof that Botox is helping some people enough to be considered a valid migraine treatment.
But these trials are not telling us Botox is the miracle treatment we’ve all been waiting for – there are issues remaining. First, though there was a general improvement, Botox was certainly a long way from drastically cutting down on everyone’s symptoms. Of course, we wouldn’t expect that with most treatments – we know that few work with everyone. The Cochair at the session, Dr. Elizabeth Loder, pointed out one of the big issues with Botox – there’s still no easy way to predict who it will work with.
There’s still a lot of work to be done with Botox. How should it be administered? How much? When? Who does it work best with? Considering how far we still need to go answering these questions, we should be encouraged that we’re already seeing such good results in trials.
Another issue with these trials was that those taking Botox did not end up taking fewer other medications. This confirms what earlier studies have told us, and it will continue to be a concern to researchers – and to insurance companies. Can we get the overall cost down, while still improving people’s quality of life?
That being said, we did see that those on Botox took fewer triptan medications. So there are some interesting questions on this front that still need to be answered.
But let’s end on an encouraging note. This study did focus on a group that has a high need. These weren’t people who have an attack a year, but people who are disabled by moderate or severe attacks on average every week or more. They’re losing many hours a month to migraine. Many of them were, by typically accepted standards, taking too much medication (though they were off it at the time of the study).
There is hope then that Botox may give back many hours of life to people who are losing the most to migraine. And if doctors and insurance companies want proof that it works, well designed trials like this are giving them what they need. Doctors already using Botox treatment are convinced that it is significantly helping many.
The researchers hope to have approval of Botox treatment from the FDA for chronic migraine by the end of next year.
References:
Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.
Botulinum Neurotoxin Reduces Headache Frequency and Disability in Chronic Migraine by Dr. Daniel M. Keller (report on this study) 16 Sep 2009
Botox is proven to help chronic migraine
7 October 2009 @ 12:24 pm
Botox is also an issue in the migraine digest that I received today from Norway’s migraine association NMF. Reports from Bloomberg news agency said that patients who received the Botox treatment had 7.8 fewer migraine days/month while the placebo group had 6.4 fewer migraine days/month. That’s very promising—a whole week of migraine-free days is like—SUNSHINE!
8 October 2009 @ 2:46 pm
I am receiving botox treatments for the migraines I have. i have chronic daily migraines, intractable migraines. I am on 400 mg topomax daily, 160 propanalol as well. I use imitrex nasal spray as a rescue. The first few weeks after the botox were a miracle. Then a doctor took away my pain med for fibromyalgia that had no tylenol in it, and put me on vicoden. That started rebound migraines that I am still trying to recover from. I am going back for another botox treatment Nov 19. I am looking forward to it because it is the only thing in years that actually let me go out in the sun and not be in tremendous pain. I would recommend botox to anyone who is crippled by migraines, even just to give it a try to see if it can improve their quality of life. I have not been able to get rid of any of my medications as the article says, but I have had experiences of sun, sound, and smells I have not been able to tolerate in a lot of years.
10 October 2009 @ 12:28 am
I participated in a trial of Botox for chronic migraines a couple years ago. After getting over my fear of needles and tendency to hyperventilate during the study doses (waaay more injections than they typically give non-study patients), the procedure itself wasn’t so bad.
My study doctor said that many of her patients received almost full relief from migraines! I experienced about a 20% reduction in migraines and about a 20% reduction in their severity when I did experience them. It’s too bad insurance companies are so behind on the game for this one. I could never afford the cost of Botox, and especially with a semi-low benefit to me…but 20% is better than nothing. 🙂
By the Way – Botox Lawsuit one to Watch…
14 October 2009 @ 6:45 pm
[…] the news is out about positive Botox for migraine trials, and the news is also out about how much Allergan is spending wining and dining doctors and nurses […]
23 September 2013 @ 1:28 pm
I am currently in one of the Botox trails. I am on my second round of shots and it is working very well for me. I was having 25+ days with migraines. Now I’m only have a few a month. it has made a huge difference in my life. I would highly recommend finding a headache clinic and see if they are running a study. Now I will say that the first treatment didn’t help as much as the second one has. I’m looking forward to more treatments and less and less migraines