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.

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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