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Evidence for Botox to treat Migraines is Questionable

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Headache related image Photo: Getty Images

There is no doubt that Botox is useful for treatment of wrinkles. However, since its introduction two decades ago, physicians have been finding new disorders that can be treated with Botox.

In most cases, the effectiveness of Botox has been based on anecdotal data. Even the few studies conducted have been sponsored by the manufacturer of Botox.

In the last decade, thousands of people have been injected with Botox for their migraines. Many neurologists even advertise on their website that they offer Botox for migraine.

Now the National Institute for Health and Clinical Excellence in England has said that there is insufficient evidence to support use of Botox in the treatment of migraine. (1)

The agency has requested that the manufacturer of Botox, Allergen, provide more objective data within the next three months.

Of course, the neurologists were disappointed because they insist that Botox does help people with migraines and relieves the nausea and vomiting.

Migraine is an agonizing disorder which often presents with:

1) severe headache
2) visual disturbances associated with flashing lights or bright spots
3) extreme sensitivity to noise, light or smell
4) nausea and vomiting
5) tingling, or pins and needle sensations in the limbs

Botox is injected into a minimum of 31 sites around the head and neck every 12 weeks. How Botox works in preventing chronic migraine is unknown. There is speculation that it may work by relaxing muscles or possibly interrupting pain signals.

However, the original data have been reassessed because of numerous patient complaints that the Botox doesn't work. Reevaluation of the results of the study has shown that the benefit of Botox was miniscule and the study design was not properly conducted.

The original studies were sponsored by Allergen and some doctors involved in the study were also paid consultants. Now the agency has asked for more data before it will recommend use of Botox for chronic migraines.

The agency has indicated that no additional data is forthcoming, the public will be advised not to spend additional money on a treatment that may have no benefits. The cost of Botox for treatment of migraine is not trivial and if not covered by health insurance plans (as is often the case) can be prohibitively expensive. In the U.S.A, each cycle of treatments can cost anywhere from $1,500-$2,500.

Allergen says it will provide that data requested.

So what should the consumer with migraine in the United States be doing today?

From past lessons, it has become evident that when pharmaceutical companies sponsor drug trials and pay doctors, the results are positive. For the consumer with migraines there is limited evidence that Botox works. (2)

Judging from anecdotal reports published on cyberspace, it appears that the majority of people indicate that Botox does not work for chronic migraines. The best advice is to speak to an honest neurologist who is more interested in your health than your money -- that is sometimes a more difficult part of the process than the migraine itself.


1. Should the NHS offer Botox as a treatment option for chronic migraines? NICE asks for more evidence . Web. 19 Feb. 2012.
Abstract: http://www.nice.org.uk/newsroom/pressreleases/BotulinumToxinTypeAChronicMigraineACD.jsp

2. Shuhendler AJ, Efficacy of botulinum toxin type A for the prophylaxis of episodic migraine headaches: a meta-analysis of randomized, double-blind, placebo-controlled trials.
Abstract: http://www.ncbi.nlm.nih.gov/pubmed/19558252

Reviewed February 20, 2012
by Michele Blacksberg RN
Edited by Jody Smith

Add a Comment4 Comments

EmpowHER Guest

No, do not worry. My personal feeling is that there is a lot of money involved and botox use is widespread in medicine. The FDA almost never discontinues drug usage based on efficacy studies from British or European agencies. As long as botox is safe and neurologists tell patients that it may or may not work- life will go on. Botox has been around for more than 15 years and going strong.

February 21, 2012 - 10:38am
EmpowHER Guest

thanks for your comment. Unfortunately, migraine is a difficult disorder to treat. The few treatments available do not work in everyone. Dissatisfaction has led many desperate patients to try out whatever is available. The problem is that doctors tend to make promises about every new therapy. Personally, my patients have not had any significant relief from Botox. The NICE data analyses was based on the initial clinical trials on about 1300 migraine patients who were treated with botox. I am sure there are patients who have had relief from botox, but one cannot discount the placebo effect.

February 20, 2012 - 6:21pm
(reply to Anonymous)

Thanks for your reply! Do you think their decision will cause the FDA to reconsider their approval of Botox for migraines?

February 21, 2012 - 10:26am

Thank you for covering this topic. I'm curious if NICE took into account that most doctors say Botox only works for certain types of migraines? Perhaps the disappointed patients weren't treated by Drs who knew when it would/wouldn't be a worthwhile solution. Considering how easy it is for any doctor, regardless of their specialty training, to offer Botox, it wouldn't be unimaginable.

Just trying to play Devil's advocate here :)

February 20, 2012 - 5:45pm
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.



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