Botox for migraine

8 June 2020

Should Botox Treatment be more “Standardized”?

James Discoveries & Stats, Medications, Treatments 0

Botox, generic name onabotulinumtoxinA, has become a common preventative treatment for migraine. But as we have noted before, you may get a different treatment depending on which doctor you go to.

During the last weeks of 2019, an anonymous questionnaire was sent to headache doctors to see just how they were using Botox, and the results might surprise you. But first, a little background.

A protocol has emerged to attempt to standardize Botox treatment, known as the PREEMPT protocol (named after Botox clinical trials). Allergan, the company that makes Botox, promotes this protocol as you can see here:

So there’s no doubt that Allergan wants doctors to use this protocol. But what did the study show?

Units? About 63% didn’t follow the protocol. “Proven sites”? Almost 58% didn’t follow the protocol. And 70% changed the injection sites. In fact, 77.5% of doctors said simply that they did not always follow the PREEMPT Paradigm.

Why not?

Going only by the abstract, the researchers explained: “The main reported reasons for changes in number, dose, and location of injections included adapting to the patients’ pain, anatomy, and preferences.”

That’s not really very specific, but the changes had to do with both doctor’s and patient’s “preferences”.

It should be noted that although some of these doctors were fairly new when it came to this treatment, many were quite experienced. In fact, 71.4% had more than three years’ experience.

The fact of the matter is that onabotulinumtoxinA research is moving on. Not just clinical trials, but also in the experience of the doctors providing the treatment. There is still a lot that we have to learn about Botox treatment – why does it work better for some patients than others? Could it be that PREEMPT is not the ideal for everyone?

Here you might find helpful some of the more recent articles on Botox treatment:

So the “why not” question is very important. If PREEMPT is the best treatment overall for migraine patients, that doesn’t mean that it’s the best for you. However, if it has the best evidence at the moment, it is a good starting place for most people. There’s a reason why Allergan is promoting this protocol.

But we should be careful to rule out the clinical experience of doctors, and the ongoing studies. What you should do is talk to your doctor and understand why she isn’t following PREEMPT in your case. She may have very good reasons. But it’s up to you to ask and get the answers you need before you start treatment.

Is your doctor adapting to “your anatomy”? Is your doctor simply not aware of PREEMPT? Has experience changed the way your doctor uses Botox for migraine? Ask!

The important message here from this study – be aware that Botox treatment is not standardized. Do your research and be aware of what your doctor is offering.

For more on this study:

2 December 2019

Botox vs. CGRP Inhibitors – the fight begins…

James News, Treatments 0

Are the newcomers to migraine treatment really any better than Botox treatment?

That’s one of the key questions being asked now. And it’s an important one, because it’s affecting migraine patients and their insurance coverage.

Patient and doctors — Are important policies being decided “behind your back”?

For example, in England, NICE (National Institute for Health and Care Excellence) recently decided not to recommend Ajovy (fremanezumab) as one of the drugs provided under the NHS (National Health Service). Why? Because current evidence doesn’t show the Ajovy is that much better than Botox (onabotulinumtoxinA) for patients who have tried several treatments already. And if the difference in success is negligible, the difference in cost is not – onabotulinumtoxinA wins easily.

Botox, once the strange newcomer to migraine treatment, is now an old standard. And it may be difficult for policy makers and insurance companies to accept the newcomers, even if they may be better for some patients.

Interestingly enough, its affect on CGRP may be one of the reasons why onabotulinumtoxinA works for migraine patients, which may explain similar results. But we’re still waiting for some good head-to-head studies to really show us which is “better” – “better”, that is, for most patients in general, not necessarily better for you. Welcome to the real world. (Also see Botox and CGRP – and the Future of Migraine Treatment.)

If new studies confirm that Botox performs as well as CGRP inhibitors, of course doctors may want to recommend Botox first, as a less expensive option, to most patients. But Is that a reason to not recommend the CGRP inhibitors at all? Or not to cover it in an insurance policy?

~~Of course, all this has nothing to do with money and politics.~~ Well, ok, maybe it does. Allergan is busy trying to convince investors that Botox for migraine sales continue strong. And there is some evidence that onabotulinumtoxinA and CGRP inhibitors may turn out to be best friends, because the anti-CGRP drugs may help the migraine-fighting effects of Botox last longer (see Concurrent CGRP Inhibitor and OnabotulinumtoxinA Therapy Boosts Relief in Severe Chronic Migraine).

But with the current expense of the new drugs, and a lack of studies to show long term safety, Botox may still have a surprising advantage.

(You can see in detail the reasoning of NICE in their paper here: Fremanezumab for preventing migraine (pdf). Also see Results of The Migraine Trust’s latest patient survey to inform new migraine drug NICE consultation.)

17 August 2015

Botox for Migraines: Will it work when other treatments don’t?

James Discoveries & Stats, Medications 1

Are patients who take Botox for migraines actually improving in the real world? In other words, are their migraine attacks actually decreasing, and is their quality of life improving? And what about patients that don’t respond well to other treatments?

Dr. Modar Khalil at the Hull Royal Infirmary in the UK has been studying headache disorders for a number of years, and most recently the use of Botox (OnabotulinumtoxinA) for migraine. His latest Botox study followed 465 patients treated in England for migraine.

It’s important to note who these patients were. First, they had a median history of four years with chronic migraine. They averaged 15 migraine attack days per month and 27 headache days. And 97% had already tried three or more preventative treatments without success.

So these aren’t people who occasionally get a headache, these are patients whose lives are seriously and constantly affected by migraine.

The best outcome was for 21% of patients, who had at least a 50% reduction in headache days in the first month after treatment, at least a 50% reduction in migraine days, and double the “crystal clear” days with no headache or migraine symptoms.

59% of patients at least hit one of these targets. botox-for-migraines-khalil

The best results came for those with 21-25 headache days per month – 74% reached at least one goal. Those with more headache days seemed harder to treat (although there was still significant improvement), and those with fewer headache days had less drastic results.

A third of the patients had a 75% reduction in either headache or migraine attack days, and at least three times the “crystal-clear” days.

The medication was tolerated well – the most common problems were a stiff neck (16%) and pain at the injection site (15%) lasting more than 24 hours.

Here are some important things you may want to note about this study. First, these results are very good considering that these are hard-core patients who have had trouble finding treatments that help. At the same time, this was a study of patients in the “real world” – helpful because it shows that Botox actually helps real patients in a normal situation. However, without controls, and without a longer period of time, it is difficult to compare statistically between patients who took Botox and those who tried another treatment, or nothing, or a sham treatment. The numbers would probably be less impressive in a controlled study.

Still, taken along with what we hear in the “real world” about the benefits of Botox (I just received another email from a patient who has been helped significantly by Botox treatment), it should encourage the community to keep pursuing and improving Botox for migraines treatment, and consider its benefits for other chronic headache disorders.

18 June 2014

Will Botox Work for You? A New Clue in Your Blood…

James Discoveries & Stats, Medications, Treatments 2

Botox injections sometimes help some migraine patients. But with so many other treatments to try, and with the expense of Botox treatments, many patients aren’t willing to risk it with that “sometimes … some” disclaimer.

Of course, this is an issue with ever migraine treatment out there. And so researchers are pushing to find out why – why does [this treatment] work for Jessica, but not for Emily?

Using Botox (onabotulinumtoxin type A), researchers in Spain wanted to know if a blood test could predict how well Botox treatments would work. They chose two indicators – two peptides that can be measured in the blood – calcitonin gene-related peptide (CGRP) and vasoactive intestinal peptide (VIP).

Both of these peptides are well known in migraine research. CGRP is a particular hot spot in migraine research today – you can read about it in The Secret of CGRP, and learn about the race to approve a CGRP-related migraine drug in New Migraine Drugs: What About CGRP?

It has been theorized that onabotulinumtoxin type A works because of the way it blocks the release of CGRP.

The most striking results came from testing levels of CGRP. The chart below shows how likely the patient is to respond well to Botox treatment:

If the level of CGRP in a patient was above 72 pg/ml, they were 28 times more likely to respond well to onabotulinumtoxin type A treatment.

Results with VIP were less obvious, but even then patients with low CGRP were more likely to respond if VIP levels were high.

Knowing how well Botox treatment will work is notoriously tricky, because not only do you have different patients, you also have different doses, injection sites, and intervals of treatment. But it would be a significant help if, with a blood test, we could know that Jessica is a good candidate for Botox while Emily is not.

This research tells us something else – it’s another clue that we may be on the right track when it comes to CGRP. The many CGRP medications currently in clinical trial may help many migraine patients that have not been helped before.

Study abstract: CGRP and VIP levels as predictors of efficacy of onabotulinumtoxin type A in chronic migraine.

27 March 2013

How to be Safe with Botox (10 tips)

James Tips, Treatments 12

Although many people are injected with Botox (onabotulinumtoxinA) (botulinum toxin type A) and they never have any significant problems, there have been cases of severe health issues.

Only receive injections from a professional trained and experienced in using Botox for migraine. Many problems can be solved simply by visiting someone who knows what they’re doing.
Be sure the doctor knows your medical history. This includes your experience with migraine, any previous Botox treatments, previous surgeries, any medications you take (including sleeping pills, allergy medication, blood thinners, antibiotics and muscle relaxants) etc.
If you have infection, muscle weakness, or inflammation where you’re going to be injected – wait for another day.
Tell your doctor if you have experienced any side effects from a previous treatment.
Check the ingredients – if you have an allergy to any ingredients in the injections, don’t have the treatment.
Do not start any new medications without telling your doctor that you’ve had Botox treatments in the past.
After the treatment, tell your doctor immediately if you’re experiencing any of these side effects: itching or rashes, trouble breathing, trouble swallowing, drooping eyelids or drainage from your eyes, vision problems (double vision or blurred vision), heart problems or chest pain, muscle weakness or paralysis, loss of bladder control, trouble talking or hoarse voice. Note that some of these symptoms could appear several weeks after your treatment.
If you are pregnant, trying to get pregnant, or breastfeeding, discuss the risks with your doctor.
Be aware that Botox could cause migraine-related symptoms. These include headache, fatigue, anxiety, and pain in other parts of the body. Hopefully you won’t experience these symptoms. However, do discuss the pros and cons with an experienced doctor before starting treatment.
Botox should not be the first treatment you try for chronic migraine. Look at other options first – not only medications, but also non-drug treatments. If your doctor recommends Botox treatment when you’ve first been diagnosed, get suspicious and seek a second opinion

Please remember that these are not reasons why no one should ever try a Botox treatment. As with just about any treatment for migraine, there are pros and cons. Being aware of them helps you to have the safest and best options without making things worse.

For more, read about Botox headache injections here.
See what Allergan (the makers of Botox) has to say about Botox safety