Dr. Bronwyn Jenkins who’s a certified neurologist, headache specialist and someone who’s very familiar with Botox for migraine. She’s co-secretary of the recently formed Australian and New Zealand Headache Society.
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Carl Cincinnato: What do we know about the effectiveness of Botox?
Dr. Jenkins: The sentinel trials or the PREEMPT trials, where these were randomized control trials–which means that they could make sure there was no bias. They didn’t actually reach their primary endpoint which was to decrease what we call headache episodes, so the start of an attack.
But they did manage to reach several secondary endpoints, including an overall decrease in headache days, a total decrease in headache hours, and a decrease in the migraine or moderate to severe headaches. That was in just under 50% of people reaching more than 50% in those areas.
Further sub-analysis of those studies have shown that there’s quality of life improvements for responders and also that there seems to be a progressive benefit with up to 70% of people responding after five courses of treatments.
Carl Cincinnato: Sometimes we’ve seen the real world results being slightly different from what’s found in clinical trials. You have experience with patients with Botox for migraine. How would you describe your experience in the success of Botox?
I was very cynical about Botox initially. When the trials came out, it became clear that this was potentially a treatment that could help people so I should be doing it. In the real world, I do think my outcomes are significantly better.
I’ve just audited my cohort of people that have Botox; the response rate seems to be better when you treat them as a whole person. So in the trial, they were only allowed this to do this one intervention. Whereas in the real world, we’d be talking about everything like we are today about triggers and lifestyle and other alternative strategies, and treating the headache as early as possible with an effective treatment and having adjunctive treatments like other preventatives, not taken away from them and actually used as well.
So you can help someone sleep with a low dose of a preventative medication which markedly improves their response to Botox, even if it is having the major effect in their migraine frequency and severity. So I’ve been really surprised at the response of some patients.
I think it’s very variable for individuals. There will be this group that almost switched off in their headaches after several courses where they get a few headaches when it’s wearing on and wearing off and in the middle months, they’re really very good and they can treat them very easily if they have any.
But then there’s a bigger group where they achieve that 50% reduction and then they just plateau and hover there, and they still need to constantly think of other strategies, too to maintain that lower frequency and severity.
So it’s very variable amongst even the responders. But I think the response rates, definitely the quality of life improvements and all of those things are better than I expected based on the small changes you see in the clinical scientific research article.
Botox for migraine is now a common treatment. Botox is indicated for chronic migraine and can potentially be claimed on insurance for migraine prevention.
You might be wondering how does an injection of Botox into wrinkles around my face help with migraine?
As with many other drugs used for migraine, Botox wasn’t invented to treat migraine. People using Botox for other purposes started reporting benefits in their migraine condition. After enough case reports, eventually a clinical trial was established to see if there was any merit to these patient examples.
Find out what it is, how effective Botox could be and what risks or side effects you should be aware of before trying Botox for migraine.
What is Botox?
According to a recent article 84% of people don’t know what’s in the injections that are given for Botox.
Botox is a type of Botulinum toxin medically known as OnabotulinumtoxinA. It’s a purified protein produced by a bacteria.
Once this purified protein enters the nerve it breaks the protein strand. Once this protein strand is broken, chemical signals from the nerve to the muscle or to other nerves are blocked.
This block is temporary, it is not permanent. Botox can effectively weaken a muscle for a period of 3 to 4 months. (1)
The chemical signals blocked are blocked are mostly those responsible for muscle contraction. (2)
Just about everyone has heard of Botox for cosmetic purposes. As we get older a few unwelcomed wrinkles tempt a growing number of people to get Botox to help them look younger.
But there are actually many legitimate medical uses for Botox than the general public is aware of.
Isn’t Botox just a beauty treatment?
Cosmetically Botox works by blocking the nerve signal to the muscle. This leads to muscle relaxation which is why a wrinkle may be smoothed out. But this is not actually how it works in migraine.
Since the 1970s Botox has been used to treat a variety of medical conditions. Today there are at least 20 conditions where Botox may be used, some of which have not been approved by medical authorities or the FDA (i.e. used off-label).
Common uses for Botox include:
- Cervical dystonia – severe neck muscle spasms
- Blepharospasm – an uncontrollable eye twitch or muscle spasm
- Severe and excessive underarm sweating
- Eye alignment or fixing ‘cross-eyes’
- Bruxism or teeth grinding (used off-label)
- Overactive bladder
- Chronic migraine – note: this has been approved for use by the FDA.
Botox for migraine
Like many other migraine treatments it’s discovery was accidental. Botox was originally discovered when patients reported an improvement in their migraine condition whilst taking Botox for cosmetic reasons.
Botox was approved for migraine in 2010 when Allergen, a supplier of Botox, presented evidence to the FDA from two studies showing a decrease in the number of headache days in patients with chronic migraine whilst undergoing Botox treatment. (3,4)
Why Botox helps with migraine is not fully understood.
Sensory nerves carry pain impulses. They also secrete chemicals such as CGRP. CGRP has been shown to be a strongly implicated in the cascade of migraine symptoms. When Botox enters the muscle, the muscle acts as a container to keep Botox around the sensory nerve, allowing it absorbed into the nerve. Once in the nerve, it decreases the release of CGRP and other chemicals involved in migraine. (9)
When Botox is used cosmetically, it works specifically on the muscle. For a muscle to contract, the nerve releases a chemical messenger called acetylcholine. Acetylcholine is a neurotransmitter which sends signals from one neuron to another. In this case, acetylcholine attaches to cells in the muscle which causes them to contract. When Botox is injected the release of acetylcholine is blocked which prevents the contraction of the muscle.
Abnormal muscle contraction is reduced by Botox which allows the muscle(s) to become less stiff. This aspect of Botox might help with neck muscle stiffness which is commonly seen in patients with chronic pain.
What to expect
Over 500,000 patients in the USA have now been treated with Botox for chronic migraine.
If you’re getting Botox, you’re getting lots of quick short-needle injections.
There needs to be a minimum of 31 injection sites over your head and neck for migraine. A specific migraine protocol strictly instructs the administering doctor exactly where to insert each needle. These injection sites target the sensory nerves involved in the cascade of a migraine attack. This migraine protocol was established in clinical trials that involved thousands of patients.
It’s a good idea to understand the areas of these injection sites not only so you know what to expect but so that you can ensure your doctor follows them. If the migraine protocol isn’t followed it can compromise the effectiveness of your treatment.
The injections may take around 15 mins with most injections feeling like a small pinch. A short needle is used and all the injections are superficial, they are not deep injections. Expect the injections around the forehead and eyebrows to be a little more uncomfortable than the rest.
5% of patients can develop a headache after the treatment is delivered. The most common symptom is neck pain which is experienced by 9% of patients. (3)
You will typically require 2-3 rounds of injections to confirm whether Botox will work for you or not. That’s up to 9 months before you may experience any meaningful improvement.
Some migraine patients can respond within the first month, while others may require 3 treatments before they can confirm one way or the other. If, after the third treatment you don’t have an improvement, then it is unlikely to help in any further attempts.
Botox doesn’t interact with the usual preventative headache medications so those may be continued during Botox therapy with the approval of your doctor.
If you respond successfully, Botox can help you experience a significant reduction in migraine frequency per month provided treatment is ongoing. It may also assist in reducing the severity and duration of your migraine. (7)
Will it make you migraine free? According to Dr. Andrew Blumenfeld, Director of the Headache Center of Southern California suggests “that this result occurs only in a small percentage of patients, it should not be expected”.
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Botox Evidence & Results
Studies began originally in the mid 1990s to see if Botox could improve headaches. Several large, quality trials were conducted for Botox with several types of headache and tested several different types of injection. It took 10 years to establish the current injection protocol and to identify the ideal patient which is someone who has chronic migraine. (8)
Two Phase 3 clinical trials recruited 1,384 patients to test Botox against placebo. These trials were called the PREEMPT trials for Phase 3 Research Evaluating Migraine Prophylaxis Therapy.
The results showed the Botox significantly outperformed placebo.
The placebo showed a reduction of 6.4-6.9 headache days per month versus the Botox treatment which showed a 7.8-9.2 fewer headache days per month. Both results were measured after 24 weeks. (7)
Like other migraine studies, the placebo factor was significant. Still, based on the results, a migraine doctor might expect an average of 7 to 9 less headache days per month with their patient after 24 weeks on Botox (or 2 treatments).
Botox has not been proven to work for the treatment of migraine headaches that occur 14 days or less per month or for other forms of headache.
Challenges to Botox for Migraine
Several criticisms have been voiced about Botox for chronic migraine. (6)
- Critics of Botox for chronic migraine have argued that the actual reduction of headache days in terms of reduced headache days greater than placebo is small from the studies. This criticism looks at the total population of patients in the clinical trials which includes both the responders and the non-responders to the treatment. In patients who do respond, there is a significant benefit that is comparable to the most effective migraine preventive treatments.
- Some have criticized the PREEMPT trial design as focusing on medication overuse headache (MOH). Although patients with medication overuse (MO) were allowed in the trial, patients whose headaches were escalating and had MOH not MO were excluded. MOH is not the same as MO. The PREEMPT trials did not contain patients with MOH and escalating headaches.
- Botox is expensive.
- Side effects included headache, droopy eyelids, neck stiffness & muscle spasm.
Other migraine specialists have observed that results from Botox vary. Some patients experience no change at all whilst others experience a very significant reduction in headache days. (6)
Interestingly, the UK’s drug regulatory agency mentioned in its approval that Botox helps avoid the systemic side effects of pills and its safety profile was better overall.
Costs for Botox varies by country and practice. Another factor which affects how much the treatment gets back is how much you can claim from your health insurer.
Health insurance rarely covers the full cost, but you may be able to get a co-contribution from your health insurer if you qualify for the treatment as a chronic migraine patient.
If you have commercial insurance, the manufacturer co-pays up to $500 per treatment for the co-pay. This means that there is no out of pocket cost for these patients.
If you have government insurance, the cost is fully reimbursed resulting in no out-of-pocket expenses.
US based Allergen offer funding program you can find out more about if your insurer does not cover Botox for migraine or if you don’t have insurance. You can find out more about that here.
For a single Botox visit you can expect the cost to be around $700 before any rebates. Depending on your health insurer, you may be able to your out of pocket expense down to $300-500.
Similarly, one 3-4 month treatment may cost up to £500-600 pounds. Botox treatment on the NHS will cost around £350.
Should I try Botox?
Botox sales are over a billion dollars a year. Half of that comes from medical conditions such as chronic migraine.
Botox may be worth considering if you:
- have frequent disabling headaches consistent with a chronic migraine diagnosis
- have trouble remembering to take your medication
- have severe side effects from your current medication
- don’t have current effective treatment(s)
In cases of migraine, prevention is important and there are also effective non medicinal preventative therapies or strategies available. Botox is not the only choice, there are many other choices such as biofeedback, devices, and medications which have all been shown to help prevent migraine attacks.
Botox does help some people.
You’ll love it if you get results. According to Dr. Peter Goadsby, the results for an individual can be “quite spectacular” for some.
Given the cost of the treatments, don’t expect a freebie to smooth out your crows feet as well as a migraine treatment. For the most part, the injections sites are in different locations besides the forehead.
In the rare case where someone gets worse it will typically resolve within 12 weeks. Severe side effects are not common and can be minimized by ensuring you consult an experienced practitioner for migraine injections.
At the end of the day, Botox is a welcomed addition into the migraine treatment toolbox.
Have you tried Botox or are thinking about it? Let me know your experience so far?
MORE TREATMENT OPTIONS TO PREVENT MIGRAINE
Get a list of the top proven preventative migraine treatments according to guideline recommendations from the US and Europe.
(1) American Society of Health-System Pharmacists (October 27, 2011). “Botulinum Toxin Type A”. drugs.com. Retrieved 4 Jul 2015.
(2) Botulinum toxin A inhibits acetylcholine release from cultured neurons in vitro, Ray P, PubMed, In Vitro Cell Dev Biol Anim. 1993 Jun;29A(6):456-60.
3) Walsh, S. “FDA approves Botox to treat chronic migraine”. FDA Press Releases. Retrieved Jun 15, 2015.
4) Watkins, T. “FDA approves Botox as migraine preventative”. CNN (US). Retrieved Jun 15, 2015.
5)Aurora, S. K., et al. “OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial.” Cephalalgia 30.7 (2010): 793-803.
6) ‘Effectiveness of Botox Questioned.’ National Headache Foundation. Mar 15, 2011.
7) Diener, H. C., et al. “OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial.” Cephalalgia 30.7 (2010): 804-814.
8) Migraine Fact Sheet “Botox For Migraine”. Migraine Trust. Accessed 7 July 2015.
9) Jenkins, Bronwyn. Migraine World Summit 2018 Interview. April, 2018.