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Botox

This is a common question I get from patients. Botox was first approved by the FDA in 1989. The CGRP monoclonal antibodies (mAbs), in 2018. Long-term safety of Botox is well established. I’ve treated many pregnant women, children as young as 8, and one patient who reached 100. Botox acts locally and has no systemic effects. It means that it cannot affect your kidneys, liver, heart, or any other organ. Injections of CGRP mAbs appear to be safer than most old medications taken by mouth. But they do have some systemic side effects and we don’t know if there are any long-term side effects. We have some 5-year safety data but only in a small number of patients. We will know more in a few years, after these drugs have been in use in a large population of patients.

Long-term safety is the main reason why I recommend trying Botox before mAbs.

Another reason to prefer Botox was presented at the 62nd annual meeting of the American Headache Society. It was conducted by Allergan, the manufacturer of Botox, so bias could be a factor. They looked at a relatively large number of patients – 1,976. Of these, 333 (17%) were treated with Botox first. Another 1134 (57%) were started on erenumab (Aimovig), 298 (15%) initiated fremanezumab (Ajovy), and 211 (11%) started galcanezumab (Emgality). More patients (75%) who were started on Botox were still receiving it 6 months later compared to patients who were first given a CGRP mAb (erenumab: 47%; fremanezumab: 55%; galcanezumab: 45%).

Not all of my patients begin with Botox. Some prefer mAbs because they don’t like the idea of having multiple injections over their face and head. Others cannot obtain insurance coverage for Botox. During COVID, some patients were reluctant to come to the office for Botox injections and they preferred to start a mAb at home. Three of the four available mAbs can be self-administered. The fourth one, eptinezumab (Vyepti) is given intravenously every 3 months.

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Fortunately, migraines improve during pregnancy in the majority of women. None of the preventive drugs for migraine are approved by the FDA for pregnant women. The only medicine that is considered safe is a beta-blocker, metoprolol. Other drugs are either labeled as dangerous (e.g. topiramate and valproate) or as not having enough information about their effect on the fetus.

Most women obviously would rather not take any drugs. However, having frequent and severe migraines can be also detrimental to the fetus. It is not only the distress caused by severe pain but also the dehydration from vomiting that can have a negative effect.

A group of British doctors collected data over a 9-year period and have found 45 patients who became pregnant while receiving Botox for chronic migraines. All patients had received Botox within 3 months prior to the date of conception. 32 patients wished to continue treatment during pregnancy while the remaining 13 stopped treatment. There was one miscarriage in the treatment group. All other patients had full-term healthy babies of normal birth weight and no congenital malformations.

A recent poster presentation at the last annual meeting of the American Headache Society by neurologists at the Medstar Georgetown University Hospital in Washington, DC described 9 women treated with Botox during 10 pregnancies. All babies were born healthy.

This is a small number of patients and we cannot make any conclusions about the safety of Botox in pregnancy. Other reports, however, also suggest that Botox is safe.

In my 25 years of using Botox for migraines, I’ve given it to more than a dozen pregnant women. A few of them continued to receive Botox throughout more than one pregnancy.

Botox has been in use for over 30 years and millions of women have been treated with it with no reports of fetal problems. Unlike oral or injected drugs, it has only a local effect. The amount of Botox given for chronic migraines is measured in nanograms. After injections, it cannot be detected in the blood. All this suggests that Botox is safer than drugs taken by mouth or given by injection.

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Two patients treated at MD Anderson Cancer Center for brain tumors were given Botox injections for their tumor-related headaches. The report at the recent meeting of the American Headache Society describes two patients, one with a meningioma (“extensive meningiomatosis”) and the second one with metastatic breast cancer. The first patient completed 14 treatments with Botox over 4 years and the second, 9 treatments over 2 years. Both patients had sustained improvement in their headache intensity, duration, headache-free days, and quality of life. The recurrence of headaches often began 90 days after each treatment, which is the usual duration of the effect of Botox.

Botox is approved by the FDA for the preventive treatment of chronic migraine headaches, which are defined as headaches occurring on at least 15 days each month. However, most headache specialists I know use it for other types of headaches as well. Cluster headaches, hemicrania continua, post-traumatic headaches, numular headaches, trigeminal neuralgia have all been reported in the medical literature to respond to Botox. I’ve also successfully treated patients with these types of headaches, as well as a large number with episodic migraines (less than 15 headache days a month) and a few with chronic tension-type headaches.

Neuropathic pain also seems to respond to Botox and I’ve treated patients with post-herpetic neuralgia (shingles), stump pain after amputation, post-surgical scar pain, and other pain types.

It is not surprising that Botox could help headaches caused by a brain tumor. The brain itself is not pain-sensitive – neurosurgeons can cut it in an awake patient without causing any pain. Most of the pain originates in the brain covering called meninges which are innervated by the trigeminal nerve and which can be stretched and irritated by a tumor. The trigeminal nerve also provides sensation over the face and the anterior part of the head. Botox works by reducing pain signals sent from the trigeminal nerve endings to the brain.

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It is hard to think or write about anything other than Covid-19, so here is some information on Covid-19 and headaches.

The bad news is that the long-suffering headache patients are suffering more. Most hospitals consider Botox injections, nerve blocks, and other procedures to treat headaches as “nonessential”. Yes, our patients will not die like some of those with Covid-19, but a more nuanced approach than just canceling all “nonessential” procedures should’ve been possible. My NYC colleagues are not needed to treat Covid-19 patients and they are just sitting around worrying about their patients and their own futures. We are a private headache clinic and are continuing to see patients in our office (with all the precautions) for Botox and other procedures, although the number of patients we are treating has dropped by three quarters. Most are understandably concerned about contracting the virus and are staying home.

As far as the relationship between Covid-19 and headaches, it appears that this virus can sometimes invade the brain. This is not surprising because many viruses that affect the respiratory system can also affect the brain. The brain symptoms of Covid-19 are similar to those seen with other brain infections, including headaches (at times with nausea and vomiting), seizures, and disturbed consciousness. Loss of sense of smell is very characteristic of Covid-19 and it happens because of the damage to olfactory nerves. These nerve endings line the nasal cavity and they are directly connected to cell bodies of neurons in the brain. This is one of the possible routes of entry of the virus into the brain.

Recent reports suggest that Covid-19 causes blood clotting in small blood vessels of the lungs, which may be contributing to deaths in some patients. A few cases of strokes in Covid-19 patients have been reported, although it is not clear if blood clotting or even the virus itself were responsible. The Mt. Sinai Hospital system to which I belong just issued guidance for the use of blood thinners in Covid-19 patients. This could be life-saving for some critically ill people.

All this may sounds very alarming, but fortunately, most neurological and other symptoms of Covid-19 resolve in over 99% of patients. The mortality rate of Covid-19 seems higher than 2% only because there are so many people who had the infection with mild or no symptoms and those people are not included in the calculations of mortality rates.

One silver lining is that now we all practice telemedicine. The technology has existed for years, but a major obstacle has been the unwillingness of insurance companies to pay for telemedicine visits. The telehealth parity law was actually passed in NYS in 2016. This pandemic will make televisits much more commonplace. Telehealth law excludes audio-only and electronic messaging-only. Fortunately, there are several HIPAA-compliant video platforms that make televisits easy to conduct. Less than half of our patients need to be in the office for a procedure while the rest can be safely and effectively treated remotely. Most people have busy lives and not having to trudge to the office will save them hours of time.

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A large study confirms previous reports of the beneficial effect of onabotulinumtoxinA (Botox) injections on depression as well as anxiety. In my two previous blog posts from 2011 and 2014 I mentioned reports of cosmetic Botox injections relieving depression but those involved a relatively small number of patients.

A study published in the Journal of Neurology, Neurosurgery, & Psychiatry under the title Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety ,described the COMPEL trial (Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy Open-Label). It was a multicenter, open-label, prospective study assessing the long-term safety and efficacy of 155 units of onabotulinumtoxinA (Botox) over nine treatments (108 weeks) in adults with chronic migraines.

OnabotulinumtoxinA treatment was associated with sustained reduction in headache days and depression and anxiety scores in the 715 patients over 108 weeks. The anxiety and depression scores were significantly reduced at all time points in patients with clinically significant symptoms of depression and/or anxiety at baseline. By week 108, 78% and 82% had clinically meaningful improvement in depression and anxiety symptoms, respectively. Sleep quality and symptoms of fatigue also improved.

In an earlier poster presentation of this data at a scientific conference the authors reported that the improvement in anxiety and depression was seen even in patients whose migraines did not improve with Botox. Even if that were true, we need a separate large study of Botox for anxiety and depression. The one study that treated patients with major depression in a double-blind, placebo-controlled trial involved only 74 patients.

In my practice, I’ve treated one young woman with severe bipolar disorder which did not respond to multiple drugs and who had a dramatic response to Botox. She has been receiving injections for over two years with sustained improvement. Another young man with depression had a very significant response as well, but has had only one treatment so far. I came to treat them accidentally – both were adopted children of my migraine patient who read about this possible effect of Botox and asked me to try it.

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A recent report by neurologists from the Mayo Clinic suggests that onabotulinumtoxinA (Botox) injections can relieve not only headache pain, but associated neurological symptoms, such as visual aura, numbness and weakness, which can precede or accompany a migraine attack. This article describes 11 patients with hemiplegic migraine, which means that these patients developed weakness on one side of their body prior and during an attack. From the description of these cases, it appears that at least a couple of patients had migraine with sensory-motor aura rather than true hemiplegic migraine. But regardless of the precise nature of their symptoms, Botox was effective in reducing these symptoms, along with headaches in 9 out of 11 patients. Ten of the 11 patients had chronic migraine and on average they failed five preventive drugs before starting Botox.

Two of the physicians who wrote the report have already presented some of these cases in 2013. As mentioned in the blog post describing this older report, I have also successfully treated many patients with visual, sensory and motor aura with Botox injections. Just like with patients in the current article, many of my patient responded to Botox after failing several preventive drugs.

We seem to understand how Botox relieves pain, but it is less clear how it helps neurological symptoms such as weakness, numbness and visual impairment. One possible explanation is that Botox reduces painful messages from the surface of the skull to the brain, which reduces excitability of the brain and this in turn prevents the brain from generating a migraine attack, including its associated symptoms.

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Injections of onabotulinumtoxinA (Botox) are approved for the treatment of chronic migraine headaches in adults. Botox is also widely used off-label (not an FDA-approved use) for the treatment of migraines in children. We know that botulinum toxin is safe in children because another very similar form of botulinum toxin, abobotulinumtoxinA (Dysport) is approved for the treatment of cerebral palsy in children as young as 2. The youngest child with chronic migraines whom I treated with Botox was 8 years old.

Two groups of physicians presented results of their treatment of migraines in children with Botox at the recent annual scientific meeting of the American Headache Society held in San Francisco.

The first report, whose lead author was Ilya Bragin of St. Luke’s University Health Network describes positive results of Botox injections in 30 adolescents with chronic migraines. All 30 had to fail amitriptyline (Elavil) and topiramate (Topamax) to be eligible to receive Botox. Seven of of them had a history of a head trauma. The adult injection protocol of 155 units injected into 31 sites was followed. Both migraine frequency and severity improved with no reported side effects.

The second report from doctors in Delaware describes 44 children aged 11 to 20, who were treated with Botox for their chronic migraines. The dose ranged from 35 to 155 units, depending on pain location and child’s tolerance of injections. About 70% of children had at least a 50% improvement in their migraine frequency and severity. No child developed any side effects.

We tend to use the Delaware group’s approach in that we tailor the dose and the injection sites to each child, depending on pain location and weight of the child. And we also find that about 70% respond, which is the rate of improvement in our adult patients.

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The FDA has approved 4 different types of botulinum toxin for various therapeutic indications. The oldest, the most popular and the only one approved for the prevention of chronic migraines is onabotulinumtoxinA, or Botox. I’ve been injecting Botox for headaches for over 25 years and have written many blog posts and long articles about it. You can read about Botox for kids with chronic migraines in this post.

A new development in the botulinum toxin field is a long-acting form of botulinum toxin, daxibotulinumtoxinA , which may become available in a couple of years. Its effect on muscles and nerve endings appears to last 6, instead of the 3 months seen with Botox.

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AbobotulinumtoxinA (Dysport) is a product that is very similar to OnabotulinumtoxinA (Botox), but only Botox is approved by the FDA for the treatment of chronic migraines. Botox is the oldest of the four neurotoxins that are being used for various medical and cosmetic indications.

While AbobotulinumtoxinA (Dysport) is very similar to Botox and small clinical trials suggest that it is also effective for the treatment of migraine headaches, it is not exactly the same and should not be substituted for Botox. They differ because these are not synthetic molecules, but rather complex proteins that are produced by a slightly different strain of the Clostridium botulinum bacteria. They are also processed in a different manner. Allergan, manufacturer of onabotulinumtoxinA, or Botox holds the patent for the use of a neurotoxin to treat migraines, so other companies cannot promote their products for this indication. Other toxins are approved for cosmetic and certain other medical indications.

Other toxins are a little cheaper than Botox, but I almost exclusively inject Botox because I’ve been using it for over 25 years with excellent results and very few side effects, because it has been extensively tested in thousands of migraine patients, and because it is the toxin that is usually covered by insurance companies.

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TMJ syndrome is a disorder which often coexists with migraine and tension-type headaches and is characterized by pain in the jaw joint and surrounding muscles. It is very common, but the exact cause remains unclear. In many people TMJ is a sleep disorder, which can occur in the absence of overt stress, but stress definitely plays a role in most people. Headaches in patients with traumatic brain injury can be also worsened by bruxism (clenching and grinding of teeth), while treating bruxism contributes to the relief of headaches.

Dentists usually advise patients to sleep with a custom-made bite guard, but it only reduces grinding and may not stop clenching.

The standard injection protocol for migraines includes injections into the temples (temporalis muscles), which are involved in clenching, but my 25 years of using Botox suggests that many patients get much better results if lower jaw (masseter) muscles are also injected.

A study just published in Neurology tested the safety and efficacy of onabotulinumtoxin-A (Botox) injections into those muscles (masseter and temporalis) in patients with sleep bruxism.

This study included adults with sleep bruxism which was confirmed by an overnight sleep study. The study was randomized and placebo-controlled (half received Botox and the other half, placebo), with an open-label extension (when everyone receives Botox). Participants were injected with 200 units of Botox – 60 into each masseter and 40 into each temporalis muscle or placebo (by comparison, a total of 155 units is used to treat chronic migraine headaches). They were examined 4 to 8 weeks after the initial treatment. Global impression scale and perceived change in bruxism and in pain were assessed. .

Of the 22 participants who completed the study (19 women, mean age 47 years), 13 were given Botox and 9 received placebo. Global impression, pain and bruxism favored the Botox group. Two participants who received Botox reported a cosmetic change in their smile. No other side effects were reported. I find that many patients like the cosmetic effect of injections into the lower jaw muscles – they often acquire a more rounded face, instead of a square-jawed one. On the other hand, if temporalis muscles are injected too far towards the front of the temple, it can lead to an unattractive caved-in appearance.

In addition to Botox and an oral appliance, many patients with bruxism and headaches benefit from stress reduction techniques, such as meditation, biofeedback, progressive relaxation, yoga, and other. When medications are needed, we most often prescribe muscle relaxants and antidepressants.

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A new report by doctors at UC Irvine describes successful treatment of 9 children aged 8 to 17 with migraine headaches using Botox injections. It may sound surprising, but unfortunately children also suffer from chronic migraines. Chronic migraine is defined as headaches that occur on 15 or more days each month and on at least 8 of those days headaches have migraine features. In children with episodic and chronic migraines, migraine features, such as throbbing, unilateral location, sensitivity to light and noise are less common than in adults.

There are only 5 treatments that are approved by the FDA for the prevention of migraine attacks. Four are drugs – 2 blood pressure medications, propranolol (Inderal) and timolol (Blocadren) and 2 epilepsy drugs, topiramate (Topamax) and divalproex sodium (Depakote). The fifth treatment is Botox injections. While Botox is not approved for kids with migraines, it is approved to treat eye conditions in children 12 years of age and older. Botox is also widely used to treat younger children with cerebral palsy (CP), although there is no official FDA clearance for such use. For a child with CP, Botox injections can make a difference between being wheelchair-bound and walking unassisted. However, very young children with CP are at the highest risk of serious complications and even death because they have small bodies and very stiff muscles, which require relatively large doses of Botox.

The dose to treat migraines is much smaller and therefore a lot safer. My youngest child with chronic migraines was a boy of 8 who weighed 50 lbs. He had excellent relief of his migraines after receiving 15 units of Botox into his forehead. He underwent a total of five treatments over a period of two years and for the last treatment, I gave him 50 units (forehead and temples). By then his weight was 65 lbs. The standard adult dose for migraines is 155 units. The dose for cerebral palsy in an adult goes up to 400 units.

The main difficulty in using Botox in children with migraines is that insurance companies often deny coverage, which they justify by the lack of FDA approval. However, Botox injections at low doses used to treat migraines in children are safer than drugs for epilepsy, high blood pressure, or depression.

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Chronic pain is known to alter the structure of the brain. Mayo Clinic researchers used MRI scans to examine brains of 29 patients with post-traumatic headaches and compared their scans to those of 31 age-matched healthy volunteers. The average frequency of headaches was 22 days a month. Patients with post-traumatic headaches were found to have thinning of several areas of their cerebral cortex which are responsible for pain processing in the frontal lobes. Cortex covers the surface of the brain and contains bodies of brain neurons. Drs. Chiang, Schwedt, and Chong, who presented their findings at the annual meeting of the International Headache Society held last month in Vancouver, also discovered that the thinning was correlated with the frequency of headaches.

This study did not address possible treatments, but it would make sense that with better control of headaches, this brain atrophy might be reversible. To treat post-traumatic headaches we often use Botox injections, which have been shown to help posttraumatic headaches. Even though Botox is approved only for chronic migraines, many patients with post-traumatic headaches do have symptoms of migraines and can be diagnosed as having post-traumatic chronic migraines (without such a designation insurance companies may not pay for Botox). We also check RBC magnesium, CoQ10 and other vitamin levels, which are often low in chronic headache sufferers and if corrected, can lead to a significant improvement. Epilepsy drugs and anti-depressants can also help.

While the above mentioned treatments can help headaches and potentially could reverse brain atrophy, there is only one intervention that has been shown to increase the thickness of the brain cortex on the MRI scan. This intervention is meditation. And this effect was demonstrated in several studies. An 8-week course of mindfulness-based stress reduction led to a measurable increase in the gray matter concentration of certain parts of the brain cortex. A pilot study of migraine sufferers showed that meditation has a potential not only to restore thickness of the brain, but also to relieve migraines.

In one of my previous blog posts that described a sceintific study of meditation, I mentioned several ways to learn meditation: Free podcasts by a psychologist Tara Brach an excellent book, Mindfulness in Plain English by B. Gunaratana, and several apps – Headspace, 10% Happier, and Calm. You can also take an individual or a group class, which are widely available.

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