Botox

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.

16 July 2015

Botox and CGRP – and the Future of Migraine Treatment

James Discoveries & Stats, Information, Medications, News 0

A new study about Botox and CGRP confirms some of our suspicions, and may point the way to future migraine research and treatment.

Although it’s really started making headlines over the past year or two, the study of CGRP in migraine has been heating up over the past 20 years. CGRP stands for calcitonin gene-related peptide neurotransmitter. These neurotransmitters are especially involved in the communication of pain messages in the body (see The Secret of CGRP).

Early on, researchers began to suspect that CGRP levels rose during a migraine attack – so far nothing surprising.

However, researchers next began to discover that CGRP levels tended to be higher in migraine patients all the time, although levels seemed to drop with triptan treatments.

Test tube A study in 2013 showed that women with various types of migraine and cluster had elevated levels of CGRP in their blood (between attacks). Among those with migraine, those with chronic migraine had the highest levels – and among those with chronic migraine, migraine with aura showed the highest levels of all.

That finally brings us to the research related to Botox. As many of you know, Botox treatment works well for some people, and not for others. Why?

Last year we talked about a study which showed that people with high levels of CGRP were far more likely to benefit from Botox (onabotulinumtoxin type A) treatments.

Last month, another study confirmed the same thing. Once again, patients with higher levels of CGRP were more likely to respond well to treatment.

But a month after the Botox treatment, levels of responders dropped – although the levels in nonresponders did not.

We are left with a lot of unanswered questions – but those questions could drive migraine research in the direction it needs to go.

Why the different levels of CGRP? Exactly what role do CGRP levels play in migraine? Could this point us to an underlying cause or disorder?

Perhaps more importantly – why the differences?

Over the past few years, research has shown us again and again and again – not all migraine disease is the same. There are “different migraines”, with different treatments, different symptoms, and different neurological manifestations.

And yet we still so often talk about “migraine” as if it’s one thing and one thing only.

Those in cancer research and treatment are learning this the hard way as well – not all cancer is the same, not all cancer is equally dangerous, and not all cancer should be treated in the same way.

Migraine research is going – and must go – the same direction.

Imagine going to the lab for tests – and then being diagnosed with a specific type of migraine – and then getting treatment for that type specifically. Your chances of excellent treatment will go way up.

For now, we have an important way forward for research into CGRP levels, and for Botox treatment. In the future – something much bigger and better.

12 January 2015

New Insights Into Trigeminal Neuralgia

James Discoveries & Stats, Information 2

Researchers in Denmark are providing new insights into the painful condition known as trigeminal neuralgia (TN).

Have you ever had a stabbing pain on one side of your face – almost like an electric shock? Maybe it just happens, or maybe it seems to come when you’re brushing your teeth, or even putting on makeup.

Trigeminal neuralgia is not a common disease, and so it hasn’t been studied nearly as much as many other pain disorders. But this study of 158 patients gives us a clearer picture.

TN seems to strike later in life than conditions like migraine. The average age when symptoms appeared was about 53 years.
Although both men and women get TN, it is somewhat more likely to affect women.
Almost 50% of patients had persistent pain in addition to the stabbing pain. Sometime TN with persistent pain has been called “atypical”, but it doesn’t seem to be as atypical as some think (the more proper name, by the way, is classical trigeminal neuralgia with concomitant persistent facial pain. Has a ring to it, wouldn’t you say?).
The pain is more often on the right side.
A little less than a third had “autonomic symptoms”, such as dizziness, and a little less than a third had “sensory abnormalities”, even if they hadn’t had surgery.

Researchers also investigated the nerve that TN affects. TN can affect different branches of the trigeminal nerve in the face. They discovered that the first branch alone was rarely the problem. Usually the culprits were the second and/or third branches.

TN is usually treated with medications such as anticonvulsants and muscle relaxants. Botox has also been used successfully for TN, and in much smaller doses than are used for migraine.

In rare cases, surgery is recommended. However, surgery is not always a guarantee that the pain is gone for good.

A clinical trial is beginning in the USA also, in Philadelphia, to investigate the use of Botox for TN. If you would like to be a part of the study, you can find more information by clicking the last link below.

For more information:

Trigeminal neuralgia–a prospective systematic study of clinical characteristics in 158 patients. (study abstract)
Trigeminal neuralgia – Treatment and Drugs (Mayo Clinic)
A new study of trigeminal neuralgia (New York Headache Clinic)
Botulinum Toxin for the Treatment of Trigeminal Neuralgia (Clinical Trial)

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.

20 February 2014

Botox and Insurance – is it driving you crazy?

James Medications, Misc 1

On the bright side, some people are being helped by Botox treatment for migraine. And that’s great.

But the common complaints of cost and insurance complications continue to put a wrinkle in the treatment that’s been such a media darling.

Dr. Allan Block weighed in on the topic in Clinical Neurology News yesterday, explaining how these complications have brought his affair with Botox to an end.

You can read his article, Botox no longer worth the headaches, but here’s one comment he makes:

In the last 2 years, the process of getting it approved became increasingly difficult. Insurance companies put up more and more restrictions to a point that it became near impossible to get it covered. Between the paperwork and rising costs, I had more and more patients deciding to stop.

Have you given up on Botox – or avoided it altogether – because of the cost and/or insurance restrictions? If you’re a doctor, what have you struggled with? Are a million insurance exceptions going to be the death of this migraine treatment?