onabotulinumtoxinA

16 February 2012

Questions about Botox in the UK

In July 2010, Botox was approved as a preventive treatment for chronic migraine in the UK by the Medicines and Healthcare Products Regulatory Agency. But is there enough evidence for Botox? Should it be offered (funded) by the NHS (National Health Service) across England and Wales?

Medicine watchdog NICE (The National Institute for Health and Clinical Excellence) is saying "not yet". They feel that more data is needed, and they’re asking the makers of Botox (Allergan) to provide it.

Although the people with NICE admit that Botox seems to have some benefits in recent studies, they claim that the benefits have been small – small enough that they could be explained simply by the way the studies were conducted.

Proffesor Carole Longson, director of the health technology evaluation centre at NICE said,"Without this additional evidence, potentially we will be unable to advise the NHS that this drug is good value for money for these adults because there are currently too many uncertainties."

But NICE remains open to comments on their recommendation before they make it official. The deadline will be the 8th of March, after which NICE will put together it’s final guidelines.

The Migraine Trust and The British Association for the Study of Headache prepared a joint statement in response to NICE. As a part of their statement they said:

We know that BOTOX® is effective for some but not all patients who suffer from chronic migraine. We also know that many other preventative treatments are not effective for treating chronic migraine and that they can cause unacceptable side-effects. It would be extremely unfortunate if this treatment is denied to those who have exhausted all other options and those who have responded well to the treatment. The Migraine Trust advocates that this treatment should be made available to those who fail to respond to at least three preventative treatments to have a fair chance to see if BOTOX® treatment will work for them.

Read the full statement here.

15 February 2012

Botox for Migraine – how does it actually work?

James Information, Treatments 31

Botox, or onabotulinumtoxinA, is an emerging and at times controversial treatment for migraine. Many patients have found relief through Botox treatment, although others have found that it wasn’t very helpful for them. Par for the course when it comes to migraine treatment.

But just why does Botox help – at least some patients?

The most obvious answer seems to be the way it relaxes muscles. Certainly if tense muscles were triggering migraine attacks, or if they were a part of the chain-reaction or vicious-cycle of migraine, we would expect to see some relief if those muscles were relaxed.

And that still could be part of the answer.

But the pain of migraine (in fact, even the pain of tension-type headaches), does not come from muscle tension. Sure, it could be a part of the cycle, but is that really enough to explain the relief that many get from Botox?

Dr. Alexander Mauskop from the New York Headache Clinic writes about his observations:

I have seen some patients who would report that injecting muscles around the head eliminated pain in the injected areas, but that they still had pain on the top of the head. There are no muscles on the top of the head and we usually do not inject Botox there, but in those patients who do have residual pain on the top, injecting Botox stops the pain. Recent research has shown that Botox in fact also exerts a direct analgesic (pain-relieving) effect. This is supported by my and other doctors’ observation that Botox also helps other types of pain, such as that of shingles or trigeminal neuralgia.

He goes on to point out that we need some solid studies to confirm what many doctors and patients are seeing.

He finishes by saying that Botox seems to help by reducing the pain messages that are being sent to the brain. Without the flurry of pain messages to the brain, the migraine chain reaction can’t begin. In fact, some patients report that, after Botox treatment, they sometimes feel like a migraine is about to start, but it never does.

If you’ve had Botox treatment, how does this compare with your experience? Leave a comment!

25 November 2011

Canada: Botox Approved for Chronic Migraine

James News, Treatments 1

In a step forward for Botox in Canada, Health Canada approved Botox (onabotulinumtoxinA) for treatment of chronic migraine.

It was a step back for the makers of Botox in the country (Allergan Canada) back in 2009 when Health Canada began warning patients that Botox could spread to other parts of the body in some cases ("distant toxin spread"). However, for many patients the benefits still outweigh the risks.

Although it hasn’t been the magic bullet for chronic migraine sufferers, it has provided significant relief for many. But that relief comes at a cost – no, quite literally – the treatment tends to be very expensive.

It is hoped that, as the official agencies in various countries recognize the benefits of Botox, that insurance companies will as well. If Botox can significantly cut down on migraine attacks and symptoms, it’s in the best interest of insurance companies to cover the treatment.

Again, this approval is for those with chronic migraine, not those who have an attack once a month. The treatment involves injecting small amounts of Botox beneath the skin, usually around the forehead and temples, and sometimes other locations such as the neck. Learn more about Botox injections here.

10 November 2011

Botox and Quality of Life: Does it really help?

James Discoveries & Stats, Medications, Treatments 6

Of course there is no treatment that helps everyone, but another study (published in Neurology) has shown that Botox treatment for migraine does help some – and help them in real ways.

You see, some treatments and medications can really cut down on the number of migraine attacks someone has, and yet not really be worth it – because of the side effects. So this study set out to check on patients’ "health-related quality of life". Overall, is their health really better?

1,384 patients were involved in the analysis using a migraine related quality of life questionnaire and the Headache Impact Test (HIT). Compared to a placebo, the quality of life of migraine patients was significantly improved while taking Botox (onabotulinumtoxinA).

Now, this study was funded by the makers of Botox, which is not unusual, but important to note. The company has certainly had its ups and downs when it comes to this migraine treatment.

However, this does support other studies and the testimonials of specialists who are treating patients. And the study was carefully done by well known experts in the field. Botox certainly seems to be a real help to some, and yet there are still important questions about who will benefit most from treatment and how treatment should be done. And in spite of the evidence, many insurance companies are still reluctant to cover a treatment which tends to be expensive.

Hopefully studies like this will provide them with the evidence they’re looking for.

The study can be found here: OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine
via: Botox improves quality of life

7 October 2009

New Botox Trials – Encouraging News on the bumpy road to acceptance

James Discoveries & Stats, Treatments 5

If you want your insurance to pay for Botox treatment for migraine, you should be encouraged by the report at last month’s International Headache Congress. Botox migraine treatment is continuing on the road to acceptance, but there’s no doubt it’s still a bumpy road.

The President-elect of the American Headache Society, Dr. David Dodick, gave the report on two trials of onabotulinumtoxinA (Botox), and there’s a lot for proponents of Botox treatment to celebrate.

First, these trials were very professionally done, a serious step toward Botox’ acceptance by the USA’s FDA. They were randomized, placebo-controlled, well balanced trials, the kind of trials that we need more of.

Botox trials for Botox migraine treatment

As you may guess, the results were positive. Patients that received Botox had fewer headache and migraine days, fewer attacks, and significantly fewer actual hours of headache and migraine attacks. Overall, those taking Botox had less disability and functioned better than the placebo group.

This is the kind of evidence we’re looking for – proof that Botox is helping some people enough to be considered a valid migraine treatment.

But these trials are not telling us Botox is the miracle treatment we’ve all been waiting for – there are issues remaining. First, though there was a general improvement, Botox was certainly a long way from drastically cutting down on everyone’s symptoms. Of course, we wouldn’t expect that with most treatments – we know that few work with everyone. The Cochair at the session, Dr. Elizabeth Loder, pointed out one of the big issues with Botox – there’s still no easy way to predict who it will work with.

There’s still a lot of work to be done with Botox. How should it be administered? How much? When? Who does it work best with? Considering how far we still need to go answering these questions, we should be encouraged that we’re already seeing such good results in trials.

Another issue with these trials was that those taking Botox did not end up taking fewer other medications. This confirms what earlier studies have told us, and it will continue to be a concern to researchers – and to insurance companies. Can we get the overall cost down, while still improving people’s quality of life?

That being said, we did see that those on Botox took fewer triptan medications. So there are some interesting questions on this front that still need to be answered.

But let’s end on an encouraging note. This study did focus on a group that has a high need. These weren’t people who have an attack a year, but people who are disabled by moderate or severe attacks on average every week or more. They’re losing many hours a month to migraine. Many of them were, by typically accepted standards, taking too much medication (though they were off it at the time of the study).

There is hope then that Botox may give back many hours of life to people who are losing the most to migraine. And if doctors and insurance companies want proof that it works, well designed trials like this are giving them what they need. Doctors already using Botox treatment are convinced that it is significantly helping many.

The researchers hope to have approval of Botox treatment from the FDA for chronic migraine by the end of next year.

References:
Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.
Botulinum Neurotoxin Reduces Headache Frequency and Disability in Chronic Migraine by Dr. Daniel M. Keller (report on this study) 16 Sep 2009
Botox is proven to help chronic migraine