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Botox treatment

Thanks to our member Ben who supplied the following info:

See Professor of Clinical Neurology Peter Goadsby carry out the procedure for injection of Botox for use in MIGRAINE, lifted from the Australian Broadcasting Corporation's "Catalyst" science-based weekly news program. CH is not mentioned.

Watch the story online at the ABC's STORY ARCHIVE
Botox for Migraines:
http://www.abc.net.au/catalyst/stories/3263945.htm

Click here for some further research links on Cluster Headache as listed by search result from the "Catalyst" site

More info:

Hi to all.

A bit about my experience with Botox in CH. Before I could receive many "off label" or "experimental' medications in CH treatment, like Botox,  I first had to have my CH case classified as chronic and intractable, (Or refractory, as some specialists will call it). Use of Botox in my case was of no direct financial cost to me, but was approved through proper channels in a major teaching hospital.


Intractable –adjective
1. not easily controlled or directed; not docile or manageable; stubborn; obstinate: an intractable disposition.
2. (of things) hard to shape or work with: an intractable metal.
3. hard to treat, relieve, or cure: the intractable pain in his leg.

This is one of the criteria I had to meet before I was allowed Botox for CH here in Australia. Chronic, Severe and Intractable CH was my diagnosis after decades of not knowing exactly what was wrong with me. Unfortunately Botox was unsuccessful in treatment of my Cluster headache condition. All it achieved was the complete paralysis of my right eyebrow for 5-6 months, quite amusing for some people around me...It still appears ineffective for most CH patients in the long term, and without specialist access and hospital subsidy, can be very expensive.

The outcomes from a couple of clinical trials of Botulinum Toxin injection for the treatment of CH:

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SUMMARY OF RESULTS
There were 7 chronic cluster headache patients. Botulinum toxin was ineffective for 3 of the patients. The injections were moderately effective for 3 of the cluster sufferers. One patient had dramatic, immediate relief that lasted for 3 months. There were 3 episodic cluster headache patients. One had complete relief, one experienced moderate relief, and the third achieved complete relief with his first set of injections, but only moderate improvement one year later, after the second set of injections.
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Botox and Cluster Headaches - Trial sheet case study:

Abstract
Ten chronic cluster headache patients received botulinum toxin for refractory clusters.

The injections were done with low dose botulinum toxin; either 24 units of BTA per patient, or the equivalent BTB (1200 units). These were patients who had been refractory to the usual preventive and abortive medications for cluster headache. Side effects were minimal in this study. For the 7 chronic cluster patients, the injections were moderately effective in 3/7, and extremely effective for one. The botulinum toxin was not effective for 3 of the chronic cluster sufferers. Of the 3 episodic cluster sufferers, 1 obtained complete relief and 1 had moderate relief. The 3rd achieved complete relief with the first set of injections, but only moderate improvement after a further set of injections one year later.

INTRODUCTION
Most patients with cluster headache receive some degree of relief from the usual preventive medications. These include verapamil, lithium, cortisone, sodium valproate, indomethacin, etc. In addition, many of the patients obtain relief from the abortive medications. The abortives include oxygen, sumatriptan injections, sumatriptan nasal spray, other forms of triptans, lidocaine nasal spray, etc. Many patients with cluster headache do not achieve an adequate response to the preventive or abortive medications. Botulinum toxin has shown promise in the treatment of migraine headache. Many therapies that have been useful for migraine headache also are somewhat beneficial for cluster headache. This study evaluated 10 patients with refractory cluster headache who were given botulinum toxin type A (BTA) or botulinum toxin type B (BTB) injections.

MATERIALS AND METHODS
There were 8 male patients and 2 females, ages 28 to 63, in this study. Seven patients had chronic cluster headache, and three suffered from episodic clusters. They were refractory to the usual preventive medications. Each patient kept a headache diary, using a visual analog scale, for four months post-injection. Twelve injections of 2 units of BTA (or 100 units of BTB) were utilized. Thus, the total was 24 units BTA, or 1200 units of BTB, per patient, which is a low dose.Eight injections were given frontally and temporally ipsilateral to the pain, and four in the contralateral frontal area. The case summaries are as follows:

CASE SUMMARIES
Chronic Cluster Patients (7): (1). 59 year old man with chronic clusters, in a severe exacerbation (2 to 3 per day). BTA was not effective. (2). 63 year old man with chronic clusters, in a severe exacerbation (4 to 5 per day). BTA was moderately effective.The clusters decreased to one daily. This relief lasted 4 months.He had been scheduled to have a surgical procedure for the clusters, but cancelled it due to the relief from the BTA. (3). 53 year old man with chronic clusters, in a moderate exacerbation. No relief from the BTA. (4). 38 year old man with chronic clusters in a severe exacerbation.There was dramatic, immediate relief after the BTA injections, with no headache for 3 months. (5). 28 year old man with chronic clusters. BTB was moderately effective. The clusters decreased from 4 to 5 per day down to 1 daily. The relief lasted 2 months. (6). 48 year old man with 2 cluster headaches per day. BTB was moderately effective.Clusters decreased to 0 to 1 attack per day, and this relief lasted 2½ months. (7). 52 year old female with chronic clusters; BTB was not effective.

Episodic Cluster Patients (3): (1). 62 year old man with episodic clusters, 2 per day. Complete relief after BTA (the injections immediately stopped the cycle). (2). 43 year old man with severe episodic clusters. He received 2 sets of injections, one year apart. After the first BTA injections there was immediate, complete relief. The second time, with BTB, there was only moderate improvement. After the second set, the clusters diminished from 4 per day (lasting 1 to 2 hours each) down to 1 headache daily lasting less than 1 hour. (3). 47 year old female with episodic cluster headache. The attacks occurred 3 times daily, and she had moderate relief after the BTB. The attacks decreased to 0 or 1 per day. The relief lasted for the remainder of the cycle.

ADVERSE EVENTS
One patient experienced a mild ptosis for 12 days post-injection. One patient described a burning sensation in both eyes that resolved after 6 days.

SUMMARY OF RESULTS
There were 7 chronic cluster headache patients.Botulinum toxin was ineffective for 3 of the patients. The injections were moderately effective for 3 of the cluster sufferers.One patient had dramatic, immediate relief that lasted for 3 months. There were 3 episodic cluster headache patients.One had complete relief, one experienced moderate relief, and the third achieved complete relief with his first set of injections, but only moderate improvement one year later, after the second set of injections.

COMMENTS

Botulinum toxin is a safe therapy that, although expensive, is relatively easy to administer. This small study demonstrated that, for some refractory cluster patients, botulinum toxin may be a worthwhile treatment. It is possible that larger doses (low doses were utilized in this study) would be more effective.

There have been a number of studies of botulinum toxin (primarily BTA, Botox) for the treatment of migraine and tension headache. The initial retrospective chart review of 106 patients revealed that 46% achieved complete relief from their migraines. Another 30% had partial improvement. The mean dose in this study was 35.5 units of BTA per patient. There have been several positive prospective randomized trials in migraineurs since that time. In one of the key studies, both the 25 unit (total) BTA patients and the 75 unit patients did better than the patients who received placebo. However, the patients who had received 75 units did have significantly more treatment-related adverse advents (primarily forehead weakness) than placebo. In another study, 51% of patients had complete relief for a mean of 4.1 months, and 38% reported a partial response. This was an open label trial of 77 patients with migraine headache.

Another open-label study over a three year period did include a small number of cluster headache patients. The doses were higher in this study, 80-150 units of BTA. Fifty-eight percent of patients with chronic tension-type headache achieved positive outcomes, 67% of migraine sufferers responded favorably, and 2 of the 4 patients with cluster headache had positive responses. In these cluster patients, a positive response was determined by termination of the cluster episode within 3 weeks of BTA injections. These same investigators went on to conduct a double blind, placebo controlled, randomized study involving 40 patients with chronic tension-type headache. The number of headache-free days was significantly increased in the BTA group at 3 months post treatment. Other studies have not been as positive for tension-type headache, however. One study that was double blind, placebo controlled and randomized revealed no significant differences through 12 weeks for chronic tension-type headache. One further report on 2 patients with episodic cluster headaches revealed complete relief after 50 units of BTA. These injections were given ipsilateral to the pain.

Naturally, in the beginning years of treatment utilizing botulinum toxin for cluster headache, only the more refractory patients will be injected. However, if experience and studies dictate that botulinum toxin is an effective therapy, and with some reduction in cost, this may become a standard treatment. The question as to the dose of injection has not been adequately answered in the studies. There are studies that indicate that low doses may be as effective as high doses. Higher doses carry the risk of increased adverse events. Further studies will be needed to determine the adequate dose. As to the location of the injections, it makes sense intuitively to inject primarily on the ipsilateral side of the cluster headache. However, a number of studies will be needed to determine the most effective location for botulinum toxin injections.

There are relatively few disadvantages for the utilization of botulinum toxin for cluster headache. Cost, pain during the injections, and the possibility of ptosis are some of the considerations.

Botulinum toxin is a relatively safe treatment, particularly in the low doses that have been utilized for migraine headache. If adequate efficacy for cluster headache can be established, botulinum toxin may become a primary first line therapy for the treatment of cluster headache.


Headache. 2004 Jan;44(1):35-42; discussion 42-3.

Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy.

Source

Department of Biology, Southwest Missouri State University, MO, USA.

Abstract

OBJECTIVES:

To determine the effect of botulinum toxin type A on calcitonin gene-related peptide secretion from cultured trigeminal ganglia neurons.

BACKGROUND:

The ability of botulinum toxins to cause muscle paralysis by blocking acetylcholine release at the neuromuscular junction is well known. Previous studies and clinical observations have failed to demonstrate sensory changes related to botulinum toxins or the disease of botulism. Recent studies, however, have suggested that botulinum toxin type A injected into pericranial muscles may have a prophylactic benefit in migraine. This observation has renewed the debate of a mechanism of sensory inhibition mediated by botulinum toxin type A.

METHODS:

Primary cultures of rat trigeminal ganglia were utilized to determine whether botulinum toxin type A could directly decrease the release of calcitonin gene-related peptide, a neuropeptide involved in the underlying pathophysiology of migraine. Untreated cultures or cultures stimulated with a depolarizing stimulus (potassium chloride) or capsaicin, an agent known to activate sensory C fibers, were treated for 3, 6, or 24 hours with clinically effective doses of botulinum toxin type A or a control vehicle. The amount of calcitonin gene-related peptide secreted into the culture media following the various treatments was determined using a specific radioimmunoassay.

RESULTS:

A high percentage (greater than 90%) of the trigeminal ganglia neurons present in 1- to 3-day-old cultures was shown to express calcitonin gene-related peptide. Treatment with depolarizing stimuli (potassium chloride), a mixture of inflammatory agents, or capsaicin caused a marked increase (4- to 5-fold) in calcitonin gene-related peptide released from the trigeminal neurons. Interestingly, overnight treatment of trigeminal ganglia cultures with therapeutic concentrations of botulinum toxin type A (1.6 or 3.1 units) did not affect the amount of calcitonin gene-related peptide released from these neurons. The stimulated release of calcitonin gene-related peptide following chemical depolarization with potassium chloride or activation with capsaicin, however, was greatly repressed by the botulinum toxin, but not by the control vehicle. A similar inhibitory effect of overnight treatment with botulinum toxin type A was observed with 1.6 and 3.1 units. These concentrations of botulinum toxin type A are well within or below the range of tissue concentration easily achieved with a local injection. Incubation of the cultures with toxin for 24, 6, or even 3 hours was very effective at repressing stimulated calcitonin gene-related peptide secretion when compared to control values.

CONCLUSIONS:

These data provide the first evidence that botulinum toxin type A can directly decrease the amount of calcitonin gene-related peptide released from trigeminal neurons. The results suggest that the effectiveness of botulinum toxin type A in the treatment of migraine may be due, in part, to its ability to repress calcitonin gene-related peptide release from activated sensory neurons.



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