Rationale for Medical Use of Botulinum Toxin A (Botox®)

Health Canada has approved the use of Botox for the treatment of chronic migraine in 2011. The clinical trials proved its efficacy and safety for the treatment of chronic migraine. Botox should be offered as a treatment to people who live with chronic migraine.

INDICATIONS AND USAGE
Chronic Migraine
BOTOX (onabotulinumtoxinA) for injection is indicated for the prophylaxis of headaches in adult patients with chronic migraine
(≥15 days per month with headache lasting 4 hours a day or longer). 

Blepharospasm and Strabismus
BOTOX is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

Erectile Dysfunction
BOTOX is injected into the corpus cavernosum (erectile tissue of the penis), where it promotes smooth muscle relaxation which in turn improves erection quality.  Although this is a newer use of BOTOX, at least three clinical studies have demonstrated that this is very safe with no reports of major side effects. Minor side effects, related to the needle may include pain, bleeding, bruising.

How does Botox work? 
Nerves communicate by releasing molecules to their targets: the muscles, the sweat glands but also the sensory organs of the skin. The molecules released bind to receptors and induce actions: muscle contraction, sweat production, sensory modulation. Botox prevents nerves from communicating with their targets. If the target is a muscle, it will stop contracting. If the target is a sweat gland, it will stop producing sweat. 

In chronic migraine, we know now that sensory nerves become inflamed and hypersensitive. The inflammation is caused by different molecules that may be released by the sensory nerves. Botox blocks this, and that has a «calming» effect on the pain. There are studies done on animals showing that Botox modifies the electric activity of the pain network of the face and neck. 

Should Botox be used for any person with migraine?
No. Botox is approved only for Chronic Migraine. Chronic migraine is the most severe form of migraine. 1 to 2% of the population suffers from chronic migraine.  These people have more than 15 days of headaches a month for at least three months, 8 or more of which are migraines. The other days can be «tension type», as the severity of headache varies in Chronic Migraine.

Unfortunately, Botox does not work for people who have a less severe form of migraine called episodic migraine. Studies on people with episodic migraine were negative. You may want to see a headache specialist to discuss if Botox would be right for you. 

What are the expected benefits of Botox therapy?
We look for an improvement of more than 50% in the frequency and intensity of migraines. If you have 20 days per month, your 50% response would be 10 days per month (not zero). 

In studies nearly 50% of patients achieved this goal after 6 months of treatment (2 sets of injections).  Some people improve more than others (responders). 23% of patients in the studies improved by 75% (super responders). If you start at 20 days, you would go down to 5. 

Other potential Benefits:
The attacks are less severe
The attacks are easier to control with acute treatments
The «baseline headache» or «baseline neck pain» are less intense 
The tolerance to triggers is higher 
The person functions better overall 
Some of those effects may be seen earlier with the first treatments, before the impact on the frequency appears. Always use a headache diary!

How long should I try Botox before making a decision? 
A trial of 3 cycles (or 9 months) is reasonable. The effect over the first treatments seems to be cumulative. 10% of people will notice an improvement only at the third treatment, especially if the situation was very severe to start with.

Could Botox work if other preventives do not? 
Yes. Botox has a different mechanism of action than oral preventives. Studies have demonstrated a benefit in patients who had tried other preventives. In real life, Botox is covered only after previous trials, and improvements are observed.

Is the effectiveness of Botox sustained over time? 
Yes. For most people who respond to Botox, the benefit are sustained over time. Remember that migraine is a fluctuating disease and that even if Botox is effective for you, you may have better phases and more difficult ones. 

CONTRAINDICATIONS -  You should not have Botox if you have:
 Hypersensitivity to any botulinum toxin preparation or to any of the
components in the formulation (4.1, 5.3, 6.2)
 Infection at the proposed injection site (4.2)

Side effects

The main side effect from Botox is muscle weakness, usually in the areas where the botox is injected (forehead, frown lines, temporalis, neck, trapezius).  Muscles of facial expression could be affected, causing asymetry, unnatural facial appearance, eyebrow heaviness or eyelid ptosis.  There have also been reports of distant muscle weakness, which is thought to be related to due to the botox being absorbed more generally into the systemic circulation.  Flu-like symptoms may also occur.

Headache, dizziness, constipation or an upset stomach, which are all common side effects.  Liver failure or heart problems, which can be rare but serious side effects.

 

Adverse reactions as per manufacturer:

In controlled studies, the most commonly observed adverse reactions (≥5% and >placebo) were:
 Chronic Migraine: neck pain, headache (6.1)
 Spasticity: pain in extremity (6.1)
 Cervical Dystonia: dysphagia, upper respiratory infection, neck pain, headache, increased cough, flu syndrome, back pain, rhinitis (6.1)
 Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary
sweating, pharyngitis, flu syndrome (6.1)

WARNING: Distant Spread of Toxin Effect. 
The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. 

By signing below, I certify that this treatment has been fully explained to me by Dr. Patrick Yam and all my questions have been answered.  I accept the risk of side effects and request that Dr. Patrick Yam adminster the treatment for me.

I agree to inform my doctor immediately (please call or text Dr. Yam at 778-772-8711) if I notice any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if any existing symptom worsens.