Of all the headaches in the world, migraine is the most debilitating kind. It affects up to 12% of people worldwide, with women three times more likely to be affected7 than men. Unfortunately, any individual with this condition can suffer a significant setback regarding productivity, education, or social interactions.
Although several medications are available to treat migraine, they come with certain risks. Interestingly, the discovery of using botulinum toxin to treat hyperfunctional lines of the face opened up new avenues for exploring its therapeutic effects. This has led to further studies regarding BOTOX®’s ability to reduce the intensity and frequency of migraines.
In this article, we will explore the role of BOTOX® in migraine therapy. Despite ongoing research, much must be learned to provide the most efficient care for individuals suffering from this condition.
Compared to other headache types, migraine is unilateral, throbbing, and often associated with sensitivity to sound and light, visual disturbances, nausea, and vomiting. It is recurrent, with each attack lasting from hours to days. The neuropeptides CGRP, serotonin, and PACAP1 have a significant role in the disease mechanism.
Migraines can be broadly divided into two types:
On the surface, a migraine headache is often the result of environmental and genetic factors acting together. The triggers can range from stress, medications, and sleep disturbances to food items, strong sensory inputs, and even the effects of the sun. Further studies are underway to understand its pathophysiology better.
A chronic migraine2 is a medical condition characterized by experiencing migraine headaches for at least 15 days per month, lasting for more than 4 hours each time, over a period of 3 months.
In contrast, an episodic migraine is a type of migraine that is less frequent, with less than 15 headache days per month.
BOTOX®, or more specifically, onabotulinumtoxinA (OBTA), is a neurotoxin derived from the bacterium Clostridium botulinum. It achieves its best clinical effect intramuscularly and is preferred by clinicians for its myorelaxant properties.
The FDA approved BOTOX® use to relieve migraines after a successful clinical study on 1384 patients in 2010. It is available in 7 serotypes, but only A and B serotypes are recommended for therapeutic use.
Evidence suggests4 that BOTOX® exerts its clinical activity through not one but several mechanisms:
These mechanisms showcase BOTOX®’s potential in managing the severity and frequency of migraines.
Patients needing BOTOX® for headaches should fulfill the following criteria:
A detailed medical profile, including details of present health condition, family history, and ongoing medications, can aid the clinician in conducting an accurate patient assessment and case selection. It is also helpful to record details regarding the use of BOTOX® products in the past four months.
According to the FDA, treating migraines with BOTOX® involves following an indication-specific regimen. The maximum cumulative dose that can be administered should be at most 360 units in 3 months.
Onabotulinumtoxin-A vials are typically vacuum-dried when supplied; therefore, they must be rehydrated with 0.9% Normal Saline injection (USP) before use.
The essential aspects of BOTOX® for chronic migraine treatment2 are listed as follows:
|Recommended Dilution||200 Units/4 mL or 100 Units/2 mL|
|Final Concentration||5 Units/0.1 mL|
|Recommended Dose||155 Units I/M|
|Injection Needle||30-gauge, 0.5-inch for most sites1-inch needle for thick neck muscles|
|Injection Sites||31 sites across 7 head/neck muscle areas|
|Avoid||Periosteum, eyelid region, visible blood vessels|
|FDA Approved Dosage||155 Units in 31 sites (PREEMPT trials)|
|Total Dose Range||25 to 360 Units over multiple injection sites|
|Target||Superficial to the peripheral sensory nerves such as:|
Occipital nerveTrigeminal nerveC3 – C5 Cervical sensory rami
|Peak Clinical Effect||7-10 days|
|Duration of Therapeutic Effect||3-4 months (neuromuscular blockade).Pain reduction can last longer.|
In 2010, the PREEMPT5 study group created an injection plan for BOTOX® in migraines, blending fixed and follow-the-pain sites2 based on studies in patients with different types of headaches.
|Muscle||Dosing (Units)||Sites||Bilateral Distribution|
|Cervical Paraspinal Group||20||4||Yes|
After injection, patients should know that optimal effects may require multiple treatments. Also, headache relief may not always align with restored muscle function.
To ensure successful treatment, clinicians should advise patients to record their headache episodes, focusing on the location, intensity, and medications used. The Migraine Disability Assessment (MIDAS) scale can also aid in assessing treatment changes and adjusting therapy.
The possibility of adverse events with BOTOX® is usually injection-related and, therefore, temporary and easy to manage. However, some complications may demand prompt medical attention.
Here are some adverse events2 associated with using BOTOX® for migraine treatments:
Therefore, the clinician must be adept at carefully selecting cases and analyzing potential complications beforehand. This will improve the overall control over the procedure and enhance patient trust in their clinician.
You can refer to this document for detailed information on BOTOX®-related side effects.
Although BOTOX® is a valuable preventive6 treatment aid for chronic migraines, its efficacy in managing its ‘episodic’ counterpart is yet under study. Typically, the BOTOX® regimen is continued until the frequency of headaches comes down to isolated incidents. However, a recent study has shown that injections of onabotulinumtoxinA could be a game-changer for those suffering from high-frequency episodic migraine (HFEM).
*Please note that BOTOX® isn’t approved for managing episodic migraines yet.
Over time, migraine-affected people have significantly benefited from a holistic treatment approach that blends healthy lifestyle modifications along with preventive and interceptive measures.
The efficacy of BOTOX® in managing migraine is comparable to topiramate and sodium valproate, with the additional benefit of better tolerance and improved effectiveness. The catch is that medications may need to be continued with BOTOX® injections.
Nonetheless, the current evidence shows that in the hands of an expert clinician, BOTOX® is a promising treatment option that is both safe and effective, with minimal adverse effects.
According to the PREEMPT protocol, specific doses of BOTOX® are injected in 31 different sites to achieve optimal therapeutic effect. These include specific spots in the scalp, forehead, temple, face, and neck region.
Yes, studies have shown that BOTOX® can effectively reduce the frequency of chronic migraines and bring them down to minimal or isolated episodes. Some studies have shown promising results by indicating a significant reduction in migraine days per month.
While BOTOX® certainly has cosmetic uses, the doses used for migraine treatment are lower. Additionally, the therapy aims to achieve functional improvements to relieve pain rather than changing one’s facial appearance.
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