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Research – Treatment of Chronic Migraine
AAT Matter (Access)
Brief
A summary of best practice treatment interventions for chronic migraines
Date
02/03/21
Requester(s)
Lee Ds47F - personal privacy
Researcher
Craig Os47F - personal privacy
Cleared
Jane Ss47F - personal privacy
Please note:
The research and literature reviews col ated by our TAB Research Team are not to be shared external to the Branch. These
are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.
Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on
access or planning matters they are to call the TAPS line for advice.
The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of
these matters.
1 Contents
2 Summary ......................................................................................................................................... 2
3 Treatment ....................................................................................................................................... 3
3.1
Medications ............................................................................................................................ 3
3.1.1
Acute medications .......................................................................................................... 3
3.1.2
Preventive / Prophylactic medications ........................................................................... 3
3.2
Complementary and alternative therapies ............................................................................. 4
3.2.1
Nutraceuticals ................................................................................................................. 4
3.2.2
Acupuncture .................................................................................................................... 5
3.2.3
Psychological / Behavioural treatment ........................................................................... 6
3.3
Neuro stimulation Devices ...................................................................................................... 7
3.3.1
Cefaly ............................................................................................................................... 7
3.3.2
gammaCore ..................................................................................................................... 8
3.3.3
Transcranial Magnetic Stimulation ................................................................................. 8
3.4
Procedures .............................................................................................................................. 9
3.4.1
Botox injections ............................................................................................................... 9
4 References .................................................................................................................................... 10
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2 Summary
• Literature sourced indicates there are several options available for the treatment of chronic
migraine which include:
o Acute medication
o Preventive medication
o Complementary treatments
o Neuro stimulation devices
o Procedures
o Psychological / Behavioural Treatments
• Research indicates that:
o The first line approach to treatment is
medication where there are two categories of
medication: Acute and Preventative
o
Preventive / Prophylactic medication appears to be underutilised in Australia with
general practitioners restricting their choice, in most cases, to pizotifen or propranolol
o New
CGRP antibodies medication for migraine may offer an new approach in the
treatment and prevention of migraine
o
Acupuncture can be an effective treatment for migraine
o There is insufficient evidence that
nutraceuticals is as an effective treatment for
migraine
o There is insufficient evidence that
psychological therapies are an effective treatment for
migraine
o
Botox injections can effectively reduce the duration and severity of migraine
o There is insufficient evidence that the currently available
neuro stimulation treatment
devices are effective treatment for migraine. However, the Cefaly device (Transcranial
supraorbital stimulation) appears to show some benefit in managing migraine
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3 Treatment
The Royal Australian College of General Practitioners (RAZCGP) recommends a pharmacological
treatment approach [1]. Although they mention a number of important issues to consider regarding
non-pharmacological treatment, they do not advocate the use of any specific treatments [1].
Migraine and Headache Australia recommend medication as the first line treatment option,
however, they also suggest are other treatment options which are reflective of much of the other
non-peer reviewed literature, and include [2]:
• Acute Medication [3]
• Preventive Medication [4]
• Complementary treatments [4]
• Neuro stimulation devices [4, 5]
• Procedures [6]
• Psychological / Behavioural Treatments [4]
3.1
Medications
3.1.1 Acute medications
Acute medications are treatments taken at the onset of a migraine attack to reduce the symptoms
associated with migraine. There are a variety of medications available for the acute treatment of
migraines, depending upon the severity of the attack [3].
Medications used at the onset of migraines include [3]:
• Aspirin or other nonsteroidal anti-inflammatory drugs
• Paracetamol
• Ergotamine
• Anti-nausea drugs (e.g. domperidone, metoclopramide, prochlorperazine)
• Triptans (e.g. sumatriptan, naratriptan, zolmitriptan)
3.1.2 Preventive / Prophylactic medications
Prophylactic medication appears to be underutilised, especially in patients with frequent migraine. A
report in the Australian Medical Journal by Stark, Valenti [7] has suggested that Australian General
Practitioners (GPs) appear to select from a limited range of therapeutic options for migraine
prophylaxis, despite the availability of several other well documented efficacious agents, and some
use inappropriate drugs for migraine prevention.
Australian Therapeutic Guidelines recommend regular preventive treatment for patients who
continue to experience more than two or three acute attacks of migraine per month [8, 9].
Influential evidence-based reviews of migraine treatment have been published by both the American
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Academy of Neurology [8, 10] and the European Federation of Neurological Societies [8, 11].
Although there are many prophylactic agents with established efficacy, Australian GP’s restrict their
choice, in most cases, to pizotifen or propranolol [7, 8].
Conventional preventative medications include [4]:
• Blood pressure medications
o Beta-blockers – propranolol, metoprolol
o Calcium channel blockers – verapamil
• Antidepressants
o Tricyclic antidepressants – amitriptyline, nortriptyline
o SNRIs – venlafaxine, duloxetine
• Antiepileptics
o Topiramate
o Sodium valproate
o Gabapentin
• Other
o Pizotifen
o Cyproheptadine
3.1.2.1 Calcitonin Gene-related Peptide Treatments
Anti-Calcitonin Gene-related Peptide (CGRP) monoclonal antibodies have recently become available
[4]. Phase 3 clinical research studies are showing that CGRP antibodies for migraine may offer an
entirely new approach in the treatment and prevention of migraine. Most treatments for migraine
were originally designed for other conditions such as epilepsy, hypertension or depression. This class
of CGRP treatments are the first preventative treatment designed specifically for migraine [12].
3.2
Complementary and alternative therapies
3.2.1 Nutraceuticals
Migraine & Headache Australia suggest that there is evidence to support that the fol owing
nutraceuticals and supplements for migraine, in particular magnesium, riboflavin and CoQ10. Al of
these have been shown in small studies to reduce migraine frequency when used as a daily
preventative [4].
• Magnesium
• Riboflavin (Vitamin B2)
• Coenzyme Q10 (CoQ10)
• Melatonin
Two studies [13, 14] were sourced both of which suggested the need for investigation of
nutraceuticals as a result of greater use by patients concerned with the lack of efficacy, cost, and
side effects of conventional pharmacologic medications.
A 2016 study reviewed the guidelines from the American Academy of Neurology/American
Headache Society, Canadian Headache Society, and European Federation of Neurological Societies in
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the use of nutraceuticals including riboflavin, coenzyme Q10, magnesium, butterbur, feverfew, and
omega-3 polyunsaturated fatty acids [14]. The authors concluded that there is a
limited number of
studies of sufficient quality available in favour of or against their use in migraine prophylaxis. Further
well designed, randomized controlled trials (RCT) on nutraceuticals are require so that clinicians can
offer evidence based recommendations to patients with migraine who are significantly affected by
migraines.
A 2014 literature review identified both observational studies and RCTs on the use of nutraceuticals
for the prophylaxis of paediatric and adult migraine [13]. Thirty studies were reviewed on six
different nutraceuticals: butterbur, riboflavin, ginkgolide B, magnesium, coenzyme Q10 and
polyunsaturated fatty acids. The study concluded that the
quality of the evidence for the use of
nutraceuticals in paediatric migraine prophylaxis is poor, and that further research is needed in
order to study the efficacy of nutraceuticals for the prophylaxis of paediatric migraine [13].
3.2.2 Acupuncture
Migraine & Headache Australia, suggest that acupuncture has been shown to be beneficial. Initial y
there was some suggestion that sham acupuncture is just as effective as true acupuncture, but more
recent studies indicate that true acupuncture is more effective than sham acupuncture. Findings
suggest that many patients respond wel to this, particularly when treatment occurs over a duration
of at least a few months [4].
A systematic review conduced in 2008 evaluated the efficacy of acupuncture for treatment of
chronic headache [15]. Databases searches were conducted to locate RCTs investigating the use of
acupuncture for chronic headache. Studies were included in which adults with chronic headache,
including migraine, tension-type headache or both, were randomized to receive needling
acupuncture treatment or control consisting of sham acupuncture, medication therapy, and other
non-pharmacological treatments. Data was extracted on headache intensity, headache frequency,
and response rate assessed at early and late fol ow-up periods.
Thirty-one studies were included in the review. The majority of included trials comparing true
acupuncture and sham acupuncture showed a trend in favour of acupuncture. The study concluded
that needling acupuncture is superior to sham acupuncture and medication therapy in improving
headache intensity, frequency, and response rate [15]. (NOTE: Sham acupuncture (SA), also cal ed
placebo acupuncture (PA), performed away from the acupuncture points established by TCM or
without stimulation and manipulation to avoid eliciting “De Qi” sensations or using a non-
penetrating technique, is used as control in scientific studies to determine the efficacy of
acupuncture [16])
A recent 2019 systematic review compared the effectiveness of acupuncture treatment with
conventional migraine preventative medications [17]. Randomized trials and RCTs with adult
patients that compared the clinical effects of acupuncture with a standard migraine preventive
medication in patients with a diagnosis of chronic or episodic migraine with or without aura were
included. Seven clinical trials (n = 1430) met the inclusion criteria. Although a meta-analysis could
not be performed due to methodological heterogeneity, several of the studies did show that
acupuncture can be more effective than standard pharmacological treatments for migraine
prevention. The study concluded that there is growing evidence that acupuncture is just as effective
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and has fewer side effects than many of the standard pharmaceutical agents that are currently used.
However, the heterogeneity of the existing studies limits effective comparison and analysis [17].
3.2.3 Psychological / Behavioural treatment
Migraine and Headache Australia, and other non-peered reviewed information websites suggest that
behavioural treatments are alternative and helpful options for the management of migraine, which
include [4]:
• Cognitive Behavioural Therapy (CBT)
• Relaxation Therapy
• Mindfulness Meditation
• Biofeedback
Research indicates that there is an absence of high-quality evidence to determine whether
psychological interventions are effective in managing migraine.
A recent 2019 Cochrane review aimed to evaluate the efficacy and adverse events of psychological
therapies for the prevention of migraine in adults [18].
Database searches were conducted to identify RCTs of any psychological intervention for adults with
migraine chronic or episodic migraine, with or without aura. Interventions could be compared to
another active treatment (psychological or medical), an attention-placebo (e.g. supportive
counselling) or other placebo, routine care, or waiting-list control. Studies were excluded if fewer
than 15 participants completed each arm [18].
Twenty one RCTs with 2,482 participants with migraine were included. Data from 14 studies were
extracted for meta-analysis. Most intervention arms were a form of behavioural or CBT.
Interventions varied from one 20-minute session to 14 hours of intervention [18].
The review concluded that [18]:
• There was an absence of good-quality evidence that psychological therapy was effective or
harmful in managing frequent migraine immediately fol owing treatment or in the longer
term
• There was no evidence that psychological treatments resulted in less migraine frequency in
the four weeks following treatment
• There was no evidence that psychological treatments affected migraine intensity,
medication use for migraine, mood or quality of life
• Fol ow-up data was rarely found, and there was no evidence to support or refute any long-
term effects of psychological treatment
• Funding of high-quality studies is needed and additional studies may change the conclusions
of the review.
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3.3
Neuro stimulation Devices
Neuro stimulation treatment has recently emerged in the last few years as a potential option for
migraine sufferers. Neuro stimulators target certain nerves or parts of the brain that we think are
involved in migraine. They act by modulating or modifying the pain system through electrical
currents or magnetic impulses. Currently there are three options that have been developed and are
available to varying degrees [4].
• Transcranial supraorbital stimulation – Cefaly
• Non-invasive vagal nerve stimulation – gammaCore
• Transcranial magnetic stimulation
3.3.1 Cefaly
CEFALY sends tiny electrical impulses through a self-adhesive electrode placed on the forehead to
stimulate the trigeminal nerve, reducing the frequency and intensity of migraine attacks [19]. The
device has American Food and Drug Administration (FDA) approval for the prevention of episodic
migraine [20]. Two research studies were sourced on the efficacy of Cafaly and concluded with
positive results [20, 21]
A 2015 research paper [20] reviewed in detail the available data for Cefaly device as a migraine
treatment including technical aspects, effect size, and safety, as wel as possible explanations for its
mode of action. The paper is based on previously conducted studies and does not involve any new
studies of human or animal subjects performed by any of the authors. The study found that the
device [20]:
• Was shown to be efficient by decreasing migraine and headache days significantly more than
sham stimulation
• Reduced the number of migraine attacks
• Could be proposed to patients who prefer non-pharmacologic treatments, or who have
contraindications to the usual preventive anti-migraine drugs or do not tolerate them
• Allows to significantly reduce acute anti-migraine medication use and therefore reduces the
risk for chronification of migraine by acute medication overuse, which represents a
pharmaco-economical advantage
A 2017 prospective, multi-center clinical study was performed in patients diagnosed with episodic or
chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly®
according to the treating physician’s suggestion [21]. A one-month period of baseline observation
was fol owed by a 3-month period of observation during the use of transcutaneous supraorbital
nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.
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A small but statistically significant decline was shown over time in the number of days with
headache (HA), the number of days with HA with intensity ≥5/10, and the number of days with use
of acute medication after 3 months (p < 0.001 for al of the three changes). Twenty-three patients
(65.7%) expressed their satisfaction and intent to continue treatment with Cefaly®. Compliance was
higher among satisfied subjects compared to non-satisfied subjects. None of the explored factors
were significantly associated with the reason for the failure of topiramate [21].
The study concluded that the three-months of preventive treatment for episodic or chronic migraine
with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients
with migraine who were intolerant or did not respond to topiramate [21].
3.3.2 gammaCore
gammaCore (nVNS) activates the vagus nerve with patented, gentle electrical stimulation [22]. The
device is cleared by the FDA for acute and preventive treatment of cluster headache and the acute
treatment of migraine in adults [23].
There is little research on the efficacy of the gammaCore. Following FDA approval of gammaCore in
April 2017 and its subsequent launch in the United States, the gammaCore Patient Registry (GPR)
was designed to provide a platform for patients receiving therapy to voluntarily provide information
that could help provide a deeper understanding of gammaCore usage and improve patient care. GPR
was a prospective observational program designed to enable patients with episodic cluster headache
who were prescribed gammaCore to voluntarily enrol and submit information on their experiences
between July 2017 and June 2018 [23].
Of the 182 participants who provided baseline data, 152 participants provided complete EuroQol
Health Index tool, 5-level format (EQ5D-5L) baseline data, and 17 provided documentation of a total
of 192 cluster headache attacks. The mean number of months of known diagnosis of cluster
headache was 57. The mean number of patients reporting attacks in their respective previous cluster
headache cycle was 14 per month with the mean pain score of 3.67 (0-4 scale), while the mean
duration of attacks was 74 minutes [23].
The study suggests that [23]:
• The gammaCore significantly adds a valuable therapeutic option for patients who suffer
from episodic attacks of cluster headaches, based on patient-documented attacks
• The successful use of gammaCore in the real-world setting provides evidence to support the
need to redefine gammaCore as no longer investigational or experimental treatment, as well
as for consideration for reimbursement by policy makers
• Evidence shows gammaCore is more cost-effective than the treatments that were standard
of care (including sumatriptan and oxygen) prior to gammaCore introduction
3.3.3 Transcranial Magnetic Stimulation
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Transcranial magnetic stimulation (TMS) works by possibly decreasing a process called cortical
spreading depression which is believed to be the mechanism behind migraine with aura. This
potentially has a role in migraine prevention as well as possibly acute treatment for migraine with
aura [4]. Research on the subject was minimal and provided little evidence of efficacy.
A recent 2019 systematic review was performed on the use of TMS and transcranial direct current
stimulation (tDCS) for the treatment of specific headache disorders (i.e., migraine, tension, cluster,
posttraumatic) [24]. Inclusion criteria of studies were:
• Adults aged 18-65 with primary or secondary headaches
• Interventions including TMS and tDCS
• Comparators such as sham or alternative standard of care
• Study type of case control, cohort or RCT
A structured synthesis was performed due to heterogeneity of participants and methods. The study
concluded that [24]:
• Of all TMS and tDCS modalities, rTMS is most promising with moderate evidence that it
contributes to reductions in headache frequency, duration, intensity, abortive medication
use, depression, and functional impairment. However, only few studies reported changes
greater than sham treatment.
• Further high-quality RCTs with standardized protocols are required for each specific
headache disorder to validate a treatment effect.
3.4
Procedures
3.4.1 Botox injections
In Australia, Botox has commonly been used for migraine for several years with good results and
received coverage on the PBS a few years ago. Usage of Botox for migraine has increased and has
now become a standard of care for people with chronic migraine who have not responded to three
or more traditional preventive migraine treatments. While Botox is on the PBS for chronic migraine,
there are still criteria to be fulfilled. Patients need to have tried or have contraindications to three of
the standard preventives first [4].
A recent 2019 Cochrane review and meta-analysis, aimed to assess the effects of Botox for
prevention of migraine in adults [25]. Included were RCTs of Botox compared with placebo, active
treatment or clinically relevant different dose for adults with chronic or episodic migraine, with or
without the additional diagnosis of medication overuse headache.
Cochrane methods were used to review double-blind RCTs. Twelve week post treatment time-point
data was analysed. Twenty-eight trials (n=4190) were included. Trial quality was mixed. Botox
treatment resulted in reduced frequency of −2.0 migraine days/month (95% CI −2.8 to −1.1, n=1384)
in chronic migraineurs compared with placebo. An improvement was seen in migraine severity,
measured on a numerical rating scale 0 to 10 with 10 being maximal pain, of −2.70 cm (95% CI −3.31
to −2.09, n=75) and −4.9 cm (95% CI −6.56 to −3.24, n=32) for chronic and episodic migraine
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respectively. Botox had a relative risk of treatment related adverse events twice that of placebo, but
a reduced risk compared with active comparators (relative risk 0.76, 95% CI 0.59 to 0.98) and a low
withdrawal rate (3%). Although individual trials reported non-inferiority to oral treatments,
insufficient data were available for meta-analysis of effectiveness outcomes [25].
The study concluded that the data suggests that Botox effectively reduces the duration and severity
of migraines in sufferers [25].
4 References
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Beran R. Management of chronic headache. Australian Family Physician [Internet]. 2014
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Migraine & Headache Australia. Prevention Strategies & Treatment For Migraine &
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