New Guidelines for the
Management of Migraine in Primary Care
Curr Med Res
Opin 18(7):414-439, 2002. © 2002 Librapharm Limited
Posted
Despite
repeated initiatives over the past decade, migraine remains under-recognised,
under-diagnosed and under-treated in everyday clinical practice. The Migraine in
Primary Care Advisors (MIPCA) group has produced new guidelines for migraine
management to attempt to rectify this situation. MIPCA is a group of physicians,
nurses, pharmacists and other healthcare professionals dedicated to the
improvement of headache management in primary care, who have also worked closely
with the Migraine Action Association (the
The principles
of the new MIPCA guidelines are:
| To arrange specific consultations for headache. |
| To institute a system of detailed history taking,
patient education and buy-in at the outset of the consultation. |
| To utilise a new screening algorithm for the
differential diagnosis of headache, which can be confirmed by further
questioning, if necessary. |
| To institute a process of management that is
individualised for each patient, using a new algorithm. Assessing the impact
on the patient's daily life is a key aspect of diagnosis and management. |
| To prescribe only treatments that have objective
evidence of favourable efficacy and tolerability. |
| To utilise prospective follow-up procedures to
monitor the success of treatment. |
| To organise a team approach to headache management
in primary care. |
Migraine is a
common, painful headache disorder that affects 10% or more of the general
population, is more common in women than in men, starts in childhood and
adolescence and is most prevalent in young adults and middle-aged people.[1]
Migraine is a markedly disabling condition,[2] and exerts a significant burden on the sufferer in terms of
pain, suffering and impaired quality of life (QOL).[3]
This results in a large economic burden on society, both in terms of direct
medical costs of care and indirect costs due to lost work time and working at
reduced productivity.[4]
However, migraine is a heterogeneous condition, with headache attacks varying in
frequency, duration, symptomatology and associated disability, both between
sufferers and between attacks in the individual sufferer.[2]
Despite the
relative seriousness of the condition, studies consistently show that migraine
is currently not well managed in primary care. Only about 50% of sufferers
currently consult their physician for care.[5] Physicians only diagnose migraine
correctly in about 50% of presenting sufferers and many patients are provided
with therapies that they find ineffective, many relying on suboptimal
over-the-counter (OTC) medications.[5] Follow-up is frequently poor, and many
patients lapse from care.[5] Lack of effective care for migraine can lead to problems.
Chronic daily headache (CDH), which can be a consequence of poor migraine
management, is a significant, and often hidden, cause of morbidity.[6]
The consequence is that patients with CDH and migraine form by far the majority
of headache patients seen by secondary care physicians.[7]
Migraine is
therefore under-recognised, under-diagnosed and under-treated in everyday
clinical practice.[8] This situation has not changed markedly over the past decade,[9,10]
despite great strides in the development of new migraine therapies, especially
the introduction of the triptan drugs. Currently, there are no consistent
guidelines for the management of migraine and other headaches in primary care
clinical practice. Indeed, two sets of guidelines are available to physicians in
the UK that do not agree on basic principles, those of the British Association
for the Study of Headache (BASH)[11] and those of the Migraine in Primary Care Advisors (MIPCA).[12]
Historically used guidelines, for example those available in the UK,[11]
USA[13]
and Germany,[14]
tend to recommend the following general scheme:
1.
Implementation of a full diagnostic procedure using the
International Headache Society (IHS) criteria;
2.
A step-wise approach to care, where treatment is initiated with
low-end therapies (e.g. simple analgesics) and migraine-specific therapies (e.g.
the triptans) are only used when all other therapies have failed.
These
guidelines, while comprehensive, are perhaps better suited for specialist use
than in primary care. They require a significant investment in time and effort
for the physician and the patient, with no guarantee of success in the short
term. There is another, more subtle point, in that, after years of promotion of
these types of guideline, there have been no major inroads into the way many
primary care physicians manage migraine.[9,10]
The inescapable conclusion is that this historical approach does not seem
worthwhile to primary care physicians. There is a wide gap between what often
happens in primary care practice and what specialists are recommending, the end
result being the poor consultation, diagnostic and treatment success rates seen
for migraine.
Reasons for
this may include:
1.
Patients may not recognise that they need medical care to control
their migraine;
2.
Primary care physicians have limited time to deal with each
patient and may find the IHS diagnostic criteria too complex and unwieldy for
everyday use;
3.
The step-care treatment strategy is not time-efficient and may
not be clinically- or cost-effective;
4.
Many therapies used for migraine are ineffective and/or may be
associated with unwanted side-effects;
5.
Follow-up procedures are inefficient or lacking altogether.[8]
New guidelines
for migraine are urgently needed that can identify and screen patients in need
of care, develop and use new and simpler diagnostic tools and algorithms and
utilise best management for migraine, using evidence-based medicine wherever
possible. This article describes the development of new guidelines for migraine
in the
Over the past 5
years, initiatives have led to the development of new guidelines for migraine
management in the
MIPCA
guidelines were first issued in 1997, and revised guidelines were published in
200012. MIPCA advocates an individualised approach to care, treatment being
prescribed according to each patient's needs. Factors considered include the
nature of the patient's attacks, the impact of headache on the individual's life
and the demands of the patient's lifestyle (Figure 1).
At the initial
consultation, the physician is recommended to conduct a diagnostic assessment
and to take a careful history covering the nature of the headaches, previous
treatments taken and the impact on the patient's life. Patients who experience
up to four attacks per month are given acute therapy with a simple analgesic
(with or without an anti-emetic) or an oral triptan if analgesics have been used
unsuccessfully in the past. Nasal spray or subcutaneous triptan formulations may
be considered if the patient has difficulties with oral therapies or requires a
fast therapeutic effect due to the demands of their lifestyle or presentation
characteristics of their headaches. It is deemed essential to establish a goal
for therapeutic intervention. Useful goals centre on preservation of function or
being free of pain and associated migraine symptoms. In our experience, merely
providing enough relief to 'get through' an attack commonly results in the
patients lapsing from care.
If the initial
therapy is unsuccessful, an alternative triptan may be provided. For patients
who fail on this therapy, and for migraine patients with four or more headaches
per month, prophylactic treatment is recommended with additional acute treatment
for breakthrough attacks. Migraine patients who fail on this treatment, and
those diagnosed with chronic daily headache, may require referral to a
specialist physician.
New practice
guidelines for the management of migraine were published by the US Headache
Consortium in 2000.[15] Identified goals of successful migraine management were
reduction of attack frequency, severity and disability, improvement of QOL,
prevention of headache, avoidance of the escalation of acute medications and the
education of patients to better self-manage their illness.
The US Headache
Consortium identified several principles of managing migraine (Figure 2).
Following a diagnostic assessment, the physician is recommended to assess the
illness severity, by taking a history of attack frequency and severity, degree
of disability, the presence of non-headache symptoms and patient-specific
factors such as their prior response to medications and co-existent conditions.
A major part of these guidelines is the education of patients about their
condition and its treatment, to establish realistic expectations and to
encourage them to participate in the management of their migraine. Finally, an
individualised treatment plan is advocated, tailoring therapy to the patient's
symptoms, illness severity, disability and personal needs.
The US Headache
Consortium mostly used evidence-based medicine (based on a database produced by
The Primary
Care Network is a group of physicians working in private practice, managed care
and academia, who provide medical programmes for the management of diseases in
Impact-based
recognition of migraine involves the physician eliciting information on how
headaches interfere with the patient's life, the frequency of headaches, any
changes in headache pattern over the preceding 6 months and the previous use and
effectiveness of headache medications. The guidelines for acute treatment are to
abort migraine symptoms and disability within 2-4 hours of initiating therapy.
Key tactics for achieving this are identified as providing patient education and
instruction and tailoring intervention to the individual's needs. The Primary
Care Network recommends treating migraine early in the attack when the headache
is mild with triptans, NSAIDs, isometheptene (Midrid®
in the
Migraine
sufferers differ in their management needs, largely due to the variation in
severity of symptoms and their impact on the sufferer.[2]
Although severely affected sufferers tend to receive more medical care than
those less affected, a significant proportion of those with severe pain and
disability remain undetected, undiagnosed and under-treated in clinical
practice.[8]
Initiatives are needed to improve migraine care in several areas to provide a
service focussed on the individual patient's needs.
As primary care
physicians are the medical service most commonly used by migraine sufferers, it
makes sense to coordinate headache management services around them.
Unfortunately, the education of primary care physicians about headache is
usually limited to the exclusion of serious but rare secondary (sinister)
headaches, rather than the management of the common benign primary headaches.
Primary care physicians also have severe limitations to the time they can give
each patient, as little as 8-10 minutes for complex consultations. Simple, clear
and unified guidelines are therefore needed to allow the primary care physician
to deal with patients with headache. The overall goals should be to:
·
Accurately diagnose and provide appropriate treatment for the
majority of patients who can be managed in primary care.
·
Rapidly identify and refer the minority of patients who need to
be seen by a specialist.[21]
·
To achieve this, a consultation of 15 minutes or more may be
needed.
The means to
achieve these goals are as follows:
·
Encourage migraine sufferers to engage with the healthcare
system, to consult their primary care provider and receive appropriate
treatment.
·
Motivate currently consulting migraine patients to continue to
seek help to optimise their treatment.
·
Provide physicians with simple but comprehensive guidelines to
allow them to diagnose migraine differentially from other headaches.
·
Encourage physicians to provide prescription medications that
have been proven to be effective.[21]
The original
MIPCA, Headache Consortium and Primary Care Network guidelines contain several
common recommendations, which can be used as the basis for new guidelines:
1.
Improve patient counselling and buy-in;
2.
Conduct a careful diagnosis;
3.
Assess the illness severity accurately, incorporating assessments
of the impact to the sufferer;
4.
Provide an individual treatment plan for each patient, with the
choice of treatment being evidence-based wherever possible;
5.
Implement follow-up procedures to monitor the outcome of therapy.[21]
The rest of
this section describes how these concepts can be translated into a practical
scheme for the management of migraine in primary care. Points 1-4 above need to
be dealt with at the patient's initial consultation. Point 5 is dealt with at
follow-up consultations. It should be noted that these general principles also
have application beyond migraine to all areas of headache management.
Headache is an
important clinical condition and needs to be taken seriously by the patient and
physician. To this end, a special consultation should be arranged so that the
physician has sufficient time to evaluate the patient efficiently, while the
patient realises that the physician takes their headache seriously and has time
to prepare to discuss it in detail. By the end of the first consultation, the
physician should have diagnosed the headache condition and either instituted an
appropriate treatment, or referred the patient to a specialist if a sinister
headache is suspected. The physician should supply the patient with clear
knowledge of their headache and what they should do to improve it. Both the
physician and the patient need to agree on a management plan, and how it is
implemented and monitored. This is a lot to achieve, but it has to be done to
ensure that the patient adheres to the agreed management plan and does not lapse
from care. Once the first consultation is over, it is important to set in place
follow-up procedures to motivate patients to persevere with their treatment and
return for further care.
Many migraine
patients who consult a physician will have suffered from the condition for
several years. They therefore bring with them a history that can be ascertained
with careful questioning. Migraine patients are frequently well educated about
their condition, and have a clear idea of what they are suffering from. This
knowledge can be used to aid diagnosis and treatment choices. On the other hand,
some patients are at the end of their tether following years of suffering, and
may have to be managed carefully by the physician.
Taking a
careful history is essential and a key task of the first consultation. Several
good history questionnaires are available, covering headache, other symptoms,
influencing factors and current and previously used medications (Figure 4). No
single symptom defines migraine and the physician can use the history to create
a clinical profile representative of the headache pattern. The history should
cover:
·
Headache: the impact, type, severity, location, duration,
frequency, timing and family history.
·
Other symptoms: visual, sensory, gastrointestinal and
neurological (e.g. slurred speech and loss of coordination).
·
Influencing factors: diet, lifestyle, hormonal and environmental.
·
Current medication taken for headaches and other conditions.[22]
Figure 4. Example of a headache history questionnaire
Patients need
good education about their condition. People with headache are often motivated
to understand their condition and physicians should provide them with
information on the nature and mechanisms of their disorder. The physician should
have a range of leaflets available, and can guide patients to professional
organisations such as The Migraine Action Association (www.migraine.org.co.uk),
The Migraine Trust (www.migrainetrust.org)
and The World Headache Alliance (www.w-h-a.org)
that can provide further information via publications and websites. The UK
Migraine Action Association has a particularly useful booklet on migraine that
is specifically designed for patient use.[23] There are also excellent short books on
migraine and other headaches that can be recommended to the patient.[21,24]
Patient buy-in
to the course of treatment can be optimised by effective communication between
the patient and their physician. Patients should be told that migraine cannot be
cured, but can be effectively controlled. Patients should also be encouraged to
manage their condition themselves, making decisions about lifestyle alterations
and how and when to take their medications. Physicians should encourage their
patients to participate in their own management and effective communication
between the physician and patient has been shown to improve care delivery.[25]
Patient preference is an important consideration in the choice of treatment.
Patients may rate such factors as speed of response, overall headache relief, a
lack of side-effects, or convenience as the most important characteristics of
treatment.[21]
Conducting a careful physical examination can aid this buy-in process, as it
reinforces to the patient that the physician takes their condition seriously.
Since their
first publication in 1988, the IHS diagnostic criteria have transformed research
into migraine and the management of the condition by providing a standardised
means of identifying migraine patients for physicians.[26]
Migraine is defined as shown in Table
1.
Diagnostic
Criteria for Migraine Aura.
| The
presence of at least three of the following four characteristics: |
 | One
or more fully reversible aura symptoms. |
| One
or more aura symptoms develop gradually over more than 4 minutes, or two
or more symptoms occur in succession. |
| No
single aura symptom lasts more than 60 minutes. |
| The
migraine headache occurs less than 60 minutes after the end of the aura
symptoms. |
| Secondary
(sinister) headaches have to be excluded as the cause of the aura
symptoms. |
| There
are also several rare subtypes of migraine characterised by aura symptoms
that differ from those described above. |
From these
diagnostic criteria, it is important to note that no single headache feature and
no single non-headache symptom are absolutely required for diagnosis. For
example, a patient with severe bilateral headache associated with photophobia
and phonophobia can be diagnosed with migraine, just as the more typical patient
with unilateral, throbbing headache that is worsened by activity and accompanied
with nausea. Migraine diagnosis using the IHS criteria is therefore somewhat of
an art and requires a flexible approach rather than the simple 'ticking of
boxes'. It is therefore perhaps better suited to the specialist or research
setting than to primary care. Primary care physicians need a means of
identifying patients with rare or secondary (sinister) headache who are best
referred to a specialist and a simple and rapid means of diagnosing migraine and
other common headaches. Two simple questionnaires have recently been developed
to screen for headache diagnosis, which can then be confirmed, if necessary,
using further questioning:
·
The impact-based recognition questionnaire of the US Primary Care
Network.[17]
·
A new diagnostic screen developed by MIPCA, which also
incorporates an impact question.
The
impact-based recognition scheme of the US Primary Care Network consists of four
questions:
1.
Do your headaches interfere with your ability to work or engage
in family and social functions? (This quickly separates medically relevant
headaches from those more trivial in nature. Migraine is considered the default
diagnosis for headache that significantly interferes with a person's ability to
function, which then necessitates questions on migraine-specific associations,
such as the presence of nausea, sensory sensitivity, positive family history,
and in women, menstrual association.)
2.
Has the pattern of your headache changed over the last 6 months?
(This is designed to alert the physician to sinister headache conditions. A new
or different headache mandates a thorough diagnostic approach, while a stable
headache pattern provides reassurance to the physician and patient.)
3.
How frequently do you have any kind of headaches? (This alerts
the physician to the possibility of chronic headache patterns.)
4.
What are you doing to treat your headaches? (This screens for
medication overuse and the effectiveness of self-treatment efforts.)
A short series
of four questions is used to screen patients with headache at their first visit
to the clinic:
1.
What is the impact of the headache on the sufferer's daily life?
(high impact = migraine or chronic daily headache; low impact = acute
tension-type headache);
2.
How many days of headache does the patient have every month?
(> 15 days = chronic headache; </= 15 days = intermittent migraine);
3.
For patients with chronic daily headache, on how may days per
week does the patient take analgesic medications? (>/= 2 =
analgesic-dependent headache; < 2 = non- analgesic-dependent headache);
4.
For patients with migraine, does the patient experience
reversible sensory symptoms associated with their attacks? (yes = migraine with
aura; no = migraine without aura).
Two further
brief investigations should be conducted in addition to these four questions:
A.
Sinister headache should be excluded before asking the first
question. (Sinister headaches tend to appear de novo in young children or
mature adults, or present as a change in character compared with older patients'
usual headache attacks. They are new-onset, acute headaches that are associated
with a range of other symptoms (e.g. rash, neurological deficit, vomiting and
pain or tenderness). Signs of neurological change or deficit do not disappear
when the patient is pain-free between headache attacks. They may also be
associated with an accident or head injury, infection or hypertension.[27])
A full neurological examination is essential if sinister headache is suspected.
B.
Once a pattern of chronic headaches is established (Question 2),
the physician should investigate whether short-lasting headaches (e.g. cluster
headache or short, sharp headaches) are the cause. (These headaches are
severe, short lasting headaches [cluster headache: 15-180 minutes; short, sharp
headaches: </= 30 seconds] that can occur up to several times per day, and
which require separate diagnosis and treatment.[21,27])
Using these two
questionnaires, sinister, chronic and intermittent headaches can be recognised
efficiently and rapidly in the outpatient setting, even when the patient is
being evaluated for other complaints. Chronic headaches can be differentiated
into short-lasting and chronic daily headaches, and patients identified who have
analgesic dependence. Acute tension-type headache can be differentiated from
migraine and attacks of migraine with aura distinguished from those of migraine
without aura. Specific questioning (including possibly the IHS criteria) can
then confirm these findings, if needed.
In general, any
episodic, acute, disabling headache can be given a default diagnosis of
migraine.[19]
Migraine generally starts during childhood and adolescence and peaks in severity
during young adulthood to middle age, before declining in older age (in women,
there may also be a peak at the menopause).[1] Attacks are more common in women than in men.
Migraine attacks typically occur up to four times per month and last from
Some of the
main headache subtypes may share certain features, but are straighforward to
differentiate due to their different overall presentations, allowing for the
accurate differential diagnosis of headache (Table
2).[21]
Migraine is a
disabling condition and attacks differ in severity in individual patients, and
even in attacks experienced by each sufferer, in terms of frequency, duration,
symptomatology and associated disability.[2] No single feature is predictive of
migraine severity, and it is recommended that the following features should be
assessed by the physician:
·
Attack frequency and duration
·
Pain severity
·
Impact
·
Non-headache symptoms
·
Individual patient factors, such as their history, treatment
preferences and other illnesses.[15,16]
Two
questionnaires have been developed to assess the impact that migraine (and
headache in general) has on the sufferer's lifestyle: the Migraine Disability
Assessment (MIDAS) Questionnaire, which assesses the disability caused by the
headache[32];
and the Headache Impact Test (HIT), which assesses impact as a composite measure
of several assessments.[33,34]
The MIDAS
Questionnaire. MIDAS is a paper-based questionnaire, designed to be accessible
at physicians' surgeries and pharmacies (information available at www.migraine-disability.net).
Migraine sufferers answer five disability questions in three activity domains
covering the previous 3-month period (Figure 5). They score the number of lost
days due to headache in employment, household work and family and social
activities. Sufferers also report the number of additional days with significant
limitations to activity (defined as at least 50% reduced productivity) in the
employment and household work domains. The total MIDAS score is obtained by
summing the answers to the five questions as lost days due to headache. This can
sometimes be higher than the actual number of lost headache days due to any one
day being counted in more than one domain. The score is categorised into four
severity grades:
·
Grade I = 0-5 (defined as minimal or infrequent disability)
·
Grade II = 6-10 (mild or infrequent disability)
·
Grade III = 11-20 (moderate disability)
·
Grade IV = 21 and over (severe disability)[32]
Figure 5. The Migraine Disability Assessment (MIDAS) Questionnaire.
The MIDAS Programme was developed by Innovative Medical Research Inc, with
sponsorship and assistance from AstraZeneca[32]
Two other
questions (A and B) are not scored, but are designed to provide the physician
with further information on migraine severity, specifically headache frequency
and pain intensity.[32]
The HIT
Questionnaire. HIT was first developed as a web-based test, designed to be
accessible to all physicians and headache sufferers through the Internet (at www.headachetest.com
and www.amIhealthy.com).
This is a dynamic questionnaire, with items derived from four validated headache
questionnaires sampling all areas of headache impact.[33]
Patients are questioned until clinical standards of score precision are met. In
practice, five questions are sufficient to grade the majority of headache
sufferers with severe, moderate or mild headache. Internet-HIT differentiates
sufferers on the basis of diagnosis and characteristics such as headache
severity and frequency, and takes only 1-2 minutes to complete.[35]
HIT-6TM
is a paper-based, short-form questionnaire based on the Internet-HIT question
pool, designed for people without access to the Internet (Figure 6). Six
questions cover pain severity, loss of work and recreational activities,
tiredness, mood alterations and cognition. Each question is scored on a
five-point scale, with the scores being added to produce the final score. HIT-6TM
scores are categorised into four grades, representing minimal, mild, moderate
and severe impact due to headache.[34]
Internet-HIT and HIT-6TM
scores compared well to each other when the two forms of the questionnaire were
tested on a group of headache sufferers.[35]
Figure 6. The Headache Impact Test (HIT-6TM)
Questionnaire. HIT was developed by QualityMetric Inc and GlaxoSmithKline[34]
Both MIDAS and
HIT have been tested extensively and shown to be reliable and valid, with wide
potential for clinical utility.[35] They can be used to:
·
Improve communication between patients and their physicians on
the impact of migraine.
·
Help the physician to assess illness severity.
·
Help the physician to produce an individualised treatment plan
for each patient, when used with other clinical assessments.[35]
In addition,
MIDAS is sensitive to change and can be used to provide an outcome measure to
monitor the success of interventions.[36,37] HIT, unlike MIDAS, can be used as a
diagnostic tool to differentiate between headache subtypes.[38]
Both questionnaires can be recommended to primary care physicians as aids to the
management of migraine and other headaches.[35]
Management of
migraine needs to be individualised for each patient due to the heterogeneity of
migraine attacks,[2] the different needs of each patient's lifestyle and the wide
variety of available therapies, both pharmacological and non-pharmacological.
These include behavioural therapies, acute therapies, prophylactic therapies and
complementary medications. Recently, the first evidence-based recommendations
for migraine therapies were published, based on the Duke database.[15,39,40]
The clinical data on each migraine therapy was rated in the order: data from
large, randomised, placebo- or comparator-controlled clinical trials and/or
meta-analyses rated superior to data from less rigorously conducted clinical
studies rated in turn superior to the consensus of a group of physicians.
Behavioural
and Physical Therapies. It has been recommended that behavioural therapies should
be provided for all migraine sufferers to help prevent the development of
attacks (Table
3).[40] Several studies support the use of biofeedback to prevent
migraine attacks, and relaxation therapy may be equally as effective, with
improvements of 30-40% in headache index reported.[40]
However, there seems to be no additive effects of combining the two therapies.
Additional efficacy was sometimes reported when the behavioural therapy was
combined with prophylactic drugs.[40] The avoidance of migraine trigger factors has been suggested to
be effective, but evidence is equivocal. About 20% of patients can reduce the
frequency of their migraine attacks by identifying specific migraine triggers
and avoiding them.[41] Several studies have shown that stress reduction is an effective
strategy to reduce the frequency and impact of migraine. There was a reduction
in the number of attacks of approximately 50% and the effect was moderately
large.[40] Avoiding red wine is also a plausible strategy, but as yet there
is little evidence for the avoidance of other foods.[40]
MIPCA is currently conducting an audit that investigates the possible role of
food intolerances in migraine.
Several
physical therapies have also been tested for migraine. Studies have shown that
cervical manipulation, massage and exercise may provide additional adjunctive
therapy if used with other stress reduction strategies.[40]
However, there is not enough evidence to allow the recommendation of hypnosis,
transcutaneous electrical nerve stimulation (TENS), occlusal adjustment and
hyperbaric oxygen.[40]
Acute
Therapies.
The goals of acute therapy should be to rapidly and effectively relieve the pain
and non-headache migraine symptoms, allowing a resumption of the patient's
normal activities.[15] Acute therapies should not be over-used, to avoid the
complications of analgesic overuse. Many physicians have advocated that acute
medications be taken regularly on < 2 days per week,[21]
although this may be different in practice if patients have attacks lasting for
several days that require effective treatment over this length of time.
It is generally
recommended that acute therapies be provided for all patients, as breakthrough
attacks inevitably occur when preventative therapies fail.[21]
Most patients with infrequent attacks will only require acute therapy. Rescue
therapy is also recommended if the first-line therapy is ineffective.[15]
Studies to evaluate acute treatments for migraine are now undertaken to rigorous
methodological standards and procedures so as to allow the objective evaluation
of results and the comparison of different medications.[42]
Acute migraine
therapies have not always been chosen systematically in the past, and often a
trial and error system has been used. One of three types of treatment strategy
is typically used; step-care, staged care and stratified care (Figure 7).[16,18]
·
In step-care, patients initiate treatment with one medication
(usually a simple analgesic) for a series of attacks. If this treatment fails,
the physician can step the patient up to alternative, stronger medications for
subsequent attacks. This stepping process continues until an effective
medication is found or the patient lapses from care.
·
Staged care is a variant of step-care, where patients initiate
treatment for each attack with a simple analgesic. If this treatment fails, they
can take stronger medications as rescue therapy.
·
In stratified care, the physician grades each patient as to the
impact the migraine has on their lifestyle. This can be done using detailed
history taking, or by using the MIDAS or HIT questionnaires.[43]
The physician then prescribes therapy appropriate to the severity of the
migraine. Patients suffering from little or no impact can be given simple
analgesics or combination medications, while those with significant impact may
be provided with migraine-specific therapies from the outset.
Figure 7. Step-care, staged care and stratified care strategies for
providing acute therapies for migraine[16,18]
In evaluating
these three treatment strategies, a single treatment is unlikely to be optimal
for all attacks in each patient, due to the heterogeneity of migraine attacks.[2]
Step-care is clearly not an option for this situation. To overcome this problem,
a combination of stratified and staged care may work best. If the patient has
access to a selection of medications, they can choose one appropriate to the
severity of the presenting attack. Migraine sufferers can often predict the
severity of an approaching attack based on their prior knowledge of premonitory
symptoms.[17]
In this scheme,
the physician assesses the severity of the migraine, and provides the patient
with a range of medications, from simple analgesics to triptans. The patient
then takes a triptan if the presenting attack is moderate-to-severe, and an
analgesic product (monotherapy, or in combination with another drug) if it is
mild-to-moderate. If either of these medications fails, the patient has rescue
medication that they can take (usually an initial or alternative triptan, or a
different triptan formulation, depending on the initial therapy). Such a scheme
provides each patient with effective medications, and helps to ensure their use
in a cost-effective way. The end result is individualised care that is patient
focused, and cost-effective.
It is therefore
useful to divide patients into those with mild-to-moderate and those with
moderate-to-severe migraine and treat according to the defined severity of
illness (Table
4).
Acute
Treatments. Many different drugs are used in the
Proven
effective therapies for patients with mild-to-moderate migraine include aspirin
and NSAIDs in high doses, analgesic-anti-emetic combinations and isometheptene-analgesic
combinations. The triptans are effective therapies for patients with
moderate-to-severe migraine.[15] All the available triptan drugs are
effective and well-tolerated and Table
6 summarises their efficacy profiles.[21,44]
The most effective triptan is subcutaneous sumatriptan 6 mg, which has the
greatest 2-hour efficacy and fastest onset of action. Following this, the nasal
spray triptans, sumatriptan 20 mg and zolmitriptan 5 mg, have faster onsets of
action and possibly slightly greater efficacy than any of the oral formulations.[44,45]
The available data shows that there seem to be only minor differences in the
clinical profile of the oral triptans,[45,46] although individual patients may respond differently to
individual triptans. The orally dispersible (ODT) formulations of zolmitriptan
and rizatriptan may provide potential advantages over the usual conventional
tablet formulations in terms of ease and convenience of use. However, it should
be noted that these dispersible formulations are not absorbed in the mouth, but
in the stomach, as with the conventional tablet formulations.
Subcutaneous
sumatriptan is also effective when used as a rescue medication,[15]
and opiate analgesics may also be used, but under controlled conditions to
prevent the development of overuse and consequent withdrawal symptoms.[15]
Certain groups
of patients should either not receive triptans, or be prescribed them with
caution. Triptans are contraindicated for patients with evidence of existing
cardiovascular disease, uncontrolled hypertension, severe renal and hepatic
impairment, and for those receiving other triptans, ergotamine and its
derivatives and monoamine oxidase inhibitors (MAOIs). Eletriptan is specifically
contraindicated for patients concomitantly using selective serotonin reuptake
inhibitors (SSRIs). Caution should be used when prescribing triptans to patients
with risk factors for cardiovascular disease (e.g. history of smoking or men
aged > 40 years), controlled hypertension, any renal or hepatic disease,
hypersensitivity reactions and pregnant or breast-feeding women.[47,48]
Patients with the rare migraine variants should also not be prescribed triptans.
Drugs without
good evidence of utility include paracetamol monotherapy (due to lack of
efficacy), and opiates and barbiturates (due to safety concerns).[15]
Oral ergotamine has limited efficacy due to poor bioavailability, and is
associated with a range of potentially severe side-effects (ergotism).[49] Parenteral formulations of ergotamine
and dihydroergotamine (DHE) are more effective,[49]
but are not currently available in the UK.
Recommendations.
Based on this evidence, aspirin and NSAIDs, used in high doses, analgesic-antiemetic
combination medications and isometheptene combination medications can be
recommended as first-line acute treatments for mild-to-moderate migraine
attacks. Triptans are the obvious choice for moderate-to-severe migraine
attacks, and for patients who fail on previous therapies. Ergotamine and
preparations containing opiate analgesics should be mostly avoided, except for
use as rescue medications and where their use can be monitored.
Migraine
Prophylaxis. The primary goals of prophylactic therapy have been identified
as reducing headache frequency by > 50% and/or improving a concurrent
condition.[50] Although the 'ideal' prophylactic would abolish migraine attacks
altogether, in clinical trials only a maximum of about one-half of patients
respond to this extent.[50] Patients therefore need to have an effective
acute treatment available for the inevitable breakthrough attacks that occur.[17,21]
Due to the risk
of side-effects with these therapies, they also need to be well tolerated. The
patient should also express a preference and/or satisfaction with these
therapies.[17]
Migraine
prophylaxis is considered worth using if the patient:
·
Suffers from frequent high-impact migraine attacks. (The
definition of what constitutes 'frequent migraine' requiring prophylaxis varies
in different countries, patients with three or more attacks per month in the USA[17]
or four or more attacks per month in the UK[12] are usually given migraine prophylaxis.)
·
Experiences significant disability, despite receiving acute
treatment.
·
Suffers from concomitant co-morbidities, or a medical illness
that precludes effective acute therapy.
·
Is at risk of over-using acute medications and therefore
developing chronic daily headache.
·
Has one of the rare migraine subtypes, such as hemiplegic or
basilar migraine, migraine with prolonged aura or migrainous infarction, for
which triptans cannot be used.[17]
However, it can
also be worth revisiting the diagnosis, as frequent migraine attacks may be an
indication of chronic daily headache.[6]
Prophylactic
Therapies.
Several different drugs are used in the
Drugs with
proven efficacy for migraine prophylaxis in well-controlled clinical trials and
which are well-tolerated include the beta-blockers propranolol, timolol and
metoprolol, the anticonvulsant sodium valproate and the antidepressant
amitriptyline. The serotonin antagonists methysergide and pizotifen have some
evidence of efficacy, but have side-effects that can limit their use, whilst the
central alpha agonist clonidine has little objective evidence for its
effectiveness.[39]
Recommendations.
Beta-blockers are the obvious first-line agents for migraine prophylaxis in
Complementary
Therapies.
Many patients prefer to use complementary medications instead of, or together
with, prescribed medications for their migraine. Reasons for this include an
exhaustion of all conventional options, feeling this is a fashionable option,
obtaining a perceived high level of care from a complementary therapist and
greater perceptions of personal control and safety.[22]
Some
complementary medications have demonstrated efficacy for migraine in one or more
controlled clinical trials, including feverfew, magnesium, vitamin B2
and acupuncture prophylaxis.[21] Therapies which are often used, but do not have convincing
evidence of efficacy to date include low-dose aspirin, homeopathic medications,
aromatherapy and food exclusions following allergy testing (Table
8).[21]
Recommendations.
Several complementary prophylactic therapies, such as feverfew, acupuncture,
riboflavin and magnesium, all show some efficacy in migraine prevention,
although their long-term side-effects are not properly understood. The physician
can recommend use of these therapies, one at a time, if the patient shows
interest and wants to try something new. However, effective acute medications
should always be available, as these therapies are no more a 'cure' than any of
the conventional prophylactic agents.
The patient
needs to decide which, if any, of these therapies appeals to them, is affordable
or practicable to their lifestyles. In addition, alternative stress reduction
strategies, such as aromatherapy, reflexology or yoga, may all be beneficial. It
needs to be stressed that patients should only consult with accredited
complementary practitioners.
Migraine
attacks typically occur for several decades of the sufferer's life,[1]
and long-term management of the condition should therefore be mandatory. After
the first consultation, the patient should be asked to return to the surgery on
a regular basis for review. The patient can be asked to complete questionnaires
that can help in the monitoring of care:
·
Headache diaries are invaluable to capture the patient's pattern
of headaches over time, and several diaries are available.[22]
·
MIDAS and HIT questionnaires can capture the impact of migraine
over time and may also be useful in assessing the response to therapy.[35]
The efficacy of
acute and prophylactic medications should be monitored at each clinic visit. For
acute medication, patients who are treated effectively should continue with
their existing therapy. Patients who fail on analgesics or analgesic-combination
medications can be provided with migraine-specific medications, usually a
triptan. Patients who fail on one triptan can be provided with an alternative
triptan. Patients who find their oral triptan effective, but inconvenient to
use, can be provided with an alternative formulation that may suit their needs
better (e.g. ODT or nasal spray formulations). Patients refractory to triptans,
or who require regular rescue therapy, may require opiate drugs for rescue.
However, due to the dangers of habituation and chronic daily headache, it is
probably best to refer these patients to a specialist for treatment.
Prophylaxis is
not intended as a long-term management strategy, but should be reviewed from 4-6
weeks. If the treatment is effective, without causing chronic side-effects,
treatment can be continued up to 6 months. If not, the dose can be increased (up
to the maximum allowed) or an alternative prophylactic drug can be supplied. At
6 months, the prophylactic drug can be withdrawn if the frequency of attacks is
reduced. Providing the frequency remains reduced after withdrawal, it may be
appropriate to revert to acute treatments only.
Patients who
are refractory to repeated acute and/or prophylactic medications may need to be
referred to a specialist for further care.
The management
of migraine in primary care is, of necessity, a long-term business. Patients
need to be evaluated and treated carefully over a period of time. The
physician's time and energy can be conserved during this process by using other
healthcare providers to form a primary care headache team. The physician,
practice nurse, ancillary clinic staff and sometimes a pharmacist provide the
core team. Pharmacists, community nurses, opticians, dentists and complementary
practitioners can all feed patients into the team, while the physician can refer
the patient to a specialist physician if necessary:
·
The physician can concentrate on the patient's diagnosis and
initial and follow-up treatments, referring them to a specialist, if necessary.
·
The practice nurse can conduct much of the communication with and
evaluation of the patient before they see the physician, and may also meet
migraine sufferers serendipitously during their regular duties.
·
Pharmacists, community nurses and other primary healthcare
providers can help with the identification, education and initial treatment of
headache sufferers, and advise appropriate sufferers to consult their primary
care physician.
·
Pharmacists can also explain when drugs (acute and prophylactic)
can be taken, and answer patients' concerns about side-effects and possible
interactions with other products.
·
Good communication needs to be established between the specialist
and primary care physicians. The specialist needs to inform the primary care
physician of their diagnosis and treatment choices, as much of the future
management of these patients devolves into primary care. the specialist does not
have to be a consultant physician. A primary care physician or Primary Care
Trust (PCT) specialist with expertise in headache may also be appropriate.
·
Last, but not least, the patient is an important member of the
team, and must be included in the treatment decision-making process. The patient
needs to be able to discuss their headache history, understand their diagnosis
and management plan, and what it is likely to achieve, agree to the course of
therapy and feel motivated to continue with long-term treatment.
In practice,
there is a core medical team of the primary care physician, practice nurse and
their assistants. Pharmacists, community nurses, opticians, dentists and
complementary practitioners form associate members of the team. The patient can
access medical care from any member of the team, who will refer them to the
primary care physician if necessary. The specialist physician then forms an
additional resource for the primary care physician to use where necessary. Such
a team can work without a formal organisation, providing all members are
educated about headache and its treatment. In practice, this is often not the
case, and there is a good argument for a more formal agreement between
healthcare professionals on headache care in the community. For the healthcare
professional with an interest in headache, help can be gained from one of the
many professional organisations that deal with headache research and treatment
in the UK, e.g. Migraine Trust (www.migrainetrust.org),
MIPCA (www.mipca.org.uk),
BASH (www.bash.org.uk) and
the Migraine Action Association (www.migraine.org.uk).
Migraine care
has the potential to improve greatly, with the development of new management
guidelines, the introduction of new treatments and the use of evidence-based
medicine to objectively rate and compare available therapies. These initiatives
have allowed the production of these new MIPCA guidelines designed to improve
migraine management in
·
Better patient, physician, nurse and pharmacist education.
·
The refinement of diagnostic procedures.
·
Improved management of children and adolescents with migraine.
·
The development of new acute and (in particular) prophylactic
drugs.
·
Specific guidelines for the use of complementary therapies.
·
The development of new, patient-friendly headache diaries.
The guidelines
discussed here will undoubtedly be refined over the coming years and we hope
that international guidelines will also be developed in the near future.
For the
management of migraine and other headaches in primary care, MIPCA recommends a
scheme of:
·
Specific consultations for headache care.
·
Detailed history taking, patient education and buy-in.
·
Diagnostic screening and confirmatory differential diagnosis.
·
Management individualised for each patient.
·
Prescribing only treatments that have objective evidence of
favourable efficacy and tolerability.
·
Prospective follow-up procedures to monitor the success of
treatment (Figure 8).