Major
Recommendations
Note from the National Guideline Clearinghouse (NGC) and the
Institute for Clinical Systems Improvement (ICSI): For a
description of what has changed since the previous version of
this guidance, refer to Summary
of Changes Report -- January 2013  .
In addition, ICSI has made a decision to transition to the
Grading of Recommendations Assessment, Development and
Evaluation (GRADE) system. This document is in transition to
the GRADE methodology. Transition steps incorporating GRADE
methodology for this document include the following:
- Priority placed upon available systematic reviews in literature
searches.
- All existing Class A (randomized controlled trials [RCTs]) studies
have been considered as high quality evidence unless
specified differently by a work group member.
- All existing Class B, C and D studies have been considered as low
quality evidence unless specified differently by a work
group member.
- All existing Class M and R studies are identified by study design
versus assigning a quality of evidence. Refer to Crosswalk
between ICSI Evidence Grading System and GRADE (see
below in the "Definitions" section).
- All new literature considered by the work group for this revision
has been assessed using GRADE methodology.
The recommendations for the diagnosis and treatment of headache are
presented in the original
guideline document
in the form of 10 algorithms with 131 components, accompanied
by detailed annotations. In addition to a Main algorithm,
algorithms are provided for: Diagnosis; Migraine Treatment;
Tension-Type Headache; Cluster Headache; Dihydroergotamine
Mesylate; Menstrual-Associated Migraine; Perimenopausal or
Menopausal Migraine; On Estrogen-Containing Contraceptives or
Considering Estrogen-Containing Contraceptives with Migraine;
Migraine Prophylactic Treatment. Clinical highlights and
selected annotations (numbered to correspond with the
algorithm) follow.
Quality of evidence (Low Quality, Moderate Quality, High Quality,
Meta-analysis, Systematic Review, Decision Analysis,
Cost-Effectiveness Analysis, Guideline, and Reference) and
conclusion grade (I-III, Not Assignable) definitions are
repeated at the end of the "Major Recommendations" field.
Clinical
Highlights
- Headache is diagnosed by history and physical examination with
limited need for imaging or laboratory tests. (Annotation
#11; Aim #1)
- Warning signs of possible disorder other than primary headache are
(Annotation #12; Aim #1):
- Subacute and/or progressive headaches which worsen over time
(months)
- A new or different headache
- Any headache of maximum severity at onset
- Headache of new onset after age 50
- Persistent headache precipitated by a Valsalva maneuver
- Evidence such as fever, hypertension, myalgias, weight loss, or
scalp tenderness suggesting a systemic disorder
- Presence of neurological signs that may suggest a secondary cause
- Seizures
- Migraine-associated symptoms are often misdiagnosed as "sinus
headache" by patients and clinicians. Most headaches
characterized as "sinus headaches" are migraines.
(Annotation #15; Aim #1)
- Early treatment of migraines with effective medications improves a
variety of outcomes including duration, severity and
associated disability. (Annotations #32, 36; Aim
#7)
- Drug treatment of acute headache should generally not exceed more
than two days per week on a regular basis. More frequent
treatment other than this may result in
medication-overuse chronic daily headaches.
(Annotation #32, 36; Aim #7 )
- Inability to work or carry out usual activities during a headache is
an important issue for migraineurs. (Annotation #30;
Aim #4)
- Prophylactic therapy should be considered for all patients.
(Annotations #66, 77, 91, 94, 122, 131; Aim #3)
- Migraines occurring in association with menses and not responsive to
standard cyclic prophylaxis may respond to hormonal
prophylaxis with use of estradiol patches, creams, or
estrogen-containing contraceptives. (Annotation #94;
Aim #3)
- Women who have migraines with aura have a substantially higher risk
of stroke with the use of estrogen-containing
contraceptive compared to those without migraines.
Headaches occurring during perimenopause or after
menopause may respond to hormonal therapy. (Annotation #109,
111; Aim #5)
- Most prophylactic medications should be started in a low dose and
titrated to a therapeutic dose to minimize side effects and
maintained at target dose for 8–12 weeks to obtain
maximum efficacy. (Annotation #122; Aims #3, 5,
7)
Special Circumstances
Adolescents
At this time the majority of the adolescent literature supports a
strong placebo effect in this age group. Success of triptans and
prophylactic medications in patients age 12-17 yield similar
positive outcomes as in adult studies, but placebo
administered in blinded, controlled studies has a similar
effect. There has been a recent study that supports the use of
almotriptan with statistically significant efficacy over
placebo. As an acute treatment, almotriptan in the dose of
12.5 mg was effective in relieving pain and associated symptoms and
was well tolerated [High Quality Evidence].
As a prophylactic treatment, topiramate 100 mg/day was effective in
reduction of the number of migraine headaches a month [High
Quality Evidence].
Psychological treatments, principally relaxation and cognitive
behavioral therapies are effective treatments of childhood headache
[Meta-analysis/Systematic Review].
Pregnancy and Breastfeeding
Special consideration should be given to medication selection and
management during pregnancy and breastfeeding, considering the risks
and benefits of selected drugs and their efficacy.
Diagnosis Algorithm
Annotations
- Patient Presents with Complaint of a Headache
Recommendation
- Clinicians should perform an appropriate prompt evaluation of the
patient who presents with headache and initiate
acute treatment.
Migraine is the most common headache disorder seen by primary care
providers [Low Quality Evidence].
A patient may present for care of headaches during an attack or
during a headache-free period. If a patient presents during a
headache, appropriate evaluation (history, examination,
appropriate testing) needs to be undertaken in a timely
fashion. Once the diagnosis of primary headache is
established, acute treatment is instituted. If the patient
has a history of recurrent headaches, a plan for treatment
(acute and prophylactic) needs to be
established.
- Critical First Steps
Recommendation:
- Clinicians should gather a detailed history, including a focused
physical and neurological exam, of the patient who
presents with headache.
Minimal general physical examination is performed at the first
consultation of patient presenting with a headache. Symptoms
and signs with the use of criteria can diagnose
headache. The International Classification of Headache
Disorders, second edition (ICHD-II) system presently
provides the gold standard. As empirical evidence and clinical
experience accumulate, criteria for diagnosing headaches
will be revised [Reference].
Detailed History
Inquire about functional disabilities at work, school, housework, or
leisure activities during the past 3 months (informally
or using well-validated disability questionnaire).
Assessment of the headache characteristics requires determination of
the following:
Temporal profile:
- Time from onset to peak
- Usual time of onset (season, month, menstrual cycle, week, hour of
day)
- Frequency and duration
- Stable or changing over past 6 months and lifetime
Autonomic features:
- Nasal stuffiness
- Rhinorrhea
- Tearing
- Eyelid ptosis or edema
Descriptive characteristics: pulsatile, throbbing, pressing, sharp,
etc.
Location: uni- or bilateral, changing sides
Severity
Precipitating features and factors that aggravate and/or relieve the
headache
Factors that relieve the headache
History of other medical problems
Pharmacological and non-pharmacological treatments which are
effective or ineffective
Aura (present in approximately 15% of migraine patients)
Focused Physical Examination
Vital signs (blood pressure, pulse, respirations, and
temperature)
Extracranial structure evaluation such as carotid arteries, sinuses,
scalp arteries, cervical paraspinal muscles
Examination of the neck in flexion versus lateral rotation for
meningeal irritation. (Even a subtle limitation of neck flexion
may be considered an abnormality.)
Focused Neurological Examination
A focused neurological examination may be capable of detecting most
of the abnormal signs likely to occur in patients with
headache due to acquired disease or a secondary
headache.
This exam should include at least the following evaluations:
- Assessment of patient's awareness and consciousness, presence of
confusion, and memory impairment
- Ophthalmological examination to include pupillary symmetry and
reactivity, optic fundi, visual fields, and ocular
motility
- Cranial nerve examination to include corneal reflexes, facial
sensation, and facial symmetry
- Symmetry of muscle tone, strength (may be as subtle as arm or leg
drift), or deep tendon reflexes
- Sensation
- Plantar response(s)
- Gait, arm and leg coordination
- Causes for Concern?
Headache features beyond that of ICHD-II system criteria should raise
concern of a more sinister underlying cause
[Guideline].
Causes for concern in the diagnosis of headaches may alter a
diagnosis of migraine to a secondary diagnosis of headache, which
can be more serious and/or life-threatening
[Guideline, Low Quality Evidence].
Causes for concern must be evaluated irrespective of the patient's
past history of headache. Warning signs of possible
disorder other than primary headache are:
- Subacute and/or progressive headaches which worsen over time
(months)
- A new or different headache or a statement by a headache patient
that "this is the worst headache ever"
- Any headache of maximum severity at onset
- Headaches of new onset after the age of 50 years old
- Persistent headache precipitated by a Valsalva maneuver such as
cough, sneeze, bending, or with exertion (physical or
sexual)
- Evidence such as fever, hypertension, myalgias, weight loss, or
scalp tenderness suggesting a systemic disorder
- Neurological signs that may suggest a secondary cause. For
example, meningismus, confusion, altered levels of
consciousness, changes or impairment of memory,
papilledema, visual field defect, cranial nerve
asymmetry, extremity drifts or weaknesses, clear sensory
deficits, reflex asymmetry, extensor plantar response,
or gait disturbances.
- Seizures
- Consider Secondary Headache Disorder
The presence of the symptoms or signs listed above suggests a
secondary cause for the headache, and could be indicative of an
underlying organic condition. Alternate diagnoses include
subarachnoid hemorrhage, tumor, meningitis,
encephalitis, temporal arteritis, idiopathic
intracranial hypertension, and cerebral venous thrombosis,
among others.
Secondary Headaches
- Subacute and/or progressive, worsening headaches over
weeks to months:
Headaches that worsen with time may be due to a progressive
intracranial lesion such as tumor, subdural hematoma, or
hydrocephalus. While the neurologic examination may
reveal abnormalities that suggest a sinister
process, this is not always the case. Accordingly,
a history of a progressive headache is an
indication for head imaging. For most processes, magnetic
resonance imaging with and without gadolinium contrast will
be more sensitive than a computed tomography head
scan. Note: in patients who receive gadolinium
contrast media used in magnetic resonance imaging (MRI),
there is the potential for renal toxicity and the rare
complication (3%-5% risk in patients with moderate
to end-stage renal disease) of life-threatening
nephrogenic systemic fibrosis. It is recommended that
gadolinium use be avoided when possible in patients with
advanced renal disease.
- A new or different headache or a statement by a headache
patient that "this is the worst headache of my
life":
Primary headache disorders (mainly tension-type headache and
migraine) are exceedingly common. A history of a primary
headache disorder does not confer protection
against a new, serious process that presents with
headache. The acuteness of a headache will largely
define the differential diagnosis. Headache that presents
suddenly, "like a thunderclap," can be
characteristic of several serious intracranial processes,
including subarachnoid hemorrhage, venous sinus
thrombosis, bacterial meningitis, spontaneous cerebral
spinal fluid leak, carotid dissection, and rarely,
pituitary apoplexy and hypertensive
encephalopathy. The first investigation is a computed
tomography head scan without contrast. If there is no evidence
of a subarachnoid hemorrhage, a lumbar puncture should
be performed. If both studies are normal and the
suspicion of subarachnoid hemorrhage is still
high, MRI with and without gadolinium should be obtained.
Neurological consultation is indicated and further
tests for consideration include magnetic resonance
angiogram and magnetic resonance venogram.
If the headache is more subacute in onset, chronic meningitis may
need to be considered along with a space occupying
intracranial lesion or hydrocephalus. Again,
neuroimaging should be performed. Whether a lumbar
puncture is done will be guided by the index of suspicion
regarding a meningeal process (e.g.,
meningitis).
- Headache of sudden onset:
This refers mainly to thunderclap headache (see above). It should
be treated as an emergency since the possible
presence of aneurysmal subarachnoid hemorrhage
needs to be assessed as outlined above. Other
secondary causes of headache will be found less
commonly.
- Headache precipitated by a Valsalva maneuver such as
cough, sneeze, bending, or with exertion:
Valsalva headaches, while often representing primary cough
headache, can signal an intracranial abnormality, usually
of the posterior fossa. The most commonly found
lesion is a Chiari malformation although other
posterior fossa lesions are sometimes found. Less
commonly there are intracranial lesions located elsewhere.
An MRI needs to be obtained to appropriately
investigate for these possibilities. Exertional headache,
such as with exercise or during sexual activity, may
represent a benign process such as migraine.
However, if the headache is severe or thunderclap in onset,
investigations will be necessary as already
outlined above.
- Headaches of new onset after the age of 50 years:
The large majority of individuals who are destined to develop a
primary headache disorder do so prior to age 50 years.
Of course, this is not universal, and migraine or
other primary headache disorders may begin even at
an advanced age. Nevertheless, care should be taken
before a diagnosis of a primary headache disorder is
assigned. Many patients who do have the onset of a
new headache disorder after age 50 years will
merit brain imaging. In addition, after the age of 50
years, a new headache disorder should evoke suspicion of possible
giant cell arteritis. Obviously, symptoms of
polymyalgia rheumatica, jaw claudication, scalp
tenderness, or fever will increase the likelihood
of this diagnosis. Findings of firm, nodular temporal
arteries and decreased temporal pulses will increase the
suspicion as will an elevated sedimentation
rate.
- Symptoms suggestive of a systemic disorder such as fever,
myalgias, weight loss, or scalp tenderness or a
known systemic disorder such as cancer or immune
deficiency:
Systemic disorders, while not incompatible with a coexistent
primary headache disorder, should signal caution.
Patients should be carefully evaluated. Obviously,
the differential diagnosis will be long and the
index of suspicion for any given process will largely
depend on the clinical setting.
- Presence of subtle neurological signs suggests a secondary
cause for headache. For example, meningismus,
confusion, altered level of consciousness, memory
impairment, papilledema, visual field defect,
cranial nerve abnormalities, pronator drift, extremity
weakness, significant sensory deficits, reflex
asymmetry, extensor plantar response, or gait
disturbance when accompanying a headache should
elicit caution:
While neurological signs may be unrelated to a headache, previously
undocumented neurological findings that are
presumably new need to be carefully considered.
Usually cranial imaging will be the initial study.
Depending on the index of suspicion, lumbar puncture and
blood studies may be indicated.
- Seizures:
While seizures can occasionally be a manifestation of a primary
headache disorder such as migraine, this is the
exception and not the rule; it is a diagnosis of
exclusion. Other etiologies for seizures including
space-occupying lesions, infection, stroke, and metabolic
derangements will need to be considered. Again, MRI
is the imaging procedure of choice unless there is
an issue of acute head trauma, in which case a
computed tomography (CT) head scan should be obtained
initially.
- Diagnosis to be included in secondary headache:
- Subdural hematoma
- Epidural hematoma
- Tumor
- Other metabolic disorders
- Craniocervical arterial dissection
- Giant cell arteritis
- Acute hydrocephalus
- Obstructive hydrocephalus
- Cerebral spinal fluid leaks
- Cerebral venous sinus thrombosis
This list is not intended to be all-inclusive but rather to
represent the most commonly seen diagnosis for secondary
headache by the primary care
clinician.
- Meets Criteria for Primary Headache Disorder?
The ICHD-II system for migraine has been studied in a community
population sample without consideration of treatment. Findings
suggest that the best criteria differentiating migraine
from other headache types are the presence of nausea
and/or vomiting in combination with two of the following
three symptoms: photophobia, phonophobia, and osmophobia
[Reference].
The table "Modified Diagnostic Criteria" in the original guideline
document has been modified from the ICDH-II system criteria
and describes the differentiating criteria applicable
for the diagnosis of migraine and other primary headache
disorders.
- Evaluate Type of Primary Headache. Initiate Patient
Education and Lifestyle Management
Recommendations:
- Clinicians should provide patient education and lifestyle
management options to patients with headache.
- Clinicians should instruct patients with headache to maintain a
diary to clarify the frequency, severity, triggers
and treatment responses to their headaches.
Migraine-associated symptoms are often misdiagnosed as "sinus
headache" by patients and providers. This has led to the
underdiagnosis and treatment of migraine.
While education is of paramount importance in managing any condition,
it is especially important in the ongoing management of
headache. Patients may have to make lifestyle changes,
are often required to make self-management choices in
the treatment of individual headaches, and should
maintain a diary to clarify the frequency, severity, triggers,
and treatment responses.
Refer to the original guideline document for detailed information
regarding type of headache, lifestyle changes and
self-management, and for mnemonic POUNDing for the
screening of migraine headache.
- Chronic Daily Headache
Chronic daily headache refers to the presence of a headache more than
15 days per month for greater than three months. Chronic
daily headache can be divided into those headaches that
occur nearly daily that last four hours or less and
those that last more than four hours, which is more
common. The shorter-duration daily headache contains less common
disorders such as chronic cluster headache and other
trigeminal autonomic cephalgias. Only daily headaches of
long duration are considered in this guideline.
Refer to the original guideline document for diagnostic criteria of
the following types of chronic daily headache:
medication-overuse headache, chronic tension-type
headache, and hemicrania continua.
- Specialty Consultation Indicated?
Recommendation:
- Clinicians may consider specialty consultation when the diagnosis
or etiology cannot be confirmed, warning signals
exist or quality of life is impaired.
The decision to seek a specialty consultation will depend upon the
practitioner's familiarity and comfort with headache and
its management. Specialty consultation may be considered
when:
- The diagnosis cannot be confirmed.
- Etiology cannot be diagnosed or warning signals are present.
- Headache attacks are occurring with a frequency or duration
sufficient to impair the patient's quality of life
despite treatment or the patient has failed to
respond to acute remedies or is in status
migrainosus.
- Perform Diagnostic Testing if Indicated
Recommendation:
- Clinicians should use a detailed headache history, that includes
duration of attacks and the exclusion of secondary
causes, as the principal means to diagnose primary
headache. Additional testing in patients without
atypical symptoms or an abnormal neurologic
examination is unlikely to be helpful.
There are, as yet, no tests which confirm the diagnosis of primary
headache. The diagnosis of primary headache is
dependent on the clinician. The work group recommends
careful consideration before proceeding with
neuroimaging (CT or MRI). It is uncommon for
neuroimaging to detect an abnormality in persistent headaches of
longer duration versus new onset situations. Selective
testing, including neuroimaging, or
electroencephalogram, lumbar puncture, cerebrospinal fluid and
blood studies, may be indicated to evaluate for secondary
headache if causes of concern have been identified in the patient
history or physical examination (see Annotation #12,
"Causes for Concern?"). Diagnosis may be complicated if
several headache types coexist in the same patient. The
following symptoms significantly increased the odds of
finding a significant abnormality on neuroimaging in
patients with non-acute headache:
- Rapidly increasing headache frequency
- History of lack of coordination
- History of localized neurologic signs or a history such as
subjective numbness or tingling
- History of headache causing awakening from sleep (although this
can occur with migraine and cluster headache)
[Guideline]
Refer to the original guideline document for more
information.
Migraine Treatment
Algorithm Annotations
- Patient Meets Criteria for Migraine
Migraine is the most common headache disorder seen by primary care
clinicians.
It is expected that a patient with headache undergo a diagnostic
work-up (see the Diagnosis Algorithm) establishing the
diagnosis of migraine before initiating acute
treatment.
- Is Patient Experiencing a Typical Headache?
Each individual headache must be evaluated in the context of the
patient's prior migraine headaches. The practitioner must
always remain alert to the possibility of secondary
causes for headache, particularly when there is a
previously established history of a primary headache
disorder such as migraine.
Migraine headache does not preclude the presence of underlying
pathology (arterial dissection, intracranial aneurysm, venous
sinus thrombosis, ischemic or hemorrhagic stroke,
temporal arteritis, etc.) that may also present with
"vascular headaches." If the history is scrutinized,
ominous causes for headaches can often be identified and
treated with the potential to avoid catastrophe.
- Categorize According to Peak Severity Based on Functional
Impairment, Duration of Symptoms, and Time to Peak
Impairment
Recommendations:
- Clinicians should categorize headache according to peak severity,
duration of symptoms and time to peak impairment.
- Clinicians should treat according to severity.
Accurate categorization and characterization by both providers and
patients is important. The categorization of migraine
influences choice of treatment method.
Severity Levels
Mild - Patient is aware of a headache but is able to
continue daily routine with minimal alteration.
Moderate - The headache inhibits daily activities
but is not incapacitating.
Severe - The headache is incapacitating.
Status - A severe headache that has lasted more than
72 hours.
There may be additional features that influence choice of treatment.
For example, parenteral administration (subcutaneous,
nasal) should strongly be considered for people whose
time to peak disability is less than one hour, who
awaken with headache, and for those with severe nausea
and vomiting.
Determining functional limitations during migraine episodes is the
key to determining the severity and therefore the best
treatment for a patient. Clinicians and patients should
stratify treatment based on severity rather than using
stepped care, though patients will often use stepped
care within an attack. This algorithm uses a stratified-care
model.
Factors That May Trigger Migraine
Certain influences can lead to a migraine attack. It is important to
note that although a single trigger may provoke the onset
of a migraine, a combination of factors is much more
likely to set off an attack.
Refer to the original guideline document for a detailed list of
triggers, including environmental triggers, lifestyle habits,
hormonal triggers, emotional triggers, and
medications.
- Mild Treatment
Recommendations:
- Clinicians may manage mild migraines with over-the-counter
medications.
- Clinicians may use triptans for mild migraine pain levels.
The guideline work group presumes most mild migraine headaches will
be managed by self-care, which implies an emphasis on
over-the-counter medications. However, since only 2% to 12%
of initially mild migraine episodes remain mild (with
the remainder progressing), treatments effective for
mild headaches may be useful for only a short time.
Studies on treatment of migraine headache at the mild level show
that triptans are more effective in abolishing pain at
this stage than if the headache is more severe. It is
acceptable to use other symptomatic headache relief
drugs as well as triptans for mild headache. However,
current retrospective analyses of mild pain treatment studies reveal
triptan response to two-hour pain freedom to be superior to
any other comparator drug. Please see Appendix A, "Drug
Treatment for Headache," and Appendix B, "Drug Treatment
for Adjunctive Therapy," in the original guideline
document.
Use of non-steroidal anti-inflammatory drugs (NSAIDs) for acute
treatment of headache for more than nine days per month or use
of aspirin for more than 15 days is associated with an
increased risk of chronic daily headache.
Early treatment of migraines with effective medications improves a
variety of outcomes including duration, severity and
associated disability [Meta-analysis].
Given a longer half-life of naratriptan, headache response is delayed
with naratriptan when compared with other selective
5-hydroxy tryptamine (5-HT) receptor agonists. However,
headache recurrence may be less frequent.
Second doses of triptans have not been shown to relieve headache more
if the first dose has been ineffective.
Studies show that sumatriptan and naproxen sodium in combination may
be more effective than either drug alone. However, there
are no studies that demonstrate that sumatriptan 85
mg/naproxen sodium 500 mg is more effective than
sumatriptan and naproxen sodium taken together.
Therefore, a dose of sumatriptan 100 mg and a dose of naproxen
sodium 550 mg taken at the same time is
recommended.
- Successful?
Success for treatment of migraine is defined as complete pain relief
and return to normal function within two hours of taking
medication. In addition, patients should not have
intolerable side effects and should find their
medications reliable enough to plan daily activities despite
migraine headache [Low Quality Evidence].
Consider reasons for treatment failure and change treatment plan.
Common reasons for migraine treatment failure are provided in the
original guideline document.
- Moderate Treatment
Recommendation:
- Clinicians should avoid the use of opiates and barbiturates in the
treatment of headache.
Early treatment of migraines with effective medications improves a
variety of outcomes including duration, severity, and
associated disability [Meta-analysis].
The use of opiates and barbiturates should be avoided. This guideline
emphasizes the use of other agents over opiates and
barbiturates, recognizing that many migraineurs are currently
treated with drugs from the latter two classes. In
general, opiates are characterized by having a short
pain-relief window, release inflammatory neurochemicals, and
increase vasodilation; none of these addresses the currently
known treatment issues and pathophysiology of
migraine.
Meperidine should be avoided. The metabolite of meperidine,
normeperidine, has a long half-life, produces less analgesic
effect, and there is an increased risk of seizures that
cannot be reversed by naloxone. The guideline developers
have specifically excluded butorphanol because of its
high potential for abuse and adverse side-effect
profile.
If an opiate must be used, meperidine should not be the opiate
selected.
See Appendix A, "Drug Treatment for Headache" and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
- Status (Greater Than 72 Hour Duration)
Recommendation:
- It is recommended that the patient be hydrated prior to
neuroleptic administration with 250-500 mL of 5% dextrose
with 0.45% sodium chloride intravenously and
advised of the potential for orthostatic
hypotension and acute extrapyramidal side effects. The
patient should be observed in a medical setting as
clinically appropriate after administration of a
neuroleptic and should not drive for 24 hours.
- Adjunctive Therapy
Recommendation:
- Clinicians may consider adjunctive therapy as a treatment option
for headache.
See Appendix B, "Drug Treatment for Adjunctive Therapy," in the
original guideline document. As adjunctive therapy, any of the
listed medications can be used singularly or in
compatible combination. For intermittent, infrequent
headache, caffeine should be added as first choice when
not contraindicated. The use of caffeine in patients with
chronic daily headache is to be discouraged. The prokinetic
agent metoclopramide could be considered next. This
guideline has no other preferences.
- Patient Meets Criteria for Dihydroergotamine Mesylate
(DHE)?
DHE is effective in halting intractable migraine attacks or migraine
status. DHE is also effective in halting the acute cycle
of cluster headaches.
DHE must not be given to patients with the following conditions:
- Pregnancy and breastfeeding
- History of ischemic heart disease
- History of Prinzmetal's angina
- Severe peripheral vascular disease
- Onset of chest pain following administration of test dose
- Within 24 hours of receiving any triptan or ergot derivative
- Elevated blood pressure
- Patients with hemiplegic or basilar-type migraine (basilar-type
migraine is defined as three of the following
features: diplopia, dysarthria, tinnitus, vertigo,
transient hearing loss or mental confusion)
[Guideline]
- Cerebrovascular disease
Intravenous DHE is the method most frequently employed to terminate a
truly intractable migraine attack or migraine status.
The protocol outlined in the DHE algorithm is effective
in eliminating an intractable migraine headache in up to
90% of patients within 48 hours. This method of
administration has also been found to be effective in
terminating an acute cycle of cluster headaches as well
as chronic daily headaches with or without
analgesic/ergotamine rebound.
- Chlorpromazine, Intravenous Valproate Sodium, Intravenous
Magnesium Sulfate or Prochlorperazine
Recommendations:
- Clinicians should treat patients with migraine >72 hours who do
not meet criteria for DHE with chlorpromazine,
intravenous valproate sodium, intravenous
magnesium sulfate or prochlorperazine.
- Clinicians should premedicate patients with diphenhydramine or
benztropine who have migraine for >72 hours who do
not meet criteria for DHE and who have a history
of dystonic reaction.
See Appendix A, "Drug Treatment for Headache" and Appendix B, "Drug
Treatment for Adjunctive Therapy" in the original
guideline document.
If chlorpromazine, valproate sodium, or intravenous magnesium sulfate
was used previously, one may not wish to
repeat.
- Opiates
These are not drugs of first choice and headache practice recommends
against the use of meperidine. Normeperidine, the active
metabolite of meperidine, has a long half-life and is
neuroexcitatory and neurotoxic. There is inconsistent
absorption of opiates, at least with meperidine, when
injected intramuscularly, and they are less effective than when
given intravenously. Opiates release inflammatory
neurochemicals and increase vasodilation that are
mechanistically counterproductive to currently known
migraine pathophysiology and can exacerbate headaches.
Studies have been done using meperidine but the effects are
likely due to class effect and other opiates are likely
to be just as effective [High Quality
Evidence]. However, it should be noted that there are no
studies to support opiate effectiveness.
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
- Dexamethasone
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
Migraine Treatment - Annotations #32, 36, 39, 44, 47, 49,
51
Adolescents
At this time the majority of the adolescent literature supports a
strong placebo effect in this age group. Success of triptans
and prophylactic medications in patients age 12-17 yield
similar positive outcomes as in adult studies, but
placebo administered in blinded, controlled studies has
a similar effect. There has been a recent study that
supports the use of almotriptan with statistically significant
efficacy over placebo. As an acute treatment, almotriptan
in the dose of 12.5 mg was effective in relieving pain
and associated symptoms and was well tolerated
[High Quality Evidence].
See Appendix A, "Drug Treatment for Headache," in the original
guideline document for more information.
Tension-Type Headache
Algorithm Annotations
- Patient Meets Criteria for Tension-Type Headache?
Tension-type headache is one of the most common primary headaches.
See Annotation #14 "Meets Criteria for Primary Headache
Disorder?" for episodic (less than 15 days per month)
and chronic tension-type headache (more than 15 days per
month).
It is important to evaluate the patient who comes to the office for
tension-type headache for the possibility of migraine.
While the ICHD-II system suggests migraine and
tension-type headaches are distinct disorders, there is
evidence to suggest that for the migraineur,
tension-type headache is actually a low-intensity migraine
[High Quality Evidence], [Low Quality
Evidence].
- Acute Treatment
Recommendation:
- Clinicians may utilize over-the-counter analgesics or prescription
NSAIDs for tension-type headache treatment.
Analgesics offer a simple and immediate relief for tension-type
headache. Medication overuse is potentially a concern that can
lead to chronic daily headache. Use of drugs for acute
treatment of headache for more than nine days per month
is associated with an increased risk of chronic daily
headache.
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
[High Quality Evidence], [Low Quality Evidence]
Electromyography biofeedback has been found to have an effect on
tension-type headaches. The goal is to help patients
recognize muscle tension. Fifty-three studies have shown
medium to large effect
[Guideline].
- Prophylactic Treatment
Recommendation:
- Prophylactic treatment, including the use of tricyclic
antidepressants, may be used for chronic tension-type
headaches.
Prophylactic therapy is reserved for patients with chronic
tension-type headache (more than 15 headaches per month).
Tricyclic antidepressants are effective in reducing the frequency and
severity of tension-type headache.
[High Quality Evidence], [Low Quality
Evidence]
Cluster Headache
Algorithm Annotations
- Patient Meets Criteria for Cluster Headache?
There is no more severe pain than that sustained by a cluster
headache sufferer. This headache is often termed "suicide
headache." Cluster headache is characterized by repeated
short-lasting but excruciating intense attacks of
strictly unilateral peri-orbital pain associated with
local autonomic symptoms or signs. The most striking
feature of cluster headache is the unmistakable circadian and
circannual periodicity. Many patients typically suffer
daily (or nightly) from one or more attacks over a period
of weeks or months [Low Quality Evidence], [High
Quality Evidence].
- Acute Treatment
Recommendations:
- Clinicians should utilize inhaled oxygen for the treatment of
cluster headaches at a rate of 7-15 L/min.
- Clinicians should consider using subcutaneous sumatriptan or
intranasal zolmitriptan as a first line option for the
treatment of cluster headaches.
Oxygen inhalation is highly effective when delivered at the beginning
of an attack with a non-rebreathing facial mask (7-15
L/min). Most patients will obtain relief within 15
minutes. Acute drugs may be difficult to obtain in
adequate quantity.
Subcutaneous sumatriptan and intranasal zolmitriptan are the most
effective self-administered medication for the relief of
cluster headaches. Sumatriptan is not effective when
used before the actual attack nor is it useful as a
prophylactic medication [Systematic Review].
Intranasal sumatriptan can also be considered for acute
treatment [Moderate Quality Evidence].
DHE provides prompt and effective relief from cluster headaches in 15
minutes, but due to the rapid peak intensity and short
duration of cluster headaches, DHE may be a less
feasible option then sumatriptan.
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
[Low Quality Evidence], [High Quality
Evidence]
- Bridging Treatment
Recommendation:
- Clinicians should initiate bridging treatment or transitional
prophylaxis simultaneously with maintenance
prophylactic treatment after acute treatment has
suppressed the initial attack for cluster
headaches.
Bridging treatment allows for the rapid suppression of cluster
attacks in the interim until the maintenance treatment reaches
therapeutic levels.
Options for bridging treatment are:
- Corticosteroids
- Occipital nerve block
[Guideline], [Low Quality Evidence], [High Quality
Evidence]
- Maintenance Prophylaxis
Recommendation:
- Clinicians should initiate maintenance prophylaxis to provide
sustained suppression of cluster headaches over the
expected cluster period.
Effective prevention cannot be overemphasized in these patients.
Maintenance prophylaxis is critically important since cluster
headache sufferers typically experience one or more
daily (or nightly) attacks for a period of weeks or
months. The goal of transitional therapy is to induce
rapid suppression of attacks while maintenance prophylaxis
is intended to provide sustained suppression over the
expected cluster period.
If the patient has intractable headache or is unresponsive to
prophylactic treatment, consider referral to a headache
specialist.
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug
Treatment for Adjunctive Therapy," in the original
guideline document.
[Low Quality Evidence], [Reference], [High
Quality Evidence]
Dihydroergotamine
Mesylate (DHE) Algorithm Annotations
- Intravenous Metoclopramide 10 mg
Metoclopramide (10 mg) is given either by direct intravenous
injection over 2-3 minutes, or infused intravenously in 50 mL of
normal saline over 15 minutes. Each dose of
metoclopramide should be administered 15 minutes prior
to each DHE injection. Although uncommon, acute
extrapyramidal side effects such as dystonia, akathisia, and
oculogyric crisis may occur after administration of
metoclopramide. Benztropine mesylate is effective in
terminating this unusual adverse event, given as a 1-mg
injection (intravenous or intramuscular). Often after five doses
of metoclopramide, it may be given as needed every eight
hours for nausea [High Quality Evidence].
- Begin Continuous DHE
Begin DHE 2 mg in 1,000 mL normal saline at 42 mL/hr. Limit the dose
of DHE to no more than 2 mg/24 hours.
Continue intravenous metoclopramide 10 mg IV every eight hours as
needed for nausea.
Side Effects
- If significant nausea occurs at any time, reduce the rate of DHE
to 21 to 30 mL/hr.
- If diarrhea occurs, give diphenoxylate with atropine, one or two
tablets, three times daily as needed.
- If excessive anxiety, jitteriness (akathisia), or dystonic
reaction occurs, give intravenous benztropine 1 mg.
It may be continued up to seven days.
This approach is an alternative to the intermittent dosing of DHE as
outlined in the Raskin protocol, and some practitioners
may prefer it rather than the intermittent DHE protocol.
Continuous DHE, like the intermittent administration,
can be continued for seven days, although 72 hours is
more typical. Opioid analgesics should not be used with
either protocol since these are likely to prolong the headache
via analgesic rebound.
Menstrual-Associated
Migraine Algorithm Annotations
- Patient Meets Criteria for Menstrual Only or
Menstrual-Associated Migraine
Recommendation:
- Clinicians should advise women who meet criteria for
menstrual-associated migraine to keep a continuous daily record
of headache occurrence, severity, duration and
menstrual flow for at least two months.
"Menstrual migraine," a term misused by both patients and clinicians,
lacks precise definition. The ICHD-II system has
proposed that menstrual-only migraine be defined as
attacks exclusively starting two days before and first
two days of the menstrual cycle
[Meta-analysis], [Guideline]. The woman should be
free from attacks at all other times of the cycle.
Many women who do not have attacks exclusively with menses are
considered to have menstrual-associated migraines [Low
Quality Evidence].
The clinician and patient need to discuss diary documentation. The
patient should keep a continuous daily record for at least
two months to include the following:
- Day/time of headache
- Severity of headache
- Duration
- Onset of menstrual flow
- Consider Cyclic Prophylaxis
Recommendations:
- Clinicians may consider non-hormonal cyclic prophylactic treatment
with NSAIDs and triptans for patients with
menstrual-associated migraine.
- NSAIDs
NSAIDs should be considered approaches of first choice in the
prophylactic treatment of migraine associated with
menses. Many clinicians consider triptans to be
equally effective, but there are no comparative
studies. [Conclusion Grade III: See Conclusion Grading
Worksheet A -- Annotation #91 (Non-Steroidal
Anti-Inflammatory Drugs) in the original guideline
document)].
Naproxen sodium has been used as a preventive agent, although other
NSAIDs may also be effective. Typically, the agent
is initiated 2 to 3 days before anticipated onset
of the headache and continued through the at-risk
period.
- Triptans
There are good placebo studies supporting the use of triptans
(sumatriptan, naratriptan, frovatriptan and
zolmitriptan) for cyclic prophylaxis [High
Quality Evidence], [Low Quality
Evidence].
- Consider Hormone Prophylaxis
Recommendations:
- Clinicians may consider hormone prophylaxis treatment for patients
with menstrual-associated migraines.
- Transdermal Estradiol
Estrogen levels decrease during the late luteal phase of the
menstrual cycle, likely triggering migraine. Estrogen
replacement prior to menstruation has been used to
prevent migraine.
Estradiol patches, 50-100 µg, are applied 48 hours prior to
expected onset of migraine and used for one week.
[Low Quality Evidence]
- Estrogen-Containing Contraceptives
Estrogen-containing contraceptives have a variable effect on
migraines, causing worsening of headaches in some
patients, improvement of headaches in a small
percentage of patients, and no change in migraines
in other patients. The guideline developers are
not aware of any population-based studies on this topic.
[Low Quality Evidence]
In a contraceptive containing drospirenone, an extended 168-day
placebo-free oral contraceptive regimen showed a
significant decrease in duration, severity of
headaches, and loss of function due to headache
compared with a standard 21/7 oral contraceptive cycle
[Low Quality Evidence]. In 2011, the Food and
Drug Administration concluded that drospirenone
may be associated with a higher risk for blood
clots than other progestin-containing pills (http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm ).
- Gonadotropin-Releasing Hormone (GnRH) Agonists with "Add
Back" Therapy
For patients with severe menstrual migraine unrelieved by other
therapies, suppression of the menstrual cycle with a
gonadotropin-releasing hormone agonist and "add
back" therapy may be effective.
Tamoxifen, danazol and bromocriptine have shown limited efficacy in
treatment of menstrual migraine.
Whether oophorectomy is an effective treatment for refractory
migraines is not settled at this time.
[Low Quality Evidence]
Perimenopausal or
Menopausal Migraine Algorithm Annotations
- Perimenopausal or Menopausal with Active Migraine History
and Is a Potential Candidate for Hormone Therapy
Recommendation:
- Clinicians should not prescribe hormone therapy for perimenopausal
or menopausal migraine treatment in patients who
are pregnant or have unexplained bleeding.
Menopause is the permanent cessation of menses.
Perimenopause is the span of time from the reproductive to the
post-reproductive interval.
Hormone therapy may worsen, improve, or leave migraines
unchanged.
[Low Quality Evidence], [High Quality Evidence]
Women with these conditions are not candidates for hormone
therapy:
- Pregnancy or unexplained bleeding: these are temporary but
absolute contraindications to hormone therapy.
- Past history of breast cancer or endometrial cancer: while usually
considered contraindications to hormone therapy,
short-term use for severe menopausal symptoms may
be considered with proper precautions.
- Hormone Therapy
- Transdermal, transvaginal or oral estrogen
- Progestin if indicated
- Estrogen-containing contraceptives
[Low Quality Evidence]
- Successful?
Successful is commonly defined as a 50% reduction in frequency in
headache days and/or severity of headaches.
On
Estrogen-Containing Contraceptives or Considering Estrogen-Containing
Contraceptives with Migraine Algorithm
Annotations
- On Estrogen-Containing Contraceptives or Considering
Estrogen-Containing Contraceptives with Migraine
Migraine patients who do not have absolute contraindications to
estrogen-containing contraceptives should consider that
estrogen-containing contraceptives may have unpredictable
effects on the severity and/or frequency of headaches.
In addition, evidence exists that the risk of ischemic
stroke increases for migraineurs taking
estrogen-containing contraceptives [Guideline],
[Low Quality Evidence].
- Evaluate Vascular Risk Factors
Recommendation:
- Clinicians should evaluate for vascular risk factors before
prescribing estrogen containing contraceptives
for treatment of
migraine.
- Risk factors for coronary artery disease
- Prior thromboembolic disease
- Migraine aura
- Smoking
Women who have migraine with an aura probably have significantly
increased ischemic stroke risk if estrogen-containing
contraceptives are used. This risk probably increases
with age as baseline stroke rates increase, so that the
increased risk may be acceptable to the younger patient
(i.e., under age 30), but not to the older patient. It is
probably too simplistic to say that no patient with migraine
with aura should use estrogen-containing contraceptives.
The decision should be individualized and should be made
with the patient.
It appears reasonable that women who have prolonged migraine auras
(certainly those beyond 60 minutes), multiple aura
symptoms, or less common aura symptoms (i.e., dysphasia,
hemiparesis) should be strongly discouraged from using
estrogen-containing contraceptives.
Patients who develop a migraine aura for the first time while using
estrogen-containing contraceptives, or whose
previous typical migraine aura becomes more
prolonged or complex, should discontinue
estrogen-containing contraceptives.
Use of oral contraceptives in patients with a history of migraine
increases the risk of stroke [Conclusion Grade
II: See Conclusion Grading Worksheet B -
Annotation #111 (Risk of Stroke) in the original
guideline document]
Women with migraine aura who smoke and are hypertensive further
increase their risk. Additional risk is also noted if they are
taking estrogen-containing contraceptives.
Migraine Prophylactic
Treatment Algorithm Annotations
- Prophylactic Treatment
Recommendation:
- Clinicians may prescribe prophylactic treatment for patients
with migraine history after realistic goals and
expectations have been established with the
patient.
- Criteria for Prophylactic Treatment
- Three or more severe migraine attacks per month that fail to
respond adequately to symptomatic therapy.
- Less frequent but protracted attacks that impair the patient's
quality of life.
- Patient is interested in prophylactic treatment.
- Prophylactic Therapy
Prior to instituting prophylactic therapy for migraine, it is
imperative that realistic goals and expectations be
established. Patients should have a clear
understanding that the goals of preventative
therapy are to:
- Decrease migraine attack frequency by 50% or more
- Decrease pain and disability with each individual attack
- Enhance response to acute, specific, anti-migraine therapy
One or more of these goals may be achieved.
- Medications
The choice of prophylactic agent depends upon:
- Side effect profile
- Comorbid conditions
- Medication interactions
- Evidence-based efficacy
- Patient preference (weight loss or gain)
Patients should also understand that there is usually a latency of
at least 3 to 6 weeks between the initiation of
medication and recognizable efficacy. Often, an 8-
to 12-week trial is necessary, allowing an
adequate period for drug titration to a dosage likely to
attain efficacy. It is also not uncommon for initial
side effects to subside after continued therapy,
and patients should be made aware of this so as to avoid
premature discontinuation of a potentially effective
medication.
The choice of prophylactic medication should be individualized
according to the side effect profile, the presence of
comorbid conditions, and risk of medication
interactions. For example, a tricyclic
antidepressant may be especially useful with a migraineur
with depression, while sodium valproate may be ideal
for a patient with epilepsy.
Reinforce education and lifestyle management. Refer to Annotation
#15, "Evaluate Type of Primary Headache. Initiate
Patient Education and Lifestyle
Management."
- Adolescents
As a prophylactic treatment topiramate 100 mg/day was effective in
reduction of the number of migraine headaches a
month [High Quality
Evidence].
Refer to the original guideline document for references pertaining to
the medications used in prophylactic treatment
(antiepileptics, beta-blockers, calcium channel
blockers, tricyclics).
Other Therapies
The treatment therapies listed below are in alphabetical order and do
not indicate work group preference or scientific
support.
- Acupuncture
A systematic (Cochrane) review of acupuncture in migraine
prophylaxis demonstrated that adding acupuncture to patients
getting only acute treatment for headaches reduced
the number of headaches patients had. When true
and sham acupuncture were compared, they both
reduced the number of headaches. There was no difference in
benefit between true and sham acupuncture groups
when results for all trials were pooled.
Acupuncture demonstrated slightly better outcomes and fewer
adverse effects than drugs shown to be helpful for
prophylaxis [Systematic
Review].
- Biofeedback
Various methods of biofeedback have been used as adjunctive therapy
for migraine and tension-type headaches. A
meta-analysis of 53 studies of biofeedback in
combination with relaxation for tension-type
headache demonstrated these to be more effective than
headache monitoring, placebo or relaxation,
especially in reducing headache frequency. Most of these
studies were randomized controlled trials. Effects
were most pronounced in adolescents
[Meta-analysis].
- Butterbur Root (Petasites hybridus)
An extract from the plant Petasites hybridus is effective
for migraine prevention. It should be used to
reduce severity and frequency of migraine attacks
[Guideline], [Moderate Quality Evidence],
[High Quality Evidence].
- Coenzyme Q10
In one randomized placebo-controlled trial, coenzyme Q10 was
superior to placebo for attack frequency, headache days
and days with nausea [High Quality
Evidence].
- Cognitive Behavioral Therapy
This therapy is based on the premise that anxiety and distress
aggravate an evolving migraine, and it has the
potential for helping the patient recognize
maladaptive responses that may trigger a headache
[Guideline], [Low Quality Evidence].
Psychological treatments, principally relaxation and cognitive
behavioral therapies, are effective treatments of
childhood headache [Meta-analysis/Systematic
Review].
- Feverfew
This herbal therapy is made from crushed chrysanthemum leaves. 250
µg of the active ingredient, parthenolide, is
considered necessary for therapeutic
effectiveness. Because these are herbal preparations, the
quantity of active ingredient varies with the
producer [Systematic Review], [High
Quality Evidence].
- Magnesium
Daily oral dosages of 400 to 600 mg of this salt have been shown to
be of benefit to migraineurs in European studies
[High Quality Evidence].
- Onabotulinum Toxin
Onabotulinum toxin has been approved by the Food and Drug
Administration for the treatment of chronic migraine. Since
this approach would be used by headache
specialists or others trained specifically for use
of this product, onabotulinum toxin is beyond the
scope of this discussion.
- Physical Therapy
Individuals unable to take medication or interested in other
nonpharmacological headache management, may benefit from
physical therapy including craniocervical
exercises. Craniocervical exercises designed to
correct postural faults by retraining and strengthening
craniocervical flexion, cervico-thoracic extension,
scapular retraction, thoracic extension and
normalization of lumbar lordosis have been shown to
significantly reduce tension-type and cervicogenic
headaches over a prolonged time frame [High Quality
Evidence].
- Relaxation Training
Relaxation training includes progressive muscular relaxation,
breathing exercises, and directed imagery. The goal is
to develop long-term skills rather than to treat
individual events. Repetitive sessions and
practice by the patient increase the success of these
therapies in reducing headache frequency [High
Quality Evidence].
- Riboflavin
A randomized, placebo-controlled study has found daily supplements
of 400 mg moderately effective in reducing the
frequency and severity of migraine [High
Quality Evidence].
Several additional treatment modalities are available. The
modalities listed below lack sufficient scientific support
to be recommended as therapies of proven
value.
- Cervical Manipulation
Previous studies suggested potentially high levels of risk
associated with improper application of this modality.
Although some studies report few complications,
the scientific evidence of significant benefit is
not convincing. There is well-documented evidence
of cerebral infarction and death from cervical manipulation
[Low Quality Evidence], [High
Quality Evidence]. A systematic review
demonstrates that numerous deaths have been associated with
high-velocity, short-lever thrusts of the upper spine
with rotation [Meta-analysis].
- Transcutaneous Electrical Stimulation Units
Transcutaneous electrical stimulation units for migraine or muscle
contraction headache have not been found to be more
beneficial than placebo when evaluated in a
controlled study [High Quality
Evidence].
- Continue Treatment for 6-12 Months, Then Reassess
Recommendation:
- After 6 to 12 months, a gradual taper of prophylactic migraine
treatment is recommended unless headaches become more
frequent or more severe.
- Try Different First-Line Medication or Different Drug of
Different Class
Recommendation:
- Monotherapy is recommended with dose increasing until patient
receives benefit, maximum recommended dose is reached,
or unacceptable side effects occur. If failure
with one medication, try another from the same
class.
- Try Combination of Beta-Blockers and Tricyclics
A beta-blocker and a tricyclic antidepressant may be more effective
and produce fewer side effects in combination than a
single drug at a higher dose from either
class.
Definitions:
Key conclusions (as determined by the work group) are supported by a
conclusion grading worksheet that summarizes the important
studies pertaining to the conclusion. Individual studies are
classed according to the system presented below and are
assigned a designator of +, -, or Ø to reflect the study
quality. Conclusion grades are determined by the work group
based on the following definitions:
Conclusion Grades
Grade I: The evidence consists of results from studies
of strong design for answering the question addressed. The
results are both clinically important and consistent with
minor exceptions at most. The results are free of any
significant doubts about generalizability, bias, and flaws in
research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.
Grade II: The evidence consists of results from
studies of strong design for answering the question addressed, but
there is some uncertainty attached to the conclusion because
of inconsistencies among the results from the studies or
because of minor doubts about generalizability, bias, research
design flaws, or adequacy of sample size. Alternatively, the
evidence consists solely of results from weaker designs for
the question addressed, but the results have been confirmed in
separate studies and are consistent with minor exceptions at
most.
Grade III: The evidence consists of results from
studies of strong design for answering the question addressed, but
there is substantial uncertainty attached to the conclusion
because of inconsistencies among the results of different
studies or because of serious doubts about generalizability,
bias, research design flaws, or adequacy of sample size.
Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the
question addressed.
Grade Not Assignable: There is no evidence available
that directly supports or refutes the conclusion.
Study Quality Designations
The symbols +, -, Ø and N/A found on the conclusion grading worksheets
are used to designate the quality of the primary research
reports and systematic reviews:
+: indicates that the report or review has clearly
addressed issues of inclusion/exclusion, bias, generalizability,
and data collection and analysis.
-: indicates that these issues (inclusion/exclusion,
bias, generalizability, and data collection and analysis) have
not been adequately addressed.
Ø: indicates that the report or review is neither
exceptionally strong nor exceptionally weak.
N/A: indicates that the report is not a primary
reference or a systematic review and therefore the quality has not
been assessed.
Following a review of several evidence rating and recommendation
writing systems, the Institute for Clinical System Improvement (ICSI)
has made a decision to transition to the Grading of
Recommendations Assessment, Development and Evaluation (GRADE)
system.
Crosswalk between ICSI Evidence Grading System and
GRADE
| ICSI GRADE System |
Previous ICSI System |
| |
| High, if no limitation |
Class A: |
Randomized, controlled trial |
| |
| Low |
Class B: |
[observational] |
| |
Cohort study |
| |
| |
Class C: |
[observational] |
| |
Non-randomized trial with concurrent or historical
controls |
| Low |
|
Case-control study |
| Low |
|
Population-based descriptive study |
| *Low |
|
Study of sensitivity and specificity of a
diagnostic test |
| *Following individual study review, may
be elevated to Moderate or High depending
upon study design |
| |
| |
Class D: |
[observational] |
| Low |
|
Cross-sectional study |
| |
|
Case series |
| |
Case report |
| |
| Meta-analysis |
Class M: |
Meta-analysis |
| Systematic Review |
|
Systematic review |
| Decision Analysis |
|
Decision analysis |
| Cost-Effectiveness Analysis |
|
Cost-effectiveness analysis |
| |
| Low |
Class R: |
Consensus statement |
| Low |
|
Consensus report |
| Low |
|
Narrative review |
| |
| Guideline |
Class R: |
Guideline |
| |
| Low |
Class X: |
Medical opinion |
Evidence Definitions
High Quality Evidence = Further research is very
unlikely to change confidence in the estimate of effect.
Moderate Quality Evidence = Further research is likely
to have an important impact on confidence in the estimate of
effect and may change the estimate.
Low Quality Evidence = Further research is very likely
to have an important impact on confidence in the estimate of
effect and is likely to change the estimate or any estimate of
effect is very uncertain.
In addition to evidence that is graded and used to formulate
recommendations, additional pieces of literature will be used to inform
the reader of other topics of interest. This literature is not
given an evidence grade and is instead identified as a
Reference throughout the document.
Clinical
Algorithm(s)
Detailed and annotated clinical algorithms are provided in the original
guideline document
for:
- Diagnosis and Treatment of Headache (main algorithm)
- Diagnosis
- Migraine Treatment
- Tension-Type Headache
- Cluster Headache
- Dihydroergotamine Mesylate (DHE)
- Menstrual-Associated Migraine
- Perimenopausal or Menopausal Migraine
- On Estrogen-Containing Contraceptives or Considering
Estrogen-Containing Contraceptives with Migraine
- Migraine Prophylactic Treatment
|
Identifying
Information and Availability
Bibliographic
Source(s)
| Beithon J, Gallenberg M, Johnson K, Kildahl P, Krenik J, Liebow
M, Linbo L, Myers C, Peterson S, Schmidt J,
Swanson J. Diagnosis and treatment of
headache. Bloomington (MN): Institute for Clinical
Systems Improvement (ICSI); 2013 Jan. 90 p. [140
references] |
Adaptation
Not applicable: The guideline was not adapted from another
source.
Date
Released
1998
Aug (revised 2013 Jan)
Guideline
Developer(s)
Institute
for Clinical Systems Improvement - Nonprofit
Organization
Guideline
Developer Comment
The Institute for Clinical Systems Improvement (ICSI) is comprised of
50+ medical group and hospital members representing 9,000
physicians in Minnesota and surrounding areas, and is
sponsored by five nonprofit health plans. For a list of
sponsors and participating organizations, see the ICSI
Web site .
Source(s)
of Funding
- The Institute for Clinical Systems Improvement (ICSI) provided the
funding for this guideline. The annual dues of the member
medical groups and sponsoring health plans fund ICSI's
work. Individuals on the work group are not paid by
ICSI, but are supported by their medical group for this
work.
- ICSI facilitates and coordinates the guideline development and
revision process. ICSI, member medical groups, and sponsoring
health plans review and provide feedback but do not have
editorial control over the work group. All
recommendations are based on the work group's
independent evaluation of the evidence.
Guideline
Committee
Committee on Evidence-Based Practice
Composition
of Group That Authored the Guideline
Work Group Members: John Beithon, MD (Work Group
Leader) (Lakeview Clinic) (Family Medicine); Jane Schmidt, NP
(Affiliated Community Medical Center) (Nursing); Pamela Kildahl, RPh
(HealthPartners Medical Group and Regions Hospital)
(Pharmacy); Julie Krenik, MD (Hutchinson Medical Center)
(Family Medicine); Mary Gallenberg, MD (Mayo Clinic)
(Gynecology); Mark Liebow, MD (Mayo Clinic) (Internal
Medicine); Linda Linbo, RN (Mayo Clinic) (Nursing); Jerry Swanson,
MD (Mayo Clinic) (Neurology); Steven Peterson, PT (OSI
Physical Therapy) (Physical Therapy); Kari Johnson, RN
(Institute for Clinical Systems Improvement [ICSI])
(Facilitator); Cassie Myers (ICSI) (Facilitator)
Financial
Disclosures/Conflicts of Interest
The Institute for Clinical Systems Improvement (ICSI) has long had a
policy of transparency in declaring potential conflicting and
competing interests of all individuals who participate in the
development, revision and approval of ICSI guidelines and
protocols.
In 2010, the ICSI Conflict of Interest Review Committee was established
by the Board of Directors to review all disclosures and make
recommendations to the board when steps should be taken to
mitigate potential conflicts of interest, including
recommendations regarding removal of work group members. This
committee has adopted the Institute of Medicine Conflict of
Interest standards as outlined in the report Clinical Practice
Guidelines We Can Trust (2011).
Where there are work group members with identified potential conflicts,
these are disclosed and discussed at the initial work group
meeting. These members are expected to recuse themselves from
related discussions or authorship of related recommendations,
as directed by the Conflict of Interest committee or requested
by the work group.
The complete ICSI policy regarding Conflicts of Interest is available
at the ICSI
Web site .
Disclosure of Potential Conflicts of Interest
John Beithon, MD (Work Group Leader)
Physician,
Family Medicine, Lakeview Clinic
National, Regional, Local
Committee Affiliations: None
Guideline Related Activities:
None
Research Grants: None
Financial/Non-Financial
Conflicts of Interest: Spouse owns Pfizer stock from
employer
Mary Gallenberg, MD (Work Group Member)
Physician,
Gynecology, Mayo Clinic
National, Regional, Local Committee
Affiliations: None
Guideline Related Activities:
None
Research Grants: None
Financial/Non-Financial
Conflicts of Interest: None
Pamela Kildahl, RPh (Work Group Member)
Pharmacist,
HealthPartners Medical Group and Regions Hospital
National, Regional, Local Committee Affiliations: None
Guideline Related Activities: None
Research Grants:
None
Financial/Non-Financial Conflicts of Interest:
None
Julie Krenik, MD (Work Group Member)
Medical
Director, Family Medicine, Hutchinson Medical Center
National,
Regional, Local Committee Affiliations: None
Guideline Related
Activities: None
Research Grants:
None
Financial/Non-Financial Conflicts of Interest:
None
Mark Liebow, MD (Work Group Member)
Medical
Consultant, Internal Medicine, Mayo Clinic
National, Regional,
Local Committee Affiliations: Employer receives program
support from a National Institutes of Health grant for ovarian
cancer research. Mark is also a chair for senate district 26
DFL Government Council, and a member of the American College
of Physicians, MN Chapter
Guideline Related Activities:
None
Research Grants: None
Financial/Non-Financial
Conflicts of Interest: None
Linda Linbo, RN (Work Group Member)
Neurology, Mayo
Clinic
National, Regional, Local Committee Affiliations:
None
Guideline Related Activities: None
Research Grants:
None
Financial/Non-Financial Conflicts of Interest:
None
Steven Peterson, PT (Work Group Member)
Clinic
Manager, Physical Therapy, OSI Physical Therapy
National,
Regional, Local Committee Affiliations: None
Guideline
Related Activities: ICSI Adult Acute and Subacute Low Back
Pain Guideline Work Group
Research Grants:
None
Financial/Non-Financial Conflicts of Interest: None
Jane Schmidt, NP (Work Group Member)
Nurse
Practitioner, Family Medicine, Affiliated Community Medical Center
National, Regional, Local Committee Affiliations:
None
Guideline Related Activities: None
Research Grants:
None
Financial/Non-Financial Conflicts of Interest:
None
Jerry Swanson, MD (Work Group Member)
Consultant
and Chair of Headache Division, Neurology, Mayo
Clinic
National, Regional, Local Committee Affiliations:
None
Guideline Related Activities: None
Research Grants:
None
Financial/Non-Financial Conflicts of Interest:
Receives compensation from UpToDate as a headache document
editor
Guideline
Status
This is the current release of the guideline.
This guideline updates a previous version: Institute for Clinical
Systems Improvement (ICSI). Diagnosis and treatment of headache.
Bloomington (MN): Institute for Clinical Systems Improvement
(ICSI); 2011 Jan. 84 p.
Availability
of Companion Documents
NGC
Status
This NGC summary was completed by ECRI on February 5, 2003. The
information was verified by the guideline developer on February 20,
2003. This summary was updated by ECRI on April 16, 2004 and
January 25, 2005. This summary was updated on April 15, 2005
following the withdrawal of Bextra (valdecoxib) from the
market and the release of heightened warnings for Celebrex
(celecoxib) and other nonselective nonsteroidal
anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI
on June 16, 2005, following the U.S. Food and Drug
Administration advisory on COX-2 selective and non-selective
non-steroidal anti-inflammatory drugs (NSAIDs). This summary was
updated on February 10, 2006. This summary was updated by ECRI on
August 29, 2006, following the U.S. Food and Drug
Administration advisory on Triptans, SSRIs, and SNRIs. This summary
was updated by ECRI Institute on May 17, 2007 following the
U.S. Food and Drug Administration (FDA) advisory on
Gadolinium-based contrast agents. This summary was updated by
ECRI Institute on June 20, 2007 following the U.S. Food and
Drug Administration (FDA) advisory on gadolinium-based contrast
agents. This NGC summary was updated by ECRI Institute on September
25, 2007. This summary was updated by ECRI Institute on
November 9, 2007, following the U.S. Food and Drug Administration
advisory on Antidepressant drugs. This summary was updated by
ECRI Institute on April 1, 2009 following the FDA advisory on
Reglan (metoclopramide). This summary was updated by ECRI
Institute on September 16, 2009. This summary was updated by
ECRI Institute on January 8, 2010 following the U.S. Food and Drug
Administration advisory on Valproate sodium. This summary was
updated by ECRI Institute on January 13, 2011 following the
U.S. Food and Drug Administration (FDA) advisory on
gadolinium-based contrast agents. This summary was updated by
ECRI Institute on May 18, 2011. This NGC summary was updated
by ECRI Institute on April 18, 2013. This summary was updated
by ECRI Institute on July 10, 2013 following the U.S. Food and Drug
Administration advisory on Valproate. This summary was updated
by ECRI Institute on October 28, 2013 following the U.S. Food
and Drug Administration advisory on
Acetaminophen.
Copyright
Statement
This NGC summary (abstracted Institute for Clinical Systems Improvement
[ICSI] Guideline) is based on the original guideline, which is
subject to the guideline developer's copyright
restrictions.
The abstracted ICSI Guidelines contained in this Web site may be
downloaded by any individual or organization. If the abstracted ICSI
Guidelines are downloaded by an individual, the individual may
not distribute copies to third parties.
If the abstracted ICSI Guidelines are downloaded by an organization,
copies may be distributed to the organization's employees but may
not be distributed outside of the organization without the
prior written consent of the Institute for Clinical Systems
Improvement, Inc.
All other copyright rights in the abstracted ICSI Guidelines are
reserved by the Institute for Clinical Systems Improvement, Inc. The
Institute for Clinical Systems Improvement, Inc. assumes no
liability for any adaptations or revisions or modifications
made to the abstracts of the ICSI Guidelines.
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