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Migraine and Tension Headache Diagnosis and Treatment Guideline 1
Copyright © 1999–2013 Group Health Cooperative. All rights reserved.
Migraine and Tension Headache
Diagnosis and Treatment Guideline
Diagnosis 2
Treatment
Migraine Headaches 4
Medication Overuse Headaches 7
Migraine Prophylaxis 8
Monitoring/Follow-up 11
Evidence Summary 12
References 13
Guideline Development Process and Team 15
Appendix 1. Dihydroergotamine Mesylate (DHE) Raskin Protocol (Urgent Care) 16
Last guideline approval: June 2011
Guidelines are systematically developed statements to assist patients and providers in choosing appropriate health
care for specific clinical conditions. While guidelines are useful aids to assist providers in determining appropriate
practices for many patients with specific clinical problems or prevention issues, guidelines are not meant to replace
the clinical judgment of the individual provider or establish a standard of care. The recommendations contained in the
guidelines may not be appropriate for use in all circumstances. The inclusion of a recommendation in a guideline
does not imply coverage. A decision to adopt any particular recommendation must be made by the provider in light of
the circumstances presented by the individual patient.
Migraine and Tension Headache Diagnosis and Treatment Guideline 2
Diagnosis: Headache Classification
Table 1. Identification of headache type: migraine, tension, or cluster
Migraine Tension Cluster
Location Unilateral Bilateral Supraorbital/temporal
Pain intensity 1
Moderate to severe Mild to moderate Severe
Duration 4–72 hours 30 minutes to 7 days 15–180 minutes
Characterization of pain Pulsing Pressure/squeezing Boring/stabbing
Sensitivity to light/sound One or both may be
present.
Both are absent or
only one is present.
No
Nausea/vomiting One or both may be
present.
No One or both may be
present.
Aggravated by routine
activity
Yes No No
Aura May be present No No
Associated symptoms None None Miosis, ptosis, rhinorrhea
1
Pain intensity
• Mild—Patient is aware of a headache, but is able to continue daily routine with minimum alterations.
• Moderate—The headache inhibits daily activities, but is not incapacitating.
• Severe—The headache is incapacitating.
Migraine and Tension Headache Diagnosis and Treatment Guideline 3
Alternative Diagnoses to Consider
For patients with a rapidly accelerating course, a recent history of head injury, or focal neurologic findings,
consult with a neurologist or neurosurgeon.
Table 2. Warning signs for possible disorders other than primary headache
Signs/symptoms Alternative diagnoses Testing/investigation
Subacute and/or progressive
headaches that worsen over time
(weeks to months)
Intracranial head lesion
• Tumor
• Subdural hematoma
• Hydrocephalus (acute or obstructive)
• MRI with or without contrast
Vasculopathy
• Subarachnoid hemorrhage
• Venous sinus thrombosis
• Carotid dissection
Infection
• Bacterial meningitis
• A new or different headache in
patients with established
headache disorders
• Statement by the patient that
“This is the worst headache of
my life.”
• Headache of sudden onset
(e.g., like a thunder clap) Structural defect
•Spontaneous cerebral spinal fluid leak
• CT scan without contrast
• If there is no evidence of
subarachnoid hemorrhage, a
lumbar puncture should be
performed.
• If both tests are normal and
suspicion is still high, order an
MRI with or without contrast (i.e.,
gadolinium).
• Discuss next steps with
Neurology.
• Red eye
• Halos
• Unilateral visual symptoms
Angle closure glaucoma Acute angle closure glaucoma is an
ophthalmological emergency.
Age 50 or older and symptoms
including:
• Polymyalgia rheumatica
• Jaw claudication
• Scalp tenderness
• Fever
• Firm, nodular temporal arteries
• Decreased temporal pulses
Giant cell arteritis • Elevated sedimentation rate
• C-reactive protein
• Consider brain imaging if
associated with focal neurologic
findings.
1
• Discuss next steps with
rheumatology
Rhinosinusitis symptoms lasting
7 days or longer and any of the
following:
• Yellow-green or blood-tinged
nasal discharge
• Pain, pressure, and fullness in
cheeks, brow, or forehead,
especially unilateral
• Unilateral maxillary sinus
tenderness
• Worsening symptoms after initial
improvement
• Fever
• Sore throat
• Cough
• Fatigue
• Achy feeling in upper teeth
Acute bacterial rhinosinusitis • Non-contrast CT is indicated in
patients with clinical signs or
symptoms of complicated acute
bacterial rhinosinusitis, including:
diminished visual acuity,
diplopia, periorbital edema,
severe headache, or altered
mental status.
• Non-contrast CT may also be
helpful in recurrent or treatment-
resistant sinusitis to help identify
anatomic blockage of the
ostiomeatal complex.
• Jaw soreness
• Pain radiating from the jaw
• Waking with headache
• Ear pain
• Hyperacusis
• Tinnitus
• Palpable or audible joint click as
the jaw is opened and closed
Temporomandibular joint (TMJ)
disorder
• History
• Exam
• Consider dental referral.
• Consider bite splint/night guard.
1
In most cases a non-contrast CT is the best initial test. Contrast-enhanced CT or MRI might be appropriate in
persons with a rapidly accelerating course, a recent history of head injury, or focal neurologic findings.
Migraine and Tension Headache Diagnosis and Treatment Guideline 4
Treatment: Migraine Headaches
Goals
Develop a written headache treatment plan for prevention and management of acute migraine to:
• Decrease headache frequency. (Aim for fewer than 5 headache days per month.)
• Decrease headache severity. (Headaches will respond quickly to an abortive therapy.)
• Avoid medication/caffeine overuse headache. (See Treatment: Medication Overuse Headaches.)
• Within Group Health, consider using the .pidxmigraine SmartPhrase in Epic to document the
headache treatment plan for the After Visit Summary.
Lifestyle Modifications/Non-Pharmacologic Options
Provide self-management education. Teach and encourage patients to:
• Maintain a healthy lifestyle. Develop an action plan to address:
- Proper nutrition
- Regular physical activity
- Adequate sleep
- Stress reduction strategies
• Identify and avoid triggers (e.g., tobacco smoke, strong odors, or sprays).
• Address workplace ergonomics. (Attention to workplace ergonomics and instruction in self-care of
neck tension can have a dramatic effect on headache frequency.)
Pharmacologic Options
• The choice of acute migraine treatments should be dictated by the rapidity of onset, headache
severity, associated symptoms (e.g., nausea/vomiting), and patient preference.
• Rule out rebound syndrome prior to initiating therapy. If rebound is present, prevention and acute
migraine medications may not be effective.
• Before considering a patient to have failed treatment with a given migraine prevention medication,
advance to the maximum recommended dose.
• If a patient doesn’t respond to 1–2 adequate doses of a given medication during a migraine
episode, it is appropriate to try another medication.
• Individuals may respond differently to different triptans. If patient does not respond to one triptan,
offer an alternative triptan.
For information on side effects, contraindications, formulary status (e.g., prior authorization), and other
pharmacy-related issues, see the Group Health Formulary online:
Migraine and Tension Headache Diagnosis and Treatment Guideline 5
Table 3. Pharmacologic options for acute treatment of headache
Eligible population Medication 1
Initial dose Maximum dose
Aspirin 1000 mg PO once. Give an
additional 1000 mg if needed.
4000 mg daily.
Do not exceed 3 days of use per
week.
Ibuprofen 400 mg PO once.
Give an additional 200–
400 mg if needed.
1200 mg daily.
Do not exceed 3 days of use per
week.
Acetaminophen/
aspirin/caffeine
500 mg (aspirin component)
PO once.
Give an additional 500 mg if
needed.
4000 mg daily.
Do not exceed 3 days of use per
week.
Patients with mild to
moderate headache
Naproxen 500–750 mg PO once.
Give an additional 250–
500 mg if needed.
1250 mg daily.
Do not exceed 3 days of use per
week.
Oral tablet
25–100 mg PO once.
May repeat after 2 hours.
Oral tablet
200 mg daily
Nasal [PA]
5–20 mg spray in one nostril
once. May repeat after
2 hours.
Nasal
40 mg daily
Sumatriptan
2,3
SQ [PA]
6 mg SQ once. May
repeat after 1 hour.
SQ
12 mg daily
Rizatriptan
2,3,4
5–10 mg PO once. May
repeat after 2 hours.
30 mg daily
Naratriptan
2,3,5
1–2.5 mg PO once. May
repeat after 4 hours.
5 mg daily
Nasal
1 spray (0.5 mg) each nostril.
May repeat after 15 minutes.
Nasal
2 mg daily (4 sprays); 4 mg/week
(8 sprays)
Dihydroergotamine
mesylate (DHE)
3,6
SQ/IM
1 mg (1 mL) SQ/IM once.
May repeat after 1 hour.
SQ/IM
3 mg daily;
6 mg/week
IM
60 mg
IM
120 mg daily
Patients with:
Moderate to severe
headache
or
Mild to severe
headache with nausea
or vomiting
or
Rapid progression to
severe headache
or
Mild to moderate
headache that
responds poorly to
first-line treatment
Ketorolac
7
IV
30 mg
IV
120 mg daily
1
If the patient is experiencing nausea, consider adding an antiemetic such as metoclopramide or
prochlorperazine.
2
If using two different formulations of a triptan, use no more than two doses combined in 24 hours. Do not
exceed 3 days of use per week.
3
Do not take triptans within 24 hours of any ergotamine or vice versa.
4
Use a 5 mg dose of rizatriptan in patients receiving propranolol with a maximum of 15 mg daily.
5
Naratriptan has a longer half-life than other triptans and therefore may be better for those patients with
headaches of long duration.
6
Some patients may benefit from DHE IV. This treatment option may be offered to patients in urgent care
settings. See Appendix 1, DHE Raskin Protocol (Urgent Care).
7
For patients under 110 lbs or aged 65 years or over: IM dose = 30 mg, IV dose = 15 mg.
Migraine and Tension Headache Diagnosis and Treatment Guideline 6
Additional pharmacologic acute treatment options: There is insufficient evidence pertaining to safety
and effectiveness to support a recommendation for or against the use of the following medications. When
the options above have failed to provide relief, local expert opinion favors consideration of the following
agents:
• Corticosteroids (60 mg PO initially, then 5 mg less per day over 12 days).
• IV valproic acid (500 mg IV x 1). FDA safety alert: Valproic acid is pregnancy category X when
used for headaches (category D for more serious conditions such as seizures and bipolar disorder).
It is therefore contraindicated in women who are pregnant or may become pregnant. It should be
used in women of childbearing age only after shared decision making of the potential risks, and
only if contraception is used regularly.
Not recommended: The following pharmacologic options are not recommended/not on the Group
Health formulary due to the high potential for the development of medication overuse headaches.
Consider virtual or phone consultation with a neurologist to discuss next steps.
• Opioid medications
• Fiorinal (butalbital, caffeine, and aspirin)
Migraine and Tension Headache Diagnosis and Treatment Guideline 7
Treatment: Medication Overuse Headaches
• Medication overuse headache is a state of daily or near-daily refractory headaches resulting from
overuse of acute pain medicines by a patient with migraine.
• Potential triggers include over-the-counter or prescribed symptomatic medications (all narcotics,
analgesics, triptans, DHE, benzodiazepines, or decongestants) and caffeine in more than moderate
amounts.
• It is imperative that this condition be eliminated in order to allow prevention and acute migraine
treatments to work.
Treatment Overview
1. Provide patient education.
2. Stop overused medication. (Tapering may be required—see the Chronic Opioid Therapy for
Chronic Non-Cancer Pain Guideline or the Adult Drug Misuse & Withdrawal Guideline.)
3. Treat symptoms during withdrawal of overused medication. (See Table 4.)
4. Develop a written headache treatment plan that includes acute and prophylactic treatment. Within
Group Health, consider using the .pidxheadachemedoveruse SmartPhrase in Epic to document
the treatment plan for the After Visit Summary.
5. Develop a follow-up and relapse prevention plan. (See Monitoring/Follow-up section.)
Table 4. Symptomatic outpatient treatment for medication overuse headache 1
Eligible population Line Medication Initial dose Maximum dose
1st
Stop overused medication. Advise patient that rebound headache may
take 2–6 weeks to resolve after elimination of medication overuse.
2nd
Prednisone 60 mg on days 1 and 2
40 mg on days 3 and 4
20 mg on days 5 and 6
or
60 mg PO with a 5 mg
per day taper over
12 days
—
Patients with:
Headache 15 or more
days/month
Regular overuse for
more than 3 months of
one or more
acute/symptomatic
treatments:
• Ergotamine, triptan,
opioids, or
combination analgesic
medications on
10 or more
days/month
• Simple analgesic or
any combination of
ergotamine, triptans,
or analgesic opioids
on 15 or more
days/month
Headache developed or
markedly worsened
during medication
overuse
3rd
Dihydroergotamine
mesylate (DHE) SQ/IM
1 mg SQ/IM at the first
sign of headache, then
repeat hourly up to total
of 3 mg
3 mg daily;
6 mg/week
Migraine and Tension Headache Diagnosis and Treatment Guideline 8
Treatment: Migraine Prophylaxis
Overview
There are no clear evidence-based recommendations for when to start preventive therapy for migraine.
The choice of migraine prevention medication should be made based on comorbid conditions (e.g.,
tricyclics for patients with depression and/or neuropathic pain syndromes, valproic acid/divalproex for
persons with seizure disorders) and the relative value the patient places on efficacy versus avoidance of
side effects.
Pharmacologic Options
Guiding principles of prophylaxis
• Each medication dose change may take 2–4 weeks to reach maximal effectiveness.
• Using 4 headache days per month as a goal, the initial dose of each medication should be fairly
low, and gradually increased to the maximal tolerated or maximal safe dose. Keep medication at
that dose for 1 month before making modifications to therapy.
• If there is no relief after 4 weeks at the maximal recommended or tolerated dose of the initial
medication, add a second prophylactic medication.
• When headache days remain fewer than 4 per month for 1 to 2 months, start tapering therapy of
the least well-tolerated medication to find the lowest effective dose.
• Patients not responding to combinations of two or three prophylactic medications should be
reassessed for an alternate diagnosis, analgesic or acute migraine drug rebound, or confounding
psychiatric or social stresses. Drug therapy alone may not be sufficient.
Migraine and Tension Headache Diagnosis and Treatment Guideline 9
Table 5a. Pharmacologic options for migraine prophylaxis 1
Eligible population Line Medication Initial dose Maximum
daily dose
Patients with:
Four or more days with
migraine headaches per
month
Fewer than four migraine
headaches per month but
with severe pain refractory
to all migraine-specific
acute therapies
Complicated migraines
(e.g., migraine associated
with focal neurologic signs
such as nystagmus or
hemiplegia)
1
st
Propranolol
2
40 mg b.i.d.; increase by
40 mg every week (in 3
divided doses).
240 mg
2nd
Nortriptyline 3
10–25 mg daily at bedtime;
increase by 10–25 mg every
week.
150 mg
3rd
Venlafaxine IR 37.5 mg daily; increase by
75 mg every week (in 2
divided doses).
150 mg
Topiramate 4,5
25 mg daily in the evening;
increase by 25 mg every
week (in 2 divided doses).
100 mg
Divalproex DR 6
125 mg twice daily; increase
by 125 mg every week (in
2 divided doses).
2,000 mg
FDA safety alert: Divalproex is pregnancy category X when used
for headaches (category D for more serious conditions such as
seizures and bipolar disorder). It is therefore contraindicated in
women who are pregnant or may become pregnant. It should be
used in women of childbearing age only after shared decision
making of the potential risks, and only if contraception is used
regularly.
1
Gabapentin is not FDA-approved for the prophylaxis of migraine headache. There is insufficient evidence to
determine the safety and efficacy of gabapentin for the prophylaxis of migraines.
2
The best evidence favors propranolol. Efficacy is less certain with other beta-blockers.
3
Other tricyclics may be as effective (e.g., amitryptiline).
4
Check serum bicarbonate after 2 weeks of therapy and every 3 months.
5
Within Group Health, see Anticonvulsant/Contraceptive Drug-Drug Interactions information for patients on
oral contraceptives, at http://incontext.ghc.org/rx/med/documents/anticonvulsant_contraceptive_ddi.pdf.
6
Check trough level, CBC, platelets, and SGOT at 500 mg twice daily. Don't exceed trough level of
100 mcg/dL. Divalproex XR is non-formulary.
Note: Consider Neurology consultation for patients with migraine headache who have not responded to
the recommended options for migraine prophylaxis. OnabotulinumtoxinA (Botox) may be an option for
patients who meet all the following criteria:
• Meet diagnostic criteria for migraine or migraine with muscle tension headache.
• Patients will do what is necessary to eliminate rebound headache prior to authorization for Botox.
• Patient has tried and failed at least four prophylactic agents and three abortive drugs listed in the
Headache Guideline.
• Patient has been seen by a neurologist who recommends the trial of Botox.
Botox is administered as a trial; if the treatment is found unhelpful after two injection sessions, then it is
discontinued. Botox is approved by the FDA for chronic migraine (defined as 15 or more headache days
per month with a headache lasting 4 hours or longer each day).
There is insufficient evidence pertaining to safety and effectiveness to support a recommendation for or
against the use of the following medications for migraine prophylaxis:
• Lisinopril
• Verapamil
Migraine and Tension Headache Diagnosis and Treatment Guideline 10
Special Population: Women With Menstruation-related Migraines
Advise a woman with suspected menstrual migraine to keep a headache diary for at least 2 months to
determine if she is having regular and predictable menses and if these correlate with headache onset.
Some women experience migraines during ovulation (either alone or in addition to menses).
Consider a short course of prophylaxis with naproxen or a triptan taken twice a day starting 2–3 days
before the anticipated onset of the headache and continued for 5 days through the at-risk period (ICSI
2011, SIGN 2008).
Table 5b. Pharmacologic options for the prevention of menstrual migraine
Eligible
population
Line Medication Daily dose Timing
1st
Naproxen 500–750 mg
Sumatriptan Oral tablet
25–100 mg
Rizatriptan 1
5–10 mg
Women with
regular and
predictable
menses that
correlate with
headache
onset
2nd
Naratriptan 1–2.5 mg
2–3 days before the anticipated onset of the
headache and continuing through the at-risk period
Women with
irregular,
unpredictable
menses that
correlate with
headache
onset
or
Women for
whom
NSAIDs and
triptans are
ineffective for
prophylaxis
of menstrual
migraines
1
st
Oral
contraceptives 2
Within Group Health, see Think Preferred OCP, at
http://incontext.ghc.org/rx/med/documents/oralcontraceptive_pocketcard.pdf
CAUTION: Women with migraines with aura should avoid taking combined
oral contraceptive pills because of increased risk for stroke. Among women
with migraine, women who also had aura had a higher risk for stroke than
did those without aura. Women with a history of migraine who use
combined oral contraceptive pills are about 2–4 times as likely to have an
ischemic stroke as nonusers with a history of migraine (CDC MMWR).
1
Use a 5 mg dose of rizatriptan in patients receiving propranolol, with a maximum of 15 mg daily.
2
Combined oral contraceptive pills may be offered for prophylaxis, although the evidence for this option is limited. In a
contraceptive-containing drosperinone, an extended 168-day placebo-free oral contraceptive regimen showed a significant
decrease in duration and severity of headaches and in loss of function due to headache compared with a standard 21/7
oral contraceptive cycle (Sulak 2007).
Migraine and Tension Headache Diagnosis and Treatment Guideline 11
Non-prescription Options for Migraine Prophylaxis and Treatment
While there is some evidence supporting their use for the prevention of migraine headaches, there is
insufficient evidence to determine the long-term safety and effectiveness of the following therapies:
Table 6. Complementary and alternative therapies for migraine prophylaxis
Eligible population Medication Initial dose
Riboflavin 1
400 mg daily
Coenzyme Q10 1
100 mg t.i.d.
Patients with:
• Four or more days of headache per month
• Four or more episodes of headache per month
• Fewer than 4 headache days per month but with severe
pain refractory to all migraine-specific acute therapies Butterbur 2
75 mg daily
1
Weak evidence from a small, placebo-controlled trial.
2
Placebo-controlled RCTs suggest that a 75 mg dose of butterbur may be effective at reducing headache
frequency; however, there is insufficient evidence pertaining to the long-term safety and efficacy of butterbur.
There is insufficient evidence to make a recommendation on the safety or efficacy of the following non-
prescription therapies for migraine prophylaxis:
• Magnesium
There is insufficient evidence to make a recommendation on the safety or efficacy of the following non-
pharmacologic therapies for the treatment of migraine:
• Transcutaneous electrical stimulation (TENS)
• Massage
• Acupuncture
Monitoring/Follow-up
Advise the patient to keep and review a headache diary to monitor the effects of treatment on severity,
frequency, and disability. Diary entries should include:
• Day/time
• Headache severity
• Other symptoms (nausea, vomiting, photophobia)
• Impact on usual activities
• Duration of attack
• Prescribed medication
• OTC medication
• Menstrual cycle day
Migraine and Tension Headache Diagnosis and Treatment Guideline 12
Evidence Summary
This guideline was adapted from the following:
Scottish Intercollegiate Guideline Network (SIGN). Diagnosis and management of headache in adults.
Edinburgh: SIGN 2008 (SIGN publication no.107, cited May 2011). Available online at:
www.sign.ac.uk/pdf/sign107.pdf [PDF].
Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of headache. ICSI 2011
(Tenth edition, cited May 2011). Available online at:
http://www.icsi.org/headache/headache__diagnosis_and_treatment_of_2609.html [PDF].
Medication overuse headache
The evidence base for the treatment of medication overuse headache is limited.
Prednisone
Two randomized controlled trials (RCTs) evaluated the efficacy of prednisone for treatment of
medication overuse headache. Results from these trials were mixed. Results from the first trial, which
included 102 patients, suggest that compared to placebo, 60 mg of prednisone tapered down over
6 days does not reduce withdrawal headaches in patients with medication overuse headache (Bøe
2007). Results from the second trial suggest that 100 mg of prednisone given once daily for the first
5 days of withdrawal may be more effective than placebo for reducing headache severity. These
results should be interpreted with caution, as the study included only 20 patients and an ITT analysis
was not performed (Pageler 2008).
Migraine prophylaxis
Gabapentin
The Group Health Pharmacy and Therapeutics (P&T) committee recently reviewed the evidence on
the safety and efficacy of gabapentin for migraine prophylaxis and concluded that the evidence does
not support the use of gabapentin for migraine prophylaxis. The published evidence on the use of
gabapentin for migraine prophylaxis mostly revolves around one study with major flaws in study
design (e.g., unblinding) and publication bias (Mathew 2001). Additionally, other unpublished studies
found negative results.
Botulinum toxin type A
Two double-blind, placebo-controlled randomized trials evaluated the safety and efficacy of
onabotulinumtoxinA (botox) for the prevention of migraine headache in adults with chronic migraines.
In both trials, participants were given two injections of onabotulinumtoxinA 12 weeks apart. The first
trial followed 679 participants for 24 weeks. There was no significant difference in the primary
outcome frequency of headache episodes after 24 weeks. However, patients who received
onabotulinumtoxinA had significantly fewer headache days and migraine days compared to patients
who received placebo. Additionally, the mean Headache Impact Test (HIT)-6 score was significantly
lower for patients who received onabotulinumtoxinA (Aurora 2010).
The second trial followed 705 participants for 24 weeks. The primary outcome was changed during
the study. Results from this study suggest that patients who received onabotulinumtoxinA had
significantly fewer headache days (new primary outcome), migraine days, moderate to severe
headache days, headache episodes, and HIT-6 scores compared to patients who received placebo
(Diener 2010). It should be noted that both of these trials received industry funding and the treatment
was compared to placebo and not to another active prophylactic treatment. The most common
adverse events with onabotulinumtoxinA were neck pain, muscle weakness, eyelid ptosis, myalgia,
worsening migraine, and musculoskeletal stiffness (Aurora 2010, Diener 2010).
Migraine and Tension Headache Diagnosis and Treatment Guideline 13
Complementary and alternative medicine
Riboflavin
There is weak evidence from one small trial with 55 patients that riboflavin has more than a placebo
effect in migraine prophylaxis and minimal adverse effects. The study showed that patients receiving
oral riboflavin (400 mg daily for 3 months) had a significantly reduced attack frequency and had fewer
migraine days compared with those in the placebo group. The trial had a valid methodology but a
very small sample size (Schoenen 1998). Larger trials are needed to provide more evidence on the
efficacy of riboflavin in migraine prophylaxis and to compare riboflavin with other standard
prophylactic agents.
Coenzyme Q10
There is weak evidence from one recent, small (N = 43) RCT that coenzyme Q10 may be effective in
migraine prophylaxis (Sandor 2005). Larger trials with longer follow-up are needed to determine the
efficacy and safety of CoQ10 in migraine prophylaxis.
Butterbur
The best evidence on the safety and efficacy of butterbur for the prevention of migraines comes from
a placebo-controlled RCT that followed 233 subjects for 16 weeks. Results from this trial suggest that
compared to placebo, a 75 mg dose of butterbur may reduce the frequency of migraine attacks. The
long-term safety and efficacy of this medication is unknown. Additionally, the efficacy of butterbur
compared with other prophylactic medications is unknown (Lipton 2004).
Magnesium
The available literature does not provide sufficient evidence to determine the efficacy of magnesium
in migraine prophylaxis.
Acupuncture
Results from a meta-analysis of RCTs suggest that compared to acute treatment only or
pharmacological prophylaxis, acupuncture may reduce headache frequency; however, there was no
significant difference when acupuncture was compared with a sham intervention (Linde 2009).
Transcutaneous electrical stimulation (TENS)
The available literature does not provide sufficient evidence to determine the efficacy of
transcutaneous electrical stimulation for the treatment of migraine.
Massage
The available literature does not provide sufficient evidence to determine the efficacy of massage for
the treatment of migraine.
References
Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results
from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. Jul
2010;30(7):793–803.
Bøe MG, Mygland A, and Salvesen R. Prednisolone does not reduce withdrawal headache: a
randomized, double-blind study. Neurology. 2007;69:26-31.
Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use.
MMWR Early Release. 2010;59:1–86.
Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results
from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. Jul
2010;30(7):804–814.
Migraine and Tension Headache Diagnosis and Treatment Guideline 14
Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of headache (10th
edition).
January 2011. Available online at:
http://www.icsi.org/headache/headache__diagnosis_and_treatment_of_2609.html.
Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, and White AR. Acupuncture for migraine
prophylaxis. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001218. DOI:
10.1002/14651858.CD001218.pub2.
Lipton RB, Gobel H, Einhaupl KM, Wilks K, and Mauskop A. Petasites hybridus root (butterbur) is an
effective preventive treatment for migraine. Neurology. 2004;63:2240-2244.
Mathew NT, Rapoport A, Saper J, et al. Efficacy of gabapentin in migraine prophylaxis. Headache. Feb
2001;41(2):119-128.
Pageler L, Katsarava Z, Diener HC, Limmroth V. Prednisone vs. placebo in withdrawal therapy following
medication overuse headache. Cephalalgia. 2008;28:152-156.
Sandor PS, Di Clemente L, Coppola G, et al. Efficacy of coenzyme Q10 in migraine prophylaxis: a
randomized controlled trial. Neurology. Feb 22 2005;64(4):713–715.
Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. A
randomized controlled trial. Neurology. Feb 1998;50(2):466–470.
Scottish Intercollegiate Guideline Network (SIGN). Diagnosis and management of headache in adults.
Edinburg: SIGN 2008; (SIGN publication no. 107) Available online at:
http://www.sign.ac.uk/pdf/sign107.pdf.
Sulak P, Willis S, Kuehl T, Coffee A, and Clark J. Headaches and oral contraceptives:impact of
eliminating the standard 7-day placebo interval. Headache. 2007;47:27–37.
Migraine and Tension Headache Diagnosis and Treatment Guideline 15
Guideline Development Process and Team
Development Process
To develop the Migraine & Tension Headache Guideline, Group Health adapted recommendations from
externally developed evidence-based guidelines. The Group Health guideline team reviewed additional
evidence in the areas of medication overuse headache, migraine prophylaxis, and complementary and
alternative medicine. For details, see Evidence Summary and References.
This edition of the guideline was approved for publication by the Guideline Oversight Group in June 2011.
Team
The Migraine & Tension Headache Guideline development team included representatives from the
following specialties: emergency medicine, family medicine, internal medicine, neurology, nursing,
pharmacy.
Content expert: Tim Scearce, MD, Neurology
Clinician lead: David K. McCulloch, MD, Medical Director, Clinical Improvement, mcculloch.d@ghc.org
Guideline coordinator: Avra Cohen, MN, Clinical Improvement & Prevention, cohen.al@ghc.org
Beth Arnold, PharmD, Pharmacy
Patricia Auerbach, MD, Emergency Medicine
Rebecca Doheny, MPH, Epidemiologist, Clinical Improvement & Prevention
Denise Hastings, MD, Internal Medicine
Jennifer Macuiba, Clinical Improvement & Prevention
Robyn Mayfield, Health Education Specialist, Clinical Improvement & Prevention
Michelle Seelig, MD, Family Medicine
Kathy Sobon, RN, Nursing Operations
Ann Stedronsky, Clinical Publications, Clinical Improvement & Prevention
Migraine and Tension Headache Diagnosis and Treatment Guideline 16
Appendix 1. Dihydroergotamine Mesylate (DHE) Raskin Protocol (Urgent Care)
This protocol is for use with patients being treated in urgent care settings. When headache relief is
achieved, patients may be discharged and directed to follow up with primary care or return to urgent care
as needed.
Table 7. Dihydroergotamine mesylate (DHE) 1
Raskin protocol for refractory migraine headache
(urgent care settings)
Step Medication Dose
Anti-emetic
premediation 2
1 Metoclopramide 10 mg IV over 30 minutes
2 DHE test dose 0.5 mg IV over 2–3 minutesAnalgesic test
dose
Monitor/assess patient for 1 hour post–test dose.
If blood pressure is greater than 165/95 mm Hg or patient develops chest pain or
severe nausea, discontinue DHE.
If not, go to Step 3.
Metoclopramide 10 mg IV every 8 hours as needed3a
Headache persists
WITH side effects 3 DHE NO DHE for 8 hours, then repeat DHE 0.3–
0.4 mg IV every 8 hours as needed, if
tolerated, for up to 3 days.
Metoclopramide 10 mg IV every 8 hours as needed3b
Headache relief, no
side effects DHE 0.5 mg IV given if/ when headache recurs
and repeated every 8 hours as needed for
2–5 days
HOLD when administering DHE 1 hour
post–test dose
Metoclopramide
10 mg IV every 8 hours as needed, with
subsequent doses of DHE
0.5 mg IV administered 1 hour post–test
dose WITHOUT metoclopramide
THEN
If patient is nauseated: 0.75 mg IV
administered WITH metaclopramide if/
when headache recurs and repeated every
8 hours as needed for 2–5 days
Analgesic
3c
Headache persists,
no side effects
DHE
If patient is NOT nauseated: 1.0 mg IV
administered WITH metaclopramide if/
when headache recurs and repeated every
8 hours as needed for 2–5 days
1
DHE should not be given within 24 hours of a triptan.
2
Consider IV hydration if needed.
3
Common side effects include: nausea, vomiting, diarrhea, abdominal cramps, dizziness, paresthesia, and leg
pain. By reducing the dose and co-administering metoclopramide as an antiemetic, these side effects can
usually be resolved.

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Migraine and headache diag guideline group health

  • 1. Migraine and Tension Headache Diagnosis and Treatment Guideline 1 Copyright © 1999–2013 Group Health Cooperative. All rights reserved. Migraine and Tension Headache Diagnosis and Treatment Guideline Diagnosis 2 Treatment Migraine Headaches 4 Medication Overuse Headaches 7 Migraine Prophylaxis 8 Monitoring/Follow-up 11 Evidence Summary 12 References 13 Guideline Development Process and Team 15 Appendix 1. Dihydroergotamine Mesylate (DHE) Raskin Protocol (Urgent Care) 16 Last guideline approval: June 2011 Guidelines are systematically developed statements to assist patients and providers in choosing appropriate health care for specific clinical conditions. While guidelines are useful aids to assist providers in determining appropriate practices for many patients with specific clinical problems or prevention issues, guidelines are not meant to replace the clinical judgment of the individual provider or establish a standard of care. The recommendations contained in the guidelines may not be appropriate for use in all circumstances. The inclusion of a recommendation in a guideline does not imply coverage. A decision to adopt any particular recommendation must be made by the provider in light of the circumstances presented by the individual patient.
  • 2. Migraine and Tension Headache Diagnosis and Treatment Guideline 2 Diagnosis: Headache Classification Table 1. Identification of headache type: migraine, tension, or cluster Migraine Tension Cluster Location Unilateral Bilateral Supraorbital/temporal Pain intensity 1 Moderate to severe Mild to moderate Severe Duration 4–72 hours 30 minutes to 7 days 15–180 minutes Characterization of pain Pulsing Pressure/squeezing Boring/stabbing Sensitivity to light/sound One or both may be present. Both are absent or only one is present. No Nausea/vomiting One or both may be present. No One or both may be present. Aggravated by routine activity Yes No No Aura May be present No No Associated symptoms None None Miosis, ptosis, rhinorrhea 1 Pain intensity • Mild—Patient is aware of a headache, but is able to continue daily routine with minimum alterations. • Moderate—The headache inhibits daily activities, but is not incapacitating. • Severe—The headache is incapacitating.
  • 3. Migraine and Tension Headache Diagnosis and Treatment Guideline 3 Alternative Diagnoses to Consider For patients with a rapidly accelerating course, a recent history of head injury, or focal neurologic findings, consult with a neurologist or neurosurgeon. Table 2. Warning signs for possible disorders other than primary headache Signs/symptoms Alternative diagnoses Testing/investigation Subacute and/or progressive headaches that worsen over time (weeks to months) Intracranial head lesion • Tumor • Subdural hematoma • Hydrocephalus (acute or obstructive) • MRI with or without contrast Vasculopathy • Subarachnoid hemorrhage • Venous sinus thrombosis • Carotid dissection Infection • Bacterial meningitis • A new or different headache in patients with established headache disorders • Statement by the patient that “This is the worst headache of my life.” • Headache of sudden onset (e.g., like a thunder clap) Structural defect •Spontaneous cerebral spinal fluid leak • CT scan without contrast • If there is no evidence of subarachnoid hemorrhage, a lumbar puncture should be performed. • If both tests are normal and suspicion is still high, order an MRI with or without contrast (i.e., gadolinium). • Discuss next steps with Neurology. • Red eye • Halos • Unilateral visual symptoms Angle closure glaucoma Acute angle closure glaucoma is an ophthalmological emergency. Age 50 or older and symptoms including: • Polymyalgia rheumatica • Jaw claudication • Scalp tenderness • Fever • Firm, nodular temporal arteries • Decreased temporal pulses Giant cell arteritis • Elevated sedimentation rate • C-reactive protein • Consider brain imaging if associated with focal neurologic findings. 1 • Discuss next steps with rheumatology Rhinosinusitis symptoms lasting 7 days or longer and any of the following: • Yellow-green or blood-tinged nasal discharge • Pain, pressure, and fullness in cheeks, brow, or forehead, especially unilateral • Unilateral maxillary sinus tenderness • Worsening symptoms after initial improvement • Fever • Sore throat • Cough • Fatigue • Achy feeling in upper teeth Acute bacterial rhinosinusitis • Non-contrast CT is indicated in patients with clinical signs or symptoms of complicated acute bacterial rhinosinusitis, including: diminished visual acuity, diplopia, periorbital edema, severe headache, or altered mental status. • Non-contrast CT may also be helpful in recurrent or treatment- resistant sinusitis to help identify anatomic blockage of the ostiomeatal complex. • Jaw soreness • Pain radiating from the jaw • Waking with headache • Ear pain • Hyperacusis • Tinnitus • Palpable or audible joint click as the jaw is opened and closed Temporomandibular joint (TMJ) disorder • History • Exam • Consider dental referral. • Consider bite splint/night guard. 1 In most cases a non-contrast CT is the best initial test. Contrast-enhanced CT or MRI might be appropriate in persons with a rapidly accelerating course, a recent history of head injury, or focal neurologic findings.
  • 4. Migraine and Tension Headache Diagnosis and Treatment Guideline 4 Treatment: Migraine Headaches Goals Develop a written headache treatment plan for prevention and management of acute migraine to: • Decrease headache frequency. (Aim for fewer than 5 headache days per month.) • Decrease headache severity. (Headaches will respond quickly to an abortive therapy.) • Avoid medication/caffeine overuse headache. (See Treatment: Medication Overuse Headaches.) • Within Group Health, consider using the .pidxmigraine SmartPhrase in Epic to document the headache treatment plan for the After Visit Summary. Lifestyle Modifications/Non-Pharmacologic Options Provide self-management education. Teach and encourage patients to: • Maintain a healthy lifestyle. Develop an action plan to address: - Proper nutrition - Regular physical activity - Adequate sleep - Stress reduction strategies • Identify and avoid triggers (e.g., tobacco smoke, strong odors, or sprays). • Address workplace ergonomics. (Attention to workplace ergonomics and instruction in self-care of neck tension can have a dramatic effect on headache frequency.) Pharmacologic Options • The choice of acute migraine treatments should be dictated by the rapidity of onset, headache severity, associated symptoms (e.g., nausea/vomiting), and patient preference. • Rule out rebound syndrome prior to initiating therapy. If rebound is present, prevention and acute migraine medications may not be effective. • Before considering a patient to have failed treatment with a given migraine prevention medication, advance to the maximum recommended dose. • If a patient doesn’t respond to 1–2 adequate doses of a given medication during a migraine episode, it is appropriate to try another medication. • Individuals may respond differently to different triptans. If patient does not respond to one triptan, offer an alternative triptan. For information on side effects, contraindications, formulary status (e.g., prior authorization), and other pharmacy-related issues, see the Group Health Formulary online:
  • 5. Migraine and Tension Headache Diagnosis and Treatment Guideline 5 Table 3. Pharmacologic options for acute treatment of headache Eligible population Medication 1 Initial dose Maximum dose Aspirin 1000 mg PO once. Give an additional 1000 mg if needed. 4000 mg daily. Do not exceed 3 days of use per week. Ibuprofen 400 mg PO once. Give an additional 200– 400 mg if needed. 1200 mg daily. Do not exceed 3 days of use per week. Acetaminophen/ aspirin/caffeine 500 mg (aspirin component) PO once. Give an additional 500 mg if needed. 4000 mg daily. Do not exceed 3 days of use per week. Patients with mild to moderate headache Naproxen 500–750 mg PO once. Give an additional 250– 500 mg if needed. 1250 mg daily. Do not exceed 3 days of use per week. Oral tablet 25–100 mg PO once. May repeat after 2 hours. Oral tablet 200 mg daily Nasal [PA] 5–20 mg spray in one nostril once. May repeat after 2 hours. Nasal 40 mg daily Sumatriptan 2,3 SQ [PA] 6 mg SQ once. May repeat after 1 hour. SQ 12 mg daily Rizatriptan 2,3,4 5–10 mg PO once. May repeat after 2 hours. 30 mg daily Naratriptan 2,3,5 1–2.5 mg PO once. May repeat after 4 hours. 5 mg daily Nasal 1 spray (0.5 mg) each nostril. May repeat after 15 minutes. Nasal 2 mg daily (4 sprays); 4 mg/week (8 sprays) Dihydroergotamine mesylate (DHE) 3,6 SQ/IM 1 mg (1 mL) SQ/IM once. May repeat after 1 hour. SQ/IM 3 mg daily; 6 mg/week IM 60 mg IM 120 mg daily Patients with: Moderate to severe headache or Mild to severe headache with nausea or vomiting or Rapid progression to severe headache or Mild to moderate headache that responds poorly to first-line treatment Ketorolac 7 IV 30 mg IV 120 mg daily 1 If the patient is experiencing nausea, consider adding an antiemetic such as metoclopramide or prochlorperazine. 2 If using two different formulations of a triptan, use no more than two doses combined in 24 hours. Do not exceed 3 days of use per week. 3 Do not take triptans within 24 hours of any ergotamine or vice versa. 4 Use a 5 mg dose of rizatriptan in patients receiving propranolol with a maximum of 15 mg daily. 5 Naratriptan has a longer half-life than other triptans and therefore may be better for those patients with headaches of long duration. 6 Some patients may benefit from DHE IV. This treatment option may be offered to patients in urgent care settings. See Appendix 1, DHE Raskin Protocol (Urgent Care). 7 For patients under 110 lbs or aged 65 years or over: IM dose = 30 mg, IV dose = 15 mg.
  • 6. Migraine and Tension Headache Diagnosis and Treatment Guideline 6 Additional pharmacologic acute treatment options: There is insufficient evidence pertaining to safety and effectiveness to support a recommendation for or against the use of the following medications. When the options above have failed to provide relief, local expert opinion favors consideration of the following agents: • Corticosteroids (60 mg PO initially, then 5 mg less per day over 12 days). • IV valproic acid (500 mg IV x 1). FDA safety alert: Valproic acid is pregnancy category X when used for headaches (category D for more serious conditions such as seizures and bipolar disorder). It is therefore contraindicated in women who are pregnant or may become pregnant. It should be used in women of childbearing age only after shared decision making of the potential risks, and only if contraception is used regularly. Not recommended: The following pharmacologic options are not recommended/not on the Group Health formulary due to the high potential for the development of medication overuse headaches. Consider virtual or phone consultation with a neurologist to discuss next steps. • Opioid medications • Fiorinal (butalbital, caffeine, and aspirin)
  • 7. Migraine and Tension Headache Diagnosis and Treatment Guideline 7 Treatment: Medication Overuse Headaches • Medication overuse headache is a state of daily or near-daily refractory headaches resulting from overuse of acute pain medicines by a patient with migraine. • Potential triggers include over-the-counter or prescribed symptomatic medications (all narcotics, analgesics, triptans, DHE, benzodiazepines, or decongestants) and caffeine in more than moderate amounts. • It is imperative that this condition be eliminated in order to allow prevention and acute migraine treatments to work. Treatment Overview 1. Provide patient education. 2. Stop overused medication. (Tapering may be required—see the Chronic Opioid Therapy for Chronic Non-Cancer Pain Guideline or the Adult Drug Misuse & Withdrawal Guideline.) 3. Treat symptoms during withdrawal of overused medication. (See Table 4.) 4. Develop a written headache treatment plan that includes acute and prophylactic treatment. Within Group Health, consider using the .pidxheadachemedoveruse SmartPhrase in Epic to document the treatment plan for the After Visit Summary. 5. Develop a follow-up and relapse prevention plan. (See Monitoring/Follow-up section.) Table 4. Symptomatic outpatient treatment for medication overuse headache 1 Eligible population Line Medication Initial dose Maximum dose 1st Stop overused medication. Advise patient that rebound headache may take 2–6 weeks to resolve after elimination of medication overuse. 2nd Prednisone 60 mg on days 1 and 2 40 mg on days 3 and 4 20 mg on days 5 and 6 or 60 mg PO with a 5 mg per day taper over 12 days — Patients with: Headache 15 or more days/month Regular overuse for more than 3 months of one or more acute/symptomatic treatments: • Ergotamine, triptan, opioids, or combination analgesic medications on 10 or more days/month • Simple analgesic or any combination of ergotamine, triptans, or analgesic opioids on 15 or more days/month Headache developed or markedly worsened during medication overuse 3rd Dihydroergotamine mesylate (DHE) SQ/IM 1 mg SQ/IM at the first sign of headache, then repeat hourly up to total of 3 mg 3 mg daily; 6 mg/week
  • 8. Migraine and Tension Headache Diagnosis and Treatment Guideline 8 Treatment: Migraine Prophylaxis Overview There are no clear evidence-based recommendations for when to start preventive therapy for migraine. The choice of migraine prevention medication should be made based on comorbid conditions (e.g., tricyclics for patients with depression and/or neuropathic pain syndromes, valproic acid/divalproex for persons with seizure disorders) and the relative value the patient places on efficacy versus avoidance of side effects. Pharmacologic Options Guiding principles of prophylaxis • Each medication dose change may take 2–4 weeks to reach maximal effectiveness. • Using 4 headache days per month as a goal, the initial dose of each medication should be fairly low, and gradually increased to the maximal tolerated or maximal safe dose. Keep medication at that dose for 1 month before making modifications to therapy. • If there is no relief after 4 weeks at the maximal recommended or tolerated dose of the initial medication, add a second prophylactic medication. • When headache days remain fewer than 4 per month for 1 to 2 months, start tapering therapy of the least well-tolerated medication to find the lowest effective dose. • Patients not responding to combinations of two or three prophylactic medications should be reassessed for an alternate diagnosis, analgesic or acute migraine drug rebound, or confounding psychiatric or social stresses. Drug therapy alone may not be sufficient.
  • 9. Migraine and Tension Headache Diagnosis and Treatment Guideline 9 Table 5a. Pharmacologic options for migraine prophylaxis 1 Eligible population Line Medication Initial dose Maximum daily dose Patients with: Four or more days with migraine headaches per month Fewer than four migraine headaches per month but with severe pain refractory to all migraine-specific acute therapies Complicated migraines (e.g., migraine associated with focal neurologic signs such as nystagmus or hemiplegia) 1 st Propranolol 2 40 mg b.i.d.; increase by 40 mg every week (in 3 divided doses). 240 mg 2nd Nortriptyline 3 10–25 mg daily at bedtime; increase by 10–25 mg every week. 150 mg 3rd Venlafaxine IR 37.5 mg daily; increase by 75 mg every week (in 2 divided doses). 150 mg Topiramate 4,5 25 mg daily in the evening; increase by 25 mg every week (in 2 divided doses). 100 mg Divalproex DR 6 125 mg twice daily; increase by 125 mg every week (in 2 divided doses). 2,000 mg FDA safety alert: Divalproex is pregnancy category X when used for headaches (category D for more serious conditions such as seizures and bipolar disorder). It is therefore contraindicated in women who are pregnant or may become pregnant. It should be used in women of childbearing age only after shared decision making of the potential risks, and only if contraception is used regularly. 1 Gabapentin is not FDA-approved for the prophylaxis of migraine headache. There is insufficient evidence to determine the safety and efficacy of gabapentin for the prophylaxis of migraines. 2 The best evidence favors propranolol. Efficacy is less certain with other beta-blockers. 3 Other tricyclics may be as effective (e.g., amitryptiline). 4 Check serum bicarbonate after 2 weeks of therapy and every 3 months. 5 Within Group Health, see Anticonvulsant/Contraceptive Drug-Drug Interactions information for patients on oral contraceptives, at http://incontext.ghc.org/rx/med/documents/anticonvulsant_contraceptive_ddi.pdf. 6 Check trough level, CBC, platelets, and SGOT at 500 mg twice daily. Don't exceed trough level of 100 mcg/dL. Divalproex XR is non-formulary. Note: Consider Neurology consultation for patients with migraine headache who have not responded to the recommended options for migraine prophylaxis. OnabotulinumtoxinA (Botox) may be an option for patients who meet all the following criteria: • Meet diagnostic criteria for migraine or migraine with muscle tension headache. • Patients will do what is necessary to eliminate rebound headache prior to authorization for Botox. • Patient has tried and failed at least four prophylactic agents and three abortive drugs listed in the Headache Guideline. • Patient has been seen by a neurologist who recommends the trial of Botox. Botox is administered as a trial; if the treatment is found unhelpful after two injection sessions, then it is discontinued. Botox is approved by the FDA for chronic migraine (defined as 15 or more headache days per month with a headache lasting 4 hours or longer each day). There is insufficient evidence pertaining to safety and effectiveness to support a recommendation for or against the use of the following medications for migraine prophylaxis: • Lisinopril • Verapamil
  • 10. Migraine and Tension Headache Diagnosis and Treatment Guideline 10 Special Population: Women With Menstruation-related Migraines Advise a woman with suspected menstrual migraine to keep a headache diary for at least 2 months to determine if she is having regular and predictable menses and if these correlate with headache onset. Some women experience migraines during ovulation (either alone or in addition to menses). Consider a short course of prophylaxis with naproxen or a triptan taken twice a day starting 2–3 days before the anticipated onset of the headache and continued for 5 days through the at-risk period (ICSI 2011, SIGN 2008). Table 5b. Pharmacologic options for the prevention of menstrual migraine Eligible population Line Medication Daily dose Timing 1st Naproxen 500–750 mg Sumatriptan Oral tablet 25–100 mg Rizatriptan 1 5–10 mg Women with regular and predictable menses that correlate with headache onset 2nd Naratriptan 1–2.5 mg 2–3 days before the anticipated onset of the headache and continuing through the at-risk period Women with irregular, unpredictable menses that correlate with headache onset or Women for whom NSAIDs and triptans are ineffective for prophylaxis of menstrual migraines 1 st Oral contraceptives 2 Within Group Health, see Think Preferred OCP, at http://incontext.ghc.org/rx/med/documents/oralcontraceptive_pocketcard.pdf CAUTION: Women with migraines with aura should avoid taking combined oral contraceptive pills because of increased risk for stroke. Among women with migraine, women who also had aura had a higher risk for stroke than did those without aura. Women with a history of migraine who use combined oral contraceptive pills are about 2–4 times as likely to have an ischemic stroke as nonusers with a history of migraine (CDC MMWR). 1 Use a 5 mg dose of rizatriptan in patients receiving propranolol, with a maximum of 15 mg daily. 2 Combined oral contraceptive pills may be offered for prophylaxis, although the evidence for this option is limited. In a contraceptive-containing drosperinone, an extended 168-day placebo-free oral contraceptive regimen showed a significant decrease in duration and severity of headaches and in loss of function due to headache compared with a standard 21/7 oral contraceptive cycle (Sulak 2007).
  • 11. Migraine and Tension Headache Diagnosis and Treatment Guideline 11 Non-prescription Options for Migraine Prophylaxis and Treatment While there is some evidence supporting their use for the prevention of migraine headaches, there is insufficient evidence to determine the long-term safety and effectiveness of the following therapies: Table 6. Complementary and alternative therapies for migraine prophylaxis Eligible population Medication Initial dose Riboflavin 1 400 mg daily Coenzyme Q10 1 100 mg t.i.d. Patients with: • Four or more days of headache per month • Four or more episodes of headache per month • Fewer than 4 headache days per month but with severe pain refractory to all migraine-specific acute therapies Butterbur 2 75 mg daily 1 Weak evidence from a small, placebo-controlled trial. 2 Placebo-controlled RCTs suggest that a 75 mg dose of butterbur may be effective at reducing headache frequency; however, there is insufficient evidence pertaining to the long-term safety and efficacy of butterbur. There is insufficient evidence to make a recommendation on the safety or efficacy of the following non- prescription therapies for migraine prophylaxis: • Magnesium There is insufficient evidence to make a recommendation on the safety or efficacy of the following non- pharmacologic therapies for the treatment of migraine: • Transcutaneous electrical stimulation (TENS) • Massage • Acupuncture Monitoring/Follow-up Advise the patient to keep and review a headache diary to monitor the effects of treatment on severity, frequency, and disability. Diary entries should include: • Day/time • Headache severity • Other symptoms (nausea, vomiting, photophobia) • Impact on usual activities • Duration of attack • Prescribed medication • OTC medication • Menstrual cycle day
  • 12. Migraine and Tension Headache Diagnosis and Treatment Guideline 12 Evidence Summary This guideline was adapted from the following: Scottish Intercollegiate Guideline Network (SIGN). Diagnosis and management of headache in adults. Edinburgh: SIGN 2008 (SIGN publication no.107, cited May 2011). Available online at: www.sign.ac.uk/pdf/sign107.pdf [PDF]. Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of headache. ICSI 2011 (Tenth edition, cited May 2011). Available online at: http://www.icsi.org/headache/headache__diagnosis_and_treatment_of_2609.html [PDF]. Medication overuse headache The evidence base for the treatment of medication overuse headache is limited. Prednisone Two randomized controlled trials (RCTs) evaluated the efficacy of prednisone for treatment of medication overuse headache. Results from these trials were mixed. Results from the first trial, which included 102 patients, suggest that compared to placebo, 60 mg of prednisone tapered down over 6 days does not reduce withdrawal headaches in patients with medication overuse headache (Bøe 2007). Results from the second trial suggest that 100 mg of prednisone given once daily for the first 5 days of withdrawal may be more effective than placebo for reducing headache severity. These results should be interpreted with caution, as the study included only 20 patients and an ITT analysis was not performed (Pageler 2008). Migraine prophylaxis Gabapentin The Group Health Pharmacy and Therapeutics (P&T) committee recently reviewed the evidence on the safety and efficacy of gabapentin for migraine prophylaxis and concluded that the evidence does not support the use of gabapentin for migraine prophylaxis. The published evidence on the use of gabapentin for migraine prophylaxis mostly revolves around one study with major flaws in study design (e.g., unblinding) and publication bias (Mathew 2001). Additionally, other unpublished studies found negative results. Botulinum toxin type A Two double-blind, placebo-controlled randomized trials evaluated the safety and efficacy of onabotulinumtoxinA (botox) for the prevention of migraine headache in adults with chronic migraines. In both trials, participants were given two injections of onabotulinumtoxinA 12 weeks apart. The first trial followed 679 participants for 24 weeks. There was no significant difference in the primary outcome frequency of headache episodes after 24 weeks. However, patients who received onabotulinumtoxinA had significantly fewer headache days and migraine days compared to patients who received placebo. Additionally, the mean Headache Impact Test (HIT)-6 score was significantly lower for patients who received onabotulinumtoxinA (Aurora 2010). The second trial followed 705 participants for 24 weeks. The primary outcome was changed during the study. Results from this study suggest that patients who received onabotulinumtoxinA had significantly fewer headache days (new primary outcome), migraine days, moderate to severe headache days, headache episodes, and HIT-6 scores compared to patients who received placebo (Diener 2010). It should be noted that both of these trials received industry funding and the treatment was compared to placebo and not to another active prophylactic treatment. The most common adverse events with onabotulinumtoxinA were neck pain, muscle weakness, eyelid ptosis, myalgia, worsening migraine, and musculoskeletal stiffness (Aurora 2010, Diener 2010).
  • 13. Migraine and Tension Headache Diagnosis and Treatment Guideline 13 Complementary and alternative medicine Riboflavin There is weak evidence from one small trial with 55 patients that riboflavin has more than a placebo effect in migraine prophylaxis and minimal adverse effects. The study showed that patients receiving oral riboflavin (400 mg daily for 3 months) had a significantly reduced attack frequency and had fewer migraine days compared with those in the placebo group. The trial had a valid methodology but a very small sample size (Schoenen 1998). Larger trials are needed to provide more evidence on the efficacy of riboflavin in migraine prophylaxis and to compare riboflavin with other standard prophylactic agents. Coenzyme Q10 There is weak evidence from one recent, small (N = 43) RCT that coenzyme Q10 may be effective in migraine prophylaxis (Sandor 2005). Larger trials with longer follow-up are needed to determine the efficacy and safety of CoQ10 in migraine prophylaxis. Butterbur The best evidence on the safety and efficacy of butterbur for the prevention of migraines comes from a placebo-controlled RCT that followed 233 subjects for 16 weeks. Results from this trial suggest that compared to placebo, a 75 mg dose of butterbur may reduce the frequency of migraine attacks. The long-term safety and efficacy of this medication is unknown. Additionally, the efficacy of butterbur compared with other prophylactic medications is unknown (Lipton 2004). Magnesium The available literature does not provide sufficient evidence to determine the efficacy of magnesium in migraine prophylaxis. Acupuncture Results from a meta-analysis of RCTs suggest that compared to acute treatment only or pharmacological prophylaxis, acupuncture may reduce headache frequency; however, there was no significant difference when acupuncture was compared with a sham intervention (Linde 2009). Transcutaneous electrical stimulation (TENS) The available literature does not provide sufficient evidence to determine the efficacy of transcutaneous electrical stimulation for the treatment of migraine. Massage The available literature does not provide sufficient evidence to determine the efficacy of massage for the treatment of migraine. References Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. Jul 2010;30(7):793–803. Bøe MG, Mygland A, and Salvesen R. Prednisolone does not reduce withdrawal headache: a randomized, double-blind study. Neurology. 2007;69:26-31. Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use. MMWR Early Release. 2010;59:1–86. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. Jul 2010;30(7):804–814.
  • 14. Migraine and Tension Headache Diagnosis and Treatment Guideline 14 Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of headache (10th edition). January 2011. Available online at: http://www.icsi.org/headache/headache__diagnosis_and_treatment_of_2609.html. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, and White AR. Acupuncture for migraine prophylaxis. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001218. DOI: 10.1002/14651858.CD001218.pub2. Lipton RB, Gobel H, Einhaupl KM, Wilks K, and Mauskop A. Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology. 2004;63:2240-2244. Mathew NT, Rapoport A, Saper J, et al. Efficacy of gabapentin in migraine prophylaxis. Headache. Feb 2001;41(2):119-128. Pageler L, Katsarava Z, Diener HC, Limmroth V. Prednisone vs. placebo in withdrawal therapy following medication overuse headache. Cephalalgia. 2008;28:152-156. Sandor PS, Di Clemente L, Coppola G, et al. Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial. Neurology. Feb 22 2005;64(4):713–715. Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial. Neurology. Feb 1998;50(2):466–470. Scottish Intercollegiate Guideline Network (SIGN). Diagnosis and management of headache in adults. Edinburg: SIGN 2008; (SIGN publication no. 107) Available online at: http://www.sign.ac.uk/pdf/sign107.pdf. Sulak P, Willis S, Kuehl T, Coffee A, and Clark J. Headaches and oral contraceptives:impact of eliminating the standard 7-day placebo interval. Headache. 2007;47:27–37.
  • 15. Migraine and Tension Headache Diagnosis and Treatment Guideline 15 Guideline Development Process and Team Development Process To develop the Migraine & Tension Headache Guideline, Group Health adapted recommendations from externally developed evidence-based guidelines. The Group Health guideline team reviewed additional evidence in the areas of medication overuse headache, migraine prophylaxis, and complementary and alternative medicine. For details, see Evidence Summary and References. This edition of the guideline was approved for publication by the Guideline Oversight Group in June 2011. Team The Migraine & Tension Headache Guideline development team included representatives from the following specialties: emergency medicine, family medicine, internal medicine, neurology, nursing, pharmacy. Content expert: Tim Scearce, MD, Neurology Clinician lead: David K. McCulloch, MD, Medical Director, Clinical Improvement, mcculloch.d@ghc.org Guideline coordinator: Avra Cohen, MN, Clinical Improvement & Prevention, cohen.al@ghc.org Beth Arnold, PharmD, Pharmacy Patricia Auerbach, MD, Emergency Medicine Rebecca Doheny, MPH, Epidemiologist, Clinical Improvement & Prevention Denise Hastings, MD, Internal Medicine Jennifer Macuiba, Clinical Improvement & Prevention Robyn Mayfield, Health Education Specialist, Clinical Improvement & Prevention Michelle Seelig, MD, Family Medicine Kathy Sobon, RN, Nursing Operations Ann Stedronsky, Clinical Publications, Clinical Improvement & Prevention
  • 16. Migraine and Tension Headache Diagnosis and Treatment Guideline 16 Appendix 1. Dihydroergotamine Mesylate (DHE) Raskin Protocol (Urgent Care) This protocol is for use with patients being treated in urgent care settings. When headache relief is achieved, patients may be discharged and directed to follow up with primary care or return to urgent care as needed. Table 7. Dihydroergotamine mesylate (DHE) 1 Raskin protocol for refractory migraine headache (urgent care settings) Step Medication Dose Anti-emetic premediation 2 1 Metoclopramide 10 mg IV over 30 minutes 2 DHE test dose 0.5 mg IV over 2–3 minutesAnalgesic test dose Monitor/assess patient for 1 hour post–test dose. If blood pressure is greater than 165/95 mm Hg or patient develops chest pain or severe nausea, discontinue DHE. If not, go to Step 3. Metoclopramide 10 mg IV every 8 hours as needed3a Headache persists WITH side effects 3 DHE NO DHE for 8 hours, then repeat DHE 0.3– 0.4 mg IV every 8 hours as needed, if tolerated, for up to 3 days. Metoclopramide 10 mg IV every 8 hours as needed3b Headache relief, no side effects DHE 0.5 mg IV given if/ when headache recurs and repeated every 8 hours as needed for 2–5 days HOLD when administering DHE 1 hour post–test dose Metoclopramide 10 mg IV every 8 hours as needed, with subsequent doses of DHE 0.5 mg IV administered 1 hour post–test dose WITHOUT metoclopramide THEN If patient is nauseated: 0.75 mg IV administered WITH metaclopramide if/ when headache recurs and repeated every 8 hours as needed for 2–5 days Analgesic 3c Headache persists, no side effects DHE If patient is NOT nauseated: 1.0 mg IV administered WITH metaclopramide if/ when headache recurs and repeated every 8 hours as needed for 2–5 days 1 DHE should not be given within 24 hours of a triptan. 2 Consider IV hydration if needed. 3 Common side effects include: nausea, vomiting, diarrhea, abdominal cramps, dizziness, paresthesia, and leg pain. By reducing the dose and co-administering metoclopramide as an antiemetic, these side effects can usually be resolved.