Practice Guidelines

Diagnosis and management of headaches in young people and adults: summary of NICE guidance

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e5765 (Published 19 September 2012) Cite this as: BMJ 2012;345:e5765
  1. Serena Carville, senior research fellow and project manager1,
  2. Smita Padhi, research fellow1,
  3. Tim Reason, statistician and health economist1,
  4. Martin Underwood, professor of primary care research2
  5. on behalf of the Guideline Development Group
  1. 1National Clinical Guideline Centre, Royal College of Physicians, London NW1 4LE, UK
  2. 2Division of Health Science, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK
  1. Correspondence to: M Underwood m.underwood{at}warwick.ac.uk

Headaches are a common problem that many clinicians in primary and secondary care find difficult to treat.1 2 Once the serious causes of headache have been excluded (such as infection, tumour, bleeding, and arteritis), the major health and social burden of headaches can be attributed to primary headache disorders (cluster headache, migraine, and tension-type headache) and headache caused by the overuse of medications. Straightforward advice is needed for anyone working in the NHS on the diagnosis and treatment of these common disorders and the prevention of medication overuse headache.

This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the diagnosis and management of headaches in young people and adults.3

Recommendations

NICE recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets.

Assessment: indications for considering additional investigation

  • Evaluate people who present with headache and any of the following features, and consider the need for further investigations or referral (or both):

    • -Worsening headache with fever

    • -Sudden onset headache that reaches maximum intensity within five minutes

    • -New onset neurological deficit

    • -New onset cognitive dysfunction

    • -Change in personality

    • -Impaired level of consciousness

    • -Recent (typically within the past three months) head trauma

    • -Headache triggered by cough, valsalva (trying to breathe out with nose and mouth blocked), or sneeze

    • -Headache triggered by exercise

    • -Orthostatic headache (headache that changes with posture)

    • -Symptoms suggestive of giant cell arteritis

    • -Symptoms and signs of acute narrow angle glaucoma

    • -A substantial change in the characteristics of their headache.

[All based on the experience and opinion of the Guideline Development Group (GDG)]

  • Consider further investigations or referral (or both) for people who present with new onset headache and any of the following:

    • -Compromised immunity, caused, for example, by HIV or immunosuppressive drugs

    • -Age under 20 years and a history of malignancy

    • -A history of malignancy known to metastasise to the brain

    • -Vomiting without other obvious cause.

[Based on very low quality evidence from two cohort studies, one of which was in an indirect population, and the experience and opinion of the GDG]

Diagnosis

  • Diagnose primary headaches such as tension-type headache, migraine, or cluster headache according to the features in the table.

Diagnosis of tension-type headache, migraine, and cluster headache

View this table:

[Based on the experience and opinion of the GDG, informed by the International Headache Society ICHD-II (International Classification of Headache Disorders II) criteria]4

  • Be alert to the possibility of medication overuse headache in people whose headache developed or worsened while they were taking the following drugs for three months or more:

    • -Triptans, opioids, ergots, or combination analgesic drugs on 10 days a month or more, or

    • -Paracetamol, aspirin, or a non-steroidal anti-inflammatory drug (NSAID), either alone or in any combination, on 15 days a month or more.

[Based on the experience and opinion of the GDG, informed by the International Headache Society ICHD-II criteria]4

Management

All headaches

  • Do not refer people diagnosed as having tension-type headache, migraine, cluster headache, or medication overuse headache for neuroimaging solely for reassurance.

[Based very low quality to moderate quality evidence from one randomised controlled trial]

  • Include the following in discussions with the person with a headache disorder:

    • -A positive diagnosis, including an explanation of the diagnosis and reassurance that other pathology has been excluded, and

    • -The options for management, and

    • -Recognition that headache is a valid medical disorder that can have a serious impact on the person and his or her family or carers.

[Based on observational studies ranging from poorly reported to well reported]

  • Explain the risk of medication overuse headache to people who are using acute treatments for their headache disorder.

[Based on the experience and opinion of the GDG]

Tension-type headache

  • Consider aspirin, paracetamol, or an NSAID for acute treatment, taking into account the person’s preferences, comorbidities, and risks of adverse events.

[Based on low quality evidence from randomised controlled trials]

Because of an association with Reye’s syndrome, do not offer preparations containing aspirin to people aged under 16 years.

  • Do not offer opioids for acute treatment.

[Based on the absence of evidence for effectiveness and the experience and opinion of the GDG]

  • Consider a course of up to 10 sessions of acupuncture over five to eight weeks for the prophylactic treatment of chronic tension-type headache.

[Based on low and very low quality evidence from single blind randomised controlled trials]

Migraine with or without aura

  • Offer combination therapy with an oral triptan and an NSAID, or an oral triptan and paracetamol, for acute treatment, taking into account the person’s preferences, comorbidities, and risk of adverse events. For people aged 12-17 years consider a nasal triptan in preference to an oral triptan.

[Based on very low to low quality evidence from direct comparisons in randomised controlled trials, which fed into mixed treatment comparisons in a network meta-analysis, and corresponding cost effectiveness analysis]

  • For people in whom oral preparations (or nasal preparations in people aged 12-17 years) for acute treatment are ineffective or not tolerated:

    • -Offer a non-oral preparation of metoclopramide or prochlorperazine, and

    • -Consider adding a non-oral NSAID or triptan if these have not been tried.

[The first point is based on very low to low quality evidence from randomised controlled trials. The second point is based on the experience and opinion of the GDG and indirect evidence of very low to low quality evidence from randomised controlled trials]

  • Offer topiramate or propranolol for prophylactic treatment according to the person’s preference, comorbidities, and risk of adverse events. Advise women and girls of childbearing potential that topiramate is associated with a risk of fetal malformations and can impair the effectiveness of hormonal contraceptives. Ensure they are offered suitable contraception.

[Based on low to high quality evidence from direct comparisons in randomised controlled trials, which fed into mixed treatment comparisons in a network meta-analysis, and corresponding cost effectiveness analysis]

  • If both topiramate and propranolol are unsuitable or ineffective, consider a course of up to 10 sessions of acupuncture over five to eight weeks or gabapentin (up to 1200 mg/day) according to the person’s preference, comorbidities, and risk of adverse events.

[Based on low to high quality evidence from direct comparisons in randomised controlled trials, which fed into mixed treatment comparisons in a network meta-analysis, and corresponding cost effectiveness analysis]

  • • Advise people with migraine that riboflavin (400 mg once a day) can reduce the frequency and intensity of migraine in some people.

[Based on moderate quality evidence from randomised controlled trials]

Combined hormonal contraceptive use by women and girls with migraine

  • For those who have migraine with aura, do not routinely offer combined hormonal contraceptives for contraception.

[Based on the experience and opinion of the GDG]

Menstrual migraine

  • For women and girls with predictable menstrual related migraine that does not respond adequately to standard acute treatment, consider treatment with frovatriptan (2.5 mg twice a day) or zolmitriptan (2.5 mg twice or three times a day) on the days that migraine is expected.

[Based on low quality evidence from two randomised controlled trials and the experience and opinion of the GDG]

Cluster headache

  • Offer oxygen and a subcutaneous or nasal triptan for acute treatment.

[Based on moderate quality evidence from randomised controlled trials]

  • When using oxygen for acute treatment:

    • -Use 100% oxygen at a flow rate of at least 12 L per minute with a non-rebreathing mask and a reservoir bag, and

    • -Arrange provision of home and ambulatory oxygen.

[The first point is based on moderate quality evidence from randomised controlled trials and the experience and opinion of the GDG. The second point is based on the experience and opinion of the GDG]

  • When using a subcutaneous or nasal triptan, ensure the person is offered an adequate supply of triptans. This should be calculated according to the person’s history of cluster bouts, taking into account the manufacturer’s maximum daily dose.

[Based on the experience and opinion of the GDG]

  • Consider verapamil for prophylactic treatment during a bout of cluster headache. If unfamiliar with its use for cluster headache, seek specialist advice before starting verapamil, including advice on electrocardiographic monitoring.

[Based on very low and low quality evidence from one randomised controlled trial]

Primary headaches during pregnancy

  • Offer pregnant women paracetamol for the acute treatment of migraine. Consider the use of a triptan or an NSAID after discussing the woman’s need for treatment and the risks associated with the use of each drug during pregnancy.

[Based on very low quality evidence from three prospective cohort studies and the experience and opinion of the GDG]

  • Seek specialist advice if prophylactic treatment for migraine is needed during pregnancy.

[Based on the experience and opinion of the GDG]

  • Seek specialist advice if treatment for cluster headache is needed during pregnancy.

[Based on low and very low quality evidence from one cohort study with an indirect population and the experience and opinion of the GDG]

Medication overuse headache

  • Explain to people with medication overuse headache that it is treated by withdrawing the drugs that are overused.

[Based on very low quality evidence from one open label randomised controlled trial and the experience and opinion of the GDG]

  • Advise people to stop taking all overused acute headache drugs for at least one month and to stop abruptly rather than gradually.

[Based on the experience and opinion of the GDG]

  • Advise people that headache symptoms will probably get worse in the short term before they improve and that there may be associated withdrawal symptoms. Provide them with close follow-up and support according to their needs.

[Based on the experience and opinion of the GDG]

  • Consider prophylactic treatment for the underlying primary headache disorder in addition to withdrawal of overused drugs.

[Based on the experience and opinion of the GDG]

Overcoming barriers

The use of combination therapy as the first choice treatment for migraine is innovative and should improve acute treatment. Compliance may, however, be better when people take one drug only, and the guideline provides this alternative. Alongside other considerations, patient preference should inform choice of acute migraine treatments. At the time of publication (September 2012), not all the recommended drugs had marketing authorisation in the United Kingdom for the indication specified or for young people. Prescribers should follow relevant professional guidance and take full responsibility for the decision when prescribing drugs that do not have marketing authorisation. Because topiramate is recommended as first line agent for migraine prophylaxis, prescribers and patients will need to be aware of its safe use in women and girls of childbearing potential. Its enzyme inducing potential means that many hormonal contraceptives may be unreliable. Prescribers should consult authoritative guidance, such as the British National Formulary (BNF) or guidance from the Royal College of Obstetricians and Gynaecologists Faculty of Sexual and Reproductive Healthcare,5 when advising on contraceptive use. In treating those with cluster headaches, general practitioners and oxygen supply companies should ensure that an urgent supply of oxygen is readily available. Challenges around medication overuse headaches include the need to recognise the risk factors, plus early preventive advice. Advice to stop taking drugs abruptly may not be welcome, especially as a definite diagnosis can be made only after the headaches resolve, which occurs in only half of those who succeed in stopping. No recommendation has been made for other therapist delivered interventions, such as manual therapy, exercise, cognitive behavioural therapy, or self management programmes because of the absence of evidence. The guideline makes research recommendations in some of these areas.

Further information on the guidance

Methods

The guideline was developed using current NICE guideline methodology (www.nice.org.uk/aboutnice/howwework/developingniceclinicalguidelines/developing_nice_clinical_guidelines.jsp). The Guideline Development Group (GDG) comprised three general practitioners (including the chair, and two with a special interest in headache), two neurologists, one paediatric neurologist, one pain specialist, three lay members, an emergency medicine physician, a pharmacist, and a specialist headache nurse.

The group developed clinical questions, collected and appraised clinical evidence, and evaluated the cost effectiveness of proposed interventions through literature review and original economic modelling. The draft guideline went through a rigorous reviewing process, in which stakeholder organisations were invited to comment; the group took all comments into consideration when producing the final version of the guideline. Quality ratings of the evidence were based on GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology (www.gradeworkinggroup.org). These relate to the quality of the available evidence for assessed outcomes rather than the quality of the clinical study. Quality assessment of diagnostic studies was based on QUADAS-II methodology (www.bris.ac.uk/quadas/quadas-2) and presented in customised GRADE tables. When standard methodology could not be applied, a customised quality assessment was undertaken. These assessments were presented as a narrative summary of the evidence or in customised GRADE tables (for example, for qualitative and prognostic reviews).

Network meta-analysis for the acute and prophylactic treatment of migraine

Two network meta-analyses were conducted as part of the clinical review. The advantage of network meta-analysis over conventional meta-analysis is that it enables treatment effects to be calculated for all interventions simultaneously, so that they can be ranked on the basis of efficacy using all available direct and indirect evidence from randomised controlled trials, while preserving randomisation. Results of the network meta-analysis were used to facilitate recommendations through treatment rankings and parameterisation of effect sizes for the economic models. In the network meta-analysis for acute treatment of migraine, triptan plus NSAID combination therapy was found to be the most effective. In the network meta-analysis for prophylactic treatment of migraine topiramate was found to be the most effective.7

Cost effectiveness analysis for acute treatment of migraine

An economic model was developed from an NHS and Personal Social Services perspective to compare the cost effectiveness of six interventions for acute treatment of migraine. Triptan plus NSAID combination therapy was the most cost effective treatment at a willingness to pay threshold of £20 000 (€25 290; $31 790) per quality adjusted life year in the base case and all sensitivity analyses.

Cost effectiveness analysis for prophylactic treatment of migraine

An economic model was developed from an NHS and Personal Social Services perspective to compare the cost effectiveness of five interventions for prophylactic treatment of migraine. Topiramate was the most cost effective treatment, at a willingness to pay threshold of £20 000 per quality adjusted life year.

Points to consider

At the time of publication (September 2012), the following drugs did not have UK marketing authorisation for the indications they have been recommended for:

  • Prochlorperazine (except for the relief of nausea and vomiting) and gabapentin for migraine

  • Frovatriptan and zolmitriptan for menstrual migraine

  • Nasal triptan for cluster headache.

The following drugs did not have a UK marketing authorisation for people aged under 18 years at the time of publication for the indication recommended:

  • Triptan (except for nasal triptan) and topiramate for migraine

  • Subcutaneous triptan or verapamil for cluster headache.

Riboflavin (400 mg) does not have marketing authorisation for migraine but is available as a food supplement.

The prescriber should follow relevant professional guidance and take full responsibility for the decision. The patient (or his or her parent or carer) should provide informed consent, which should be documented.

Future research

The GDG identified some important questions that need to be answered:

  • Is amitriptyline a clinically and cost effective prophylactic treatment for recurrent migraine?

  • Is pizotifen a clinically and cost effective prophylactic treatment for recurrent migraine?

  • Is topiramate a clinically and cost effective prophylactic treatment for recurrent cluster headache?

  • Can a psychological intervention such as cognitive behavioural therapy improve headache outcomes and quality of life for people with chronic headache disorders?

  • Can a course of steroid treatment or drugs used for headache prophylaxis help people with medication overuse headaches withdraw from medication?

Notes

Cite this as: BMJ 2012;345:e5765

Footnotes

  • This is one of a series of BMJ summaries of new guidelines based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists.

  • The members of the Guideline Development Group were Ria Bhola, Sam Chong, Brendan Davies, Mark Dunne-Willows, Carole Gavin, Kay Kennis, David Kernick, Manjit Matharu, Peter May, Wendy Thomas, Martin Underwood (chair), and William Whitehouse. The technical team at the National Clinical Guideline Centre comprised Sara Buckner, Serena Carville, Elisabetta Fenu, Zahra Naqvi, Norma O’Flynn, Smita Padhi, Tim Reason, and Carlos Sharpin.

  • Contributors: SC wrote first draft. All authors reviewed the draft, were involved in writing further drafts, and reviewed and approved the final version for publication. MU is guarantor.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors were funded by NICE for the submitted work; after completion of the guideline and before its publication a member of MU’s division obtained substantial funding from Bayer for an investigator led study in an unrelated clinical area; no other relationships or activities that could appear to have influenced the submitted work.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References