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National Clinical Guideline Centre (UK). Headaches: Diagnosis and Management of Headaches in Young People and Adults [Internet]. London: Royal College of Physicians (UK); 2012 Sep. (NICE Clinical Guidelines, No. 150.)

  • Update information - February 2020: A footnote was added to recommendation 1.3.17 on the potential risk of propranolol overdose in people with migraine who also have depression. November 2015: New and updated recommendations on the prophylactic treatment of migraine were added.

Update information - February 2020: A footnote was added to recommendation 1.3.17 on the potential risk of propranolol overdose in people with migraine who also have depression. November 2015: New and updated recommendations on the prophylactic treatment of migraine were added.

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Headaches: Diagnosis and Management of Headaches in Young People and Adults [Internet].

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23Management of medication overuse headache

23.1. Introduction

Medication overuse headache are frequent or daily headaches which occur as result of taking excessive acute relief medication for migraine or tension type headache in a susceptible person. All acute relief medication drugs have been implicated including simple analgesics, opiates, NSAIDs and triptans. The aetiology is unknown but may be related to the sensitisation of central pain processing pathways.

Not only can sustained medication overuse cause headache but it can result in tolerance and addiction to drugs. Management may be hindered by the fact that participants may have an artificially low view of (or consciously under-report) the scale of their medication use. Unfortunately, many people will relapse after an initially successful withdrawal. Given the complexities of management of this headache, the GDG were interested in looking for the evidence for the different management strategies currently used.

23.1.1. Clinical question

What is the clinical evidence and cost-effectiveness of withdrawal strategies (of abortive treatments), psychological therapies, corticosteroids and NSAIDs for the treatment of probable medication overuse headache?

A literature search was conducted for RCTs and observational studies comparing the clinical effectiveness of different strategies for the management of medication overuse headache. The management strategies we included in our search were withdrawal strategies, psychological therapies, corticosteroids and NSAIDs. We looked for any studies that compared the effectiveness of withdrawal strategies with each other, psychological therapies with attention control, corticosteroids or NSAIDS with placebo and all of these interventions with one another (See protocol C.2.16). Each of the studies included in the evidence reviews define medication overuse headache slightly define differently. (See Evidence tables, Appendix E4).

The GDG were interested in the use of psychological therapies, corticosteroids and NSAIDs to treat medication overuse headache, but no evidence was found in the review and therefore there is no section in this chapter.

Imprecision for the effect size relating to the outcome headache or migraine days was assessed using a value agreed by the GDG for the MID of 0.5 days.

23.1.2. Withdrawal strategies vs prophylactic treatment

23.1.2.1. Clinical evidence

See evidence tables in appendix section E.4, forest plots in Figures 216222, appendix G.3.

One study was identified comparing withdrawal treatment to prophylactic treatment97. This is an open label randomised clinical trial.

Table 191. Withdrawal treatment vs prophylactic treatment-Quality assessment.

Table 191

Withdrawal treatment vs prophylactic treatment-Quality assessment.

Table 192. Withdrawal treatment vs prophylactic treatment – Clinical summary of findings.

Table 192

Withdrawal treatment vs prophylactic treatment – Clinical summary of findings.

23.1.2.2. Economic evidence

No economic evaluations comparing withdrawal strategies to prophylactic treatment were identified. The GDG discussed the economic implications of withdrawal strategies compared to prophylactic treatment. There are higher medication costs in the prophylactic treatment strategy due to the prophylactic treatment itself but also to the more frequent acute medication use; however in the studies included in the clinical review (23.1.2) inpatient and outpatient detoxification programmes were components of the withdrawal strategies and their costs make withdrawal strategies more costly.

23.1.2.3. Evidence statements

Clinical

One study with 64 people with suspected medication overuse headache suggested that prophylactic treatment may be more clinically effective than withdrawal treatment in reducing the number of headache days at 3 months follow-up, but there is some uncertainty. [Very low quality].

One study with 64 people with suspected medication overuse headache suggested that prophylactic treatment may be more clinically effective than withdrawal treatment in reducing the number of headache days at 12 months follow-up, but there is some uncertainty. [Very low quality].

One study with 64 people with suspected medication overuse headache suggested that prophylactic treatment may be more clinically effective than withdrawal treatment in improving the responder rate at 12 months follow-up, but there is some uncertainty. [Very low quality].

In one study with 64 people with suspected medication overuse headache, there is too much uncertainty to determine whether there is a difference between withdrawal treatment and prophylactic treatment in improving quality of life, assessed with the mental health component score of SF-12 at 12 months follow-up. [Very low quality].

One study with 64 people with suspected medication overuse headache suggested that prophylactic treatment may be more clinically effective than withdrawal treatment in improving the physical health component score of SF-12 from baseline at 12 months follow-up, but there is some uncertainty. [Very low quality].

One study with 64 people with suspected medication overuse headache suggested that withdrawal treatment may be more clinically effective than prophylactic treatment in reducing the use of acute medication at 3 months follow-up, but there is some uncertainty. [Very low quality].

One study with 64 people with suspected medication overuse headache suggested that withdrawal treatment may be more clinically effective than prophylactic treatment in reducing the use of acute medication at 12 months follow-up, but there is some uncertainty. [Very low quality].

No studies reported outcome data for relapse back to medication overuse headache, headache specific quality of life or resource use.

Economic

Withdrawal strategies have lower cost of medications compared to prophylactic treatment; however they might have higher costs associated with outpatient and inpatient detoxification programmes.

23.1.3. Outpatient withdrawal treatment vs inpatient withdrawal treatment

23.1.3.1. Clinical evidence

See evidence tables in appendix section E.4, forest plots in Figures 223227, appendix G.3.

Four studies were identified comparing inpatient withdrawal treatment to outpatient withdrawal treatment43,213,214,246. All studies were open label randomised clinical trials.

Table 193. Outpatient withdrawal vs inpatient withdrawal – Quality assessment.

Table 193

Outpatient withdrawal vs inpatient withdrawal – Quality assessment.

Table 194. Outpatient withdrawal vs inpatient withdrawal – Clinical summary of findings.

Table 194

Outpatient withdrawal vs inpatient withdrawal – Clinical summary of findings.

23.1.3.2. Economic evidence

No economic evaluations comparing outpatient withdrawal treatment with inpatient withdrawal treatment were identified.

Based on the studies213,214 included in our clinical review (23.1.3.1), both outpatient and inpatient withdrawal treatments are associated with drug costs. However, inpatient withdrawal treatment is expected to have higher costs due to the hospital admission.

23.1.3.3. Evidence statements

Clinical

Two studies with 200 people with suspected medication overuse headache suggested that there is no difference between outpatient and inpatient withdrawal at improving responder rate at 12 months follow-up, but there is some uncertainty. [Very low quality].

One study with 257 people with suspected medication overuse headache suggested that outpatient withdrawal may be more clinically effective than inpatient withdrawal in reducing the number of headache days at 5 years follow-up, but there is some uncertainty. [Very low quality].

In one study with 120 people with suspected medication overuse headache, there is too much uncertainty to determine whether there is a difference between outpatient withdrawal and inpatient withdrawal in reducing relapse at 12 months follow-up. [Very low quality].

One study with 257 people with suspected medication overuse headache suggested that outpatient withdrawal may be more clinically effective than inpatient withdrawal at reducing relapse at 5 years follow-up, but there is considerable uncertainty. [Very low quality].

One study with 257 people with suspected medication overuse headache showed that there is no difference between outpatient and inpatient withdrawal at reducing headache intensity at 5 years follow-up. [Low quality].

No studies reported outcome data for functional health status and quality of life, change in acute medication use or resource use.

Economic

No economic evidence was found. Both outpatient and inpatient withdrawal treatments are expected to have considerable costs; inpatient withdrawal treatment is expected to have higher costs compared to outpatient withdrawal treatment.

23.2. Recommendations and link to evidence

Explain to people with medication overuse headache that it is treated by withdrawing overused medication.
Advise people to stop taking all overused acute headache medications for at least 1 month and to stop abruptly rather than gradually.
Advise people that headache symptoms are likely to get worse in the short term before they improve and that there may be associated withdrawal symptoms, and provide them with close follow-up and support according to their needs.
Consider prophylactic treatment for the underlying primary headache disorder in addition to withdrawal of overused medication for people with medication overuse headache.
Relative values of different outcomesThe GDG agreed that reduction in the number of headache days was considered to be the most important outcome when considering the patient’s perspective.
Trade off between clinical benefits and harmsHeadache symptoms typically get worse for up to two weeks before improvement. Other withdrawal symptoms depend on drug being used Relapse rate is very high.
Economic considerationsThe GDG discussed the economic implications of withdrawal strategies compared to prophylactic treatment. There are higher medication costs in the prophylactic treatment strategy due to the prophylactic treatment itself but also to the more frequent acute medication use; however inpatient and outpatient detoxification programmes are also associated with costs. The GDG considered advising people to withdraw the overused medication as the most cost-effective option. However, when this proves unsuccessful, given the evidence on its clinical benefit, the adjunct of prophylactic treatment was considered cost-effective.
Quality of evidenceThe recommendations were based on very low quality evidence from one study97 and the consensus opinion of the GDG.
No economic evidence was found on medication overuse headache.
Other considerationsThe GDG recommended a minimum period of withdrawal of one month, and acknowledged that although this was different from the IHS criteria, which state a minimum of 8 weeks as the period of withdrawal, it is a more practical approach.
The GDG experience was that the majority of people could manage withdrawal without the addition of adjunctive treatments such as steroids, anxiolytics and antiemetics. These have been used to assist withdrawal and manage associated symptoms. There is evidence that the majority of people can withdraw from overused treatment without further medication213. However, the GDG acknowledged that some people will benefit from introduction of prophylactic treatment for their primary headache disorder. This can be instituted at the time of withdrawal of acute medication but the GDG did not consider this was always necessary. Withdrawal of medication may result in significant reduction of headache so prophylaxis might not be required.
The GDG also discussed the issues with abrupt and gradual withdrawal and acknowledged that in the first week or two after stopping medications, most people experience a worsening of symptoms, before improvement. Patient experience suggested that gradual withdrawal is preferred. The GDG concluded that this may differ was according to the individual concerned and was best decided on a case by case basis and following discussion between practitioner and patient. The GDG also felt that gradual withdrawal could be managed in the community by those experienced in managing withdrawal.
Research recommendation:
The GDG agreed to form a research recommendation to investigate whether pharmacological treatments used for prophylaxis or steroids can help withdrawal from overused medication for people with medication overuse headache as there was an absence of evidence for this, but the GDG considered it may be of benefit to some people. See appendix M.
RecommendationsDo not routinely offer inpatient withdrawal for medication overuse headache.
Consider specialist referral and/or inpatient withdrawal of overused medication for people who are using strong opioids, or have relevant comorbidities, or in whom previous repeated attempts at withdrawal of overused medication have been unsuccessful.
Relative values of different outcomesThe GDG agreed that responder rate and reduction in headache days were the most relevant outcomes for this recommendation. The recommendation was also based on GDG informal consensus.
Trade off between clinical benefits and harmsThe aim of withdrawal management is to help the person stop using the medications causing their headache. Maximising the likelihood of success would be beneficial to the individual and less costly to health service overall.
There is a high relapse rate associated with management of medication overuse headache which may occur within the period of withdrawal. There is often a worsening of symptoms before any improvement is seen. However, the benefits of subsequent successful withdrawal greatly outweigh this.
Economic considerationsNo economic evidence was found on medication overuse headache. The GDG considered the resources associated with different strategies and concluded that inpatient withdrawal management has high costs due to hospital admission. In the absence of good quality evidence on its effectiveness the GDG decided offering inpatient withdrawal management to all people with medication overuse headache does not represent a good use of NHS resources. However, targeting inpatient management to those people who would benefit from it the most was considered a good use of NHS resources.
Referring people to specialists is associated with costs. However, referring only selected people was considered a good use of NHS resources.
Quality of evidenceThe recommendation is based on the consensus opinion of the GDG as the evidence reviewed was of very low quality. This evidence suggested that community or outpatient treatment was better than inpatient treatment with respect to reducing the number of headache days and relapse back to medication overuse headache, but the GDG informal consensus decision was that in some specific cases, inpatient withdrawal may be appropriate.
No economic evidence was found on medication overuse headache.
Other considerationsThe GDG also discussed the practical aspects of implementation of this recommendation. The majority of cases can be managed in a primary care setting. It was discussed that inpatient withdrawal should take place in centres with specialist expertise in this area and that those services may differ by areas e.g. they may be within a drug dependency service or a specialist headache service.
The GDG discussed the practical aspects of referral and agreed that specialist referral could be to a community drugs team if available and deemed appropriate.
RecommendationsReview the diagnosis of medication overuse headache and further management 4–8 weeks after the start of withdrawal of overused medication.
Relative values of different outcomesGDG informal consensus was used to form this recommendation.
Trade off between clinical benefits and harmsThere is a high relapse rate associated with management of medication overuse headache which may occur within the period of withdrawal. There is often a worsening of symptoms before any improvement is seen. However, the benefits of subsequent successful withdrawal greatly outweigh this.
Economic considerationsNo economic evidence was reviewed to inform this recommendation.
Reviewing diagnosis and further management at 4–8 weeks is also associated with costs and no economic evidence was reviewed to inform this recommendation.
Quality of evidenceThese recommendations were based on the consensus opinion of the GDG. No economic evidence was found on medication overuse headache.
Other considerationsDue consideration should also be given to informing people about medication overuse headache and its prevention.
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Copyright © 2012, National Clinical Guideline Centre.

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