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Which migraine treatment strategy is most effective?

Trial
Results
Comment
A number of strategies can be used to treat acute migraine attacks, each utilising some part of the evidence base.

For instance, the initial attack could be treated with aspirin or simple analgesic, and if or when that fails, a triptan could be used. That is a step strategy within an attack .

A different approach may be to try aspirin or simple analgesic for a few attacks. It will work for some, but for those for whom it does not work, a triptan may be an alternative treatment. That is a step strategy across attacks , and is probably the strategy most likely to be used in the UK as it is probably seen as the cheapest.

A third way would be to assess the individual patient for the severity of the disorder, and then to treat appropriately: mild disease might be treated with aspirin or simple analgesics, while more severe disease might be treated with a triptan. This would be stratified care .

It just so happens that a randomised controlled trial indicates that stratified care produces the best results [1].

Trial


The trial was randomised, but open-label, and examined multiple migraine attacks for patients with established diagnosis of migraine according to International Headache Society criteria. Patients completed the MIDAS questionnaire, one that measures lost time in three domains of activity [2]. Patients were assigned a grade of disability from I (little or infrequent disability), grade II (mild or infrequent disability), grade III (moderate disability) to grave IV (severe disability). Patients with grade II-IV disability were included.

Randomisation was to:

Stratified care: grade II patients received aspirin 800 to 1000 mg plus metoclopramide 10 mg for all six attacks. Those with grade III or IV received zolmitriptan 2.5 mg.

Step care across attacks : Patients treated the first three attacks with aspirin 800 to 1000 mg plus metoclopramide 10 mg. Those without adequate relief took zolmitriptan 2.5 mg for the next three attacks.

Step care within attacks : Patients treated all attacks with aspirin 800 to 1000 mg plus metoclopramide 10 mg first. If adequate relief was not obtained by two hours, they then took zolmitriptan 2.5 mg.

Patients had to have pain of moderate or severe intensity before taking their medicine. Two hours later, if their pain was gone, or of only mild intensity, this was considered a headache response. If the pain was gone, this was a "pain free" outcome. These are standard migraine outcomes, and other outcomes are available in the study.

Results


In the three treatments groups, 1062 patients were randomised. Twenty percent of patients withdrew or were lost for various reasons, mostly innocuous. Only 3% withdrew because of an adverse event, and 0.2% because of deteriorating condition. Groups were well balanced.

More patients had a two-hour headache response in the stratified care strategy than for either step care strategy (Figure 1). About half the patients in the stratified strategy had a two hour headache response.

Figure 1: Two-hour headache response for up to six migraine attacks with different treatment strategies



More patients were pain free at two hours in the stratified care strategy than for either step care strategy (Figure 2). About one in five patients in the stratified strategy was pain free at two hours.

Figure 2: Two-hour pain free for up to six migraine attacks with different treatment strategies



Adverse events were equally common in all three groups, and were predominantly mild and transient. Adverse event study withdrawals were evenly distributed across the groups.

Comment


Most guidelines probably use a step up approach, similar to that of step up across attacks, but with many more steps. Because of the time involved, and because of repeated failure of treatment, some patients simply become disenchanted and seek other forms of treatment. Treating the appropriate patient appropriately from the beginning is a better bet. It takes less time, is more effective, and is without the 'hassle factor' for patient and doctor. This is exactly what evidence-based medicine was supposed to be about, and reading the definition of EBM in the context of this trial is rewarding. It is striking, though, that the best treatment strategy still means that four out of every five migraine sufferers who are treated still have some pain two hours after treatment started.

References:

  1. RB Lipton et al. Stratified care vs step care strategies for migraine: The disability in strategies of care (DISC) study: a randomized trial. JAMA 2000 284: 2599-2605.
  2. WF Steward et al. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain 2000 88: 41-52.
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