The American Headache Society (AHS), working in cooperation with the American Academy of Neurology (AAN), has provided an updated assessment of the evidence for individual pharmacologic therapies for acute migraine treatment. The findings were published in the January issue of Headache. The study report was written by three headache specialists who are members of the Guidelines Section of the AHS: Michael J. Marmura, MD, Assistant Professor of Neurology, and Stephen D. Silberstein, MD, FACP, Director of the Headache Center, both at Thomas Jefferson University in Philadelphia, and Todd J. Schwedt, MD, MSCI, Associate Professor of Neurology at Mayo Clinic Arizona in Scottsdale.
It has been 15 years since the AAN and the US Headache Consortium published a complete set of evidence-based guidelines for the acute treatment of migraine. Since that publication, the AAN has updated its guideline-development process and criteria for evidence, basing recommendations largely on the quality of evidence in published literature. Although the AAN and the AHS updated the guidelines for the prevention of migraine in adults in 2012 using the newer criteria, a comparable effort to reassess pharmacotherapies for the acute treatment of migraine in adults was not undertaken until more recently.
Guideline Based on New Evidence and Criteria
In a guest editorial accompanying the study report in Headache, Drs. Silberstein and Marmura explain that the newer set of criteria used in the 2000 guidelines created a problem because many of the older drugs assessed at that time were rated by older criteria. “We have attempted to update these drugs when possible,” said the two authors. “The AHS Guidelines Committee is developing and will publish a companion piece to allow translation of the evidence-based guidelines to daily practice.”
By providing an updated assessment of the most effective treatments to use when a migraine attack occurs, the 2015 recommendations will form the basis of a new set of AHS treatment guidelines and, in the meantime, will help inform treatment choices by clinicians and facilitate doctor–patient discussion, according to the American Migraine Foundation, a nonprofit organization supported by the AHS.
“We hope that this assessment of the efficacy of currently available migraine therapies helps patients and their physicians utilize treatments that are the most appropriate for them,” stated Dr. Silberstein. “Several large, randomized acute pharmacologic migraine treatment trials have been conducted since the release of the 2000 AAN–AHS guidelines, so it was important that we update our guidelines to reflect the latest evidence.”
Triptans and Ergotamine Derivatives Were Considered Effective
For this latest assessment, the researchers conducted a systematic review of clinical trials published from 1998 to 2013 that compared the efficacy of acute migraine treatments versus that of placebo. A level of evidence was assigned to each drug based on the quality of its supporting studies. For an agent to be established as effective or ineffective (Level A), it had to be supported by at least two Class I studies. A rating of probably effective (or ineffective) (Level B) required one Class I study or two Class II studies, and a rating of possibly effective (or ineffective) (Level C) required one Class II study or two Class III studies. When evidence was either conflicting or inadequate to support the drug’s use, it was designated Level U.
The evaluation of the quality of each study was based on the AAN therapeutic classification of evidence scheme, ranging from Class I—well-designed double-blind, randomized, placebo-controlled trials—to Class IV, typically retrospective studies or case reports with unclear outcomes data.
Specific medications found to be effective for the acute therapy of migraine include agents in drug classes such as triptans (eg, almotriptan, eletriptan, frovatriptan, and various forms of sumatriptan and zolmitriptan), ergotamine derivatives (eg, the nasal spray and inhaler forms of dihydroergotamine [DHE]), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, diclofenac and ibuprofen), as well as the combination medications sumatriptan–naproxen and acetaminophen–aspirin–caffeine. Other forms of DHE, NSAIDs such as ketoprofen, and antiemetics such as droperidol were found to be probably effective. Butalbital, phenazone, and dexamethasone were considered possibly effective.
The study authors noted that, in addition to a drug’s efficacy, clinicians should take into account potential side effects and adverse events, drug–drug interactions, and patient-specific contraindications to the use of a particular agent when prescribing medication for acute migraine therapy. For example, although opioids such as butorphanol, codeine–acetaminophen, and tramadol–acetaminophen are probably effective, they are not recommended for regular use because of concerns about tolerance and dependence.
From Expert Opinion to Evidence-Based Treatment
“This report focusing on acute migraine treatment reflects the changing nature of guidelines toward evidence-based treatment rather than expert opinion,” said Dr. Marmura. “Large, double-blind, placebo-controlled trials are the basis of determining the effectiveness of acute migraine treatment. Some clinical trials for headache performed prior to publication of the previous guidelines do not meet the more rigorous standards for clinical trials today.”