Defining the Pharmacologically Intractable Headache for Clinical Trials and Clinical Practice
Stephen D. Silberstein, MD, FACP; David Dodick, MD; Starr Pearlman, PhD
The terms refractory headache and intractable headache have been used interchangeably to describe persistent headache that is difficult to treat or fails to respond to standard or aggressive treatment modalities. A variety of definitions of intractability have been published, but as yet, an accepted/established definition is not available. To advance clinical and basic research in this population of patients, a universal and graded classification scheme of intractability is needed, and must include a definition of failure, to which and how many treatments the patient has failed, the level of headache-related disability and, finally, the intended intervention (clinical or research) and intensity of the intervention. This paper addresses each of these variables with the intent of providing a graded classification scheme that can be used in defining intractability for clinical practice interventions and clinical research initiatives.
Excerpt: Defining Treatment Failure in Intractable Headache
Lipton and colleagues proposed several reasons why standard headache treatments fail, and these reasons should be considered in the clinical evaluation of patients with treatment-resistant headache.
- Diagnosis is incomplete or incorrect
- Exacerbating factors are unrecognized: medication overuse, psychological conditions; hormone factors. This requires ascertainment of these factors, and in certain circumstances (eg, overuse of acute headache pain medications) stratification based on the variable.
- Pharmacotherapy is inadequate: too low a dose; incorrect dose escalation; inadequate duration of treatment; wrong type of medication; non-compliance. This often, but not always, requires obtaining medical records or accurate diary information.
- Non-pharmacologic treatment in inadequate: cognitive and behavioral step interventions; lifestyle modifications including sleep-wake cycle, caffeine consumption, alcohol consumption, medications that may exacerbate the disorder (eg, phosphodiesterase inhibitors, nitrates). In clinical trials these interventions need to be standardized.
- Presence of risk factors or comorbid conditions: depression, obesity; anxiety; among others. Screening instruments are very useful for their identification.
- Unrealistic expectations.