Response to BotulinumtoxinA in a migraine cohort with multiple comorbidities and widespread pain

Reg Anesth Pain Med. 2019 Jun;44(6):660-668. doi: 10.1136/rapm-2018-100196.


Background: The phase III research evaluating migraine prophylaxis therapy (PREEMPT) protocol was developed in low-risk migraine patients. We studied longitudinal response to treatment in a sequential retrospective observational cohort to evaluate predictors of effectiveness in patients with multiple overlapping pain syndromes treated in a quaternary pain management clinic.

Methods: We evaluated indicators of individual response in 402 consecutive chronic migraine patients who provided demographic information and used the Collaborative Health Outcomes Information Registry.

Results: The patients were middle aged 47 (38-56) median (IQR) years old and 83% women. They reported multiple complex pain problems with 11 (6-18) regions represented on a pain body map. Evaluated with National Institutes of Health Patient-Reported Outcomes Measurement Information System measures, they reported higher scores for sleep impairment and disturbance, anxiety, depression, fatigue, pain behavior, pain interference and worse function and satisfaction with social roles compared with the general US population; p<0.001 for all domains. Within 120 days of treatment, 62% of patients reported reduced headache frequency. The best multivariable model developed for prediction of reduced headache frequency in response to treatment included lower treatment number, lower pain interference score, and less depression (p=0.001, 0.002, and 0.009). Depression may have been an obstacle to successful treatment; there was no association between depression score and number of treatments (p=0.54).

Conclusions: Our findings point to the importance of identifying and addressing pain interference and depression early in chronic migraine management and, more broadly, highlights the importance of multidisciplinary evaluation and treatment in chronic migraine.

Keywords: PREEMPT; effectiveness trial; migraine; persistence of effect; risk factors.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anxiety
  • Botulinum Toxins, Type A / therapeutic use*
  • Cohort Studies
  • Comorbidity
  • Fatigue
  • Female
  • Headache
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / epidemiology*
  • Pain
  • Pain Measurement
  • Retrospective Studies


  • Botulinum Toxins, Type A