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Response to BotulinumtoxinA in a migraine cohort with multiple comorbidities and widespread pain
  1. Meredith Barad1,
  2. John Andrew Sturgeon1,
  3. Shannon Fish1,
  4. Franklin Dexter2,
  5. Sean Mackey1 and
  6. Pamela Dru Flood1
  1. 1 Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States
  2. 2 Anesthesia, University of Iowa, Iowa City, Iowa, USA
  1. Correspondence to Dr Pamela Dru Flood, Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA 94140, USA; pflood{at}stanford.edu

Abstract

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.

  • migraine
  • effectiveness trial
  • PREEMPT
  • risk factors
  • persistence of effect

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Footnotes

  • Contributors MB made substantial contributions to the conception, design, and the interpretation of data. She critically revised it for important intellectual content. She approves the final version and agrees to be accountable for the integrity of the work. JAS made substantial contributions to the conception, design, and the interpretation of data. He critically revised it for important intellectual content. He approves the final version and agrees to be accountable for the integrity of the work. SF made substantial contributions to the conception of the work. She critically revised it for important intellectual content. She approves the final version and agrees to be accountable for the integrity of the work. FD made substantial contributions to the interpretation of data. He critically revised it for important intellectual content. He approves the final version and agrees to be accountable for the integrity of the work. SM made substantial contributions to the interpretation of data. He critically revised it for important intellectual content. He approves the final version and agrees to be accountable for the integrity of the work. PDF made substantial contributions to the conception, design, and the interpretation of data. She critically revised it for important intellectual content. She approves the final version and agrees to be accountable for the integrity of the work.

  • Funding Intradepartmental, NIH K24DA029262 (SM), Redlich Pain Research Endowment (SM), T32DA035165 (JS).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the Stanford University Institutional Review board on August 6, 2013 (IRB#28435).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data are available upon reasonable request.