Sunday, October 09, 2011

Botox reduces the impact of chronic migraine

This article summarizes data supporting the use of "botox" for migraine treatment. JR

Neurology. 2011 Sep 28. [Epub ahead of print]

OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine.


From the Albert Einstein College of Medicine (R.B.L., B.G.), Bronx; Montefiore Headache Center (R.B.L., B.G.), Bronx, NY; Allergan, Inc. (S.F.V., R.E.D., C.C.T.), Irvine, CA; Associated Neurologists of Southern Connecticut (P.J.M.), Fairfield, CT; Baylor University Medical Center (F.F.), Dallas, TX; Swedish Neuroscience Institute (S.K.A.), Seattle, WA; Mayo Clinic Arizona (D.W.D.), Phoenix; Thomas Jefferson University (S.D.S.), Philadelphia, PA; University of Essen (H.C.D.), Essen, Germany; and Imprint Publication Science (M.E.N.), New York, NY.



To assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM).


The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered "following the pain." Prespecified analysis of headache impact (Headache Impact Test [HIT]-6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here.


A total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001).


Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL.Classification of evidence:This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.
[PubMed - as supplied by publisher]

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