Cochrane for Clinicians
Putting Evidence into Practice
OnabotulinumtoxinA for the Prevention of Chronic Migraine in Adults
Am Fam Physician. 2020 Feb 1;101(3):144-145.
Author disclosure: No relevant financial affiliations.
Is onabotulinumtoxinA (Botox) safe and effective at reducing the frequency of chronic migraine headaches in adults?
OnabotulinumtoxinA reduces the number of migraine days per month by two days compared with placebo in adults with chronic migraines. Nonserious adverse effects are more common in patients treated with onabotulinumtoxinA (number needed to harm [NNH] = 7; 95% CI, 4 to 17) than adverse effects overall (NNH = 7; 95% CI, 6 to 9).1 (Strength of Recommendation: A, based on consistent, good-quality patient-oriented evidence.)
Chronic migraine is defined as 15 or more headache days per month, with at least eight of those headaches being a migraine. In the United States, 26.2% of patients with chronic migraine vs. 13.9% of patients with episodic migraine (i.e., zero to 14 headache days per month) reported visiting a primary care physician in the preceding three months (P < .001).2 Many have frequent attacks despite available treatments and find themselves dependent on long-term opiate or barbiturate therapy. Although onabotulinumtoxinA is approved by the U.S. Food and Drug Administration for the treatment of chronic migraine, its effectiveness in the prevention of chronic migraine had not been evaluated previously.
This Cochrane review included 28 clinical trials (21 of which had fewer than 50 participants each) involving 4,190 participants who were an average age of 42 years.1 One-half of participants had chronic migraines, and 80% were female. Most of the trials lasted only a few months. The treatment regimen (dosage, timing, and exact placement of injections) of onabotulinumtoxinA varied across studies. Twenty-three trials compared onabotulinumtoxinA with placebo. Sixteen trials, which involved 80% of participants, were industry funded.
OnabotulinumtoxinA reduced the number of migraine days per month by 3.1 days in patients with chronic migraine (95% CI, 1.4 to 4.7; four trials; 1,497 participants; low-quality evi
1. Herd CP, Tomlinson CL, Rick C, et al. Botulinum toxins for the prevention of migraine in adults. Cochrane Database Syst Rev. 2018;(6):CD011616.
2. Stokes M, Becker WJ, Lipton RB, et al. Cost of health care among patients with chronic and episodic migraine in Canada and the USA: results from the International Burden of Migraine Study (IBMS). Headache. 2011;51(7):1058–1077.
3. National Institute for Health and Care Excellence. Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Technology appraisal guidance [TA260]. January 2016. Accessed September 3, 2018. https://www.nice.org.uk/guidance/ta260
This series is coordinated by Corey D. Fogleman, MD, assistant medical editor.
A collection of Cochrane for Clinicians published in AFP is available at https://www.aafp.org/afp/cochrane.
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