Cochrane Review: What is the Evidence for the Prevention of Migraines Using Botulinum toxins?
BACKGROUND AND PURPOSE:
FDA has approved onabotulinumtoxinA as a preventative treatment for adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people ≥18 years of age
Mechanism not well understood
May inhibit release of neuropeptides that are involved in the initiation of the migraine
Herd et al. (Cochrane Library, 2018) examined how Botulinum toxin type A compares to active treatment for adults with chronic or episodic migraines
Systematic review and meta-analysis
Literature search of RCTs of botulinum toxin injections into the head and neck for prophylaxis of chronic or episodic migraine in adults
Studies were selected that compared as follows
Botulinum toxin vs. placebo
Botulinum toxin vs. other active treatment
Too avoid bias, two independent researchers selected trials and extracted data
GRADE methods used to assess result quality
90 articles describing 28 trials and 4,190 participants were included in the study
Botulinum toxin vs placebo
Botulinum toxin reduced the number of chronic migraine days per month by by 1.9 days (95% CI, -2.7 to -1.0, 2 trials, high-quality evidence)
Severity of migraines with botulinum was also reduced but larger trials required
Botulinum toxin groups had a greater risk for adverse events
Risk ratio (RR) 1.28, (95% CI 1.12 to 1.47; moderate-quality evidence)
Botulinum toxin vs other prophylactic agents
Individual trials reported no differences between groups for multiple efficacy measures
No difference was seen when comparing side effects to other oral treatments
Patients taking botulinum toxin were 4x less likely to stop their treatment due to adverse events compared to an alternative (P = 0.02, 2 trials, N = 119)
Botulinum toxin side effects were reported in approximately 60%, consisted mostly of droopy eyelid or muscle weakness (40% reported in placebo groups)
The quality of the evidence is limited
Botulinum toxin type A may reduce number of migraines in chronic migraine sufferers by 2 days a month
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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