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Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical
Maria Tiziana Corasaniti1, Giacinto Bagetta2, Pierluigi Nicotera3
1Department of Health Sciences, University "Magna Graecia" of Catanzaro, 88100 Catanzaro, Italy.
Abstract:
Some 14% of global prevalence, based on high-income country populations, suffers from migraine. Chronic migraine is very disabling, being characterized by at least 15 headache days per month of which at least 8 days present the features of migraine. Onabotulinumtoxin A, targeting the machinery for exocytosis of neurotransmitters and neuropeptides, has been approved for use in chronic migraine since 2010. This systematic review and meta-analysis appraises the safety of onabotulinumtoxin A treatment for chronic migraine and the occurrence of treatment-related adverse events (TRAEs) in randomized, clinical studies in comparison with placebo or other comparators and preventative treatments according to the most updated Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 recommendations. The search retrieved 888 total records. Nine studies are included and seven were eligible for meta-analysis. The present study demonstrates that toxin produces more TRAEs than placebo, but less than oral topiramate, supporting the safety of onabotulinumtoxin A, and highlights the heterogeneity of the studies present in the literature (I2 = 96%; p < 0.00001). This points to the need for further, adequately powered, randomized clinical trials assessing the safety of onabotulinumtoxin A in combination with the newest treatment options.
Insights
Onabotulinumtoxin A is a safe treatment for chronic migraine, causing fewer adverse events than topiramate. Further research is needed due to study heterogeneity.
Area of Science:
- Neurology
- Pharmacology
Background:
- Chronic migraine affects 14% globally, causing significant disability.
- Onabotulinumtoxin A has been approved for chronic migraine since 2010.
Approach:
- Systematic review and meta-analysis of randomized clinical studies.
- Evaluated safety and treatment-related adverse events (TRAEs) compared to placebo and other treatments.
- Followed PRISMA 2020 guidelines, analyzing 888 records and including 9 studies (7 for meta-analysis).
Key Points:
- Onabotulinumtoxin A demonstrated more TRAEs than placebo but fewer than oral topiramate.
- Significant heterogeneity was observed across studies (I² = 96%, p < 0.00001).
Conclusions:
- Onabotulinumtoxin A exhibits a favorable safety profile for chronic migraine management.
- The heterogeneity highlights the need for more robust, adequately powered clinical trials.
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