ArticleFrontiers in pharmacology2026
Trends and off-label use of botulinum toxin type A in Chinese neurological practice from 2016 to 2023: a real-world study.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
Background: Botulinum toxin type A (BoNT-A) is an effective therapeutic tool for various neurological conditions, but it is frequently prescribed off-label in clinical practice. Currently, real-world prescribing trends and off-label utilization in China remain unclear. This study aimed to describe the trends in BoNT-A use, analyze off-label prescribing patterns, and evaluate the supporting scientific evidence. Methods: In this retrospective study, prescription data were extracted to analyze patient demographics, monotherapy and co-prescribing therapy of BoNT-A, and trends in BoNT-A usage from 2016 to 2023. We categorized the prescriptions into on-label and off-label groups according to the indications approved by the National Medical Products Administration of China. Additionally, the scientific evidence supporting off-label indications was evaluated based on randomized controlled trials (RCTs). Results: Our study included 9,561 BoNT-A prescriptions from patients with a median age of 59 years. Of these, 35.82% (3,425) were off-label. Over the study period, the number of BoNT-A prescriptions and the proportion of off-label use generally increased. Most prescriptions were issued for dystonia or facial nerve disorders, accounting for 51.00% and 43.48%, respectively. BoNT-A monotherapy comprised 93.54% of prescriptions, whereas among polypharmacy regimens, antiepileptics were the most frequently prescribed comedications. The majority of off-label prescriptions were issued for extrapyramidal and movement disorders, with cervical dystonia being the most frequent specific indication. Based on RCT evidence, 89.99% of off-label prescriptions were evidence-supported, peaking within extrapyramidal and movement disorders. Conclusion: This study indicated that BoNT-A prescriptions and off-label prescribing increased in Chinese neurological practice. Although such off-label use was often evidence-supported, unsubstantiated utilization may still raise potential safety concerns, highlighting the need for continuing efforts to align regulatory approvals with evolving clinical practice.
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