Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjunctive lower facial injections in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial
Issued Date
2025-01-01
Resource Type
ISSN
07853890
eISSN
13652060
Scopus ID
2-s2.0-105011957000
Journal Title
Annals of Medicine
Volume
57
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Medicine Vol.57 No.1 (2025)
Suggested Citation
Eiamsamarng A., Chirapapaisan N., Chuenkongkaew W., Rattanathamsakul N., Joradoln M., Mukdar Y., Rueangcharin P. Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjunctive lower facial injections in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial. Annals of Medicine Vol.57 No.1 (2025). doi:10.1080/07853890.2025.2537921 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/111531
Title
Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjunctive lower facial injections in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial
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Abstract
Purpose: To evaluate the necessity of botulinum toxin A (BoNT-A) administration in the lower face of patients with hemifacial spasm (HFS). Methods: A randomized controlled non-inferiority crossover trial was conducted with 46 HFS patients (non-inferiority margin = 1). Patients were randomized (1:1) to receive either isolated periocular BoNT-A injections followed by conventional injections (periocular and lower face area) or the reverse sequence, with a 16-week washout. Primary outcomes were visual analog scale (VAS) for periocular and lower face regions at 4 weeks post injection. Secondary outcomes included the Hemifacial Spasm Grading Scale (HSGS), Samsung Medical Center grading system (SMC), HFS questionnaire (HFS-30), and adverse events. Trial registration: TCTR20220916002. Results: Data from 43 patients were analyzed. Isolated periocular injections demonstrated non-inferiority to conventional injections. Periocular VAS was 0.488 ± 0.140 (isolated injections) and 0.279 ± 0.085 (conventional) , mean difference 0.209 (95% CI: 0.064, 0.354, p<0.01). Lower face VAS was 0.878 ± 0.167 and 0.582 ± 0.113, mean difference 0.295 (95% CI: 0.039, 0.552, p<0.01). No significant differences were noted in HSGS, SMC, or HFS-30 scores. Minor adverse events were observed in both techniques, while mouth drooping occured only with conventional injections. Conclusion: Isolated periocular injections resulted in slightly poorer symptom relief but did not exceed the non-inferiority margin, providing comparable efficacy to conventional injections in controlling HFS while using a lower total toxin dose and minimizing adverse effects.