ArticleAnnals of medicine2025
Efficacy of isolated periocular botulinum toxin A injections versus periocular and adjunctive lower facial injections in hemifacial spasm: a randomized, controlled, noninferiority, crossover trial.
Article in Annals of medicine, 2025. 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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7 authors.
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Abstract
purposeTo evaluate the necessity of botulinum toxin A (BoNT-A) administration in the lower face of patients with hemifacial spasm (HFS).
methodsA 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.
resultsData 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.
conclusionIsolated 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.
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