Table 2.
Characteristics of the single-arm studies (mean ± SD)
| Study | Study design | Region | Participant (M/F) | Age (years) | Disease duration (years) | Injection site | Type of BoNT | Dose (U) | Dosing interval (months) / Dose frequency | Follow-up duration |
|---|---|---|---|---|---|---|---|---|---|---|
| Rollnik et al., 2000 [25] | R | Germany | 21 (7/14) | 59.0 ± 12.9 | NR | Orbicularis oculi muscle | ② | (24 ± 6.2) *10–3 | 5 injections | 17 months |
| Defazio et al., 2002 [26] | R | Italian | 65 (19/46) | 50.0 ± 11.3 | NR | Orbicularis oculi muscle | ③ | 17.3 ± 7.9 | When symptoms reappear (3–4 injections) | 1 years |
| Hsiung et al., 2002 [27] | R | Canada | 70 (40/30) | 57 | NR | NR | ① | 29.4 | 3 | 2 years |
| Meena Gupta et al., 2003 [28] | R | India | 62 (29/33) | 46.5 ± 7.12 | 6.2 ± 1.2 | Orbicularis oculi, mentalis, platysma | ② | 142.5 ± 6.2 | 3 | 3.7 years |
| Au et al., 2004 [29] | R | Asian countries | 137 (49/91) | NR | 5 | NR | NR | NR | NR | 1 month |
| Poonyathalang et al., 2005 [30] | R | Thailand | 26 | 56.7 | 3 | 0rbicularis oculi, Perioral muscles | ①④ | 7.5—12.5 | 3—4 | 13.6 months |
| Ortisi et al., 2006 [31] | R | UK | 60 | NR | NR | Orbicularis oculi muscle | NR | 20 | 3—4 | 49 months |
| Mohammadi et al., 2009 [32] | R | Germany | 19 (5/9) | 69 ± 12 | NR | Orbicularis oculi, Perioral muscles | ②⑤ | 25 ± 12 | NR | NR |
| Barbosa et al., 2010 [33] | R | Brazil | 54 (13/41) | 48.3 ± 10.8 | NR | The muscles around the eye, mouth and chin | ⑥ | 34.47—37.61 | 3 | 5.88 years |
| Rudzinska et al., 2010 [17] | R | Poland | 56 (21/35) | 60 ± 11 | 10.8 ± 5.8 | Orbicularis oculi, lower part and the upper part of the face | ②⑥ | 120 U of Dysport or 25 U of Botox | 3 injections | 2 weeks and 14 weeks |
| Kollewe et al., 2010 [34] | R | Germany | 97 | Range: 37—98 | NR | Orbicularis oculi of the upper, lower eyelid, the zygomaticus major, buccinator, corrugator or frontalis muscles | ②⑥ | (22 ± 10) *10–3 | 3 injections | NR |
| A. Çoban et al., 2012 [35] | R | Turkey | 92 (42/50) | 60 ± 12 | 8 ± 4 | NR | ②⑥ | 25—135 | NR | 4 years |
| Wang et al., 2014 [36] | R | China | 665 (238/427) | 46.6 ± 11.5 | 7.1 ± 6.2 | Orbicularis oculi, zygomaticus major, nasalis, and mentalis, orbicularis oris, rizorius and platysma | ① | 10—100 | NR | NR |
| Ababneh et al., 2014 [37] | R | Turkey | 11 | 59.7 ± 12.5 | 5.6 ± 7.2 | NR | ⑥ | 28.1 ± 8.7 | 3.5 injections | 14 ± 3.1 |
| Sorgun et al., 2015 [38] | R | Turkey, Germany | 68 (31/37) | 63.1 | NR | Orbicularis oculi or Perioral muscles | ②⑥ | 34.5 | ≥ 2 injections | NR |
| Choe et al., 2016 [39] | R | Korea | 26 (21/5) | 61.8 ± 14.6 | NR | The frontalis, procerus, corrugator, perioral area of the orbicularis oris, levator labii superioris, depressor anguli oris, and periocular | ②⑥ | 28.6 ± 4.9 | NR | NR |
| Koyuncuoğlu et al., 2016 [40] | R | USA | 70 (26/44) | 61.6 ± 13.2 | NR | NR | ⑥ | 15.7 ± 4.80 | ≥ 2 injections | 3.2 years |
| Batisti et al., 2017 [41] | R | Paraguay | 100 (28/72) | 63.1 ± 12.4 | NR | Orbicularis oculi, procerus, corrugator supercilii, risorius, orbicularis oris, and platysma muscles | ② | 28 ± 8.6 | 5.8 months | 2.6 years |
| Pandey et al., 2018 [42] | R | India | 34 (17/17) | 43.7 ± 12.2 | 4.8 ± 3.3 | NR | ① | 21 | 1–5 injections | 2 years |
| Gutierrez et al., 2021 [43] | R | Philippines | 162 | 47.7 ± 10.7 | 12.7 ± 5.8 | NR | ②⑥ | 17.9 ± 4.52 or 60.9 ± 9.13 | 6 ± 5 months | 2.96 years |
| Herrero-Infante et al., 2021 [10] | R | Spain | 125 (33/92) | 58.63 ± 15.4 | 6.7 ± 4.3 | NR | ⑥ | 21.53 ± 11.74 | > 3 injections | 10.45 years |
| Yahalom et al., 2022 [44] | R | Israel | 12 (5/7) | 56.6 ± 16.3 | 6.8 ± 11.6 | NR | ⑦ | 18.9 ± 12.8 | When symptoms reappear | NR |
| Tian, S et al., 2024 [45] | R | China | 118 (45/73) | 54.2 ± 11.95 | 0.08—20 | Orbicularis oculi, frontalis, orbicularis oris, and platysma | ① | 1–5 | NR | 2–4 weeks |
| Suputtitada et al., 2004 [46] | P | Thailand | 112 (41/71) | 45 ± 11.1 | 3.4 + 3.1 | Orbicularis occuli, orbicularis oris, zygomaticus, nasalis, mentalis, platysma, frontalis, corrugator | ⑥ | 25 ± 0.6 | 3 months | 4 weeks |
| Tunç et al., 2008 [47] | P | Turkey | 46 (20/26) | 54.4 ± 12.4 | 35.4 ± 23.6 | NR | ⑥ | NR | NR | NR |
| Cillino et al., 2010 [48] | P | Italy, France | 58 (21/37) | 71.7 ± 11.4 | 13.3 ± 8.8 | NR | ⑥ | 18.7 ± 9.4 | NR | 10 years |
| Rudzińska et al., 2012 [49] | R | Poland | 85 (27/58) | 60.8 ± 10.3 | 7.1 ± 5.1 | the five standard locations within the face | ⑥ | NR | NR | 2 / 12 weeks |
| Gürsoy et al., 2013 [50] | R | Turkey | 53 (13/40) | 58.0 ± 11.9 | 8.1 ± 5.3 | 3 or 5 sites in the pretarsal regions of the orbicularis oculi muscle | ⑥ | 21.10 ± 6.66 | 5.82 injections | 3 months / 4 weeks |
| Weiss et al., 2017 [51] | R | Germany | 73 (32/41) | 65.2 ± 10.4 | 9.0 ± 6.3 | NR | ②⑥⑧ | 26.3 ± 10.4 | NR | NR |
| Dong et al., 2019 [52] | R | China | 90 (36/54) | 52.3 ± 9.5 | NR | frontalis, orbicularis oculi, zygomaticus, temporalis, buccinator, masseter muscle, levator labii superioris, and mentalis | ⑨ | 33 – 66 | 1 – 2 weeks | 2 months |
| Yuksel et al., 2019 [53] | P | Turkey | 40 (19/21) | NR | NR | NR | NR | NR | NR | 4 weeks |
| Wei et al., 2022 [54] | R | China | 65 (27/38) | 54.7 ± 11.8 | NR | Orbicularis oculi muscle, zygomatic muscle, orbicularis oris muscle, and mental muscle of the affected side | ⑨ | NR | NR | 2 months |
| Trashin, A. V et al., 2023 [55] | R | Russia | 14 (4/10) | 58.07 | 5.6 | NR | NR | NR | NR | NR |
Type of BoNT: ①Botulinum toxin type A; ②Botulinum toxin type A (Dysport®); ③Botulinum toxin type A (Allergan, Irvine, Calif); ④Botulinum toxin A (Botox, Allergan, Irvine, CA, USA); ⑤Botulinum toxin type A (ASBTA); ⑥Botulinum toxin Type A (BOTOX®); ⑦Incobotulinumtoxin A (Xeomin®, INCO);⑧Botulinum toxin Type A (Xeomin®); ⑨BTX-A dry powder (Hengli, Lanzhou Institute of Biological Products, Lanzhou, China)
R Retrospective single-arm study, P Prospective single-arm study, GCI global clinical improvement, NR not reported, SE subjective evaluation, VAS visual analog scale