Jitpimolmard Suthipun, Thinkhamrop Bandit, Tiamkao Somsak, Arunpongpaisal Suwanna, Arayavichanon Preeda, Kosuwan Weerachai, Jitpimolmard Siriya, Sawanyawisuth Kittisak
Department of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand.
Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand.
Adv Ther. 2022 May;39(5):2025-2034. doi: 10.1007/s12325-022-02077-6. Epub 2022 Mar 10.
Hemifacial spasm (HFS) is a condition causing poor quality of life. Treatment with botulinum toxin A (BTX) injection is effective. Only one randomized controlled trial with a single-blind fashion has evaluated if oral injection is needed in HFS. The present study aimed to evaluate the necessity of oral BTX injection in HFS by a randomized, double-blind, placebo-controlled method.
We conducted a double-blind, placebo-controlled trial in patients with HFS who never received BTX treatment. Eligible patients randomly received either 15 units of BTX around the eye and normal saline around the mouth (group A) or 15 units of BTX around both the eye and the mouth (group B). The primary outcomes were self-reported symptoms and observed frequency of spasms, while the secondary outcome was the duration of improvement or the time between the injection and the recurrence of symptoms to the same condition as before treatment. Student t test and survival analyses were used to compare the duration of symptoms between both groups. The mean changes were compared to secondary outcomes between the two groups.
There were 60 patients enrolled, half in each group. Baseline characteristics between both groups were similar. The mean (SD) of the duration of improvement in group A and B was 22.97 (18.85) and 17.53 (14.90) weeks, respectively (p = 0.220). There was no difference between both groups by survival analysis. Group B had a higher percentage of mouth improvement but there was no difference in the percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm. Group B had a higher incidence of side effects particularly mouth drooping (30% vs 10%) than group A (p = 0.053).
The mouth injection of BTX may not be necessary for HFS. It may be beneficial to reduce mouth symptoms with a higher rate of mouth drooping.
面肌痉挛（HFS）是一种会导致生活质量下降的疾病。肉毒杆菌毒素A（BTX）注射治疗有效。仅有一项单盲随机对照试验评估了面肌痉挛是否需要进行口腔注射。本研究旨在通过随机、双盲、安慰剂对照方法评估面肌痉挛口腔注射BTX的必要性。
我们对从未接受过BTX治疗的面肌痉挛患者进行了一项双盲、安慰剂对照试验。符合条件的患者随机接受眼部周围注射15单位BTX且口腔周围注射生理盐水（A组）或眼部和口腔周围均注射15单位BTX（B组）。主要结局是自我报告的症状和观察到的痉挛频率，次要结局是改善持续时间或注射至症状复发至治疗前相同状态的时间。采用学生t检验和生存分析比较两组症状持续时间。将两组的平均变化与次要结局进行比较。
共纳入60例患者，每组30例。两组的基线特征相似。A组和B组改善持续时间的平均值（标准差）分别为22.97（18.85）周和17.53（14.90）周（p = 0.220）。生存分析显示两组之间无差异。B组口腔改善的百分比更高，但眼部改善的百分比、眼部和口腔痉挛的视觉模拟评分或眼部和口腔痉挛的频率无差异。B组的副作用发生率，尤其是口角下垂发生率（30%对10%）高于A组（p = 0.053）。
面肌痉挛可能无需进行口腔注射BTX。减少口腔症状可能有益，但口角下垂发生率较高。
