Efficacy of botulinum toxin in treating myofascial pain in bruxers: A controlled placebo pilot study
Efficacy of botulinum toxin in treating myofascial pain in bruxers: A controlled placebo pilot study
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DOI：
10.1179/crn.2008.017
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发表时间：
2008-04-01
影响因子：
1.6
通讯作者：
Ferronato, Giuseppe
中科院分区：
文献类型：
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作者：
Guarda-Nardini, Luca;Manfredini, Daniele;Ferronato, Giuseppe
本研究是一项初步的双盲、安慰剂对照、随机临床试验，随访期为六个月。该研究旨在评估A型肉毒杆菌毒素（Botox，Allergan，Inc. Irvine，CA）治疗肌筋膜疼痛症状并减少磨牙者的肌肉过度活跃。二十名临床诊断为磨牙症和咀嚼肌肌筋膜疼痛的患者（十名男性，十名女性;年龄范围25-45岁）参加了一项双盲、对照安慰剂、随机临床试验，其中包括治疗组（十名受试者接受肉毒杆菌毒素注射治疗- BTX-A）和对照组（十名受试者接受生理盐水安慰剂注射治疗）。在基线时间和1周、1个月和6个月随访时，评估了一些客观和主观临床参数（休息时和咀嚼时的疼痛;咀嚼效率;最大无辅助和辅助张口度、咀嚼和侧伸运动;常规下颌运动期间的功能限制;治疗的主观疗效;治疗耐受性）。描述性分析显示，肉毒杆菌治疗组的客观（下颌运动范围）和主观（休息时疼痛;咀嚼时疼痛）临床结果变量的改善高于安慰剂治疗组。接受BTX-A治疗的患者对治疗效果的主观改善程度高于安慰剂组。由于样本量较小，在某些情况下差异不显著。本研究的结果支持BTX-A减轻磨牙症患者肌筋膜疼痛症状的疗效，并提供了试验数据，需要通过更大样本的进一步研究来证实。
The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.