Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro - UFRJ, Brazil.
Faculty of Pharmacy, Universidade Federal do Rio de Janeiro - UFRJ, Brazil.
Phytomedicine. 2019 May;58:152869. doi: 10.1016/j.phymed.2019.152869. Epub 2019 Feb 18.
The present randomized controlled clinical trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children.
Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatment (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.
At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children's sleep diary with parent's/guardian's perceptions of their children's sleep quality, the trait of anxiety scale (TAS) to identify changes in children's anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.
Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.
MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.
本随机对照临床试验评估了顺势疗法药物 Melissa officinalis（MO）、Phytolacca decandra（PD）及其组合治疗儿童疑似睡眠磨牙症（SB）的疗效。
根据父母对 SB 的报告，选择患者（n=52）（6.62±1.79 岁）。该研究采用交叉设计，包括 30 天治疗的 4 个阶段（安慰剂；MO 12c；PD 12c；和 MO 12c+PD 12c），每个阶段之间有 15 天的洗脱期。
在基线和每个阶段后，使用视觉模拟评分（VAS）作为主要结果测量，评估治疗对减少 SB 的影响。使用以下附加结果测量：儿童睡眠日记，记录父母/监护人对其儿童睡眠质量的看法；特质焦虑量表（TAS），以识别儿童焦虑特征的变化；以及不良反应报告。数据采用重复测量方差分析，然后进行事后 LSD 检验。
与基线相比（4.91±1.87），使用安慰剂（-1.72±0.29）、MO（-2.36±0.36）、PD（-1.44±0.28）和 MO+PD（-2.21±0.30）后，VAS 中 SB 的显著减少。MO 与 PD（p=0.018）和安慰剂（p=0.050）相比，结果更好，与 MO+PD（p=0.724）相比，结果相似。睡眠日记结果和 TAS 结果不受任何治疗的影响。治疗后未观察到不良反应。
MO 在治疗儿童疑似睡眠磨牙症方面显示出有希望的结果，而 PD 的联合使用并未改善 MO 的结果。
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