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在治疗颞下颌关节紊乱相关疼痛中,咬合稳定器的治疗效果是否不仅仅是安慰剂效应?一项随机临床试验的网络荟萃分析。

Is the therapeutic effect of occlusal stabilization appliances more than just placebo effect in the management of painful temporomandibular disorders? A network meta-analysis of randomized clinical trials.

机构信息

Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Thamar, Yemen.

Consultant, Oral and Maxillofacial Surgery, King Abdulaziz Medical City - National Guard, Riyadh, Saudi Arabia.

出版信息

J Prosthet Dent. 2021 Jul;126(1):24-32. doi: 10.1016/j.prosdent.2020.08.015. Epub 2020 Oct 16.

DOI:10.1016/j.prosdent.2020.08.015
PMID:33070972
Abstract

STATEMENT OF PROBLEM

Occlusal devices, particularly the stabilization appliances, have been commonly used as treatment for painful temporomandibular disorders (TMDs). However, the mechanisms of action of these devices are still unclear, including the role of the placebo effect in the pain management.

PURPOSE

The purpose of this network meta-analysis was to identify to what extent the degree of efficacy of stabilization appliances in the management of painful TMDs arises from the placebo effect only or whether it arises chiefly from an actual effect.

MATERIAL AND METHODS

An electronic search was undertaken to identify randomized clinical trials (RCTs) published up to April 2020, comparing the efficacy of the stabilization appliances in patients with painful temporomandibular disorders, with nonoccluding appliances (active placebo), and untreated controls (passive placebo). Outcome variables were pain intensity at follow-ups, the proportion of participants reporting pain improvement, and the number needed to treat. The quality of evidence was rated as per the Cochrane tool for assessing risk of bias. Mean difference was used to analyze via frequentist network meta-analysis by using the STATA software program.

RESULTS

Treatment with stabilization appliances showed a significant reduction in pain intensity when compared with the other groups; but, the lower pain intensity at follow-ups in favor of stabilization appliances when compared with nonoccluding appliances was not statistically significant. However, a significantly higher number of participants reported pain improvement after treatment with stabilization appliances when compared with those treated with nonoccluding appliances or untreated participants.

CONCLUSIONS

This network meta-analysis showed no significant difference in reported pain intensity at follow-ups between the treatment of painful TMDs with stabilization appliances or nonoccluding appliances (active placebo). However, a significant difference in participants reporting treatment satisfaction with reduced pain, and a significantly lower number needed to treat in favor of stabilization appliances were found. Patient-reported treatment satisfaction probably included more domains than just pain intensity, such as improvements in physical functioning and psychosocial factors, and deserves further investigation. The authors concluded that stabilization appliances treatment efficacy is beyond the placebo effect.

摘要

问题陈述

咬合装置,特别是稳定装置,已被广泛用作治疗疼痛性颞下颌关节紊乱(TMD)的方法。然而,这些装置的作用机制尚不清楚,包括安慰剂效应在疼痛管理中的作用。

目的

本网络荟萃分析的目的是确定稳定装置在治疗疼痛性 TMD 中的疗效在多大程度上仅来自安慰剂效应,或者主要来自实际效果。

材料和方法

进行电子检索,以确定截至 2020 年 4 月发表的比较疼痛性颞下颌关节紊乱患者使用稳定装置与非咬合装置(活性安慰剂)和未治疗对照组(被动安慰剂)疗效的随机临床试验(RCT)。结局变量为随访时的疼痛强度、报告疼痛改善的参与者比例以及需要治疗的人数。根据 Cochrane 评估偏倚风险工具对证据质量进行评级。使用 STATA 软件程序通过频率主义网络荟萃分析分析均数差值。

结果

与其他组相比,使用稳定装置治疗可显著降低疼痛强度;但是,与非咬合装置相比,稳定装置在随访时疼痛强度较低,但无统计学意义。然而,与使用非咬合装置或未治疗的参与者相比,使用稳定装置治疗的参与者报告疼痛改善的人数明显更多。

结论

本网络荟萃分析显示,治疗疼痛性 TMD 时使用稳定装置或非咬合装置(活性安慰剂)在随访时报告的疼痛强度无显著差异。然而,发现报告治疗满意度(疼痛减轻)存在显著差异,并且稳定装置的需要治疗人数明显更低。患者报告的治疗满意度可能包括疼痛强度以外的更多方面,例如身体功能和社会心理因素的改善,值得进一步研究。作者得出结论,稳定装置的治疗效果不仅仅是安慰剂效应。

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