经颅直流电刺激治疗纤维肌痛的镇痛效果：临床疗效潜在影响因素的系统评价、荟萃分析和荟萃回归。
The Analgesic Effect of Transcranial Direct Current Stimulation in Fibromyalgia: A Systematic Review, Meta-Analysis, and Meta-Regression of Potential Influencers of Clinical Effect.
机构信息
MGH Institute of Health Professions, Boston, MA, USA; Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA.
Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.
出版信息
Neuromodulation. 2023 Jun;26(4):715-727. doi: 10.1016/j.neurom.2022.10.044. Epub 2022 Nov 23.
BACKGROUND
There is tentative evidence to support the analgesic effect of transcranial direct current stimulation (tDCS) in fibromyalgia (FM), with large variability in the effect size (ES) encountered in different clinical trials. Understanding the source of the variability and exploring how it relates to the clinical results could characterize effective neuromodulation protocols and ultimately guide care in FM pain. The primary objective of this study was to determine the effect of tDCS in FM pain as compared with sham tDCS. The secondary objective was to explore the relationship of methodology, population, and intervention factors and the analgesic effect of tDCS in FM.
MATERIALS AND METHODS
For the primary objective, a systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials (RCTs) investigating tDCS as an intervention for FM pain were searched in MEDLINE, Embase, and the Web Of Science. Studies were excluded if they used cross-over designs or if they did not use tDCS as an intervention for pain or did not measure clinical pain. Analysis for the main outcome was performed using a random-effects model. Risk of bias and evidence certainty were assessed for all studies using Cochrane Risk of Bias and Grading of Recommendations Assessment, Development, and Evaluation tools. For the secondary objective, a meta-regression was conducted to explore methodology, population, and intervention factors potentially related to the ES.
RESULTS
Sixteen RCTs were included. Six studies presented a high risk of bias. Significant reduction in pain scores were found for FM (standardized mean difference = 1.22, 95% CI = 0.80-1.65, p < 0.001). Subgroup analysis considering tDCS as a neural target revealed no differences between common neural sites. Meta-regression revealed that the duration of the tDCS protocol in weeks was the only factor associated with the ES, in which protocols that lasted four weeks or longer reported larger ES than shorter protocols.
CONCLUSIONS
Results suggest an analgesic effect of tDCS in FM. tDCS protocols that last four weeks or more may be associated with larger ESs. Definite conclusions are inadequate given the large heterogeneity and limited quality of evidence of the included studies.
背景
有初步证据支持经颅直流电刺激（tDCS）在纤维肌痛（FM）中的镇痛作用，但不同临床试验中遇到的效应大小（ES）存在很大差异。了解这种变异性的来源并探索其与临床结果的关系，可以确定有效的神经调节方案，并最终指导 FM 疼痛的护理。本研究的主要目的是确定 tDCS 与假刺激相比在 FM 疼痛中的作用。次要目的是探讨方法学、人群和干预因素与 tDCS 在 FM 中的镇痛效果的关系。
材料和方法
为了实现主要目标，根据系统评价和荟萃分析的首选报告项目进行了系统评价。在 MEDLINE、Embase 和 Web Of Science 中搜索了调查 tDCS 作为 FM 疼痛干预措施的随机临床试验（RCT）。如果研究采用交叉设计，或者不将 tDCS 用作疼痛干预措施，或者不测量临床疼痛，则将其排除在外。使用随机效应模型对主要结局进行分析。使用 Cochrane 风险偏倚评估和推荐评估、制定和评估工具评估所有研究的风险偏倚和证据确定性。为了实现次要目标，进行了荟萃回归分析，以探讨可能与 ES 相关的方法学、人群和干预因素。
结果
纳入了 16 项 RCT。六项研究存在高偏倚风险。FM 的疼痛评分显著降低（标准化均数差=1.22，95%置信区间=0.80-1.65，p<0.001）。考虑到 tDCS 作为神经靶点，亚组分析显示常见神经部位之间没有差异。荟萃回归显示，tDCS 方案的持续时间以周为单位是与 ES 相关的唯一因素，持续四周或更长时间的方案比持续时间较短的方案报告的 ES 更大。
结论
结果表明 tDCS 在 FM 中具有镇痛作用。持续四周或更长时间的 tDCS 方案可能与更大的 ES 相关。鉴于纳入研究的异质性大且证据质量有限，无法得出明确的结论。
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