经皮神经电刺激（TENS）治疗成人急性和慢性疼痛的疗效和安全性：381 项研究的系统评价和荟萃分析（meta-TENS 研究）。

OBJECTIVE: To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Cochrane Central, Embase (and others) from inception to July 2019 and updated on 17 May 2020. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Randomised controlled trials (RCTs) comparing strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis. DATA EXTRACTION AND SYNTHESIS: Reviewers independently screened, extracted data and assessed risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development and Evaluation). Mean pain intensity and proportions of participants achieving reductions of pain intensity (≥30% or 50%) during or immediately after TENS. Random effect models were used to calculate standardised mean differences (SMD) and risk ratios. Subgroup analyses were related to trial methodology and characteristics of pain. RESULTS: The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=-0·96 (95% CI -1·14 to -0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = -0·72 (95% CI -0·95 to -0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild and not different to comparators. CONCLUSION: There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events. PROSPERO REGISTRATION NUMBER: CRD42019125054.

目的：探讨经皮神经电刺激（TENS）缓解成人疼痛的疗效和安全性。

设计：系统评价和荟萃分析。

资料来源：从创建到 2019 年 7 月的 Medline、Cochrane 中心、Embase（及其他）数据库，并于 2020 年 5 月 17 日更新。

研究选择的入选标准：比较疼痛部位或附近强无痛 TENS 与安慰剂或其他治疗成人疼痛的随机对照试验（RCT），无论诊断如何。

数据提取和综合：审查员独立筛选、提取数据并评估偏倚风险（Cochrane 工具）和证据确定性（分级和推荐、评估、发展和评估）。在 TENS 期间或之后立即测量平均疼痛强度和达到疼痛强度降低（≥30%或 50%）的参与者比例。使用随机效应模型计算标准化均数差值（SMD）和风险比。亚组分析与试验方法学和疼痛特征有关。

结果：该综述纳入了 381 项 RCT（24532 名参与者）。与安慰剂相比，TENS 期间或之后的疼痛强度较低（91 项 RCT，92 个样本，n=4841，SMD=-0.96（95%CI-1.14 至-0.78），中等确定性证据）。方法学（如 RoB、样本量）和疼痛特征（如急性与慢性、诊断）并没有改变这种效果。与作为标准护理一部分的药理学和非药理学治疗相比，TENS 期间或之后的疼痛强度较低（61 项 RCT，61 个样本，n=3155，SMD=-0.72（95%CI-0.95 至-0.50），低确定性证据）。由于对幅度估计的不精确性有小样本试验的贡献，因此证据水平被降级。数据有限，无法评估其他结局，包括不良反应，这些不良反应报告不佳，通常为轻度，与对照无差异。

结论：有中等确定性证据表明，与安慰剂相比，TENS 期间或之后的疼痛强度较低，且无严重不良事件。

PROSPERO 注册号：CRD42019125054。