PDF(Pubmed)
Abstract：
Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological treatment that works by delivering electrical currents via electrodes attached to the skin at the site of pain. It can be an alternative to pharmacological treatments. The mechanism of action of TENS for pain relief is related to the inhibition of the transmission of painful stimuli, release of endogenous opioids, and reduced muscle ischaemia of the uterus. Although it has been used for primary dysmenorrhoea ((PD); period pain or menstrual cramps), evidence of the efficacy and safety of high-frequency TENS, low-frequency TENS, or other treatments for PD is limited.
To evaluate the effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) in comparison with placebo, no treatment, and other treatments for primary dysmenorrhoea (PD).
We searched the Gynaecology and Fertility Group\'s Specialized Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, and the Korean and Chinese language databases up to 9 April 2024. We also searched for ongoing trials in trials registries and the reference lists of relevant studies for additional trials. Language restrictions were not applied.
We included randomized controlled trials (RCTs) that included women (aged 12 to 49 years) with PD. Included trials compared low-frequency TENS or high-frequency TENS with other TENS, placebo, or other treatment.
Four review authors screened the trials, extracted the data according to the protocol, assessed the risk of bias using RoB 2, and assessed the certainty of evidence for all review comparisons and primary outcomes (i.e. pain relief and adverse effects) using the GRADE approach.
This review replaces the current review, published in 2009. We included 20 RCTs involving 585 randomized women with high-frequency TENS, low-frequency TENS, placebo or no treatment, or other treatment. We included five comparisons: high-frequency TENS versus placebo or no treatment, low-frequency TENS versus placebo or no treatment, high-frequency TENS versus low-frequency TENS, high-frequency TENS versus other treatments, and low-frequency TENS versus other treatments. High-frequency TENS versus placebo or no treatment High-frequency TENS may reduce pain compared with placebo or no treatment (mean difference (MD) -1.39, 95% confidence interval (CI) -2.51 to -0.28; 10 RCTs, 345 women; low-certainty evidence; I2 = 88%). Two out of three RCTs reported no adverse effects and hence we were unable to estimate the effect of high-frequency TENS on adverse effects. Low-frequency TENS versus placebo or no treatment Low-frequency TENS may reduce pain compared with placebo or no treatment (MD -2.04, 95% CI -2.95 to -1.14; 3 RCTs, 645 women; low-certainty evidence; I2 = 0%). No trials reported adverse effects for this comparison. High-frequency TENS versus low-frequency TENS It is uncertain whether high-frequency TENS had an effect on pain relief compared with low-frequency TENS (MD 0.89, 95% CI -0.19 to 1.96; 3 RCTs, 54 women; low-certainty evidence; I2 = 0%). One trial contributed data on adverse effects but no adverse events occurred. High-frequency TENS versus other treatments It is uncertain whether high-frequency TENS had an effect on pain relief compared to acupressure (MD -0.66, 95% CI -1.72 to 0.40; 1 RCT, 18 women; very low-certainty evidence), acetaminophen (paracetamol) (MD -0.98, 95% CI -3.30 to 1.34; 1 RCT, 20 women; very low-certainty evidence), and interferential current therapy (MD -0.03, 95% CI -1.04 to 0.98; 2 RCTs, 62 women; low-certainty evidence; I2 = 0%). The occurrence of adverse effects may not differ significantly between high-frequency TENS and NSAIDs (OR 12.06, 95% CI 0.26 to 570.62; 2 RCTs, 88 women; low-certainty evidence; I2 = 78%). Low-frequency TENS versus other treatments It is uncertain whether low-frequency TENS had an effect on pain relief compared with acetaminophen (MD -1.48, 95% CI -3.61 to 0.65; 1 RCT, 20 women; very low-certainty evidence). No trials reported adverse effects for this comparison.
High-frequency TENS and low-frequency TENS may reduce pain compared with placebo or no treatment. We downgraded the certainty of the evidence because of the risk of bias. Future RCTs should focus more on secondary outcomes of this review (e.g. requirement for additional analgesics, limitation of daily activities, or health-related quality of life) and should be designed to ensure a low risk of bias.
To evaluate the effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) in comparison with placebo, no treatment, and other treatments for primary dysmenorrhoea (PD).
We searched the Gynaecology and Fertility Group\'s Specialized Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, and the Korean and Chinese language databases up to 9 April 2024. We also searched for ongoing trials in trials registries and the reference lists of relevant studies for additional trials. Language restrictions were not applied.
We included randomized controlled trials (RCTs) that included women (aged 12 to 49 years) with PD. Included trials compared low-frequency TENS or high-frequency TENS with other TENS, placebo, or other treatment.
Four review authors screened the trials, extracted the data according to the protocol, assessed the risk of bias using RoB 2, and assessed the certainty of evidence for all review comparisons and primary outcomes (i.e. pain relief and adverse effects) using the GRADE approach.
This review replaces the current review, published in 2009. We included 20 RCTs involving 585 randomized women with high-frequency TENS, low-frequency TENS, placebo or no treatment, or other treatment. We included five comparisons: high-frequency TENS versus placebo or no treatment, low-frequency TENS versus placebo or no treatment, high-frequency TENS versus low-frequency TENS, high-frequency TENS versus other treatments, and low-frequency TENS versus other treatments. High-frequency TENS versus placebo or no treatment High-frequency TENS may reduce pain compared with placebo or no treatment (mean difference (MD) -1.39, 95% confidence interval (CI) -2.51 to -0.28; 10 RCTs, 345 women; low-certainty evidence; I2 = 88%). Two out of three RCTs reported no adverse effects and hence we were unable to estimate the effect of high-frequency TENS on adverse effects. Low-frequency TENS versus placebo or no treatment Low-frequency TENS may reduce pain compared with placebo or no treatment (MD -2.04, 95% CI -2.95 to -1.14; 3 RCTs, 645 women; low-certainty evidence; I2 = 0%). No trials reported adverse effects for this comparison. High-frequency TENS versus low-frequency TENS It is uncertain whether high-frequency TENS had an effect on pain relief compared with low-frequency TENS (MD 0.89, 95% CI -0.19 to 1.96; 3 RCTs, 54 women; low-certainty evidence; I2 = 0%). One trial contributed data on adverse effects but no adverse events occurred. High-frequency TENS versus other treatments It is uncertain whether high-frequency TENS had an effect on pain relief compared to acupressure (MD -0.66, 95% CI -1.72 to 0.40; 1 RCT, 18 women; very low-certainty evidence), acetaminophen (paracetamol) (MD -0.98, 95% CI -3.30 to 1.34; 1 RCT, 20 women; very low-certainty evidence), and interferential current therapy (MD -0.03, 95% CI -1.04 to 0.98; 2 RCTs, 62 women; low-certainty evidence; I2 = 0%). The occurrence of adverse effects may not differ significantly between high-frequency TENS and NSAIDs (OR 12.06, 95% CI 0.26 to 570.62; 2 RCTs, 88 women; low-certainty evidence; I2 = 78%). Low-frequency TENS versus other treatments It is uncertain whether low-frequency TENS had an effect on pain relief compared with acetaminophen (MD -1.48, 95% CI -3.61 to 0.65; 1 RCT, 20 women; very low-certainty evidence). No trials reported adverse effects for this comparison.
High-frequency TENS and low-frequency TENS may reduce pain compared with placebo or no treatment. We downgraded the certainty of the evidence because of the risk of bias. Future RCTs should focus more on secondary outcomes of this review (e.g. requirement for additional analgesics, limitation of daily activities, or health-related quality of life) and should be designed to ensure a low risk of bias.
摘要：
背景：经皮神经电刺激（TENS）是一种非药物治疗，通过在疼痛部位附着于皮肤的电极传递电流。它可以替代药物治疗。TENS缓解疼痛的作用机制与抑制疼痛刺激的传递有关，内源性阿片类药物的释放，减少子宫的肌肉缺血。尽管它已用于原发性痛经（（PD）;经期疼痛或月经来潮），高频TENS的有效性和安全性的证据，低频TENS,或其他治疗PD是有限的。
目的：为了评估经皮神经电刺激（TENS）与安慰剂的有效性和安全性，没有治疗,和其他治疗原发性痛经（PD）。
方法：我们搜索了妇科和生育组的对照试验专业注册，中部,MEDLINE,Embase,PsycINFO,AMED,CINAHL,以及截至2024年4月9日的韩语和中文数据库。我们还在试验登记处和相关研究的参考列表中搜索了正在进行的试验，以获得更多试验。未应用语言限制。
方法：我们纳入了随机对照试验（RCT），其中包括患有PD的女性（12至49岁）。纳入试验将低频TENS或高频TENS与其他TENS进行了比较，安慰剂,或其他治疗。
方法：四位综述作者筛选了试验，根据协议提取数据，使用RoB2评估偏倚风险,并使用GRADE方法评估所有综述比较和主要结局(即疼痛缓解和不良反应)的证据确定性.
结果：此评论取代了当前的评论，2009年发表。我们纳入了20项RCT，涉及585名具有高频TENS的随机女性，低频TENS,安慰剂或不治疗，或其他治疗。我们包括五个比较：高频TENS与安慰剂或不治疗，低频TENS与安慰剂或不治疗，高频TENS与低频TENS，高频TENS与其他治疗相比，和低频TENS与其他治疗。与安慰剂或不治疗相比，高频TENS可以减轻疼痛（平均差异（MD）-1.39，95％置信区间（CI）-2.51至-0.28；10项随机对照试验，345名女性；低确定性证据；I2=88%）。三个RCT中有两个报告没有不良反应，因此我们无法估计高频TENS对不良反应的影响。低频TENS与安慰剂或无治疗相比，低频TENS可以减轻疼痛与安慰剂或无治疗相比（MD-2.04，95％CI-2.95至-1.14；3项随机对照试验，645名女性；低确定性证据；I2=0%）。没有试验报道这种比较的不良反应。高频TENS与低频TENS相比，不确定高频TENS是否对疼痛缓解有影响（MD0.89，95％CI-0.19至1.96；3项RCT，54名女性；低确定性证据；I2=0%）。一项试验提供了有关不良反应的数据，但未发生不良事件。高频TENS与其他治疗相比，不确定高频TENS与穴位按压相比是否对疼痛缓解有影响（MD-0.66，95％CI-1.72至0.40；1个RCT，18名女性；非常低的确定性证据)，对乙酰氨基酚（扑热息痛）（MD-0.98，95％CI-3.30至1.34；1RCT，20名女性；确定性非常低的证据)，和干扰电流治疗(MD-0.03，95%CI-1.04至0.98；2项随机对照试验，62名女性；低确定性证据；I2=0%）。不良反应的发生在高频TENS和NSAIDs之间没有显着差异（OR12.06，95％CI0.26至570.62；2个随机对照试验，88名女性；低确定性证据；I2=78%）。低频TENS与其他治疗相比，不确定低频TENS与对乙酰氨基酚相比是否对疼痛缓解有影响（MD-1.48，95％CI-3.61至0.65；1RCT，20名女性；确定性非常低的证据)。没有试验报道这种比较的不良反应。
结论：与安慰剂或不治疗相比，高频TENS和低频TENS可以减轻疼痛。由于存在偏差的风险，我们降低了证据的确定性。未来的随机对照试验应更多地关注本综述的次要结果（例如，对额外镇痛药的要求，限制日常活动，或与健康相关的生活质量），并且应设计为确保低偏倚风险。
目的：为了评估经皮神经电刺激（TENS）与安慰剂的有效性和安全性，没有治疗,和其他治疗原发性痛经（PD）。
方法：我们搜索了妇科和生育组的对照试验专业注册，中部,MEDLINE,Embase,PsycINFO,AMED,CINAHL,以及截至2024年4月9日的韩语和中文数据库。我们还在试验登记处和相关研究的参考列表中搜索了正在进行的试验，以获得更多试验。未应用语言限制。
方法：我们纳入了随机对照试验（RCT），其中包括患有PD的女性（12至49岁）。纳入试验将低频TENS或高频TENS与其他TENS进行了比较，安慰剂,或其他治疗。
方法：四位综述作者筛选了试验，根据协议提取数据，使用RoB2评估偏倚风险,并使用GRADE方法评估所有综述比较和主要结局(即疼痛缓解和不良反应)的证据确定性.
结果：此评论取代了当前的评论，2009年发表。我们纳入了20项RCT，涉及585名具有高频TENS的随机女性，低频TENS,安慰剂或不治疗，或其他治疗。我们包括五个比较：高频TENS与安慰剂或不治疗，低频TENS与安慰剂或不治疗，高频TENS与低频TENS，高频TENS与其他治疗相比，和低频TENS与其他治疗。与安慰剂或不治疗相比，高频TENS可以减轻疼痛（平均差异（MD）-1.39，95％置信区间（CI）-2.51至-0.28；10项随机对照试验，345名女性；低确定性证据；I2=88%）。三个RCT中有两个报告没有不良反应，因此我们无法估计高频TENS对不良反应的影响。低频TENS与安慰剂或无治疗相比，低频TENS可以减轻疼痛与安慰剂或无治疗相比（MD-2.04，95％CI-2.95至-1.14；3项随机对照试验，645名女性；低确定性证据；I2=0%）。没有试验报道这种比较的不良反应。高频TENS与低频TENS相比，不确定高频TENS是否对疼痛缓解有影响（MD0.89，95％CI-0.19至1.96；3项RCT，54名女性；低确定性证据；I2=0%）。一项试验提供了有关不良反应的数据，但未发生不良事件。高频TENS与其他治疗相比，不确定高频TENS与穴位按压相比是否对疼痛缓解有影响（MD-0.66，95％CI-1.72至0.40；1个RCT，18名女性；非常低的确定性证据)，对乙酰氨基酚（扑热息痛）（MD-0.98，95％CI-3.30至1.34；1RCT，20名女性；确定性非常低的证据)，和干扰电流治疗(MD-0.03，95%CI-1.04至0.98；2项随机对照试验，62名女性；低确定性证据；I2=0%）。不良反应的发生在高频TENS和NSAIDs之间没有显着差异（OR12.06，95％CI0.26至570.62；2个随机对照试验，88名女性；低确定性证据；I2=78%）。低频TENS与其他治疗相比，不确定低频TENS与对乙酰氨基酚相比是否对疼痛缓解有影响（MD-1.48，95％CI-3.61至0.65；1RCT，20名女性；确定性非常低的证据)。没有试验报道这种比较的不良反应。
结论：与安慰剂或不治疗相比，高频TENS和低频TENS可以减轻疼痛。由于存在偏差的风险，我们降低了证据的确定性。未来的随机对照试验应更多地关注本综述的次要结果（例如，对额外镇痛药的要求，限制日常活动，或与健康相关的生活质量），并且应设计为确保低偏倚风险。
