College of Pharmacy, The University of Texas at Austin, Austin, TX, USA.
Jaseng hospital of Korean medicine, Seoul, Korea, South.
Cochrane Database Syst Rev. 2024 Jul 22;7(7):CD013331. doi: 10.1002/14651858.CD013331.pub2.
BACKGROUND: 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. OBJECTIVES: 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). SEARCH METHODS: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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; I = 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; I = 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; I = 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; I = 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; I = 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. AUTHORS' CONCLUSIONS: 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.
背景:经皮神经电刺激(TENS)是一种非药物治疗方法,通过将电极贴在疼痛部位的皮肤上传递电流来发挥作用。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、内啡肽的释放以及减少子宫缺血有关。尽管它已被用于原发性痛经(PD;经期疼痛或经痛),但高频 TENS、低频 TENS 或其他治疗 PD 的有效性和安全性证据有限。 目的:评估经皮神经电刺激(TENS)与安慰剂、无治疗和其他治疗原发性痛经(PD)的疗效和安全性。 搜索方法:我们检索了 Gynaecology and Fertility Group 的专门对照试验注册库、CENTRAL、MEDLINE、Embase、PsycINFO、AMED、CINAHL 和韩国及中文数据库,截至 2024 年 4 月 9 日。我们还在试验登记处和相关研究的参考文献中搜索了正在进行的试验,以寻找其他试验。没有应用语言限制。 选择标准:我们纳入了比较低频 TENS 或高频 TENS 与其他 TENS、安慰剂或其他治疗的随机对照试验(RCT)。纳入的试验包括年龄在 12 至 49 岁之间的 PD 女性患者。 数据收集和分析:四名综述作者筛选了试验,根据方案提取数据,使用 RoB 2 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。 主要结果:本综述取代了 2009 年发表的当前综述。我们纳入了 20 项 RCT,涉及 585 名随机接受高频 TENS、低频 TENS、安慰剂或无治疗或其他治疗的女性。我们纳入了五个比较:高频 TENS 与安慰剂或无治疗、低频 TENS 与安慰剂或无治疗、高频 TENS 与低频 TENS、高频 TENS 与其他治疗、低频 TENS 与其他治疗。高频 TENS 与安慰剂或无治疗 高频 TENS 可能比安慰剂或无治疗更能减轻疼痛(MD-1.39,95%CI-2.51 至-0.28;10 项 RCT,345 名女性;低确定性证据;I=88%)。三项 RCT 中有两项报告没有不良反应,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 低频 TENS 可能比安慰剂或无治疗更能减轻疼痛(MD-2.04,95%CI-2.95 至-1.14;3 项 RCT,645 名女性;低确定性证据;I=0%)。没有试验报告这一比较的不良反应。高频 TENS 与低频 TENS 高频 TENS 是否比低频 TENS 更能缓解疼痛尚不确定(MD0.89,95%CI-0.19 至 1.96;3 项 RCT,54 名女性;低确定性证据;I=0%)。一项试验提供了不良反应的数据,但没有发生不良反应。高频 TENS 与其他治疗 高频 TENS 是否比穴位按压(MD-0.66,95%CI-1.72 至 0.40;1 项 RCT,18 名女性;极低确定性证据)、对乙酰氨基酚(扑热息痛)(MD-0.98,95%CI-3.30 至 1.34;1 项 RCT,20 名女性;极低确定性证据)和干扰电流疗法(MD-0.03,95%CI-1.04 至 0.98;2 项 RCT,62 名女性;低确定性证据;I=0%)更能缓解疼痛尚不确定。高频 TENS 和 NSAIDs 发生不良反应的可能性可能没有显著差异(OR12.06,95%CI0.26 至 570.62;2 项 RCT,88 名女性;低确定性证据;I=78%)。低频 TENS 与其他治疗 低频 TENS 是否比乙酰氨基酚更能缓解疼痛尚不确定(MD-1.48,95%CI-3.61 至 0.65;1 项 RCT,20 名女性;极低确定性证据)。没有试验报告这一比较的不良反应。 作者结论:高频 TENS 和低频 TENS 可能比安慰剂或无治疗更能减轻疼痛。我们降低了证据的确定性,因为存在偏倚风险。未来的 RCT 应更关注本综述的次要结局(例如需要额外的镇痛药、日常活动受限或健康相关生活质量),并应设计为确保低偏倚风险。
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