一项经皮神经电刺激对 2 型糖尿病患者血糖控制效果的随机试验。

A randomized trial on the effect of transcutaneous electrical nerve stimulator on glycemic control in patients with type 2 diabetes.

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.

Department of Laboratory Medicine, National Taiwan University Hospital, Taipei, Taiwan.

出版信息

Sci Rep. 2023 Feb 15;13(1):2662. doi: 10.1038/s41598-023-29791-7.

DOI:10.1038/s41598-023-29791-7

PMID:36792682

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9932095/

Abstract

Transcutaneous electrical nerve stimulator (TENS) has been demonstrated to be beneficial in glycemic control in animal models, but its application in humans has not been well studied. We randomly assigned 160 patients with type 2 diabetes on oral antidiabetic drugs 1:1 to the TENS study device (n = 81) and placebo (n = 79). 147 (92%) randomized participants (mean [SD] age 59 [10] years, 92 men [58%], mean [SD] baseline HbA level 8.1% [0.6%]) completed the trial. At week 20, HbA decreased from 8.1% to 7.9% in the TENS group (- 0.2% [95% CI - 0.4% to - 0.1%]) and from 8.1% to 7.8% in the placebo group (- 0.3% [95% CI - 0.5% to - 0.2%]) (P = 0.821). Glycemic variability, measured as mean amplitude of glycemic excursion (MAGE) at week 20 were significantly different in the TENS group vs. the placebo group (66 mg/dL [95% CI 58, 73] vs. 79 mg/dL [95% CI 72, 87]) (P = 0.009). Our study provides the clinical evidence for the first time in humans that TENS does not demonstrate a statistically significant HbA reduction. However, it is a safe complementary therapy to improve MAGE in patients with type 2 diabetes.

摘要

经皮神经电刺激（TENS）已被证明可有益于动物模型中的血糖控制，但它在人类中的应用尚未得到充分研究。我们将 160 名正在服用口服降糖药的 2 型糖尿病患者随机分为 TENS 研究设备组（n=81）和安慰剂组（n=79）。147 名（92%）随机参与者（平均[标准差]年龄 59[10]岁，92 名男性[58%]，平均[标准差]基线 HbA 水平 8.1%[0.6%]）完成了试验。在第 20 周时，TENS 组的 HbA 从 8.1%降至 7.9%（-0.2%[95%置信区间-0.4%至-0.1%]），安慰剂组从 8.1%降至 7.8%（-0.3%[95%置信区间-0.5%至-0.2%]）（P=0.821）。在 TENS 组与安慰剂组之间，第 20 周的血糖变异性（用血糖波动幅度 MAGE 衡量）差异有统计学意义（66mg/dL[95%置信区间 58，73]vs.79mg/dL[95%置信区间 72，87]）（P=0.009）。我们的研究首次在人类中提供了临床证据，表明 TENS 并不能显著降低 HbA。然而，它是一种安全的补充治疗方法，可以改善 2 型糖尿病患者的 MAGE。