Hoelzer Bryan C, Edgar Deborah, Lu Shiao-Ping, Taylor Rod S
Medical Director, Southwest Spine and Pain Center, Provo, UT 84059, USA.
Commexus Ltd., Dunblane FK15 0DF, UK.
Biomedicines. 2022 Oct 19;10(10):2630. doi: 10.3390/biomedicines10102630.
Spinal cord stimulation (SCS) is increasingly used to treat painful diabetic neuropathy (PDN). At the time of a recent meta-analysis in this field, data were only available from randomized controlled trials (RCTs) of traditional low-frequency SCS (LF-SCS). However, outcomes from high-frequency 10 kHz SCS treatment are now available. Our study aimed to systematically review the contemporary evidence for SCS in patients with lower limb pain due to PDN and include an indirect comparison of the high- and low-frequency modalities. We searched the PubMed/CENTRAL databases up to 18 August 2022, for peer-reviewed RCTs of SCS that enrolled PDN patients with lower limb pain symptoms. The quality of the evidence was assessed with the Cochrane Risk of Bias tool. Using SCS treatment arm data from the RCTs, we indirectly compared the absolute treatment effect of 10 kHz SCS and LF-SCS. Results are presented in tables and forest plots. This systematic review was reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines. Three RCTs met our eligibility criteria, including the recent 10 kHz SCS RCT (N = 216, 90 implanted) and 2 others that examined LF-SCS (N = 36, 17 implanted; N = 60, 37 implanted). Our analysis of 6-month data found clinically meaningful pain relief with each SCS modality. However, significantly greater pain reduction was identified for 10 kHz SCS over LF-SCS: average pain reduction in the 10 kHz SCS cohort was 73.7% compared with 47.5% in the pooled LF-SCS group (p < 0.0001). In the permanent implant subset, the 50% pain reduction responder rate was 83.3% in the 10 kHz SCS cohort versus 63.0% in the pooled LF-SCS group (p = 0.0072). The overall risk of bias of each included RCT was deemed high, mainly due to the absence of patient blinding. Our analysis indicates that paresthesia-free 10 kHz SCS can provide superior pain relief and responder rate over LF-SCS for managing PDN patients refractory to conventional medical management.
脊髓刺激（SCS）越来越多地用于治疗疼痛性糖尿病神经病变（PDN）。在该领域最近一次荟萃分析时，仅有来自传统低频SCS（LF-SCS）随机对照试验（RCT）的数据。然而，现在已有高频10kHz SCS治疗的结果。我们的研究旨在系统回顾当代关于SCS治疗PDN所致下肢疼痛患者的证据，并对高频和低频模式进行间接比较。我们检索了截至2022年8月18日的PubMed/CENTRAL数据库，以查找纳入有下肢疼痛症状的PDN患者的SCS同行评审RCT。使用Cochrane偏倚风险工具评估证据质量。利用RCT的SCS治疗组数据，我们间接比较了10kHz SCS和LF-SCS的绝对治疗效果。结果以表格和森林图呈现。本系统评价按照系统评价和荟萃分析的首选报告项目（PRISMA）2020指南进行报告。三项RCT符合我们的纳入标准，包括最近的10kHz SCS RCT（N = 216，90例植入）以及另外两项研究LF-SCS的RCT（N = 36，17例植入；N = 60，37例植入）。我们对6个月数据的分析发现，每种SCS模式都能带来具有临床意义的疼痛缓解。然而，与LF-SCS相比，10kHz SCS的疼痛减轻更为显著：10kHz SCS队列的平均疼痛减轻为73.7%，而合并的LF-SCS组为47.5%（p < 0.0001）。在永久植入亚组中，10kHz SCS队列的50%疼痛减轻反应率为83.3%，而合并的LF-SCS组为63.0%（p = 0.0072）。每项纳入RCT的总体偏倚风险被认为较高，主要是因为缺乏患者盲法。我们的分析表明，对于传统药物治疗无效的PDN患者，无感觉异常的10kHz SCS在缓解疼痛和反应率方面优于LF-SCS。
