Hong Kun, Gao Juan, Hu Li-Juan, Zhou Xiu-Juan, Long Xiao-Mei, Wen Bo-Ping, Wu Xi
Department of Acupuncture and Moxibustion, No.3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu, China.
College of Acupuncture, Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Med (Lausanne). 2025 Jul 15;12:1610141. doi: 10.3389/fmed.2025.1610141. eCollection 2025.
The global prevalence of diabetes mellitus (DM) has exceeded 589 million, with the proportion of type 2 diabetes mellitus (T2DM) patients with comorbid cognitive impairment (CI) as high as 49.1%, which has a serious impact on disease management and quality of life. While acupuncture has been shown to improve cerebral glucose metabolism and synaptic plasticity, existing clinical trials are plagued by critical limitations: small sample sizes (often <100 participants) fail to detect subtle treatment effects, methodological heterogeneity in acupuncture protocols (e.g., varying acupoint selections, stimulation intensities, and treatment durations) hinders evidence synthesis, and insufficient blinding (e.g., sham acupuncture controls with low plausibility) introduces performance bias. These limitations have constrained the generalizability of findings and created a significant evidence gap in defining acupuncture's role in diabetic cognitive impairment (DCI). The aim of this study is to assess the efficacy and safety of acupuncture for DCI through a systematic review with Bayesian network meta-analysis (NMA), addressing these methodological flaws via rigorous evidence synthesis.
Following PRISMA-NMA and STRICTA-2010 guidelines, we will systematically search 10 databases (PubMed, Cochrane Library, CNKI, etc.) from inception to 30 June 2025 and gray literature (January 1, 1995, to June 30, 2025) for randomized controlled trials (RCTs) comparing acupuncture with pharmacotherapy, sham acupuncture, or standard care. Inclusion criteria: adults (≥18 years) with T2DM and CI diagnosed via validated scales such as Montreal Cognitive Assessment (MoCA), and Mini-Mental State Examination (MMSE). Primary outcomes include cognitive function scores; secondary outcomes assess adverse events (CTCAE v5.0). The risk of bias will be evaluated using Cochrane RoB 2.0 and GRADE. Bayesian NMA will synthesize direct and indirect evidence to simultaneously assess the relative efficacy and safety of acupuncture.
The study will clarify the relative efficacy and safety of acupuncture in improving DCI and provide evidence-based treatment options for clinical use. The results of Bayesian analyses may support acupuncture as a low-cost, low-risk adjunctive therapy, especially for patients intolerant of conventional medications. The results of the study will fill the current evidence gap and promote the standardized use of acupuncture in the management of DCI.
CRD42021275161.
全球糖尿病（DM）患病率已超过5.89亿，2型糖尿病（T2DM）合并认知障碍（CI）患者的比例高达49.1%，这对疾病管理和生活质量产生了严重影响。虽然针灸已被证明可改善脑葡萄糖代谢和突触可塑性，但现有临床试验存在严重局限性：样本量小（通常<100名参与者）无法检测到细微的治疗效果，针灸方案中的方法学异质性（例如，不同的穴位选择、刺激强度和治疗持续时间）阻碍了证据合成，而盲法不足（例如，假针灸对照的可信度低）会引入性能偏差。这些局限性限制了研究结果的普遍性，并在确定针灸在糖尿病认知障碍（DCI）中的作用方面造成了重大证据空白。本研究的目的是通过贝叶斯网络荟萃分析（NMA）进行系统评价，评估针灸治疗DCI的疗效和安全性，通过严格的证据合成来解决这些方法学缺陷。
遵循PRISMA-NMA和STRICTA-2010指南，我们将系统检索10个数据库（PubMed、Cochrane图书馆、中国知网等），从建库至2025年6月30日，以及灰色文献（1995年1月1日至2025年6月30日），以查找比较针灸与药物治疗、假针灸或标准护理的随机对照试验（RCT）。纳入标准：通过蒙特利尔认知评估（MoCA）和简易精神状态检查表（MMSE）等经过验证的量表诊断为T2DM和CI的成年人（≥18岁）。主要结局包括认知功能评分；次要结局评估不良事件（CTCAE v5.0）。将使用Cochrane RoB 2.0和GRADE评估偏倚风险。贝叶斯NMA将综合直接和间接证据，同时评估针灸的相对疗效和安全性。
本研究将阐明针灸改善DCI的相对疗效和安全性，并为临床应用提供循证治疗选择。贝叶斯分析结果可能支持针灸作为一种低成本、低风险的辅助治疗方法，特别是对于不耐受传统药物的患者。研究结果将填补当前的证据空白，并促进针灸在DCI管理中的规范使用。
CRD42021275161。
