Liu Meilu, Chen Jianrong, Ren Qing, Zhu Weifeng, Yan Dongmei, Nie Heyun, Chen Xiaofan, Zhou Xu
Evidence-based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi.
Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing.
Medicine (Baltimore). 2019 Jan;98(2):e14059. doi: 10.1097/MD.0000000000014059.
Type 2 diabetes mellitus (T2DM) is a major global health problem. As a complementary treatment, acupuncture and related techniques are widely used to treat metabolic and endocrine diseases, but their efficacy and safety for T2DM are yet to be established. This systematic review will qualitatively and quantitatively summarize the current randomized controlled trial (RCT) evidence regarding the efficacy and safety of acupuncture and related techniques in patients with T2DM.
Comprehensive literature searches will be performed on PubMed, Embase, Cochrane Central Register of Controlled Trials, and a trial registry "ClinicalTrials.gov" from inception to December 3, 2018. We will include RCTs for patients with T2DM that compared acupuncture with placebo, antidiabetic drugs, lifestyle interventions, or the combination. Primary outcomes are fasting blood glucose and hemoglobin A1c. Secondary outcomes include 2-hour blood glucose, fasting insulin, homeostatic model assessment for insulin resistance, incidence of diabetic complications, and acupuncture-related adverse events. The risk of bias of the RCTs included in the review will be examined using a revised Cochrane handbook tool. Heterogeneity will be detected using Cochran Q test and I statistics. With the use of random effects model, we will perform meta-analyses to pool results of RCTs. The effect measures will be weighted or standardized mean difference with 95% confidence intervals (CIs) for the continuous outcomes and risk ratio with 95% CIs for the dichotomous outcomes. Subgroup analyses and meta-regression with predefined effect modifiers will be performed to explore the sources of heterogeneity. Where appropriate, we will assess the possibility of reporting bias based on funnel plots and quantitative detection. We will appraise the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation system for each outcome.
This study will provide accurate results and balanced inferences on the efficacy and safety of acupuncture and related techniques on T2DM.
This well-designed systematic review will establish high-quality evidence of the efficacy and safety of acupuncture and related techniques for T2DM to facilitate the clinical practice and guideline development.
CRD42018115639.
2型糖尿病（T2DM）是一个重大的全球健康问题。作为一种辅助治疗方法，针灸及相关技术被广泛用于治疗代谢和内分泌疾病，但其对T2DM的疗效和安全性尚未得到证实。本系统评价将定性和定量地总结当前关于针灸及相关技术对T2DM患者疗效和安全性的随机对照试验（RCT）证据。
将对PubMed、Embase、Cochrane对照试验中央注册库以及一个试验注册库“ClinicalTrials.gov”进行全面的文献检索，检索时间从建库至2018年12月3日。我们将纳入针对T2DM患者的RCT，这些试验将针灸与安慰剂、抗糖尿病药物、生活方式干预或联合治疗进行了比较。主要结局指标为空腹血糖和糖化血红蛋白A1c。次要结局指标包括餐后2小时血糖、空腹胰岛素、胰岛素抵抗稳态模型评估、糖尿病并发症发生率以及与针灸相关的不良事件。将使用修订后的Cochrane手册工具检查纳入评价的RCT的偏倚风险。将使用Cochran Q检验和I统计量检测异质性。使用随机效应模型，我们将进行荟萃分析以汇总RCT的结果。效应量将为连续结局的加权或标准化均数差及95%置信区间（CI），二分结局的风险比及95%CI。将进行亚组分析和带有预定义效应修饰因素的荟萃回归，以探索异质性的来源。在适当情况下，我们将基于漏斗图和定量检测评估报告偏倚的可能性。我们将使用推荐分级的评估、制定和评价系统对每个结局的证据质量进行评估。
本研究将为针灸及相关技术对T2DM的疗效和安全性提供准确的结果和平衡的推断。
这项精心设计的系统评价将建立针灸及相关技术对T2DM疗效和安全性的高质量证据，以促进临床实践和指南制定。
PROSPERO注册号：CRD42018115639。
