针刺疗法对2型糖尿病的有效性和安全性：纳入21项随机对照试验的系统评价和Meta分析

Shu-qing LI; Jian-rong CHEN; Mei-lu LIU; Yan-ping WANG; Xu ZHOU; Xin SUN

doi:10.1007/s11655-021-3450-2

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针刺疗法对2型糖尿病的有效性和安全性：纳入21项随机对照试验的系统评价和Meta分析

Evidence-Based Integrative Medicine | Updated：2022-06-27

- 针刺疗法对2型糖尿病的有效性和安全性：纳入21项随机对照试验的系统评价和Meta分析
- Effect and Safety of Acupuncture for Type 2 Diabetes Mellitus:A Systematic Review and Meta-analysis of 21 Randomised Controlled Trials
- Chinese Journal of Integrative Medicine 2022年28卷第5期页码：463-471
- Affiliations：
  
  1.Evidence-Based Medicine Research Centre, Jiangxi University of Traditional Chinese Medicine, Nanchang (330004),China
  2.Department of Endocrinology, the First Affiliated Hospital of Nanchang University, Nanchang (330006), China
  3.Department of Integrated Chinese and Western Medicine,West China Hospital, Sichuan University, Chengdu (610041),China
  4.Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu (610041), China
- Author bio：
  
  Prof. ZHOU Xu, Email: zhouxu_ebm@hotmail.com
- Funds：
  
  the Teaching Reform Project of Colleges and Universities in Jiangxi Province(JXJG-19-12-14);Education Science "13th Five-Year Plan" Project of Jiangxi Province(20YB148);Jiangxi University of Traditional Chinese Medicine 1050 Youth Talent Project(5142001011)
- DOI：10.1007/s11655-021-3450-2
  中图分类号：
- 纸质出版日期：2022-05-01，
  
  网络出版日期：2021-08-25，
  
  录用日期：2021-04-05
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Shu-qing LI, Jian-rong CHEN, Mei-lu LIU, 等. 针刺疗法对2型糖尿病的有效性和安全性：纳入21项随机对照试验的系统评价和Meta分析[J]. Chinese Journal of Integrative Medicine, 2022,28(5):463-471.

Shu-qing LI, Jian-rong CHEN, Mei-lu LIU, et al. Effect and Safety of Acupuncture for Type 2 Diabetes Mellitus:A Systematic Review and Meta-analysis of 21 Randomised Controlled Trials[J]. Chinese Journal of Integrative Medicine, 2022,28(5):463-471.
Shu-qing LI, Jian-rong CHEN, Mei-lu LIU, 等. 针刺疗法对2型糖尿病的有效性和安全性：纳入21项随机对照试验的系统评价和Meta分析[J]. Chinese Journal of Integrative Medicine, 2022,28(5):463-471. DOI： 10.1007/s11655-021-3450-2.

Shu-qing LI, Jian-rong CHEN, Mei-lu LIU, et al. Effect and Safety of Acupuncture for Type 2 Diabetes Mellitus:A Systematic Review and Meta-analysis of 21 Randomised Controlled Trials[J]. Chinese Journal of Integrative Medicine, 2022,28(5):463-471. DOI： 10.1007/s11655-021-3450-2.

摘要

目的:

评价针刺疗法对2型糖尿病患者降糖相关结局的影响.

方法:

检索PubMed、Embase、Cochrane Library和ClinicalTrials.gov

时限为建库起至2020年7月

纳入以2型糖尿病患者为研究对象、对比针刺疗法联合降糖药与单用降糖药的随机对照试验 (randomised controlled trial

RCT) . 主要结局为糖化血红蛋白 (haemoglobin A1c

HbA1c) 和空腹血糖 (fasting blood glucose

FBG) ; 次要结局包括餐后2小时血糖 (two-hour blood glucose

2hBG) 、空腹胰岛素 (fasting insulin

FINS) 、稳态模型胰岛素抵抗指数 (homeostatic model assessment for insulin resistance

HOMA-IR) 和针刺疗法相关不良事件. Meta分析中效应量为均数差 (Mean difference

MD) 和95%可信区间 (confidence interval

CI) . 证据质量评价采用GRADE工具 (Grading of Recommendations Assessment

Development and Evaluation tool) .

结果:

共纳入21项RCT (n=1188) . Meta分析结果显示: 与对照组相比

针刺组FBG (MD -6.46 mg/dL

95% CI -11.95 ~ -0.98; 中等质量证据) 和HOMA-IR (MD -1.23

95% CI -2.16 ~ -0.31; 低质量证据) 的降幅显著更大; 但两组HbA1c (MD -0.39%

95% CI -0.84 ~ 1.61; 极低质量证据) 、2hBG (MD -4.99 mg/dL

95% CI -20.74 ~ 10.76; 低质量证据) 和FINS (MD -1.32 μIU/mL

95% CI -3.76 ~ 1.12; 低质量证据) 的差异无统计学意义. 无研究报告糖尿病并发症发生率的相关数据. 所有研究报告的针刺疗法相关不良事件均为轻微程度.

结论:

当前证据表明: 作为2型糖尿病的补充治疗

针刺疗法可小幅降低FBG和改善胰岛素抵抗

差异有统计学意义. 但针刺疗法对HbA1c、2hBG和FINS的作用尚不明确. 针刺疗法用于轻度糖尿病患者的安全性总体较好. 针刺疗法对T2DM的长期效果仍需更多证据. (试验注册号: CRD42018115639)

Abstract

Objective:

To evaluate the effects of acupuncture on hypoglycaemic outcomes in type 2 diabetes mellitus (T2DM).

Methods:

PubMed

Embase

Cochrane Library

and ClinicalTrials.gov were searched from inception up to July 2020

to identify randomised controlled trials (RCTs) that enrolled patients with T2DM and compared acupuncture combined with antidiabetic drugs to antidiabetic drugs alone. The primary outcomes were haemoglobin A

(HbA

) and fasting blood glucose (FBG). The secondary outcomes included 2-h blood glucose (2hBG)

fasting insulin (FINS)

homeostatic model assessment for insulin resistance (HOMA-IR)

and acupuncture-related adverse events. Mean difference (MD) and 95% confidence interval (CI) were used as the effect measure in the meta-analysis. The quality of evidence was assessed using the Grading of Recommendations Assessment

Development and Evaluation tool.

Results:

Twenty-one RCTs (

188) were included. The meta-analytic results showed that the acupuncture group had greater reductions in FBG (MD –6.46 mg/dL

95% CI –11.95 to –0.98; moderate-quality evidence) and HOMA-IR (MD –1.23

95% CI –2.16 to –0.31; low-quality evidence)

but comparable changes in HbA1c (MD –0.39%

95% CI –0.84 to 1.61; very-low-quality evidence)

2hBG (MD –4.99 mg/dL

95% CI –20.74 to 10.76; low-quality evidence)

and FINS (MD –1.32 μIU/mL

95% CI –3.76 to 1.12; low-quality evidence). No data on the incidence of diabetic complications were found. All acupuncture-related adverse events reported were mild.

Conclusions:

The current evidence suggests that acupuncture

as a complementary therapy to antidiabetic drugs

has a small but statistically significant effect on decreasing FBG and improving insulin resistance. The effects of acupuncture on HbA

2hBG

and FINS remain uncertain. Acupuncture is generally safe in patients with mild diabetes. More evidence for the long-term effects of acupuncture on T2DM is needed. (Registration No. CRD42018115639)

关键词

Keywords

acupuncturetype 2 diabetes mellitussystematic reviewmeta-analysis

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