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中药治疗糖耐量受损的系统评价和 Meta 分析: 随机对照试验。

Traditional Chinese Patent Medicine for Treating Impaired Glucose Tolerance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

1 Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences , Beijing, China .

2 South Area of Guang'anmen Hospital of China Academy of Chinese Medical Sciences , Beijing, China .

出版信息

J Altern Complement Med. 2018 Jul;24(7):634-655. doi: 10.1089/acm.2017.0302. Epub 2018 Apr 6.

Abstract

INTRODUCTION/AIM: To assess the effectiveness and safety of Traditional Chinese patent medicines (TCPMs) for managing impaired glucose tolerance (IGT).

METHODS

Seven databases were searched to identify eligible trials published from incepting to May 1, 2016. Randomized controlled trials (RCTs) involving TCPM for IGT with a minimum follow-up duration of 6 months were included for analysis. Data extraction and quality assessment were performed by two reviewers independently. Data synthesis was analyzed using Review Manager 5.3 software. Subgroup analysis was carried out to assess the robustness of results of meta-analysis.

RESULTS

Eighteen trials with a total of 3172 participants met the inclusion criteria. The methodological quality of the RCTs was variable. Comparing with receiving lifestyle modification (LM) alone, TCPM plus LM was significantly better at reducing the incidence of diabetes (risk ratio [RR] 0.45; 95% confidence interval [CI] 0.36-0.57, p < 0.00001) and normalizing the blood glucose (RR 0.72; 95% CI 0.64-0.82, p < 0.00001). TCPM plus LM was superior in decreasing the levels of 2hPG, body mass index (BMI), fasting insulin, and 2 h insulin compared with LM alone (2hPG: mean difference [MD] -1.13; 95% CI -1.68 to -0.58, p < 0.0001; BMI: MD -0.42; 95% CI -0.71 to -0.14, p = 0.004; fasting insulin: MD -2.44; 95% CI -3.79 to -1.09, p = 0.0004; and 2 h insulin: MD -8.26; 95% CI -8.47 to -8.05, p < 0.00001). Compared with placebo plus LM, TCPM plus LM was superior in reducing diabetes (RR 0.54; 95% CI 0.42-0.69, p < 0.00001) and normalizing blood glucose (RR 0.55; 95% CI 0.41-0.73, p < 0.00001; the interventions were also associated with a decline in the two-hour postprandial blood glucose (2hPG) levels (MD -1.45; 95% CI -2.11 to -0.79, p < 0.0001) and BMI levels (MD -1.12; 95% CI -2.00 to -0.24, p < 0.0001). There were no significant differences in adverse events between two groups. Subgroup analysis found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable.

CONCLUSIONS

The study indicated that TCPM combined with moderate lifestyle modification had significant effect on IGT. Further studies are needed to provide more reliable evidence. The PROSPERO registration is No. CRD42016039312.

摘要

介绍/目的:评估中药复方治疗糖耐量受损(IGT)的有效性和安全性。

方法

检索了七个数据库,以确定从成立到 2016 年 5 月 1 日发表的合格试验。纳入了至少随访 6 个月的 TCPM 治疗 IGT 的随机对照试验(RCT)进行分析。两名评审员独立进行数据提取和质量评估。使用 Review Manager 5.3 软件进行数据分析。进行亚组分析以评估荟萃分析结果的稳健性。

结果

共有 18 项试验,共 3172 名参与者符合纳入标准。RCT 的方法学质量各不相同。与单独接受生活方式改变(LM)相比,中药复方加 LM 显著降低糖尿病发病率(风险比 [RR] 0.45;95%置信区间 [CI] 0.36-0.57,p<0.00001)和血糖正常化(RR 0.72;95% CI 0.64-0.82,p<0.00001)。与单独接受 LM 相比,中药复方加 LM 可降低 2hPG、体重指数(BMI)、空腹胰岛素和 2 小时胰岛素水平(2hPG:MD-1.13;95%CI-1.68 至-0.58,p<0.0001;BMI:MD-0.42;95%CI-0.71 至-0.14,p=0.004;空腹胰岛素:MD-2.44;95%CI-3.79 至-1.09,p=0.0004;和 2 小时胰岛素:MD-8.26;95%CI-8.47 至-8.05,p<0.00001)。与安慰剂加 LM 相比,中药复方加 LM 可降低糖尿病(RR 0.54;95%CI 0.42-0.69,p<0.00001)和血糖正常化(RR 0.55;95%CI 0.41-0.73,p<0.00001;干预措施还与餐后两小时血糖(2hPG)水平(MD-1.45;95%CI-2.11 至-0.79,p<0.0001)和 BMI 水平(MD-1.12;95%CI-2.00 至-0.24,p<0.0001)的下降相关。两组间不良反应无显著差异。亚组分析发现,所有研究特征的总体效果差异无统计学意义,表明总体效果稳定。

结论

该研究表明,中药复方联合中等强度生活方式改变对 IGT 有显著疗效。需要进一步研究提供更可靠的证据。PROSPERO 注册号为 No. CRD42016039312。

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