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苦瓜 L. 降低 2 型糖尿病患者的高血糖:系统评价和荟萃分析。

Momordica charantia L. lowers elevated glycaemia in type 2 diabetes mellitus patients: Systematic review and meta-analysis.

机构信息

Pharm-BioTechnology and Traditional Medicine Center (PHARMBIOTRAC), World Bank-Africa Center of Excellence (ACE II), Mbarara University of Science and Technology, Uganda.

School of Integrative Health Sciences, Trans-disciplinary University, 74/2, Jarakabande Kaval, Post Attur Via Yelahanka, Bengaluru 560064, India.

出版信息

J Ethnopharmacol. 2019 Mar 1;231:311-324. doi: 10.1016/j.jep.2018.10.033. Epub 2018 Oct 30.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Momordica charantia Linnaeus (Cucurbitaceae) has been extensively used traditionally as food and herbal medicine for type 2 diabetes mellitus in Asia, Brazil, and east Africa. In vitro and in vivo studies suggest its glycemic control potential; however, clinical studies produced conflicting results.

AIM OF THE STUDY

To evaluate the efficacy of M. charantia preparations in lowering elevated plasma glucose level in prediabetes and type 2 diabetes mellitus patients.

METHODS

Electronic search of the Cochrane library, PubMed®, CINAHL, and SCOPUS databases was done from 1st January 1960-30th April 2018 without language restriction. Two independent reviewers extracted data and assessed risk of bias of articles. Revman var. 5.3 software was used for data synthesis in meta-analysis. Heterogeneity was assessed using Chi-square and I tests. Treatment effect was estimated using mean difference at follow up in outcome measures between M. charantia preparations and placebo or oral hypoglycemic agents control group. The protocol of this study has a registration number PROSPERO CRD42018083653.

RESULTS

Ten studies of type 2 diabetes mellitus (n = 1045) were included in the meta-analysis. They had 4-16 weeks follow up and overall moderate to high risk of bias. Compared to placebo, M. charantia monoherbal formulation significantly reduces FPG, PPG and HBA with mean difference of - 0.72 mmol/L, (95% CI: -1.33, -0.12), I = 14%, - 1.43 mmol/L, (95% CI: -2.18, -0.67), I = 0, - 0.26%, (95% CI: -0.49, -0.03), I = 0 respectively. M. charantia also lowered FPG in prediabetes (mean difference -0.31 mmol/L, n = 52); the evidence was downgraded to low quality because the study had unclear risk of bias and inadequate sample size. No serious adverse effects were reported.

CONCLUSION

M. charantia adjunct preparations improved glycemic control in T2DM patients. However, this conclusion is based on low to very low quality evidences for the primary outcomes and sparse data for several safety outcomes, thus, warrant further research. Particularly needed are the researches that focus on standardizing M. charantia formulation and determine its efficacy and safety in clinical trials with adequate sample size, designed with random sequence generation, allocation concealment of intervention and blinding of both research personnel and participants.

摘要

民族药理学相关性

苦瓜(葫芦科)在亚洲、巴西和东非,被广泛用作治疗 2 型糖尿病的传统食品和草药。体外和体内研究表明其具有控制血糖的潜力;然而,临床研究结果却相互矛盾。

研究目的

评估苦瓜制剂在降低糖尿病前期和 2 型糖尿病患者的升高的血浆葡萄糖水平方面的疗效。

方法

从 1960 年 1 月 1 日至 2018 年 4 月 30 日,对 Cochrane 图书馆、PubMed®、CINAHL 和 SCOPUS 数据库进行电子检索,无语言限制。两名独立的综述作者提取数据并评估文章的偏倚风险。Revman var. 5.3 软件用于荟萃分析中的数据合成。使用 Chi-square 和 I 检验评估异质性。使用随访期间苦瓜制剂与安慰剂或口服降糖药对照组之间的结局测量的平均差值来估计治疗效果。本研究的方案有一个注册号 PROSPERO CRD42018083653。

结果

共有 10 项 2 型糖尿病研究(n=1045)纳入荟萃分析。它们的随访时间为 4-16 周,总体偏倚风险为中至高。与安慰剂相比,苦瓜单味制剂显著降低 FPG、PPG 和 HBA,平均差值分别为-0.72mmol/L(95%CI:-1.33,-0.12),I=14%,-1.43mmol/L(95%CI:-2.18,-0.67),I=0,-0.26%(95%CI:-0.49,-0.03),I=0。苦瓜还降低了糖尿病前期患者的 FPG(平均差值-0.31mmol/L,n=52);由于研究存在偏倚风险不明确和样本量不足,证据质量被降级为低质量。未报告严重不良事件。

结论

苦瓜辅助制剂改善了 2 型糖尿病患者的血糖控制。然而,这一结论是基于主要结局的低至极低质量证据,以及几个安全性结局的数据稀疏,因此需要进一步研究。特别需要的是专注于标准化苦瓜配方的研究,并确定其在临床试验中的疗效和安全性,设计具有随机序列生成、干预的分配隐藏和研究人员和参与者的盲法。

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