Berberine and Metformin in the Treatment of Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis of Randomized Clinical Trials

Objective: To assess the effects of berberine and metformin on glucose in patients with type 2 diabets mellitus (T2DM) with a systematic review and meta-analysis. Methods: The databases including PubMed, Excerpta Medica Database (EMBase), Cochrane Library, Chinese National Knowledge Infrastructure database (CNKI), WanFang, the Chinese Scientific and Technical Journals database (VIP), China Doctor Dissertation Full-text Database (CDFD) and China Master Dissertation Full-text Database (CMFD) from the inception to April 2021 in Chinese or English language were searched. Randomized controlled trials (RCTs) of berberine only or combined with metformin versus metformin were included. Data extraction and paper quality assessment were conducted according to the Cochrane Handbook. RevMan 5.4 was used for the meta-analysis. Results: A total of thirteen studies were included, covering 1173 participants. The clinical heterogeneity of the included trials was relatively high. The methodological quality of most trials was generally low with bias in terms of random sequence generation, allocation concealment, blinding method, outcome data and selective reporting. Interventions were divided into two subgroups for analysis. Meta-analysis suggested that there was no statistical significance in the hypoglycemic effect between berberine and metformin for T2DM. However, berberine combined with metformin could reduce fasting plasma glucose (FPG) [MD = −1.49, 95% CI (−2.22, −0.76), P < 0.0001], 2-hour postprandial blood glucose (2hPG) [MD = −1.89, 95% CI (−2.94, −0.84), P = 0.0004], glycosylated hemoglobin A1c (HbA1c) [MD = −0.65, 95% CI (−0.91, −0.40), P < 0.00001] and homeostasis model assessment of insulin resistance (HOMA-IR) [MD = −0.53, 95% CI (−1.03, −0.03), P = 0.04] levels significantly compared with metformin group. No severe adverse effects were reported in all trials. Conclusions: The hypoglycemic effect of berberine alone is not better than metformin. But berberine combined with metformin has good efficacy and safety in the treatment of T2DM. The current clinical studies are low in methodology and reporting quality, which needs to be further proved by more high quality, large sample size and multi-center RCTs.

Efficacy and Safety of Berberine in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis

Objective To assess the efficacy and safety of berberine（BBR） in patients with type 2 diabetes mellitus（T2DM） by performing a systematic review. Methods PubM ed, Cochrane Library, Embase, CNKI, and CBM were searched until May 2014. The randomized controlled trials（RCTs） of the effects of BBR on blood glucose in patients with T2 DM were included. The quality of RCTs was assessed by the Jadad scale, and the Review Manager 5.1 software was used for data syntheses and analyses. Results Seventeen RCTs involving 1198 patients were included. The methodological quality of these RCTs was generally low. Compared with the control groups（placebo or no intervention with medicine）, BBR suggested the statistically significant benefits in improving fasting blood glucose（FBG）, postprandial blood glucose（PBG）, glycosylated hemoglobin, and homeostasis model assessment of insulin resistance. Subgroups analysis of BBR compared with metformin（MET） showed that 1.5g/d MET was significantly better than BBR（0.9-1.5 g/d） in lowering FBG and PBG. However, there was no significant difference between 1.5g/d BBR and 0.75g/d MET groups in blood glucose profiles. In comparison with rosiglitazone, BBR suggested the statistically significant benefits in lowering FBG. And there was no significant difference between BBR and glipizide groups in blood glucose profiles. In addition, the combination therapy of BBR and oral hypoglycemic agents had the advantages over oral hypoglycemic agents alone. No serious adverse effects of BBR have been reported. Conclusion BBR may have the beneficial effects in the control of blood glucose levels, though the efficacy of BBR is not superior to MET. BBR appeares to have advantages over rosiglitazone in improving FBG levels. In addition, the combination therapy of BBR and oral hypoglycemic agents may be a new attempt. However, the efficacy of BBR in patients with T2 DM should be further evaluated by more RCTs in a larger population of patients.

中成药联合口服降糖西药治疗2型糖尿病效果的网状Meta分析

目的:评估临床常用的中成药分别联合常用口服降糖西药治疗2型糖尿病的有效性。方法:检索国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、中国生物医学文献数据库(CBM)、PubMed、Embase、Cochrane Library等数据库,文献时间范围为建库至2020年12月23日,根据纳入、排除标准进行文献筛选、资料提取并评价纳入研究的偏倚风险后,分别对不同结局指标包括空腹血糖、餐后2 h血糖、糖化血红蛋白采用网状Meta分析进行有效性比较及排序。结果:1)空腹血糖方面:7种中成药联合口服降糖西药均优于单纯口服降糖西药治疗,参芪降糖颗粒联用口服降糖西药疗效更为显著。2)餐后血糖方面:除消渴丸外,其余6种中成药联合口服降糖西药治疗效果均优于单纯口服降糖西药治疗,参芪降糖颗粒联用口服降糖西药疗效最为显著;3)糖化血红蛋白方面:除参芪降糖颗粒外,其余6种中成药联合口服降糖西药治疗效果均优于单纯口服降糖西药治疗,其中消渴丸疗效最佳。结论:7种中成药均能改善空腹血糖、餐后血糖、糖化血红蛋白,但由于临床试验的局限性,仍需要更多严谨、科学的临床试验为临床治疗提供切实有效的依据。

甘精胰岛素联合口服降糖药治疗2型糖尿病的疗效与分析

目的研究甘精胰岛素联合口服降糖药治疗2型糖尿病的临床疗效。方法选取2021年1月—2022年10月泰州市中西医结合医院收治的2型糖尿病患者62例作为研究对象,采用随机数表法分为两组,对照组(n=31)给予降糖药物口服治疗;研究组(n=31)在对照组基础上联合使用甘精胰岛素。对比两组患者血糖指标、胰岛功能指标、疾病疗效以及不良反应发生情况。结果治疗后,研究组空腹血糖(FPG)、餐后2 h血糖(2 hPG)以及糖化血红蛋白(HbA1c)水平比对照组更低,差异有统计学意义(P<0.05);研究组稳态模型胰岛素抵抗指数(HOMA-IR)、空腹胰岛素(FINS)比对照组更低,差异有统计学意义(P<0.05);研究组治疗总有效率高于对照组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论2型糖尿病患者于降糖药物口服基础联合使用甘精胰岛素可有效降低其血糖水平,且促进血糖稳定与胰岛素敏感性的控制,值得推广。