Sanjari Mojgan, Shamsinejad Behrang, Khazaeli Payam, Safi Zohreh, Mirrashidi Fatemeh, Naghibzadeh-Tahami Ahmad
Associate Professor of endocrinology and metabolism, Endocrinology and metabolism Research Center, institute of Basic and clinical physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.
Physiology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.
J Diabetes Metab Disord. 2020 Mar 4;19(1):71-80. doi: 10.1007/s40200-019-00478-z. eCollection 2020 Jun.
To evaluate the safety and efficacy of methanol extract of root on type 2 diabetes compared to metformin.
In a parallel triple blind clinical trial, 80 type 2 diabetic patients,, were randomized into two groups (treated with Berberis integerrima root, 480 mg (oral), compared to control group treated with metformin 1000 mg daily). Efficacy was evaluated by fasting and prandial glucose and HbA1c and side effects confirmed by physical examination, biology and hematology tests and urinalysis on days 15, 45 and 90. They were followed for 3 months.
Two hundred and eighteen patients were recruited and 80 (55female and 25 male) patients randomized in two groups and 60 patient were analysed. The mean age of patients was 51.8 ± 9.3 and 46.5 ± 10 in the experimental ( and control (metformin) groups respectively ( = 0.02). The mean HbA1c at baseline was 8.1 ± 1.6% and 7.9 ± 1.6% for and metformin group respectively (P = 0.53), and there was no significant difference between the two groups (7.5 vs. 7.2) after 3 months (P = 0.34).Weight loss was observed in both groups compared to baseline.No adverse event led to preventing the study was reported.
root not only was effective as much as metformin in reducing blood glucose and controlling type 2 diabetes but also, no specific side effect was reported (in short term).So, it might be an effective and safe complementary therapy in diabetic patients.Iranian Research and Clinical Trial (IRCT) registeration number; 201,207,191,774 N5.Funding: Vice chancellor for research, Physiology Research Center of Kerman University of Medical Sciences and the Exir pharmaceutical company.
与二甲双胍相比，评估某种植物根甲醇提取物对2型糖尿病的安全性和有效性。
在一项平行三盲临床试验中，80名2型糖尿病患者被随机分为两组（一组接受刺檗根480毫克口服治疗，另一组对照组每日接受1000毫克二甲双胍治疗）。在第15天、45天和90天通过空腹和餐后血糖、糖化血红蛋白评估疗效，并通过体格检查、生物学和血液学检查以及尿液分析确认副作用。对患者进行了3个月的随访。
招募了218名患者，80名（55名女性和25名男性）患者被随机分为两组，分析了60名患者。试验组和对照组（二甲双胍组）患者的平均年龄分别为51.8±9.3岁和46.5±10岁（P=0.02）。基线时试验组和二甲双胍组的平均糖化血红蛋白分别为8.1±1.6%和7.9±1.6%（P=0.53），3个月后两组之间无显著差异（7.5对7.2）（P=0.34）。与基线相比，两组均观察到体重减轻。未报告导致研究中止的不良事件。
该植物根在降低血糖和控制2型糖尿病方面不仅与二甲双胍一样有效，而且（短期内）未报告有特定副作用。因此，它可能是糖尿病患者一种有效且安全的辅助治疗方法。伊朗研究与临床试验（IRCT）注册号：201,207,191,774N5。资金来源：克尔曼医科大学研究副校长、生理学研究中心和Exir制药公司。
