Razi Drug Research Center, Iran University of Medical Sciences, Tehran, Iran.
Avesta Pharmed Hakim, Tehran, Iran.
J Diet Suppl. 2021;18(1):31-43. doi: 10.1080/19390211.2020.1727076. Epub 2020 Feb 21.
are used traditionally as an herbal combination for treatment of diabetic patients in Iran. Despite the clinical evidence supporting their use in solitary form, no controlled human study has determined the efficacy and safety of their combination in treatment of diabetic patients.
A total 150 type II diabetic patients of both sexes under the oral anti-hyperglycemic drugs treatment (maximum 10 mg glyburide and 1000 mg metformin daily) were randomly assigned to three groups. The patients in each group received either herbal combination or placebo or metformin capsule daily for three months, without any change in their previous oral anti-hyperglycemic drugs dosage. Herbal combination, placebo and metformin capsules matched by shape and color were prepared in the Institute of Medicinal Plants Karaj, Iran. To assess the efficacy and safety of the treatments, the patients fasting plasma glucose, HbA1c, lipid profile, liver enzymes and renal function were determined at the beginning of the study and after three months.
Results showed that after three months, the fasting plasma glucose, HbA1c and cholesterol levels in herbal combination were decreased significantly as compared to placebo group (20% and 12% respectively) and also compared to base line (25% and 15% respectively). The herbal combination was as effective as metformin in reduction of FPG ( = 0.001, = 0.001) and HbA1c ( = 0.028 and = 0.050 respectively) compared to placebo. No notable hepatic, renal and gastrointestinal side effects were observed in the trial groups.
The results suggest that traditional herbal combination may safely improve glycemic control in type II diabetic patients with no significant adverse effect. [Formula: see text].
在伊朗，传统上使用草药混合物来治疗糖尿病患者。尽管有临床证据支持它们单独使用，但没有对照人体研究确定它们组合使用治疗糖尿病患者的疗效和安全性。
总共 150 名男女 2 型糖尿病患者正在接受口服降糖药物治疗（最大剂量为每天 10 毫克格列吡嗪和 1000 毫克二甲双胍），随机分为三组。每组患者每天分别接受草药混合物、安慰剂或二甲双胍胶囊治疗，而不改变其以前的口服降糖药物剂量。草药混合物、安慰剂和二甲双胍胶囊在伊朗卡拉季药用植物研究所按形状和颜色匹配制备。为了评估治疗的疗效和安全性，在研究开始时和三个月后测定患者的空腹血糖、HbA1c、血脂谱、肝酶和肾功能。
结果表明，与安慰剂组相比（分别为 20%和 12%），以及与基线相比（分别为 25%和 15%），三个月后，草药混合物组的空腹血糖、HbA1c 和胆固醇水平显著降低。与安慰剂相比，草药混合物在降低 FPG（ = 0.001， = 0.001）和 HbA1c（ = 0.028 和 = 0.050）方面与二甲双胍一样有效。在试验组中未观察到明显的肝、肾和胃肠道副作用。
结果表明，传统的草药混合物可能安全地改善 2 型糖尿病患者的血糖控制，而没有明显的不良反应。[公式：见正文]。
