The Effects of Berberis integerrima Fruit Extract on Glycemic Control Parameters in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

BACKGROUND: Berberis integerrima Bunge fruits have been utilized in traditional medicine to control diabetes mellitus (DM). However, no clinical survey has been done in this regard. This study was conducted to clinically evaluate the effects of fruit extract of this plant in improving glycemic control indices in patients with type 2 DM (T2DM). METHODS: In a randomized controlled clinical trial, patients with T2DM who met the inclusion criteria were randomly divided into two groups of drug (Berberis) and control to receive the extract solution 5 ml twice daily (equivalent to 1000 mg of dry extract) with standard treatment (metformin) or only standard treatment, respectively, for 8 weeks. Before and after the intervention, fasting blood sugar (FBS), serum glycosylated hemoglobin (HbA1c), serum insulin, the homeostasis assessment model for insulin resistance (HOMA-IR), body mass index (BMI), and systolic and diastolic blood pressure were determined and compared between the two groups. RESULTS: During the study, 30 and 35 patients in the drug and control groups, respectively, completed the study. Although no significant changes occurred in any parameter within each group, postintervention FBS (117.5 [107–128.8] versus 134 [120–142], P = 0.001) and HbA1c (7 [6.4–7.7] versus 7.5 [6.8–7.9], P = 0.045) were significantly lower in the drug group than in the control one. In terms of other parameters, there were no significant differences between the groups. CONCLUSION: Consumption of B. integerrima Bunge fruit extract at a dosage of 1000 mg daily decreases FBS and HbA1c but does not affect HOMA-IR in patients with type 2 diabetes mellitus.