Berberine and Prediabetes: A Clinical Observational Study

Objective: To observe the clinical efficacy and safety of berberine in treating patients with prediabetes. Methods: A total of 76 patients with prediabetes were enrolled, and at the end of a one-month run-in period, 70 patients were eligible to participate in the clinical trial and randomly assigned to two groups in a 1:1 ratio, namely a treatment group (n = 35) and a control group (n = 35). Members of the control group underwent lifestyle interventions, including dietary interventions and exercise prescriptions, while participants of the treatment group received both lifestyle interventions and oral administration of 300 mg berberine, three times daily for three months. Subsequently, the treatment group entered a washout period of two months, during which time the medication was stopped, and the lifestyle interventions continued. Following the washout period, the oral administration of berberine was resumed at the same dose and lasted for three months. Blood glucose parameters were evaluated after different treatment periods. Results: 1) Intra-group comparison: Following the first and the second treatment periods, the treatment group experienced a significant decrease in fasting plasma glucose (FPG), 2-hour PG (2hPG) based on oral glucose tolerance test (OGTT), HbA1c, and HOMA-IR (P < 0.05); for the control group, although the blood glucose parameters exhibited a downward trend, the differences lacked statistical significance. 2) Intergroup comparison: Compared to the control group, the treatment group showed a significant decline in the levels of FPG, 2hPG, and HbA1c, whereas the decrease in HOMA-IR had no statistical significance. 3) Safety evaluation: No serious adverse events occurred in either group. Conclusion: Berberine is safe and effective in controlling blood glucose levels in patients with prediabetes and deserves to be promoted in clinical practice.