Background Berberine and Bifidobacterium have been reported to improve glucose tolerance in people with hyperglycemia or other metabolic disorders. This study aimed to assess the hypoglycemic effect and the regulation of the gut microbiota caused by berberine and Bifidobacterium and the possible additive benefits of their combination. Methods This was an 18-week, multi-center, randomized, double-blind, parallel-controlled study of patients newly diagnosed with hyperglycemia. After a 2-week run-in period, 300 participants were randomly assigned to the following four groups for 16 weeks of treatment: berberine (Be), Bifidobacterium (Bi), berberine and Bifidobacterium (BB), and placebo group. The primary efficacy endpoint was the absolute value of fasting plasma glucose (FPG) compared with baseline after 16 weeks of treatment. Results Between October 2015 and April 2018, a total of 297 participants were included in the primary analysis. Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group, with a least square (LS) mean difference of − 0.50, 95% CI [− 0.85, − 0.15] mmol/L, and − 0.55, 95% CI [− 0.91, − 0.20] mmol/L, respectively. The Be and BB groups also showed significant reductions in 2-h postprandial plasma glucose. A pronounced decrease in HbA1c occurred in the BB group compared to the placebo group. Moreover, compared with the Bi and placebo groups, the Be and BB groups had more changes in the gut microbiota from the baseline. Conclusions Berberine could regulate the structure and function of the human gut microbiota, and Bifidobacterium has the potential to enhance the hypoglycemic effect of berberine. These findings provide new insights into the hypoglycemic potential of berberine and Bifidobacterium. Trial registration ClinicalTrials.gov, NCT03330184. Retrospectively registered on 18 October 2017

Objective. Insulin replacement therapy is the main treatment method for type 1 diabetes, and adjuvant comprehensive treatment to reduce the complications of diabetes is still the focus of research. The purpose of this study is to explore the clinical efficacy of Tresiba combined with Ingredient Rehmannia Pill in the treatment of type 1 diabetes. Methods. A total of 216 patients with type 2 diabetes admitted to our hospital from January 2019 to July 2019 were enrolled in this study. Patients in the control and observation groups were treated with Tresiba and Tresiba combined with Ingredient Rehmannia Pill, respectively. The change of TCM symptom score, blood glucose level and fasting insulin level before and after treatment were evaluated, and the insulin resistance index was calculated to observe the adverse reactions of patients. Results. After treatment, the TCM syndrome scores of the two groups decreased significantly, and the TCM syndrome scores of the observation group were significantly lower than those of the control group. The fasting blood glucose, 2 h postprandial blood glucose and insulin resistance index of the observation group were lower than those of the control group. The levels of FBG, 2 hBG and HbA1C in the observation group were significantly lower than those in the control group. The total effective rate of the observation group was 91.7%, which was significantly higher than that of the control group (77.1%). The adverse reactions of patients in the observation group were slightly more than those in the control group. Conclusion. Our study demonstrated that Ingredient Rehmannia Pill combined with Tresiba is effective in the treatment of type 2 diabetes, providing alternative therapies for the treatment of diabetes.