The role of a fixed Berberis aristata/Silybum marianum combination in the treatment of type 1 diabetes mellitus.

To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol(®)) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus.

85 type 1 diabetic patients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile.

We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo.

The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.