Comparative study of metformin therapy alone and metformin combined with notholaena nivea tincture therapy in patients with type 2 diabetes

Abstract

Introduction: Type 2 diabetes is a complex progressive metabolic disorder, which represents a significant threat to human health and accounts for more than 91% of all diabetes cases. Objective: to evaluate the effect of adding Notholaena nivea tincture to metformin treatment in patients with impaired glucose tolerance (IGT) and type 2 diabetes (DMT2). Materials and Method: Unicentral, randomized, single-blind, placebo- controlled clinical trial. All participants diagnosed with IGT and T2DM who were taking metformin were randomly assigned to receive authentic Notholaena nivea tincture kits (40 patients) or placebo (58 patients), setting 6 drops daily, 30 minutes before breakfast and lunch for 26 weeks. , 3 controls were made (0, 13 and 26 weeks) measuring fasting plasma glucose (FPG), glycosylated hemoglobin level (HbA1C) and lipid profile. Results: the treatment group (Notholaena nivea tincture plus metformin) were significantly efficient at 13 weeks from the start of the trial, maintaining the plasma glucose reduction guideline (FPG), at the start of the study the control and treatment groups obtained levels of Similar FPG with values of .57±1.7 and 7.84±1.9 mmol/l respectively (p>0.05), at 13 weeks it was reduced to 7.21±1.mmol/l for the control group and 6.49±2.33 mmol/l for the treatment group (p<0.01), while at week 26 the control group reported 7.09±1.41 mmol/l while the treatment group obtained 5.98±0.71 mmol/l (p<0.01). There was a reduction in HbA1C levels within the groups, but no differences due to treatment effect were observed. In the lipid profile, the treatment with Metformin alone showed a better response with the reduction of total cholesterol and an increase in high-density lipoproteins (HDL) but increased the concentration of triglycerides, while the treatment with Notholaena nivea tincture maintained the lipid profiles at the same as at the beginning (p>0.05).  Conclusions: the combined treatment of metformin plus Notholaena nivea tincture rapidly and effectively reduces FPG concentrations in the blood of patients with IGT or DMT2, but it is ineffective in the treatment of the lipid profile.Keywords: Type 2 diabetes, Notholaena nivea, FPG, Metformin, lipids