Clinical efficacy of Diabecon in treatment of type 2 diabetes mellitus, in newly diagnosed diabetic patients and in those on drug treatment (Glibenclamide and Metformin) in Erbil Governarate-Kurdistan Region/ Iraq.

Abstract

Various herbs have been found beneficial in the management of type 2 diabetes and are gaining considerable recognition in the management of type 2diabetes worldwide. The present study was planned to evaluate the clinical efficacy of Diabecon (Herbal formulation) as a mono therapy and also as an adjunct with other oral hypoglycemic agents, in the management of type 2 DM. A total of 80 patients of either sex, between 30-68 years of age, in whom the diagnosis of type 2 diabetes was confirmed, and who were willing to give informed consent were included in the study.All enrolled patients were categorized into 4 groups. Group A included 20 newly diagnosed patients who were not consuming any oral hypoglycemic agent (OHA), while group B included 20 patients who were already consuming glibenclamide but were not controlled, while group C included 20 patients who were already consuming metformin but were not controlled and lastly group D included 20 patients who were already consuming glibenclamide and metformin combination but were not controlled. Patients from all the groups were advised to consume Diabecon at a dose of 2 tablets, three times daily (30 minutes) before meal for a period of 3 months, either as monotherapy for group A or as adjunct in the other three groups.
For all the patients, fasting blood glucose (FBG) and postprandial blood glucose (PPG) were assessed at the time of enrollment and thereafter every month, for 3 months, While Glycoselated haemoglubin (HbA1c), Total cholesterol (TC), Triglyceride (TG), High density lipoprotein-Cholesterol (HDL-c), Low density lipoprotein-Cholesterol (LDL-c), Basal serum insulin, C-peptide and body weight (BW) were assessed at the time of enrollment and after 3 months.
Diabecon significantly reduced FBG, PPG and HbA1c in all groups, which indicating an improved glucose homeostasis under the influence of this herbal formulation. There was a mild improvement in serum basal insulin and C-peptide level after using Diabecon either as monotherapy or as adjunct to glibenclamide, metformin or glibenclamide and metformin combination in those with type 2 diabetic patients who were not controlled by such oral
hypoglycemic agent. Diabecon caused improvement of lipid profile including TC, TG and LDL-c to a variable extent in all groups except for group B. Its main effect is on the reduction of TC which could be beneficial since hypercholesterolemia is strongly associated with cardiovascular
disease. A significant reduction in body weight was noticed at the end of the study among all groups except in group B who showed an increase in body weight but it was not significant. This weight reduction is a desired effect in type 2 diabetic patients and may play a role in improving insulin resistance. Most of the patients reported a sense of well-being and no side effect were recorded either by patient or observer except rare cases of gastric upset.
Therefore, it may be concluded that Diabecon is clinically effective herbal formulation in the management of type 2 diabetes either as a monotherapy in newly diagnosed patients or as an adjunct therapy in patients on conventional OHAs.