The effect of Nigella sativa oil versus metformin on the biochemical parameters and clinical outcome of newly diagnosed type 2 diabetes mellitus patients

Abstract

This randomized controlled trial was designed to study the clinical and biochemical effects of Nigella sativa (NS) on newly diagnosed type 2 diabetes mellitus (T2DM) patients and to compare its efficacy and safety with metformin, the gold standard oral anti-diabetic (OAD). NS has been previously tested for its hypoglycemic effects as an adjunct therapy to the conventional OADs for management of T2DM. However, it was not, as far as we know, compared as a monotherapy to metformin or to any other OAD. This thesis examines the background of diabetes disease, its risk factors, pathogenesis, disease prevention, diagnosis, and complications. In addition, it outlines the pharmaceutical care plan of DM management. It describes metformin‟s mechanism of action, its adverse effects, pharmacokinetics, its effects on glycemic profile and weight, and its multiple benefits. It also addresses the use of complementary and alternative medicines in various ailments, including diabetes. It focuses on Nigella sativa‟s potential hypoglycemic, hypolipidemic, antioxidant, and weight reduction potentials. Sixty two newly diagnosed T2DM patients were randomly assigned into 2 groups, metformin group (n = 33) and NS oil group (n = 29). Both groups were followed up for three months. Patients received comprehensive education about the disease and the medications. Glycemic markers, lipid profile, oxidative stress markers, liver and kidney function, weight, body mass index, and waist circumference were tested at baseline, and 3 months thereafter. Diabetes symptoms and drug side effects were reported at the end of the study. The results of the study show that NS reduced the fasting plasma glucose, but did not significantly reduce post prandial blood glucose or glycated hemoglobin. It demonstrated weight reduction effects that were equivalent to those of metformin. The present study supports the results of previous studies, indicating the favorable effect of NS on glucose homeostasis and weight reduction. NS oil was tolerable and effective in T2DM management. However, it was inferior to metformin. Further clinical trials are recommended to move forward in this promising area of research.