CLINICAL EFFICACY AND SAFETY OF METFORMIN VERSUS APPLE CIDER VINEGAR (ACV) IN PREDIABETICS

Abstract

Prediabetes is defined as a state of abnormal glucose homeostasis where blood glucose levels are elevated above normal, but not as high as those required for diagnosis of diabetes. Usually there are no clinical features except overweight or obesity but it may be characterized by hyperglycemia, increased thirst and food intake, frequent urination, fatigue. etc. If kept un-checked it proceeds to development of type 2 diabetes. . Following registration with clinical trials.gov vide NCT number 05759442, a clinical trial was conducted after approval of ERC & FRC. The objectives of the study were (1) to evaluate and compare the clinical efficacy of metformin HCl versus apple cider vinegar (ACV) along with lifestyle modification of diet control and exercise in pre-diabetics and (2) to assess the adverse effects, safety profile and cost effectiveness of metformin and ACV in pre-diabetics. After approval of ERC and FRC screening of prediabetics was started. Males and females ,17-40 years of age as per ADA 2010 and ISPAD 2018 criteria, were then enrolled following written informed consent. The subjects were randomized by computer generated list into Group A (control)being given (N=25, tablet Metformin HCl, 500 mg orally BD and Group B given (N=25, Apple cider vinegar 15 ml diluted in 200 ml water with dinner) for 12 weeks after excluding the 1st week of study due to escalation dose strategy. Both groups were kept on lifestyle modifications, including diet control and exercise alongside the treatment. Subjects were evaluated at baseline, week 6 and 12 for Anthropometric and Physiological parameters (Weight, Height, BMI, Waist circumference, Hip circumference, Waist hip ratio, Neck circumference, Blood pressure, Acanthosis nigricans). Metabolic parameters (HbA1c, FBG, Lipid profile) and Safety profile (CBC, SGOT, Serum Creatinine) were evaluated at baseline & week 12. Blood group was determined at baseline only while adverse effects were evaluated at 6 and 12 weeks. Cost effectiveness was evaluated at the end of study. Majority of participants were in age group 32 to 40 years. Blood group AB was found to be the commonest. In group A, the reduction in weight, HBA1c, FBG, HDL, was highly significant when day 0 values were compared with week 12. In group B, highly significant reduction resulted in weight, BMI, waist circumference, hip circumference, FBG, HDL with significant viii reduction in waist hip ratio and triglycerides with no effect on the neck circumference. Parameters for safety profile showed non-significant results in both groups for day 0 & week 12 indicating metformin and ACV being safe in the dose and for duration used. Metformin has exerted significant reducing effects on weight, HbA1c and FBG while apple cider vinegar has shown significant reduction in weight and FBG only.Study concluded that clinical efficacy of metformin is superior than the apple cider vinegar in prediabetics. Both drugs are found to be safe and no adverse effect in either group was reported , furthermore. Metformin is far more cost effective than apple cider vinegar