Combination Treatment with a Novel Polyherbal Formulation and Metformin: A Single Blind Placebo-Controlled Study in Patients with T2DM and Cognitive Impairments

th , 2015 Published: August 27 th , 2015 ABSTRACT Background: Older people suffering from Type 2 Diabetes Mellitus (T2DM) are at major risk for age related cognitive dysfunction and dementia, mainly due to vascular complications. Stud- ies have shown that T2DM is also associated with Alzheimer's Disease (AD) and is responsible for accelerating the pathology through insulin resistance. A polyherbal drug containing Bacopa Monnieri, Hippophae rhamnoides and Dioscorea bulbifera has shown a potent neuroprotective effect in management of cognitive deficits in elderly; and metformin a well-accepted antidia - betic agent responsible for lowering blood glucose in T2DM, can together provide an intrigu- ing potential combination therapy for prevention and amelioration of cognitive impairments in T2DM patients. Objective: The present study is aimed to evaluate the combined effect of a polyherbal drug and metformin on improving cognitive functions in patients suffering from T2DM. Method: Elderly patients with an age range of 60-75 years diagnosed for T2DM were enrolled in the study and randomized into two groups; Group I=T2DM patients given metformin and placebo, Group II=T2DM patients given metformin and polyherbal drug. The subjects received the combination therapy of metformin (500 mg) and placebo or metformin (500 mg) and poly- herbal drug (500 mg) twice daily for a period of 24 weeks. Estimation of Mini Mental State Examination (MMSE) score, blood glucose, HbA1c, insulin, lipid profile (total cholesterol, LDL-c, HDL-c, triglycerides), homocysteine, Interleukin-6 (IL-6), TNF-α and C-reactive pro- tein (CRP) were measured at baseline and were repeated at three months and six months. The primary end point was a change from baseline to week 24 in MMSE score. Key secondary end points included change from baseline to week 24 in Digital Symbol Substitution (DSS); subtest of the Wechsler Adult Intelligence Scale-Revised), word recall (digital memory apparatus - Medicaid systems, Chandigarh, India), attention span (Attention Span Apparatus - Medicaid systems, Chandigarh, India), Functional Activity Questionnaire (FAQ) and Hamilton Depres- sion Scale (HDS) score. Further inflammatory markers and level of oxidative stress were anal - ysed using standard biochemical tests. Result: The trial was performed in 120 elderly diabetic patients out of whom 112 patients