Efficacy and safety of Ginkgo biloba extract as an “add-on” treatment to metformin for patients with metabolic syndrome: a pilot clinical study

Tavga Ahmed Aziz,1 Saad Abdulrahman Hussain,2 Taha Othman Mahwi,3 Zheen Aorahman Ahmed1 1Department of Pharmacology and Toxicology, College of Pharmacy, University of Sulaimani, Kurdistan, Iraq; 2Department of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Rafidain University College, Baghdad, Iraq; 3Department of Internal Medicine, College of Medicine, University of Sulaimani, Kurdistan, Iraq Background and aim: Ginkgo biloba (GKB) extract has shown to be beneficial in experimental models of metabolic and inflammatory disorders such as diabetes and metabolic syndrome (MTS). The objective of this pilot clinical study was to evaluate the effects of GKB extract as an “add-on” treatment with metformin (Met) in MTS patients. Patients and methods: We performed a randomized, placebo-controlled, double-blinded clinical study in subjects with MTS. Forty patients completed the 90-day clinical trial and were randomly allocated to administer either GKB extract (120 mg capsule/day) or placebo (120 mg starch/day) as an add-on treatment with their currently used doses of Met for 90 days. During the study, body mass index (BMI), waist circumference (WC), serum leptin, glycated hemoglobin (HbA1c), fasting serum glucose (FSG), insulin, insulin resistance (IR), visceral adiposity index (VAI), lipid profile, and the inflammatory markers high sensitive C-reactive protein (hsCRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were evaluated. Results: GKB extract significantly decreases HbA1c, FSG and insulin levels, IR, BMI, WC, VAI, serum leptin, and the inflammatory markers compared to baseline values. Simultaneously, GKB did not negatively affect the functions of the liver, kidney, and hematopoietic system. Conclusion: The use of GKB extract as an adjuvant with Met was effective in improving the outcome of patients with MTS. Keywords: Ginkgo biloba, metabolic syndrome, metformin, adiposity, insulin resistance, inflammatio

The efficacy and safety of Ginkgo biloba extract as an adjuvant in type 2 diabetes mellitus patients ineffectively managed with metformin: a double-blind, randomized, placebo-controlled trial

Tavga Ahmed Aziz,1 Saad Abdulrahman Hussain,2 Taha Othman Mahwi,3 Zheen Aorahman Ahmed,1 Heshu Sulaiman Rahman,4–6 Abdullah Rasedee6 1Department of Pharmacology and Toxicology, College of Pharmacy, University of Sulaimani, Sulaimani City, 2Department of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Rafidain University, Baghdad, 3Department of Medicine, College of Medicine, 4Department of Clinic and Internal Medicine, College of Veterinary Medicine, University of Sulaimani, 5Department of Medical Laboratory Sciences, College of Health Sciences, Komar University of Science and Technology, Chaq-Chaq-Qularaisi, Sulaimani City, Iraq; 6Department of Veterinary Laboratory Diagnosis, Faculty of Veterinary Medicine, Universiti Putra Malaysia, Selangor, Malaysia Background and aim: Type 2 diabetes mellitus (T2DM) is one of the major diseases confronting the health care systems. In diabetes mellitus (DM), combined use of oral hypoglycemic medications has been shown to be more effective than metformin (Met) alone in glycemic control. This study determined the effects of Ginkgo biloba (GKB) extract as an adjuvant to Met in patients with uncontrolled T2DM.Subjects and methods: Sixty T2DM patients were recruited in a randomized, placebo-controlled, double-blinded, and multicenter trial. The patients, currently using Met, were randomly grouped into those treated with either GKB extract (120 mg/day) or placebo (starch, 120 mg/day) for 90 days. Blood glycated hemoglobin (HbA1c), fasting serum glucose, serum insulin, body mass index (BMI), waist circumference (WC), insulin resistance, and visceral adiposity index (VAI) were determined before (baseline) and after 90 days of GKB extract treatment.Results: GKB extract significantly decreased blood HbA1c (7.7%±1.2% vs baseline 8.6%±1.6%, P<0.001), fasting serum glucose (154.7±36.1 mg/dL vs baseline 194.4±66.1 mg/dL, P<0.001) and insulin (13.4±7.8 µU/mL vs baseline 18.5±8.9 µU/mL, P=0.006) levels, BMI (31.6±5.1 kg/m2 vs baseline 34.0±6.0 kg/m2, P<0.001), waist WC (102.6±10.5 cm vs baseline 106.0±10.9 cm, P<0.001), and VAI (158.9±67.2 vs baseline 192.0±86.2, P=0.007). GKB extract did not negatively impact the liver, kidney, or hematopoietic functions.Conclusion: GKB extract as an adjuvant was effective in improving Met treatment outcomes in T2DM patients. Thus, it is suggested that GKB extract is an effective dietary supplement for the control of DM in humans. Keywords: T2DM, Ginkgo biloba extract, metformin, BMI, glycemic control, insulin resistanc