Cynara scolymus l. in treatment of hypercholesterolemic type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial

ABSTRACT

Type 2 diabetes mellitus with hyperlipidemia is a common disease. Conventional anti-hyperglycemic and anti-hyperlipidemic drugs have limited efficacies and important side effects, so that alternative agents are needed. Previous studies suggest that fiber-free artichoke [Cynara scolymus L.] leaf extract may have anti-hyperglycemic and anti-hypercholesterolemic effects in hypercholesterolemic type 2 diabetic patients. Moreover, artichoke leaves are used traditionally as an anti-hyperglycemic and anti-hyperlipidemic remedy to treat diabetes mellitus and hyperlipidemia. The effects of artichoke leaf extract in treatment of hypercholesterolemic type 2 diabetic patients were studied. In this randomized double-blind placebo-controlled clinical trial with hypercholesterolemic type 2 diabetic patients aged 40 to 60 years not using other antihyperlipidemic agents and resistant to daily intake of two 5 mg glyburide tablets and two 500 mg metformin tablets, the efficacy and safety of taking fiber-free artichoke leaf extract [one 400 mg capsule t.i.d. for 2 months] combined with the aforementioned drugs in treatment of 36 patients were evaluated and compared with the placebo group [n = 36]. The extract lowered the blood levels of total cholesterol and LDL cholesterol significantly [P=0.002 and p=0.040 respectively] without any significant effects on the blood levels of fasting glucose, postprandial glucose, glycosylated hemoglobin, other lipids, SGOT, SGPT and creatinine [P>0.05] compared with placebo at the endpoint. No adverse effects were reported. Fiber-free artichoke extract may be a safe anti-hypercholesterolemic agent but does not improve glycemic control in hypercholesterolemic type 2 diabetic patients, suggesting the involvement of fibers in the anti-hyperglycemic effect of artichoke