en <i>Cynara scolymus</i> L. in Treatment of Hypercholesterolemic Type 2 Diabetic Patients: a Randomized Double-Blind Placebo-Controlled Clinical Trial فارماكولوژی و سم شناسی Pharmacology & Toxicology پژوهشی Research <div dir="ltr" style="text-align: justify;"><strong>Background:</strong> 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 (<em>Cynara scolymus</em> 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. <strong>Objective:</strong> The effects of artichoke leaf extract in treatment of hypercholesterolemic type 2 diabetic patients were studied. <strong>Methods: </strong>In this randomized double-blind placebo-controlled clinical trial with hypercholesterolemic type 2 diabetic patients aged 40 to 60 years not using other anti-hyperlipidemic 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). <strong>Results:</strong> 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. <strong>Conclusion:</strong> 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.</div> <div dir="ltr" style="text-align: justify;"><strong>Background:</strong> 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 (<em>Cynara scolymus</em> 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. <strong>Objective:</strong> The effects of artichoke leaf extract in treatment of hypercholesterolemic type 2 diabetic patients were studied. <strong>Methods: </strong>In this randomized double-blind placebo-controlled clinical trial with hypercholesterolemic type 2 diabetic patients aged 40 to 60 years not using other anti-hyperlipidemic 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). <strong>Results:</strong> 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. <strong>Conclusion:</strong> 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.</div> Artichoke, Hyperlipidemia, Patient, Type 2 diabetes Artichoke, Hyperlipidemia, Patient, Type 2 diabetes 58 65 http://jmp.ir/browse.php?a_code=A-10-71-6&slc_lang=en&sid=1 H Fallah Huseini H Fallah Huseini 100319475328460037145 100319475328460037145 No Department of Pharmacology and Applied Medicine, Institute of Medicinal Plants, ACECR Department of Pharmacology and Applied Medicine, Institute of Medicinal Plants, ACECR S Kianbakht S Kianbakht skianbakht@yahoo.com 100319475328460037146 100319475328460037146 Yes Department of Pharmacology and Applied Medicine, Institute of Medicinal Plants, ACECR Department of Pharmacology and Applied Medicine, Institute of Medicinal Plants, ACECR R Heshmat R Heshmat 100319475328460037147 100319475328460037147 No Department of Biostatistics and Epidemiology, Tehran University of Medical Sciences Department of Biostatistics and Epidemiology, Tehran University of Medical Sciences