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Study | Type of study | Comparison | Study population | Follow-up | Inclusion criteria | Outcomes |
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Velussi et al. 1997 [26] | 12-month open, controlled study | Silymarin plus standard therapy versus standard therapy alone | 60 insulin-treated diabetics with alcoholic cirrhosis | 4 mo | Age 45 to 70 years (i) NIDDM with alcoholic liver cirrhosis (ii) BMI < 29 kg/m2 (iii) Ascertained diabetes for a period of at least 5 years and being treated with insulin only (iv) Stable insulin therapy for a period of at least 2 years (v) Negative for markers of hepatitis A, hepatitis B, and hepatitis C and being not addicted to alcohol for a period of at least 2 years prior to the start of the study (vi) No bleeding from varices (vii) Liver biopsy (liver cirrhosis) | Fasting blood glucose Mean daily blood glucose levels Daily glycosuria levels HbA1c Malondialdehyde levels |
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Huseini et al. 2006 [28] | Randomized double-blind clinical trial | Silymarin plus conventional therapy versus placebo plus conventional therapy | 51 patients with type 2 DM | 4 mo | Type 2 diabetes according to ADA criteria (2003) (i) Age 40–65 years (ii) Having a fasting blood glucose level less than 250 mg/dL (iii) Duration of diabetes was more than 2 years, and their diabetes was not controlled exclusively by diet | Fasting blood glucose HbA1c Total cholesterol, LDL, and HDL and triglyceride GOT and GPT levels |
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Hussain 2007 [29] | Randomized, double-blind, placebo-controlled trial | silymarin + glibenclamide versus placebo + glibenclamide versus glibenclamide alone | 59 patients with type 2 DM | 4 mo | T2DM for at least 5 years (i) Already maintained on 10 mg/day glibenclamide and on diet control (ii) Fasting plasma glucose ≥ 10 mmol/L (iii) HbA1c ≥ 8% (iv) BMI ≥ 29 kg/m2 | Fasting blood glucose HbA1c Body mass index (BMI) |
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Fallahzadeh et al. 2012 [19] | Randomized, double-blind, placebo-controlled, 2-arm parallel trial | Silymarin versus placebo | 60 patients with type 2DM and macroalbuminuria | 6 mo | Urinary albumin excretion >300 mg/24 h Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin Treatment of hypercholesterolemia with a statin Presence of diabetic retinopathy | Absolute change in urinary albumin-creatinine ratio Urinary and serum levels of TNF-α Malondialdehyde and TGFβ |
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Ebrahimpour Koujan et al. 2015 [30] | Randomized, triple-blinded, placebo-controlled clinical trial | Silymarin versus placebo | 40 patients with type 2 DM | 45 days | Type 2 diabetes patients (i) taking hypoglycaemic medications, (ii) having a body mass index (BMI) between 27 and 35 kg/m2, and (iii) following a stable habitual diet for the past three months | Antioxidant indices Superoxide dismutase (SOD) and glutathione peroxidase (GPX) activity and total antioxidant capacity C reactive protein |
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