Journal of Diabetes Research / 2016 / Article / Tab 1

Review Article

Silymarin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Table 1

Studies included in analysis.

Study Type of studyComparison Study populationFollow-upInclusion criteriaOutcomes

Velussi et al. 1997 [26]12-month open, controlled studySilymarin plus standard therapy versus standard therapy alone60 insulin-treated diabetics with alcoholic cirrhosis4 moAge 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

Huseini et al. 2006 [28]Randomized double-blind clinical trialSilymarin plus conventional therapy versus placebo plus conventional therapy51  patients with type 2 DM 4 moType 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

Hussain 2007 [29]Randomized, double-blind, placebo-controlled trialsilymarin + glibenclamide versus placebo + glibenclamide versus glibenclamide alone59  patients with type 2 DM4 moT2DM 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)

Fallahzadeh et al. 2012 [19]Randomized, double-blind, placebo-controlled, 2-arm parallel trialSilymarin versus placebo60  patients with type 2DM and macroalbuminuria6 moUrinary 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

Ebrahimpour Koujan et al. 2015 [30]Randomized, triple-blinded, placebo-controlled clinical trialSilymarin versus placebo40 patients with type 2 DM45 daysType 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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