الفهرس 
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Abstract
Diabetes mellitus has been defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of DM is associated with long term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessel.
The most common form of diabetes is T2DM, which is a multifactorial disease, the pathophysiology of which involves not only the pancreas but also the liver, skeletal muscle, adipose tissue, gastrointestinal tract, brain, and kidney. Reduced sensitivity to insulin in liver, muscle, and adipose tissue, and a progressive decline in pancreatic β-cell function leading to impaired insulin secretion, eventually result in hyperglycemia, the hallmark feature of T2DM.
The current standard of care for patients with DM includes non-pharmacological treatment (caloric restriction and physical exercise), and pharmacological treatment (oral and injectable anti-diabetic drugs). The fact that a lack of highly effective drug therapy with existing synthetic agents and their resulting adverse effects motivated further search into traditional medicine in order to find new safe and effective natural entities to be used as anti-diabetic products.
Silymarin, the active component of the milk thistle plant (Silybum marianum (L.) Gaertn.), was reported to have anti-diabetic properties in various animal studies and that was attributed to its antioxidant, anti-inflammatory and hypoglycemic properties.
The current study was designed to evaluate the effect of silymarin as an adjuvant therapy on the clinical outcome of type 2 diabetic patients. This was accomplished by assessing its effect on glycemic control, insulin resistance, lipid profile, oxidative stress marker [malondialdehyde], inflammatory marker [high sensitive c reactive protein], kidney functions, liver functions and patients’ quality of life. The study was conducted on 40 type 2 diabetic patients. These patients were randomized to one of the two groups:
Control group: received placebo as add on to standard diabetes treatment for 3 months.
Summary
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Silymarin group: received silymarin at dose of 140 mg three times daily as add on to standard diabetes treatment for 3 months.
All patients were subjected to a thorough history taking and the following parameters were evaluated at baseline and at the end of the 3 months of either receiving placebo or silymarin:
a- Fasting blood glucose (FBG) level.
b- Glycated hemoglobin (HbA1c) level.
c- Fasting serum insulin (FSI) level.
d- Lipid profile (TC, TG, HDL-C, LDL-C and VLDL-C).
e- Oxidative stress marker (MDA) level.
f- Inflammatory marker (hs-CRP) level.
g- Kidney functions (SC and BUN).
h- Homeostasis model assessment of insulin resistance (HOMA-IR) index.
i- Diabetes-39 questionnaire score.
j- Adverse events/effects profile.
The current study showed that:
There was a significant decrease in serum FBG, HbA1c and FSI levels between baseline and the end of the study in silmarin group while there was a significant increase in control group.
There was a significant improvement in HOMA-IR index between baseline and after 3 months in silymarin group.
Silymarin showed a significant improvement in levels of TC, TG, LDL-C, HDL-C and VLDL-C after 3 months of treatment.
The type 2 diabetic patients are subjected to increased oxidative stress and inflammation which was revealed by higher levels of serum MDA and hs-CRP compared to non-diabetic healthy adults. Also, there was a significant difference in serum MDA and hs-CRP levels between the study groups at the end of the study.
Silymarin significantly improved patients’ quality of life regarding D-39 Q total scores after 3 months of treatment.
Comparison of the percent change in HDL-C, BUN and SC levels among the 2 groups showed significant differences.
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Conclusion:
Administration of silymarin at dose 140 mg thrice daily for 3 months had a significant effect on glycemic control in type 2 diabetic patients than standard treatment alone.
Administration of silymarin at dose 140 mg thrice daily for 3 months showed significant improvement in patients’ insulin resistance, lipid profile, oxidative stress markers and markers of inflammation than standard treatment alone.
Administration of silymarin at dose 140 mg thrice daily for 3 months showed significant improvement in patients’ quality of life.
Silymarin administered at dose 140 mg thrice daily for 3 months showed no significant adverse effects that necessitated treatment discontinuation and was tolerable by the patients.
Recommendations:
Further studies with larger sample sizes and different dose ranges are needed to evaluate the potential effect of silymarin on type 2 diabetic patients.