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Evidence-Based Supplement Research
Evidence-Based Supplement Research

The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial.

  • 2006
  • Phytotherapy research : PTR 20(12)
    • H Fallah Huseini
    • B Larijani
    • R Heshmat
    • H Fakhrzadeh
    • B Radjabipour
    • T Toliat
    • Mohsin Raza

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 26
Population
51 type II diabetic patients in two well-matched groups
Methods
randomized double-blind clinical trial, 4 months, silymarin (200 mg) tablet 3 times a day plus conventional therapy vs placebo
Blinding
Double-blind
Duration
4 months
Funding
Unclear
  • Highly Cited
Oxidative stresses are increasingly implicated in the pathogenesis of diabetic complications which may either cause direct pancreatic beta-cell damage or lead to metabolic abnormalities that can induce or aggravate diabetes. The valuable effect of antioxidant nutrients on the glycemic control of diabetic patients has been reported in experimental and clinical studies. The present study was designed to investigate the effects of the herbal medicine, Silybum marianum seed extract (silymarin), which is known to have antioxidant properties on the glycemic profile in diabetic patients. A 4-month randomized double-blind clinical trial was conducted in 51 type II diabetic patients in two well-matched groups. The first group (n = 25) received a silymarin (200 mg) tablet 3 times a day plus conventional therapy. The second group (n = 26) received the same therapy but a placebo tablet instead of silymarin. The patients were visited monthly and glycosylated hemoglobin (HbA(1)c), fasting blood glucose (FBS), insulin, total cholesterol, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and the end of the study. The results showed a significant decrease in HbA(1)c, FBS, total cholesterol, LDL, triglyceride SGOT and SGPT levels in silymarin treated patients compared with placebo as well as with values at the beginning of the study in each group. In conclusion, silymarin treatment in type II diabetic patients for 4 months has a beneficial effect on improving the glycemic profile.

Research Insights

  • a significant decrease in ... total cholesterol ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in ... FBS ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in HbA(1)c ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in ... LDL ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in ... SGOT ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in ... SGPT levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
  • a significant decrease in ... triglyceride ... levels in silymarin treated patients compared with placebo

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    200 mg tablet 3 times a day
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