Anti-Inflammatory Effect of Crocus sativus on Serum Cytokine Levels in Subjects with Metabolic Syndrome: A Randomized, Double-Blind, Placebo- Controlled Trial.

BACKGROUND/AIMS: A growing body of evidence supports an important role of inflammatory cytokines in the development and progression of the Metabolic Syndrome (MetS), which explains, at least in part, its relationship with an increased cardiovascular-risk. Several studies have reported the therapeutic-impact of crocus-sativus in a preclinical/clinical setting. Here we have explored the effects of crocus-sativus, on the serum concentrations of twelve serum cytokines in subjects with MetS in a randomized control trial. METHODS: Forty four adult volunteers, who met the diagnostic-criteria of MetS, were enrolled and randomly divided into 2 groups, to receive 100 mg/day crocus-sativus for 12 weeks. 12 cytokines, including IL-1α, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α, MCP-1, IFN-γ, EGF, and VEGF were measured using sandwich chemi-luminescence assays before/after therapy. RESULTS: Individuals with MetS who received crocus-sativus had significantly (P<0.05) lower levels of total-cholesterol, low density-lipoprotein-cholesterol and triglyceride (TG), fasting-blood-sugar and hsCRP, however the serum concentration of high density-lipoprotein-cholesterol markedly enhanced after therapy (e.g., TG level reduced from 148.86±71.49 to 101.90±38.19 after therapy, P= 0.003). Moreover, we observed that treatment with Crocus-sativus affected the serumconcentrations of some pro-/anti-inflamatory cytokines. In particular, the level of VEGF was increased from 12.64 pg/mL (95% CI: 9.60-17.67) to 16.59 (95% CI: 11.33-35.98, P= 0.033. Similar results were detected for IL-6 and EGF. CONCLUSION: Our findings provide a novel insight into the therapeutic effects of this therapy in MetS patients via perturbation of serum cytokines and reducing the levels of triglyceride and LDL/TC, but further studies are required in larger populations.

A double-blind, randomized and placebo-controlled trial of Saffron (Crocus sativus L.) in the treatment of anxiety and depression.

BACKGROUND: Depression and anxiety are prevalent serious psychiatric disorders. Several drugs are used to treat these conditions but these are often associated with serious side effects. For this reason alternative therapies, including herbal medication such as saffron, have been proposed. We aimed to assess the effects of saffron extract for the treatment of anxiety and depression using a 12-week double-blind, placebo-controlled trial design. METHODS: Sixty adult patients with anxiety and depression were randomized to receive a 50 mg saffron capsule (Crocus sativus L. stigma) or a placebo capsule twice daily for 12 weeks. Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) questionnaires were used at baseline, 6 and 12 weeks after initiating medication. 54 subjects completed the trial. RESULTS: Saffron supplements had a significant effect on the BDI and BAI scores of subjects in comparison to placebo at the 12 week time-point (p<0.001). CONCLUSIONS: Saffron appears to have a significant impact in the treatment of anxiety and depression disorder. Side effects were rare.

Saffron supplements modulate serum pro-oxidant-antioxidant balance in patients with metabolic syndrome: A randomized, placebo-controlled clinical trial.

OBJECTIVES: We have investigated the effect of a saffron supplement, given at a dose of 100 mg/kg, on prooxidant-antioxidant balance (PAB) in individuals with metabolic syndrome. MATERIALS AND METHODS: A randomized, placebo-controlled trial design was used in 75 subjects with metabolic syndrome who were randomly allocated to one of two study groups: (1) the case group received 100mg/kg saffron and (2) the placebo control group received placebo for 12 weeks. The serum PAB assay was applied to all subjects before (week 0) and after (weeks 6 and 12) the intervention. RESULTS: There was a significant (p=0.035) reduction in serum PAB between week 0 to week 6 and also from week 0 to week 12. CONCLUSION: Saffron supplements can modulate serum PAB in subjects with metabolic syndrome, implying an improvement in some aspects of oxidative stress or antioxidant protection.

Saffron in metabolic syndrome: its effects on antibody titers to heat-shock proteins 27, 60, 65 and 70.

BACKGROUND: The metabolic syndrome is the most important risk factor for cardiovascular disease. The heat shock proteins (HSPs) are highly conserved families of proteins expressed by a number of cell types following exposure to stressful environmental conditions include several known risk factors for cardiovascular disease. Recent studies have shown the potential of constituents of saffron in the treatment of atherosclerosis. We aimed on investigating the effect of saffron on antibody titers to HSP in patients with metabolic syndrome. METHODS: This was a randomized, placebo-controlled clinical trial. One-hundred and five subjects with metabolic syndrome were randomly allocated to one of the three groups: the case group received 100 mg/day saffron, the placebo control group received a capsule of placebo and a non-placebo control group received no capsule, for 12 weeks. RESULTS: Antibodies against heat shock proteins 27, 60, 65 and 70 were determined in all patients before (week 0) and after (week 6 and 12) intervention. At 12 weeks, saffron produced a significantly decrease in AntiHSP27, 70 levels. Saffron can decrease AntiHSP27, 70 levels in patients with metabolic syndrome. CONCLUSIONS: The results of this study indicate the efficacy of saffron in the improvement of some markers of autoimmunity HSPs in patients with metabolic syndrome.