Effects of crocin on inflammatory biomarkers and mental health status in patients with multiple sclerosis: A randomized, double-blinded clinical trial.

BACKGROUND: Multiple sclerosis (MS), as a demyelinating disease correlated with inflammation and oxidative stress, affects the central nervous system and causes a wide range of complications, including psychiatric disorders. Considering the anti-inflammatory and antioxidant properties associated with the bioactive components of saffron, such as crocin (trans-crocetin bis(ß-d-gentiobiosyl) ester), and their potential impact on ameliorating psychiatric symptoms, our study aimed to investigate the effect of crocin on biomarkers of inflammation, oxidative stress, and mental health, e.g., depression and anxiety in individuals with MS. METHOD: Patients with MS were randomized into two groups, taking either 15 mg crocin tablets twice a day (n = 25; 30 mg/day) or placebo tablets (n = 25) for 8 weeks. The valid and reliable Beck depression and anxiety scale questionnaire was recorded, and fasting blood samples were collected to measure biomarkers, including high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), and nitric oxide (NO) at baseline and week 8 following the intervention. RESULTS: The data analysis using ANCOVA showed that supplementation with crocin for 8 weeks significantly lowered hs-CRP levels (p-value= 0.01). In addition, within-group comparisons showed crocin significantly decreased anxiety (p-value= 0.01). However, crocin did not affect serum MDA and NO after 8 weeks of intervention. CONCLUSION: Our findings suggest that crocin may keep promise in attenuating inflammation, evidenced by reducing hs-CRP in patients with MS. However, supplementation for 8 weeks may not be sufficient to improve mental health, and future clinical studies with higher sample sizes and various doses and durations are recommended.

The influence of propolis plus Hyoscyamus niger L. against COVID-19: A phase II, multicenter, placebo-controlled, randomized trial.

The incubation period of COVID-19 symptoms, along with the proliferation and high transmission rate of the SARS-CoV-2 virus, is the cause of an uncontrolled epidemic worldwide. Vaccination is the front line of prevention, and antiinflammatory and antiviral drugs are the treatment of this disease. In addition, some herbal therapy approaches can be a good way to deal with this disease. The aim of this study was to evaluate the effect of propolis syrup with Hyoscyamus niger L. extract in hospitalized patients with COVID-19 with acute disease conditions in a double-blinded approach. The study was performed on 140 patients with COVID-19 in a double-blind, randomized, and multicentral approach. The main inclusion criterion was the presence of a severe type of COVID-19 disease. The duration of treatment with syrup was 6 days and 30 CC per day in the form of three meals. On Days 0, 2, 4, and 6, arterial blood oxygen levels, C-reactive protein (CRP), erythrocyte sedimentation rate, and white blood cell, as well as the patient's clinical symptoms such as fever and chills, cough and shortness of breath, chest pain, and other symptoms, were recorded and analyzed. Propolis syrup with H. niger L. significantly reduces cough from the second day, relieving shortness of breath on the fourth day, and significantly reduces CRP, weakness, and lethargy, as well as significantly increased arterial blood oxygen pressure on the sixth day compared to the placebo group (p < 0.05). The results in patients are such that in the most severe conditions of the disease 80% < SpO2 (oxygen saturation), the healing process of the syrup on reducing CRP and increasing arterial blood oxygen pressure from the fourth day is significantly different compared with the placebo group (p < 0.05). The use of syrup is associated with a reduction of 3.6 days in the hospitalization period compared with the placebo group. Propolis syrup with H. niger L. has effectiveness in the viral and inflammatory phases on clinical symptoms and blood parameters and arterial blood oxygen levels of patients with COVID-19. Also, it reduces referrals to the intensive care unit and mortality in hospitalized patients with COVID-19. So, this syrup promises to be an effective treatment in the great challenge of COVID-19.

Nano-curcumin effects on nicotine dependence, depression, anxiety and metabolic parameters in smokers: A randomized double-blind clinical study.

Background: Smoking is clearly associated with metabolic profiles/abnormalities, psychological dysfunction, and symptoms of nicotine dependence. Nano-Curcumin (Nano-CUR) is a medicinal herb with antianxiety, antioxidant antidepressant-like effects, and anti-inflammatory properties. This RCT aimed to determine the therapeutic effects of Nano-CUR in smokers on clinical symptoms and metabolic parameters. Methods: This trial was conducted on 70 participants with cigarette smoking. Smokers in two arms received soft gel capsules Nano-CUR 80 mg/daily for 3 months (n = 35) and placebo (n = 35), respectively. Primary outcomes (Nicotine dependence syndrome scale, depression, and anxiety beck score), and secondary outcomes (glycemic, lipid, stress oxidative, and inflammation profiles) were analyzed before and 3-months after the intervention in smokers. Results: Nano-CUR supplementation significantly decreased nitric oxide, malondialdehyde, and C-reactive protein levels (P < 0.05), compared to the control. Furthermore, no significant effect change was shown in nicotine dependence syndrome, depression, anxiety, and other metabolic parameters (p > 0.05). Conclusion: Nano-CUR intake may have favorable effects on C-reactive protein, malondialdehyde, and nitric oxide in subjects with cigarette smoking. More RCT are required to evaluate the effectiveness of Nano-CUR supplementations in smokers in order to reject or support these conclude.

The Effect of Selenium Supplementation on Clinical Outcomes, Metabolic Profiles, and Pulsatility Index of the Uterine Artery in High-Risk Mothers in Terms of Preeclampsia Screening with Quadruple Test: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial : Selenium and preeclampsia.

Data on the effects of selenium (Se) supplementation on clinical outcomes, metabolic profiles, and pulsatility index (PI) in high-risk mothers in terms of preeclampsia (PE) screening with quadruple tests are scarce. This study evaluated the effects of Se supplementation on clinical outcomes, metabolic profiles, and uterine artery PI on Doppler ultrasound in high-risk mothers in terms of PE screening with quad marker. The current randomized, double-blind, placebo-controlled trial was conducted among 60 high-risk pregnant women screening for PE with quad tests. Participants were randomly allocated into two groups (30 participants each group), received either 200 µg/day Se supplements (as Se amino acid chelate) or placebo from 16 to 18 weeks of pregnancy for 12 weeks. Clinical outcomes, metabolic profiles, and uterine artery PI were assessed at baseline and at the end of trial. Se supplementation resulted in a significant elevation in serum Se levels (ß 22.25 µg/dl; 95% CI, 18.3, 26.1; P < 0.001) compared with the placebo. Also, Se supplementation resulted in a significant elevation in total antioxidant capacity (ß 82.88 mmol/L; 95% CI, 3.03, 162.73; P = 0.04), and total glutathione (ß 71.35 µmol/L; 95% CI, 5.76, 136.94; P = 0.03), and a significant reduction in high-sensitivity C-reactive protein levels (ß - 1.52; 95% CI, - 2.91, - 0.14; P = 0.03) compared with the placebo. Additionally, Se supplementation significantly decreased PI of the uterine artery in Doppler ultrasound (ß - 0.09; 95% CI, - 0.14, - 0.04; P = 0.04), and a significant improvement in depression (ß - 5.63; 95% CI, - 6.97, - 4.28; P < 0.001), anxiety (ß - 1.99; 95% CI, - 2.56, - 1.42; P < 0.001), and sleep quality (ß - 1.97; 95% CI, - 2.47, - 1.46; P < 0.001). Se supplementation for 12 weeks in high-risk pregnant women in terms of PE screening with quad marker had beneficial effects on serum Se level, some metabolic profiles, uterine artery PI, and mental health. IRCT Registration: htpp:// www.irct.ir ; identifier IRCT20200608047701N1.

The effect of vitamin D supplementation on tobacco-related disorders in individuals with a tobacco use disorder: a randomized clinical trial.

Vitamin D deficiency in cigarette smokers (CS) might associate with several complications, including metabolic deficits, depression and anxiety. This study evaluated the effects of vitamin D on mental health symptoms, nicotine misuse, and biomarkers of metabolic diseases in individuals with a tobacco use disorder. A randomized, double-blind, placebo-controlled trial was conducted with 60 CS subjects receiving either 50,000 IU vitamin D supplements (n = 30) or placebo (n = 30) every 2 weeks for 24-weeks. Nicotine misuse, mental health scale, and metabolic parameters were measured before and after the intervention in the CS subjects. Compared with the placebo-group, after the 24-weeks intervention, serum 25 (OH) vitamin D levels increased in the intervention group (ß 2.96; 95% CI, 0.91, 5.01; P = 0.006). In addition, vitamin D supplementation significantly improved Beck Depression Inventory (BDI) (ß -2.06; 95% CI, -3.84, -0.28; P = 0.02). In addition, vitamin D administration significantly decreased fasting plasma glucose (FPG) (ß -4.56; 95% CI, -8.94, -0.19; P = 0.04), insulin (ß -0.50; 95% CI, -0.88, -0.13; P = 0.009), and homeostasis model of assessment-estimated insulin resistance (HOMA-IR) levels (ß -0.21; 95% CI, -0.33, -0.08; P = 0.001). Furthermore, vitamin D resulted in a significant elevation in total antioxidant capacity (TAC) (ß 81.20; 95% CI, 18.30, 144.11; P = 0.01), and plasma glutathione (GSH) levels (ß 73.05; 95% CI, 18.56, 127.54; P = 0.01), compared with the placebo-group. Administration of vitamin D for 24-weeks to CS subjects had beneficial effects on symptoms of depression and several metabolic biomarkers. While this preliminary study suggests that vitamin D might have beneficial effects, its clinical efficacy in individuals with a tobacco use disorder should be further validated in future clinical trials.

A Narrative Review of Third-Wave Cognitive-Behavioral Therapies in Addiction.

Substance use disorder (SUD) is a prevalent health issue with serious social and personal consequences. SUDs are linked to numerous physical health problems. In the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V), the essential characteristic of a SUD is a collection of cognitive, behavioral, and psychological manifestations indicative of the subject's unbaiting substance use despite experiencing significant problems due to continued use. Several alternative interventions have been indicated. Among them, mindfulness-based therapies are receiving growing attention. This article reviews evidence for the use of third-wave cognitive-behavioral therapies (CBTs) in addiction treatment. We have reviewed the literature published from 1990 to 2019. Further research is required to better understand the types of mindfulness-based interventions that work best for specific types of addiction, patients, and situations. Current findings increasingly support third-wave CBTs as a promising complementary therapy for the treatment and prevention of addiction.

The effect of propolis plus Hyoscyamus niger L. methanolic extract on clinical symptoms in patients with acute respiratory syndrome suspected to COVID-19: A clinical trial.

The outbreak of Coronavirus disease 2019 (COVID-19) has caused a global health crisis. Nevertheless, no antiviral treatment has yet been proven effective for treating COVID-19 and symptomatic supportive cares have been the most common treatment. Therefore, the present study was designed to evaluate the effects of propolis and Hyoscyamus niger L. extract in patients with COVID-19. This randomized clinical trial was conducted on 50 cases referred to Akhavan and Sepehri Clinics, Kashan university of medical sciences, Iran. Subjects were divided into two groups (intervention and placebo). This syrup (containing 1.6 mg of methanolic extract along with 450 mg of propolis per 10 mL) was administered three times a day to each patient for 6 days. The clinical symptoms of COVID-19 such as: dry cough, shortness of breath, sore throat, chest pain, fever, dizziness, headache, abdominal pain, and diarrhea were reduced with propolis plus Hyoscyamus niger L. extract than the placebo group. However, the administration of syrup was not effective in the control of nausea and vomiting. In conclusion, syrup containing propolis and Hyoscyamus niger L. extract had beneficial effects in ameliorating the signs and symptoms of COVID-19 disease, in comparison with placebo groups.

The Effects of Probiotic and Selenium Co-supplementation on Clinical and Metabolic Scales in Chronic Schizophrenia: a Randomized, Double-blind, Placebo-Controlled Trial.

This study evaluated the effects of probiotic and selenium co-supplementation on clinical and metabolic symptoms in patients with chronic schizophrenia. A randomized, double-blind, placebo-controlled trial was conducted among 60 people with chronic schizophrenia to receive either 8 × 109 CFU/day probiotic plus 200 µg/day selenium (n = 30) or placebo (n = 30) for 12 weeks. Probiotic and selenium co-supplementation resulted in a significant improvement in the general Positive and Negative Syndrome Scale (PANSS) score (ß - 1.29; 95% CI, - 2.48, - 0.10; P = 0.03) compared with the placebo. Compared with the placebo, probiotic and selenium co-supplementation resulted in a significant elevation in total antioxidant capacity (ß 91.09 mmol/L; 95% CI, 35.89, 146.30; P = 0.002) and total glutathione (ß 96.50 µmol/L; 95% CI, 26.13, 166.87; P = 0.008) and a significant reduction in high-sensitivity C-reactive protein levels (ß - 1.44 mg/L; 95% CI, - 2.22, - 0.66; P = 0.001). Additionally, co-supplementation significantly decreased fasting glucose (ß - 7.40 mg/dL; 95% CI, - 10.15, - 4.64; P < 0.001), insulin levels (ß - 1.46 µIU/mL; 95% CI, - 2.35, - 0.57; P = 0.002), and homeostasis model of assessment-insulin resistance (ß - 0.51; 95% CI, - 0.72, - 0.29; P < 0.001) and a significant increase in quantitative insulin sensitivity check index (ß 0.01; 95% CI, 0.006, 0.01; P < 0.001) compared with the placebo. Probiotic and selenium co-supplementation for 12 weeks to patients with chronic schizophrenia had beneficial effects on the general PANSS score and some metabolic profiles. http://www.irct.ir , identifier IRCT20170513033941N41.

The effects of zinc supplementation on clinical response and metabolic profiles in pregnant women at risk for intrauterine growth restriction: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: This investigation was conducted to assess the effects of zinc supplementation on clinical response and metabolic status among pregnant women at risk for intrauterine growth restriction (IUGR). METHODS: This randomized, double-blind, placebo-controlled, clinical trial was conducted among 52 women at risk for IUGR according to abnormal uterine artery Doppler waveform. Participants were randomly assigned to take either 233 mg zinc gluconate (containing 30 mg zinc) supplements (n = 26) or placebo (n = 26) for 10 weeks from 17 to 27 weeks of gestation. Fasting blood samples were taken at baseline and after the 10-week treatment to quantify related variables. RESULTS: After the 10-week intervention, taking zinc led to a significant reduction in serum high-sensitivity C-reactive protein (hs-CRP) (ß â€’1.17 mg/L; 95% CI, -1.77, -0.57; p < .001) and plasma malondialdehyde (MDA) levels (ß -0.23 µmol/L; 95% CI, -0.45, -0.02; p = .03); also a significant rise in total antioxidant capacity (TAC) (ß 59.22 mmol/L; 95% CI, 25.07, 93.36; p = .001) was observed in comparison to placebo. In addition, zinc supplementation significantly reduced serum insulin (ß -1.33 µIU/mL; 95% CI, -2.00, -0.67; p < .001) and insulin resistance (ß -0.30; 95% CI, -0.44, -0.15; p < .001), and significantly increased insulin sensitivity (ß 0.008; 95% CI, 0.003, 0.01; p < .001) compared with the placebo. Zinc supplementation did not influence pulsatility index (PI) and other metabolic parameters. CONCLUSIONS: Overall, zinc supplementation in pregnant women at risk for IUGR had beneficial effects on TAC, MDA, hs-CRP, and insulin metabolism, but did not affect PI and other metabolic profiles.

The effect of crocin (the main active saffron constituent) on the cognitive functions, craving, and withdrawal syndrome in opioid patients under methadone maintenance treatment.

Individuals under methadone maintenance treatment (MMT) programs are susceptible to several complications, including withdrawal syndrome, craving, and cognitive deficits. This study was designed to elevate the effect of crocin administration on withdrawal syndrome, craving, and cognitive function in subjects under MMT programs. It was a clinical trial that was conducted among 60 patients referred to Soltan Mirahmad Clinic for addict patients in Kashan, Iran. The patients were allocated to two groups including placebo and intervention groups. The intervention group received 30 mg/day crocin (n = 30) and placebo (n = 30) once a day, in 12 weeks. Withdrawal syndrome, craving, and cognitive function parameters were measured before and after the intervention in subjects under MMT programs. Compared with the placebo group, crocin resulted in a significant improvement in craving score (p = .03), and withdrawal symptoms score (p = .01) in the intervention group. In addition, crocin supplementation did not affect cognitive function parameters (e.g., TMT, FAS test, and DGSP score). Overall, crocin supplementation for 12 weeks to patients under MMT programs had beneficial effects on craving and withdrawal symptoms score, but did not affect the cognitive function parameters.

A systematic review and meta-analysis: The effects of probiotic supplementation on metabolic profile in patients with neurological disorders.

BACKGROUND AND OBJECTIVE: The objective of meta-analysis of randomized controlled trials (RCTs) was to evaluate the effects of probiotic supplementation on metabolic status in patients with neurological disorders. METHODS: The following databases were search up to April 2019: Pubmed, Scopus, Google scholar, Web of Science, and Cochrane Central Register of Controlled Trials. The quality of the relevant extracted data was assessed according to the Cochrane risk of bias tool. Data were pooled by the use of the inverse variance method and expressed as mean difference with 95 % Confidence Intervals (95 % CI). RESULTS: Nine studies were included in this meta-analysis. The findings suggested that probiotic supplementation resulted in a significant reduction in C-reactive protein (CRP) [Weighted Mean Difference (WMD): -1.06; 95 % CI: -1.80, -0.32] and malondialdehyde (MDA) levels (WMD: -0.32; 95 % CI: -0.46, -0.18). Supplementation with probiotics also significantly reduced insulin (WMD: -3.02; 95 % CI: -3.88, -2.15) and homeostatic model assessment for insulin resistance (HOMA-IR) (WMD: -0.71; 95 % CI: -0.89, -0.52). Probiotics significantly reduced triglycerides (WMD: -18.38; 95 % CI: -25.50, -11.26) and VLDL-cholesterol (WMD: -3.16; 95 % CI: -4.53, -1.79), while they increased HDL-cholesterol levels (WMD: 1.52; 95 % CI: 0.29, 2.75). CONCLUSION: This meta-analysis demonstrated that taking probiotic by patients with neurological disorders had beneficial effects on CRP, MDA, insulin, HOMA-IR, triglycerides, VLDL-cholesterol and HDL-cholesterol levels, but did not affect other metabolic parameters.

Combination Therapy with Nanomicellar-Curcumin and Temozolomide for In Vitro Therapy of Glioblastoma Multiforme via Wnt Signaling Pathways.

Glioblastoma (GBM) is the most serious brain tumor and shows a high rate of drug resistance. Wnt signaling is a very important pathway in GBM that can activate/inhibit other pathways, such as apoptosis and autophagy. In this study, we evaluated the efficacy of a combination of temozolomide (TMZ) plus curcumin or nanomicellar-curcumin on the inhibition of GBM growth in vitro, via effects on autophagy, apoptosis, and the Wnt signaling pathway. Two concentrations of curcumin and nanomicellar-curcumin (i.e., 20 µM and 50 µM) alone, and in combination with TMZ (50 µM) were used to induce cytotoxicity in the U87 GBM cell line. Wnt signaling-, autophagy-, and apoptosis-related genes were assessed by quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) and Western blots. All treatments (except 20 µM curcumin alone) significantly decreased the viability of U87 cells compared to controls. Curcumin (50 µM), nanomicellar-curcumin alone and in combination with TMZ significantly decreased the invasion and migration of U87 cells. Autophagy-related proteins (Beclin 1, LC3-I, LC3-II) were significantly increased. Apoptosis-related proteins (Bcl-2 and caspase 8) were also significantly increased, while Bax protein was significantly decreased. The expression levels of Wnt pathway-associated genes (ß-catenin, cyclin D1, Twist, and ZEB1) were significantly reduced.

The Effect of Transcranial Direct Current Stimulation on Relapse, Anxiety, and Depression in Patients With Opioid Dependence Under Methadone Maintenance Treatment: A Pilot Study.

BACKGROUND AND OBJECTIVE: Patients under methadone maintenance therapy (MMT) are susceptible to several complications including mental disturbances and risk of relapse. The present study was designed to evaluate the effects of tDCS on relapse, depression, and anxiety of opioid-dependent patients under methadone maintenance treatment (MMT). METHODS: It was a randomized-clinical trial that conducted among 27 male patients referred to the outpatient addiction clinic of Ibn-e-Sina psychiatric hospital in Mashhad from July 2018 to May 2019. Participants were allocated to two treatment groups including intervention and sham groups. The intervention group received seven sessions of tDCS, in the F3 (cathode) and F4 (anode) areas of the brain, each one lasts 20 min, in two consecutive weeks. Depression, anxiety, and stress scale-21 (DASS-21) were measured before, during, and after the intervention in patients under MMT. Relapse on the morphine, cannabis, and methamphetamine was screened by urine dipstick tests of morphine, cannabis, and methamphetamine. RESULTS: Depression, anxiety, and stress of participants were significantly reduced in the intervention group compared with the control after the seventh session of tDCS (P < 0.001, P=0.01, and P=0.01, respectively). In addition, the relapse rate showed no significant changes between the two groups (P=0.33). CONCLUSION: Overall, our study demonstrated that depression, anxiety, and stress of participants were significantly reduced after the seventh session of tDCS, but did not affect on the relapse rate. Therefore, it can be applied as a safe and effective technique to relieve mental disorder among receiving MMT. CLINICAL TRIAL REGISTRATION: http://www.irct.ir, identifier IRCT20180604039979N1.

The effects of probiotic supplementation on mental health, biomarkers of inflammation and oxidative stress in patients with psychiatric disorders: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND OBJECTIVE: In the current meta-analysis of randomized controlled trials (RCTs), the effects of probiotic supplementation on mental health, biomarkers of inflammation and oxidative stress in patients with psychiatric disorders were assessed. METHODS: The following databases were search up to February 2019: PubMed, Scopus, Web of Science, Google scholar and Cochrane Central Register of Controlled Trials. RESULTS: Twelve studies were included in the current meta-analysis. The findings demonstrated that probiotic supplementation resulted in a significant reduction in Hamilton Depression Rating Scale (HAMD) [Weighted Mean Difference (WMD): -9.60; 95 % CI: -10.08, -9.11]. In addition, a significant reduction in C-reactive protein (CRP) (WMD: -1.59; 95 % CI: -2.22, -0.97), interleukin 10 (IL-10) (WMD: -0.29; 95 % CI: -0.48, -0.11) and malondialdehyde (MDA) levels (WMD: -0.38; 95 % CI: -0.63, -0.13) was found after probiotics supplementation. No significant change was seen in Beck Depression Inventory (BDI) score (WMD: -11.17; 95 % CI: -24.99, 2.65), tumor necrosis factor-α (TNF-α) (WMD: -0.12; 95 % CI: -0.20, -0.05), IL-1B (WMD: -0.34; 95 % CI: -1.43, 0.74), IL-6 (WMD: 0.03; 95 % CI: -0.32, 0.38), nitric oxide (NO) (WMD: -0.54; 95 % CI: -2.16, 1.08), glutathione (GSH) (WMD: 46.79; 95 % CI: -17.25, 110.83) and total antioxidant capacity (TAC) levels (WMD: 15.21; 95 % CI: -59.96, 90.37) after probiotics supplementation. CONCLUSION: Overall, the current meta-analysis demonstrated that taking probiotic by patients with psychiatric disorders had beneficial effects on HAMD, CRP, IL-10 and MDA levels, but it did not affect BDI score, other markers of inflammation and oxidative stress.

The effects of saffron (Crocus sativus L.) on mental health parameters and C-reactive protein: A meta-analysis of randomized clinical trials.

BACKGROUND: The findings of trials investigating the effects of saffron (Crocus sativus L.) supplementation on depression, anxiety, and C-reactive protein (CRP) are inconsistent. The current meta-analysis of randomized controlled trials (RCTs) was carried out to assess the effects of saffron (Crocus sativus L.) administration on mental health parameters and CRP levels. METHODS: Two independent authors systematically searched online databases including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until 30th July 2019. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of included trials. The heterogeneity among the included studies was assessed using Cochrane's Q test and I-square (I2) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. RESULTS: Twenty one trials were included in this meta-analysis. Consumption of saffron resulted in a significant reduction in Beck Depression Inventory (BDI) (11 studies with 12 effect size) (WMD: -4.86; 95 % CI: -6.58, -3.14), Beck Anxiety Inventory (BAI) (5 studies) (WMD: -5.29; 95 % CI: -8.27, -2.31) and Pittsburgh Sleep Quality Index (PSQI) scores (3 studies with 4 effect size) (WMD: -2.22; 95 % CI: -2.73, -1.72). Saffron intake did not affect Hamilton Depression Rating Scale (HDRS-D), Hamilton Anxiety Rating Scale (HARS-A) scores and C-reactive protein (CRP) levels. CONCLUSIONS: This meta-analysis demonstrated that saffron intake significantly reduced BDI, BAI and PSQI scores, but did not affect HDRS-D, HARS-A scores and CRP levels.

Exploring the Effects of Vitamin D Supplementation on Cognitive Functions and Mental Health Status in Subjects Under Methadone Maintenance Treatment.

OBJECTIVES: Vitamin D deficiency may be linked to several mental complications including cognitive deficits, depression, and anxiety in patients under methadone maintenance treatment (MMT). This study was designed to explore the effect of vitamin D supplementation on cognitive functions and mental health parameters in subjects under MMT. METHODS: This randomized, double-blinded, placebo-controlled clinical trial was carried out among 64 patients under MMT. Participants were randomly allocated to receive either 50,000 IU vitamin D supplements (n = 32) or placebo (n = 32) every 2 weeks for 24 weeks. Cognitive functions and mental health parameters were taken at baseline and posttreatment to evaluate relevant variables. RESULTS: After the 24-week intervention, compared with the placebo, serum 25(OH) vitamin D levels significantly increased in participants who received vitamin D supplements (ß 14.50; 95% confidence interval [CI], 13.17-15.83; P < 0.001). In addition, compared with the placebo, subjects who received vitamin D had a significant reduction in Iowa Gambling Task (ß -6.25; 95% CI, -8.60 to -3.90; P < 0.001), and significant increases in Verbal Fluency Test (ß 2.82; 95% CI, 0.78-4.86; P = 0.007), Immediate Logic Memory (ß 1. 32; 95% CI, 0.27-2.37; P = 0.01), Reverse Digit Span (ß 2.06; 95% CI, 1.18-2.94; P < 0.001) and visual working memory (ß 0.75; 95% CI, 0.33-1.16; P = 0.001). Also, vitamin D supplementation significantly improved BDI (ß -2.76; 95% CI, -3.97 to -1.55; P < 0.001) compared with the placebo. When we applied Bonferroni correction, LM-Immediate (P = 0.07) became nonsignificant, and other mental health parameters did not alter. CONCLUSIONS: Overall, taking 50,000 IU vitamin D supplements every 2 weeks for 24 weeks by patients under MMT had beneficial effects on cognitive functions and some mental health parameters. Further studies are needed to confirm our findings.

Clinical and metabolic responses to crocin in patients under methadone maintenance treatment: A randomized clinical trial.

Patients under methadone maintenance treatment (MMT) programs are susceptible to several complications including metabolic and clinical disorders. This study was designed to determine the effect of crocin supplementation on mental health parameters and metabolic profiles in subjects under MMT. The current randomized, double-blind, placebo-controlled, clinical trial was conducted among 53 patients under MMT to receive either 15 mg/day of crocin (n = 26) or placebo (n = 27) twice a day for 8 weeks. Crocin administration significantly decreased Beck Depression Inventory score (P = 0.01) and Beck Anxiety Inventory score (P = 0.008) compared with the placebo. In addition, crocin administration resulted in a significant reduction in fasting glucose (P = 0.003), insulin levels (P = 0.01), insulin resistance (P = 0.008), triglycerides (P = 0.001), very low-density lipoprotein (P = 0.001), total cholesterol levels (P = 0.03), and a significant increase in insulin sensitivity (.003) compared with the placebo. Additionally, crocin intake was associated with a significant reduction in high-sensitivity C-reactive protein (p < .001) and malondialdehyde (P = 0.001) and a significant rise in total antioxidant capacity levels (P = 0.01) compared with the placebo. The findings of this clinical trial indicate that taking crocin for 8 weeks by patients under MMT had beneficial effects on their mental health and improved their metabolic profiles.

The effects of vitamin D supplementation on mental health, and biomarkers of inflammation and oxidative stress in patients with psychiatric disorders: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In the current meta-analysis of randomized controlled trials (RCTs), the effects of vitamin D supplementation on mental health, and biomarkers of inflammation and oxidative stress in patients with psychiatric disorders are assessed. METHODS: The following databases were search up to March 2019: MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials. The quality of the relevant extracted data was assessed according to the Cochrane risk of bias tool. Data were pooled by the use of the inverse variance method and expressed as mean difference with 95% Confidence Intervals (95% CI). RESULTS: Eleven effect sizes from nine studies were included in the final analyses. A pooled analysis of 9 effect sizes showed a significant reduction in Beck Depression Inventory (BDI) score following supplementation with vitamin D [weighted mean difference (WMD): -3.91; 95% CI: -5.15 -2.66), I2= 85.9%]. Combining data from two available studies on the effects of vitamin D supplementation on Pittsburgh Sleep Quality Index (PSQI) also revealed a significant reduction in this score following the intervention (WMD: -1.78; 95% CI: -2.28, -1.28). In addition, there were significant increase in glutathione (GSH) through 3 studies (WMD: 180.70; 95% CI: 6.76, 354.64), and in total antioxidant capacity (TAC) through 3 studies (WMD: 90.09; 95% CI: 56.36, 123.82) after vitamin D supplementation. Combining data from five studies, we found a significant reduction in C-reactive protein (CRP) concentrations after vitamin D supplementation (WMD: -1.74; 95% CI: -2.82, -0.66). CONCLUSIONS: Overall, the current meta-analysis demonstrated that taking vitamin D supplements among patients with psychiatric disorders had beneficial effects on BDI, PSQI, GSH, TAC and CRP levels, but did not affect other biomarkers of inflammation and oxidative stress.

Effects of magnesium supplementation on carotid intima-media thickness and metabolic profiles in diabetic haemodialysis patients: a randomised, double-blind, placebo-controlled trial.

This study evaluated the effects of Mg administration on carotid intima-media thickness (CIMT), glycaemic control and markers of cardio-metabolic risk in diabetic haemodialysis (HD) patients. This randomised, double-blind, placebo-controlled clinical trial was conducted in fifty-four diabetic HD patients. Participants were randomly divided into two groups to take either 250 mg/d Mg as magnesium oxide (n 27) or placebo (n 27) for 24 weeks. Mg supplementation resulted in a significant reduction in mean (P<0·001) and maximum levels of left CIMT (P=0·02) and mean levels of right CIMT (P=0·004) compared with the placebo. In addition, taking Mg supplements significantly reduced serum insulin levels (ß=-9·42 pmol/l; 95% CI -14·94, -3·90; P=0·001), homoeostasis model of assessment-insulin resistance (ß=-0·56; 95 % CI -0·89, -0·24; P=0·001) and HbA1c (ß=-0·74 %; 95 % CI -1·10, -0·39; P<0·001) and significantly increased the quantitative insulin sensitivity check index (ß=0·008; 95 % CI 0·002, 0·01; P=0·002) compared with the placebo. In addition, Mg administration led to a significant reduction in serum total cholesterol (ß=-0·30 mmol/l; 95% CI -0·56, -0·04; P=0·02), LDL-cholesterol (ß=-0·29 mmol/l; 95% CI -0·52, -0·05; P=0·01), high-sensitivity C-reactive protein (hs-CRP) (P<0·001) and plasma malondialdehyde (MDA) (P=0·04) and a significant rise in plasma total antioxidant capacity (TAC) levels (P<0·001) compared with the placebo. Overall, we found that taking Mg for 24 weeks by diabetic HD patients significantly improved mean and maximum levels of left and mean levels of right CIMT, insulin metabolism, HbA1c, total cholesterol and LDL-cholesterol, hs-CRP, TAC and MDA levels.