The effect of nigella sativa supplementation on cardiometabolic outcomes in patients with non-alcoholic fatty liver: A randomized double-blind, placebo-controlled trial

BACKGROUND AND PURPOSE: Non-alcoholic fatty liver disease (NAFLD) is one of the metabolic disturbances associated with liver cell inflammation. Nigella sativa (N.sativa) is a widely used medicinal plant known for its anti-inflammatory, antimicrobial, antioxidant, and hepato-protective properties. This study aimed to assess the effect of supplementation of N. sativa oil on plasma levels of adiponectin, leptin, and blood pressure (BP) in patients diagnosed with NAFLD. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted on 44 NAFLD patients. Participants were randomly assigned to two groups (n = 22/group); the experimental group received 1000 mg of N. sativa oil per day, while the control group received a placebo for eight weeks. The primary outcome measures were serum levels of adiponectin, leptin, and systolic and diastolic blood pressure measured at the baseline and the end of the intervention. RESULTS: After eight weeks of supplementation with N. sativa oil, no statistically significant differences were found in serum levels of adiponectin (p = 0.40), leptin (p = 0.89), systolic BP (p = 0.13), and diastolic BP (p = 0.09) between the two groups. Furthermore, after supplementation with N. sativa, no significant changes were observed in leptin (p = 0.07), adiponectin (p = 0.13), systolic BP (p = 0.82), and diastolic BP (p = 0.38) within the two groups. CONCLUSION: These results indicate that administration of N. sativa oil 1000 mg/day for 8 weeks has no favorable effect on cardiometabolic measures in NAFLD patients. Further studies with higher dosage over a longer period are needed to investigate whether this effect is dose- and time-dependent

Corrigendum to "The effect of green-coffee extract supplementation on obesity:A systematic review and dose-response meta-analysis of randomized controlled trials” [Phytomedicine Volume 63 October 2019 Article 153018] (Phytomedicine (2019) 63, (S0944711319301849), (10.1016/j.phymed.2019.153018))

The authors regret that the original version of this Article (https://doi.org/10.1016/j.phymed.2019.153018I) contained an error about in data extraction for Dellalibera O et al. 2006 in body weight section. This article reported that green coffee reduces body Wight -2.52 kg but we mention it 2.52. We edited this mistake and revised results. According to new results Green-Coffee Extract supplementation significantly reduced body weight (WMD: -0.94 kg, 95 CI: -1.73, -0.16, p = 0.019). The authors would like to apologise for any inconvenience caused (Figure 1). © 2019 Elsevier Gmb

Reply to "Double-counting of effect sizes and inappropriate exclusion of studies in "The influence of vitamin D supplementation on IGF-1 levels in humans: A systematic review and meta_analysis"

Dear Editor, We appreciate the comments provided to us in the letter from Amiri et al. We would like to offer some clarifications in response to the comments. Firstly, the authors claimed that we included the control group more than once from the same publication including different arms. The authors also identified mistakes made during data screening and expressed concerns that the mistakes would lead to errors within our analysis (Kord-Varkaneh et al., 2020). We sincerely thank the authors for pointing out these mistakes. In response, based on The Cochrane Handbook for Systematic Reviews, we have now reanalyzed the results by combining the intervention groups to create a single pair-wise comparison and updated our meta-analysis as displayed below. We initially excluded Sorva, Antti et al. from our study because based on our inclusion criteria we only included studies that had more than 10 participants in each group (Sorva et al., 1994), although we did not originally include this criterion in our publication (Kord-Varkaneh et al., 2020). However, after including Norenstedt, S. et al. and Sinha-Hikim, I. et al. (Sinha-Hikim et al., 2015; Norenstedt et al., 2013) our overall effect size changed from (WMD: 4 ng/ml, 95 % CI: -4 to 11, p = 0.35) to (WMD: 1.01 ng/ml, 95 % CI: --6.78 to 8.81, p = 0.799) without a change in overall significance (Fig. 1). In addtion, subgroup analyses showed that vitamin D dosage ≤1000 IU/day (WMD: 11.36 ng/ml, 95 % CI: 1.57–21.16, I2 = 79 %) significantly increased IGF-1 than vitamin D dosage <1000 IU/day (WMD: -2.8 ng/ml, 95 % CI: -7.02 to 1.6, I2 = 51 %). Moreover, an intervention duration of ≤12 weeks (WMD: 9.92 ng/ml, 95 % CI: 3–16.83, I2 = 77 %) significantly increased IGF-1 compared to a duration of <12 weeks (WMD: -5.43 ng/ml, 95 % CI: -10.25 to -0.61, I2 = 0.0 %). In addition, baseline serum vitamin D (<20 ng/mL vas ≥20 ng/mL) we did not observe significantly.The authors sincerely thank Shahid Beheshti University of Medical Sciences for all moral and material supports. This study was supported by grants from the S tudent Research Committee, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran (Grant's ID: 1398/3995).Scopu

The influence of vitamin D supplementation on IGF-1 levels in humans: A systematic review and meta-analysis

© 2019 Elsevier B.V. Background: Inconsistencies exist with regard to influence of vitamin D supplementation on IGF-1 levels. The inconsistencies could be attributed to several factors, such as dosage and duration of intervention, among others. To address these inconsistencies, this study was conducted to determine the impact of vitamin D supplementation on IGF-1 levels through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: A comprehensive systematic search was carried out in PubMed/MEDLINE, Web of Science, SCOPUS and Embase for RCTs that investigated the impact of vitamin D intake on circulating IGF-1 levels from inception until June 2019. Weighted mean difference (WMD) with the 95 % CI were applied for estimating combined effect size. Subgroup analysis was performed to specify the source of heterogeneity among studies. Results: Pooled results from eight studies demonstrated an overall non-significant increase in IGF-1 following vitamin D supplementation (WMD: 4 ng/ml, 95 % CI: −4 to 11). However, a significant degree of heterogeneity among studies was observed (I2 = 66 %). The subgroup analyses showed that vitamin D dosage of ≤1000 IU/day (WMD: 10 ng/ml) significantly increased IGF-1 compared to the vitamin D dosage of <1000 IU/day (WMD: −1 ng/ml). Moreover, intervention duration ≤12 weeks (WMD: 11 ng/ml) significantly increased IGF-1 compared to intervention duration <12 weeks (WMD: −3 ng/ml). In the epidemiological cohort study, participants under 60 years of age with a higher dietary vitamin D intake had significantly higher IGF-1 levels when compared to those with lower dietary vitamin D intake in second categories. Conclusion: The main results indicate a non-significant increase in IGF-1 following vitamin D supplementation. Additionally, vitamin D dosages of <1000 IU/day and intervention durations of <12 weeks significantly raised IGF-1 levels.The authors sincerely thank Shahid Beheshti University of Medical Sciences for all moral and material supports. This study was supported by grants from the Student Research Committee, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran (Grant’s ID: 1398/3995)