The effect of Nigella sativa oil on serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar in patients with non-alcoholic fatty liver

Rashidmayvan, Mohammad; Mohammadshahi, Majid; Seyedian, Seyed Saeed; Haghighizadeh, Mohammad Hossein

doi:10.1007/s40200-019-00439-6

Cited by 54 publications

(78 citation statements)

References 37 publications

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“…Of the 80 trials identified that used mineral oil, 16 reported high-sensitivity C-reactive protein (hsCRP) levels ranging from −15.9% to +33.3%; levels were increased in 10 studies, 8 , 40 , 42 , 53 , 55 , 56 , 62–64 decreased in 5 studies, 47 , 50 , 61 , 65 , 66 and unchanged in 1 study. 67 As with lipid parameters, most changes were inconsistent and not reported as statistically significant.…”

Section: Resultsmentioning

confidence: 99%

“…Formal analyses of a theoretical mineral oil effect evaluated during an FDA Advisory Committee showed that hsCRP changes had little to no impact on the primary and secondary composite endpoints of REDUCE-IT ( Figure 2 , Supplementary material online , Table S1 ). 16 Inconsistent increases and decreases in other inflammatory markers across a range of conditions, including interleukin (IL)-6, 56 , 62 , 66 , 69 , 70 IL-1β, 56 , 61 , 70 , 71 IL-10, 69 tumour necrosis factor-α, 37 , 56 , 61 , 69 , 70 , 72 intercellular adhesion molecule 1, 62 monocyte chemoattractant protein-1, 71 and immunoglobulin E 52 have been reported. However, these changes have been small and in general, the clinical significance of hsCRP changes in CV outcome trials is unclear.…”

Section: Resultsmentioning

confidence: 99%

“…Trials that did report blood pressure are summarized in Table 3 , and include seven studies. 40–42 , 54 , 60 , 61 , 73 More than half of the studies were conducted in CV or high-risk patients, and, similar to blood lipids, results were highly variable. For systolic blood pressure, reported changes ranged from a 0.3 mmHg decrease to a 2.5 mmHg increase.…”

Section: Resultsmentioning

confidence: 99%

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Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Olshansky

Chung

Budoff³

et al. 2020

European Heart Journal Supplements

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Mineral oil is often used as a clinical trial placebo. Pharmaceutical-grade mineral oil consists of a mixture of saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils. Interest in mineral oil was piqued by suggestions that a portion of the substantially positive results of the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) might be attributable to the theoretical negative effects of mineral oil rather than being due to the clinical benefits of icosapent ethyl. The objective of this review was to explore possible mineral oil safety and efficacy effects and contextualize these findings in light of the REDUCE-IT conclusions. A literature search identified studies employing mineral oil placebos. Eighty studies were identified and relevant data extracted. Adverse events associated with mineral oil were generally gastrointestinal and consistent with use as a lubricant laxative. Changes in triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and other biomarkers were inconsistent and generally not statistically significant, or clinically meaningful with mineral oil, as were changes in blood pressure. There was no consistent evidence that mineral oil in the amounts used in the REDUCE-IT or Effect of Vascepa on Progression of Coronary Atherosclerosis in Patients With Elevated Triglycerides on Statin Therapy (EVAPORATE) trials affects absorption of essential nutrients or drugs, including statins. These results were then considered alongside publicly available data from REDUCE-IT. Based on available evidence, mineral oil does not appear to impact medication absorption or efficacy, or related clinical outcomes, and, therefore, does not meaningfully affect study conclusions when used as a placebo at the quantities used in clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Olshansky

Chung

Budoff³

et al. 2020

European Heart Journal Supplements

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“…Rashidmayvan et al (2019) showed that treatment with 1 g/ day N. sativa oil after 8 weeks significantly altered serum level of Creactive protein marker, tumor necrosis factor and interlukin-6.Antiinflammatory property of N. sativa has been described in vitro and in vivo models and multiple action mechanisms has been proposed for its beneficial effects. Antiinflammatory property in black seed may be due to multiple ingredients that exist in N. sativa such as thymoquinon, thymol, limonene, nigellon, and polyphenols.Thymoquinon as a primary constituent of N. sativa has antiinflammatory and antioxidant effects.…”

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confidence: 99%

Effects of Nigella sativa on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress: A systematic review and meta‐analysis of randomized controlled clinical trials

Hallajzadeh

Milajerdi

Mobini

et al. 2020

Phytotherapy Research

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The aim of this systematic review and meta-analysis was to evaluate the effects of Nigella sativa (N. sativa) on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress. Two independent authors systematically examined online databases consisting of, EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until October 30, 2019. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of the studied trials. The heterogeneity among the included studies were assessed using the Cochrane's Q test and I-square (I 2) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. A total of 50 trials were included in this meta-analysis. We found a significant reduction in

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“…In the same way, Th17/Treg ratio was lower in N. sativa treated group compared to the standard treated group [ 138 ]. Supplementation with N. sativa oil in patients with nonalcoholic fatty liver disease (NAFLD) for 8 weeks decreased the level of FBS, lipid profiles (TG, TC, LDL, and VLDL), liver enzymes (AST and ALT), inflammatory marker (hs-CRP, IL-6, and TNF- α ), whereas it increased the HDL-C levels compared to the placebo (paraffin oil) group [ 139 ]. N. sativa supplementation (2 g/day for 12 weeks) in patients who have cardiovascular disorders risk factors and also in patients with NAFLD 2 significantly decreased glucose and insulin serum levels and also decreased hepatic steatosis percentage compared to the placebo [ 140 ].…”

Section: Resultsmentioning

confidence: 99%

The Possible Therapeutic Effects of Some Medicinal Plants for Chronic Cough in Children

Moghaddam

Kianmehr

Khazdair

2020

Evidence-Based Complementary and Alternative Medicine

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The use of plants or their isolated bioactive components for the prevention and treatment of various disorders has been developed. Here, we aim to identify effective medicinal plants for relief of cough and respiratory symptoms in children. The data of this review article were obtained from published articles in scientific databases, including PubMed, Google Scholar, and Scopus, until December 2019. The keywords, including “Zataria multiflora Boiss.” OR “Portulaca oleracea L.” OR “Ferula assa-foetida L.” OR “Nigella sativa L.” AND “respiratory symptoms” OR “airway inflammation” OR “smooth muscle relaxant effects,” were searched individually or combined. The mentioned medicinal plants decreased total white blood cell (WBC), neutrophils, and eosinophils counts of blood and lung lavage in animal model-induced respiratory disorders. These plants also have protective effects on serum immunoglobulin, antibody titer, eosinophil count, and proinflammatory cytokines. Evidence from the studies indicated that the abovementioned medicinal plants have smooth muscle relaxant properties (bronchodilator effects) via stimulation of β-adrenoceptor or inhibition of muscarinic receptors (in vitro) and also improved the pulmonary function test in clinical settings. These medicinal plants are safe and easy to use. Based on the anti-inflammatory, anti-antispasmodic, and immunomodulatory effects, the clinical benefit may be assumed, therefore considering a place for these medicinal plants in relieve of chronic cough and symptoms of children’s allergy, asthma, and common cold.

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The effect of Nigella sativa oil on serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar in patients with non-alcoholic fatty liver

Cited by 54 publications

References 37 publications

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies

Effects of Nigella sativa on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress: A systematic review and meta‐analysis of randomized controlled clinical trials

The Possible Therapeutic Effects of Some Medicinal Plants for Chronic Cough in Children

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