Efficacy Of Omega-3 Fatty Acids Research Articles

Role of omega-3 fatty acids in reducing proteinuria: A systematic review and meta-analysis.

Proteinuria, a hallmark of renal and systemic disorders, is associated with adverse outcomes, especially in chronic kidney disease and cardiovascular disease. Omega-3 fatty acids have garnered attention for their cardiovascular benefits and potential therapeutic effects on proteinuria. This systematic review and meta-analysis aimed to evaluate the impact of omega-3 fatty acid supplementation on proteinuria levels across various kidney-related conditions. Studies published from 1989 to 2023 were systematically identified, including randomized controlled trials, cohort, case-control, and cross-sectional studies. Nine studies involving a total of 347 participants were included in the analysis. The meta-analysis revealed a neutral overall effect size of omega-3 fatty acid supplementation on proteinuria levels, assessed under both common and random effect models. Despite the lack of statistically significant evidence supporting the efficacy of omega-3 fatty acids in reducing proteinuria, the variability in interventions and patient populations suggests potential individual responses. The find-ings highlight the heterogeneity in responses to omega-3 fatty acid supplementation and emphasize the need for cautious interpretation. While no definitive conclusion can be drawn, the results underscore the importance of targeted research focusing on specific subgroups or conditions that may benefit from omega-3 supplementation. These findings contribute to the evolving understanding of personalized kidney health strategies and pave the way for further exploration and optimization of omega-3 fatty acids' therapeutic applications.

Efficacy of Omega-3 in Improving Sleep Quality of Healthcare Workers with Shiftwork Sleep Disorder: Phase III, Double-blind, Placebo-controlled Trial Study Protocol (SLEEP-O3 Trial)

Efficacy of Omega-3 in Improving Sleep Quality of Healthcare Workers with Shiftwork Sleep Disorder: Phase III, Double-blind, Placebo-controlled Trial Study Protocol (SLEEP-O3 Trial)

Efficacy of Omega-3 in Improving Sleep Quality of Healthcare Workers with Shiftwork Sleep Disorder: Phase III, Double-blind, Placebo-controlled Trial Study Protocol (SLEEP-O3 Trial)

Introduction: Healthcare workers are especially vulnerable to sleep disturbances, including shift work sleep disorder (SWSD). Even though omega-3 supplementation has been studied to enhance sleep quality in different populations, there is lack of evidence to support its effectiveness in SWSD. This trial aims to evaluate this compound potential benefits towards health care personnel suffering from SWSD. Methods: This study protocol consists of a phase III, single-center, double-blind, placebo-controlled randomized clinical trial. Participants will receive sleep hygiene orientation in addition to either omega-3 dietary supplementation or placebo for 8 weeks. The primary outcome will be sleep quality as measured by the Pittsburgh Sleep Quality Index and one of the secondary outcomes would be actigraphy as a reliable sleep assessment. The sample size will be 136 subjects. Discussion: The importance of improving sleep quality of health care workers relies on its impact on their wellness, and on patient safety. Sleep deprivation and disorders are responsible for multiple workplace errors and worse health outcomes alike. This trial can help determine if omega-3 supplementation can contribute to ameliorate sleep disturbances in health care professionals.

Comparative Efficacy of Omega-3 Fatty Acid with Other Interventions for Depression in Children and Adolescents: A Systematic Review and Network Meta-Analysis.

Background: The administration of omega-3 polyunsaturated fatty acid supplements is recommended as an adjuvant therapy for adults diagnosed with major depressive disorder. The evaluation of replicated data in combination treatment with omega-3 has been extensively conducted in adults over the past decade. However, the generalizability of these findings to pediatric groups is still uncertain. The objectives of this evaluation were twofold: (1) to evaluate the effectiveness of omega-3 and associated combination therapies in reducing the severity of depressive symptoms, and (2) to include remission rates (i.e., reduction of more than 50% in depression symptoms) as a measure of therapeutic efficacy. Methods: We conducted a literature search on PubMed/EMBASE from inception to October 2023. Data analyses were conducted using Stata (version 17.0). Results: We identified a total of 3168 articles. After eligibility screening of identified studies, nine studies (n = 561 participants) were included in our analysis herein. Pairwise comparisons revealed no significant improvement in depression symptoms for any intervention versus placebo. However, a clustered ranking plot identified omega-3 plus inositol as the most effective treatment for pediatric depression (77.3% efficacy). Omega-3 paired with psychoeducational psychotherapy significantly lowered the remission rate compared to placebo (standardized mean difference = 0.44, 95% confidence interval: 0.00-0.87, p = 0.048), resulting in a 91.5% remission rate, making it the most effective treatment in the study. Conclusions: Taken together, this network meta-analysis presents compelling evidence supporting the antidepressant effects of omega-3 in pediatric groups with depression. Future research should aim to investigate omega-3 as monotherapy for young individuals with depression, as well as investigate the efficacy of omega-3 in comparison to psychosocial interventions for affected individuals.

The efficacy of omega-3 fatty acids (O3FAs) as a complementary in colorectal cancer patients: A systematic review and meta-analysis

Background & AimsColorectal cancer (CRC) is the third most common malignancy in developed countries. Therefore, omega-3 fatty acids (O3FAs) have been suggested as a beneficial complementary treatment due to their ability to regulate inflammatory responses and improve nutrition levels.This study aimed to evaluate the effects of O3FAs as a complementary treatment for inflammation, nutrition levels, post-operative infectious complications, and enhancement of recovery in CRC patients. MethodsThe literature search was carried out through three databases. The outcomes of interest were assessed by measuring pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) and CRP levels, serum albumin levels for nutrition assessment, post-operative infectious complications, and length of stay for recovery evaluation. Quality appraisal and meta-analysis were performed using RoB 2.0 and RevMan 5.4, respectively. ResultsThe result showed that O3FAs significantly reduced IL-6, CRP, and TNF-α, but did not affect IL-1β. Furthermore, the variable slightly increased serum albumin levels and the supplementation led to a decrease in post-operative infectious complications and shortened hospital stays. ConclusionO3FAs as a complementary treatment provided advantages for CRC patients, Further clinical trials and experiments should also be made emphasizing the impact and clinical implementation of O3FA in the nutritional status of CRC patients.

Efficacy of Omega-3 Intake in Managing Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

To explore the efficacy of omega-3 fatty acids (FAs) on patients suffering from dry eye disease (DED), a complex inflammatory condition, we reviewed data from PubMed, Embase, ClinicalTrials.gov, Web of Science, and Cochrane CENTRAL in the past 10 years (2013 to 2023). These sources provided randomized clinical trials (RCTs) that examined the efficacy of omega-3 FAs on DED patients with accessible pre- and post-intervention data, excluding trials with overlapping participants, without omega-3 supplementation, or those lacking placebo control or quantitative assessments. Two independent reviewers extracted data related to dry eye symptom scores, tear break-up time (TBUT), Schirmer's tests, osmolarity, and corneal fluorescein staining (CFS), and the results were analyzed by Comprehensive Meta-Analysis software version 4. We incorporated 19 related RCTs assessed by the Cochrane Risk of Bias tool, encompassing 4246 DED patients with various etiologies. Patients given omega-3 treatment demonstrated more significant improvements in dry eye symptoms (Hedges' g = -1.047; p < 0.001), TBUT [standardized mean difference (SMD) = -0.939; p < 0.001], scores from the Schirmer test (SMD = -0.372; p < 0.001), CFS (SMD = -0.299; p = 0.037), and osmolarity (SMD = -0.721; p < 0.001) compared to those on a placebo regimen. In the meta-regression analysis of DED symptoms, the daily dose of omega-3 (coefficient = -0.0005, p = 0.002), duration of omega-3 intake (coefficient = -0.1399, p = 0.021), and percentage of eicosapentaenoic acid (EPA) (coefficient = -0.0154, p < 0.001) exhibited a significant positive correlation with a reduction in dry eye symptom scores. Apart from CFS, similar trends were noted in TBUT, Schirmer tests, and osmolarity scores. Based on the evidence, omega-3 FAs effectively reduce DED symptoms, especially in high doses, for a long duration, and with increased EPA levels. However, given the heterogeneity in study results and diverse patient characteristics, caution is needed in generalizing these findings. In conclusion, omega-3 FA supplementation is still recommended for DED management in clinical settings.

Efficacy of omega-3 fatty acids for hospitalized COVID-19 patients: a systematic review and meta-analysis of randomized controlled trials.

Emerging expert consensuses and guidelines recommend that omega-3 fatty acids may have anti-inflammatory effects in hospitalized patients with coronavirus disease (COVID-19). However, these recommendations are based on pathophysiological studies of inflammation rather than direct clinical evidence. We conducted this systematic review and meta-analysis to evaluate the efficacy of omega-3 fatty acid supplementation in hospitalized patients with COVID-19. We retrieved literature from PubMed, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), WANFANG, Chinese Biomedical Literature Database, and Cochrane Library databases up to May 1, 2023. Data from studies comparing omega-3 fatty acids with a placebo or other pharmaceutical nutrients were analyzed. Of 3032 records, 42 full-text articles were reviewed, five eligible studies were identified, and one study was found in the references. In total of six studies involving 273 patients were included, pooled, and analyzed. Compared to the control group, omega-3 fatty acid intervention reduced the overall mortality of hospitalized patients with COVID-19 (RR=0.76; 95% CI, [0.61, 0.93]; p=0.010). No serious or unexpected drug-related adverse events were observed. No statistical significance was observed in inflammatory markers such as CRP (MD=-9.69; 95% CI, [-22.52, 3.15]; p=0.14; I2=97%) and IL-6; however, the neutrophil/lymphocyte ratio was significantly lower in the omega-3 FAs group on day 7 of intervention (p < 0.001). Omega-3 fatty acid administration may be associated with reduced mortality in hospitalized patients with COVID-19. Given the small sample size of enrolled studies, more rigorous and large-scale trials are urgently needed in the future to verify its efficacy.

Omega-3 Fatty Acid Supplementation for the Treatment of Persistent COVID-Related Olfactory Dysfunction.

To evaluate the efficacy of omega-3 fatty acid (O3FA) supplementation in the treatment of COVID-related olfactory dysfunction (OD). Patients with laboratory-confirmed or clinically-suspected COVID-19 infection and new-onset OD from August 2020 to November 2021 were prospectively recruited. Patients with quantitative OD, defined as a brief smell identification test (BSIT) score of 9 or less, were eligible for study inclusion. The experimental group received 2 g of O3FA supplementation, while the control group received an identical placebo to be taken daily for 6 weeks. The primary outcome was a change in BSIT score between the initial and 6-week follow-up tests. One hundred and seventeen patients were included in the analysis, including 57 patients in the O3FA group and 60 in the placebo group. O3FA group patients demonstrated a mean BSIT improvement of 1.12 ± 1.99 compared to 0.68 ± 1.86 in the placebo group (p = 0.221). Seventy-seven patients, 42 within the O3FA group and 35 in the placebo group, completed a follow-up BSIT survey at an average of 717.8 days from study onset. At long-term follow-up, there was an average BSIT score improvement of 1.72 within the O3FA group compared to 1.76 within the placebo group (p = 0.948). Among patients with persistent COVID-related OD, our study showed no clear evidence of relative short-term or long-term olfactory recovery among patients receiving high doses of O3FA supplementation.

Effect of a collagen-enriched beverage with or without omega-3 fatty acids on wound healing, metabolic biomarkers, and adipokines in patients with major burns

This study investigated the effects of collagen hydrolysate and omega-3 fatty acids (FAs) on the rate and quality of wound healing, metabolic disorders, and adipose-derived peptides in patients with major burns. In this randomized clinical trial, 66 patients with 20-45% deep partial or full-thickness burns were randomly assigned to three groups to receive either a beverage containing collagen (40 gr/d), collagen (40 gr/d) plus 3 gr/d omega-3 (ω-3) FAs, or placebo for four weeks. Wound healing rate, Vancouver scar scale (VSS), as well as baseline, weeks two and three serum concentrations of adiponectin, fibroblast growth factor 21 (FGF21), neuregulin 4 (NRG4), transforming growth factor (TGF)-β1, and pre-albumin/hs-CRP ratio were assessed. The wound healing rate during the weeks post-burn (p=0.006 and p=0.01), and days of 95% (21.3±6.8 and 22.9±8.7 vs. 34.3±14.8 days, p=0.003 and p=0.03) and complete (26±7.7 and 27.4±9.4 vs. 41.1±16.6 days, p=0.003 and p=0.01) wound healing were significantly better with Collagen and Collagen. ω-3 compared to the placebo group. The VSS was significantly lower, indicated better scar status, in the both intervention groups compared to the placebo (p=0.02 and p=0.01). Wound healing outcomes were not statistically different between the Collagen and Collagen. ω-3 groups. Hs-CRP/pre-albumin ratio was significantly lower in the Collagen. ω-3 than the placebo group at week three (1.2±1.9 vs. 4.8±7.7dl/l, p=0.03). The significant decrease in serum adiponectin seen during the trial course within the placebo (10±8.8 to 5.8±4.9mg/l, p=0.03) and Collagen (11.8±14 to 8.6±11.7mg/l, p=0.03) groups was prevented in the Collagen. ω-3 group (p=0.4). Circulating FGF21 decreased significantly within the Collagen (p=0.005) and Collagen. ω-3 (p=0.02) groups at the end of week three compared to the baseline. Adding collagen hydrolysate as part of adjunctive therapy improved wound healing rate and quality. These findings as well as the efficacy of omega-3 FAs need to be further confirmed in larger populations. This study was registered with the Iranian Registry of Clinical Trials (IRCT20090901002394N42).

Omega-3 fatty acids in the treatment of spinal cord injury: untapped potential for therapeutic intervention?

Omega-3 fatty acids constitute a group of fatty acids with anti-inflammatory and preventive effects against various diseases. Studies in animal models have demonstrated the preventive and therapeutic effects of omega-3 fatty acids after spinal cord injury (SCI) in reducing inflammatory reactions and promoting neuroregeneration. However, studies on the efficacy of omega-3 fatty acids in treatment and prevention after SCI seem to be questionable. This study evaluates potential reasons for omega-3 fatty acid therapy oversight in populations after SCI. Therefore, some of the reasons could cover heterogeneous patient groups in size, level of injury, quality of life assessment, time since injury, no single standardised dose, various follow-up durations and metabolic changes, often insufficient to record. Due to the difficulty of collecting cases for the study, especially in the acute phase after SCI, multicenter, coordinated studies are needed to establish the effects of omega-3 fatty acids on treatment, recovery, and disease prevention in patients after SCI. Although the present results of such studies are still inconclusive, the failure to exploit the potential properties of omega-3 fatty acids in the treatment of patients with SCI solely due to methodological difficulties should be considered a potential waste.

Dietary rescue of adult behavioral deficits in the Fmr1 knockout mouse.

The current study aimed to further address important questions regarding the therapeutic efficacy of omega-3 fatty acids for various behavioral and neuroimmune aspects of the Fmr1 phenotype. To address these questions, our experimental design utilized two different omega-3 fatty acid administration timepoints, compared to both standard laboratory chow controls ("Standard") and a diet controlling for the increase in fat content ("Control Fat"). In the first paradigm, post-weaning supplementation (after postnatal day 21) with the omega-3 fatty acid diet ("Omega-3") reversed deficits in startle threshold, but not deficits in prepulse inhibition, and the effect on startle threshold was not specific to the Omega-3 diet. However, post-weaning supplementation with both experimental diets also impaired acquisition of a fear response, recall of the fear memory and contextual fear conditioning compared to the Standard diet. The post-weaning Omega-3 diet reduced hippocampal expression of IL-6 and this reduction of IL-6 was significantly associated with diminished performance in the fear conditioning task. In the perinatal experimental paradigm, the Omega-3 diet attenuated hyperactivity and acquisition of a fear response. Additionally, perinatal exposure to the Control Fat diet (similar to a "Western" diet) further diminished nonsocial anxiety in the Fmr1 knockout. This study provides significant evidence that dietary fatty acids throughout the lifespan can significantly impact the behavioral and neuroimmune phenotype of the Fmr1 knockout model.

The effect of omega-3 fatty acids supplementation on pediatric patients with non-alcoholic fatty liver disease: a systematic review and meta-analysis

Rationale: Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children and several studies have investigated the potential role of omega-3 fatty acids supplementation as a treatment option. A meta-analysis was conducted to evaluate the efficacy of omega-3 fatty acids (n-3 FA) in the treatment of pediatric NAFLD.

Supplementation of omega-3 and dietary factors can influence the cholesterolemia and triglyceridemia in hyperlipidemic Schnauzer dogs: A preliminary report.

Primary hyperlipidaemia in Schnauzer is characterized by increased plasma triglycerides (TG) and/or total cholesterol (TC) concentration and is associated with an increased risk of developing pancreatitis, insulin resistance and seizures. In humans, omega-3 fatty acids in addition to a low-fat diet can be used to reduce TG and TC. This study evaluated the therapeutic efficacy of omega-3 fatty acids associated to a diet management with two different fat content in Schnauzer with primary hyperlipidaemia. Eighteen dogs with primary hyperlipidaemia were divided into two groups: group 1, n = 10, 8 females, 2 males, age (mean ± standard deviation) of 7.13 ± 2.70 years and body weight (BW) (mean ± standard deviation) of 7.25 ± 1.22 kg were treated with fish oil (approximately 730 mg/day of omega-3) associated with a low-fat and low-calorie diet (approximately 24g of fat/1000 kcal) for 90 days (T90); and group 2, n = 8 dogs, 6 females, 2 males, with 7.0 ± 1.77 years old and average BW of 8.36 ± 1.51 kg, treated with fish oil (approximately 730 mg/day of omega-3) and maintenance diet with moderate amount of fat (approximately 33g of fat/1000 kcal) for 90 days. Plasma TG and TC concentrations and lipoprotein (LP) profile (VLDL, LDL, HDL) were evaluated before and after treatment. TG and TC serum concentrations, expressed in mg/dL (mean ± standard deviation), before and after treatment in group 1 were: TG = 391.30 ± 487.86 (T0) and 118.7 ± 135.21 (T90); TC = 308.2 ± 63.06 (T0) and 139 ± 36.91 (T90). As for group 2, TG = 391.63 ± 336.89 (T0) and 250.75 ± 211.56 (T90); TC = 257.25 ± 92.88 (T0) and 207.25 ± 63.79 (T90). A reduction (p<0.05) of TG and TC was observed in both groups. The distribution of TG and TC among LP was not different between the pre (T0) and post treatment (T90) periods. After 90 days of treatment, the administration of omega-3 fatty acids, associated with a low-fat or maintenance diet reduced triglyceridemia and cholesterolemia without altering LP profile. The current investigation shows that both therapies were effective in reducing plasma TC and TG concentrations without altering LP profile.

Are omega-3 fatty acids efficacious in the treatment of depression? A review

The hypothesis that omega-3 fatty acids may play a role in preventing and treating depression is based on correlative associations between fish consumption, omega-3 fatty acid intake and the prevalence of major depressive disorder. Reduced omega-3 fatty acid erythrocyte levels have been found in individuals with depressive disorders. These observational findings are unable to establish a causal relationship between omega-3 fatty acids and depression. The results of randomized controlled trials of omega-3 fatty acids for depressive disorders are inconclusive and also fail to prove causation. The therapeutic efficacy of omega-3 fatty acids appears to be moderate at best but is more likely to be minimal or non-existent. Potential long-term adverse effects of omega-3 fatty acid supplementation should be considered. Large-scale, well-controlled clinical trials are required to establish potential anti-depressive effects of omega-3 fatty acids. Such studies need to consider baseline values of omega-3 fatty acids and symptom severity, the dosage and types of the fatty acids used, the duration of supplementation and the concomitant use of medication. Conclusive evidence of the efficacy of omega-3 fatty acids in depression is currently lacking. The recommendation of potentially ineffective therapies may have considerable opportunity costs, with other possibly more useful treatments remaining unutilized.

Eicosapentaenoic and docosahexaenoic acids attenuate methotrexate-induced apoptosis and suppression of splenic T, B-Lymphocytes and macrophages with modulation of expression of CD3, CD20 and CD68

Methotrexate (MTX) is a chemotherapeutic agent used for cancer and autoimmune disorders. MTX may cause multi-organ affections. However, few studies examined MTX-induced splenic suppression and therapeutic modalities against it. This is the first study to explore the efficacy of omega-3 fatty acids; Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) against MTX-induced splenic suppression and its effect on splenic macrophages and lymphocytes. Five groups of Sprague Dawley rats were used. Group 1 received saline; group 2: omega-3 only; group 3: a single dose of MTX (20 mg/kg); groups 4 and 5: MTX (20 mg/kg) + either omega-3 (150) or (300 mg/kg) once daily, respectively, given for two days before MTX and three days after it. Splenic tissues were then removed, evaluated for oxidative stress markers; GSH, MDA, and for mRNA expression of the apoptotic marker caspase-3, the anti-apoptotic marker Bcl-2 and the inflammatory cytokine TNFα. Moreover, H&E stain, Prussian blue stain for iron, and immunohistochemical staining for TNFα, T lymphocyte marker; CD3, B lymphocyte marker; CD20, and macrophage marker; CD68, were performed with morphometric analysis. EPA and DHA could decrease the MTX-induced increase in the histopathological injury score, splenic hemosiderin, splenic MDA, mRNA expression of TNFα, caspase-3 and could increase the MTX-induced decrease in Splenic GSH and mRNA expression for Bcl-2. It also decreased the MTX-induced elevation in the immunopositive area of TNFα, and increased the area percentage of CD3+, CD20+ and CD68+ cells. Therefore, omega-3 can be a promising adjuvant to help MTX action with prevention of its deleterious effects on spleen.

Effect of omega-3 fatty acids on dry eye following phacoemulsification

Purpose The aim of this study was to evaluate the efficacy of omega-3 fatty acids on dry eye after phacoemulsification.Patients and methods This is a randomized controlled clinical trial which included 50 patients who developed dry eye symptoms following phacoemulsification. They were randomly allocated into two groups, with 25 patients each. The first group received an omega-3 dietary supplementation of 1000 mg in addition to the conventional treatment (artificial tears and anti-inflammatory eye drops) for 3 months. The second group received only artificial tears and anti-inflammatory eye drops. Both groups received treatment from September 2019 to March 2020, and they were followed up for 3 months. All patients had the same diagnostic tests (Schirmer test, ocular surface disease index, and tear break-up time), postoperatively.Results There was no statistically significant difference between the two groups in the demographic data. However, a significant difference was noted in the tear break-up time test scores (11.08±3.29 and 9.20±1.87 s) in the treatment and control groups, respectively. In addition, the ocular surface disease index showed a statistically significant difference between the treatment and control groups (19.41±9.69 and 31.23±11.66, respectively) after 3 months. No significant difference (P=0.186) was noted in the Schirmer test between the treatment and the control groups (9.16±2.72 and 8.12±2.76 mm, respectively).Conclusions The study showed that the addition of omega-3 fatty acid supplements after phacoemulsification can reduce the incidence of dry eye and improve both the objective and subjective measurements of dry eye.

Omega-3 fatty acid supplementation is associated with favorable outcomes in patients with sepsis: an updated meta-analysis.

ObjectivesThe efficacy of omega-3 fatty acids in the treatment of sepsis is controversial. We conducted an updated meta-analysis to clarify the efficacy of omega-3 fatty acids in patients with sepsis.MethodsPubMed, EMBASE, and the Cochrane Library were searched for randomized clinical trials (RCTs) on omega-3 fatty acid supplementation in adults with sepsis.ResultsTwenty eligible RCTs involving 1514 patients were included in the meta-analysis. Omega-3 fatty acid supplementation was linked to reductions of mortality (I2 = 0, relative risk [RR] = 0.82, 95% confidence interval [CI] = 0.69–0.97), the duration of mechanical ventilation (DMV; I2 = 74%, weighted mean difference [WMD] = −2.20, 95% CI = −4.00 to −0.40), and intensive care unit (ICU) length of stay (LOS; I2 = 91%, WMD = −3.86, 95% CI = −5.72 to −2.01). Subgroup analysis illustrated that mortality was significantly reduced in patients with sepsis and gastrointestinal dysfunction (RR = 0.5, 95% CI = 0.29–0.86, I2 = 0).ConclusionOmega-3 fatty acid supplementation might be associated with reduced mortality in patients with sepsis, especially those with gastrointestinal dysfunction. Furthermore, omega-3 fatty acid administration could shorten DMV and ICU LOS.

Icosapent Ethyl - More than Just a Fish Tale?

Icosapent ethyl (Vascepa®) is a purified preparation of the omega-3 fatty acid eicosapentaenoic acid, which is marketed by Amarin Pharma. The product was initially approved by the U.S. Food and Drug Administration for the use of a high dose (4 g/day) in the treatment of hypertriglyceridemia. On the basis of the results of the REDUCE-IT trial, the agency later granted a label extension to include the additional indication of a reduction in risk of cardiovascular events in persons with serum triglyceride levels 150 mg/dl or greater and established cardiovascular disease or diabetes. Data supporting the efficacy of omega-3 fatty acids in the prevention of cardiovascular disease have been inconsistent and controversial. The story of the development of icosapent ethyl has been fraught with challenges, including the invalidation of six core patents on the product, and recently, the completion of a new clinical trial, STRENGTH, that directly contradicts REDUCE-IT and calls into question whether icosapent ethyl is actually effective in the secondary prevention of cardiovascular events. This article traces the course of the development of this fascinating product and discusses lessons that can be learned from its complex history, which is still continuing to unfold.

Continued post-retraction citation of a fraudulent clinical trial report, 11\xa0years after it was retracted for falsifying data

This paper presents a case study of long-term post-retraction citation to falsified clinical trial data (Matsuyama et al. in Chest 128(6):3817–3827, 2005. https://doi.org/10.1378/chest.128.6.3817), demonstrating problems with how the current digital library environment communicates retraction status. Eleven years after its retraction, the paper continues to be cited positively and uncritically to support a medical nutrition intervention, without mention of its 2008 retraction for falsifying data. To date no high quality clinical trials reporting on the efficacy of omega-3 fatty acids on reducing inflammatory markers have been published. Our paper uses network analysis, citation context analysis, and retraction status visibility analysis to illustrate the potential for extended propagation of misinformation over a citation network, updating and extending a case study of the first 6 years of post-retraction citation (Fulton et al. in Publications 3(1):7–26, 2015. https://doi.org/10.3390/publications3010017). The current study covers 148 direct citations from 2006 through 2019 and their 2542 second-generation citations and assesses retraction status visibility of the case study paper and its retraction notice on 12 digital platforms as of 2020. The retraction is not mentioned in 96% (107/112) of direct post-retraction citations for which we were able to conduct citation context analysis. Over 41% (44/107) of direct post-retraction citations that do not mention the retraction describe the case study paper in detail, giving a risk of diffusing misinformation from the case paper. We analyze 152 second-generation citations to the most recent 35 direct citations (2010–2019) that do not mention the retraction but do mention methods or results of the case paper, finding 23 possible diffusions of misinformation from these non-direct citations to the case paper. Link resolving errors from databases show a significant challenge in a reader reaching the retraction notice via a database search. Only 1/8 databases (and 1/9 database records) consistently resolved the retraction notice to its full-text correctly in our tests. Although limited to evaluation of a single case (N = 1), this work demonstrates how retracted research can continue to spread and how the current information environment contributes to this problem.

Efficacy of Omega-3 and Korean Red Ginseng in Children with Subthreshold ADHD: A Double-Blind, Randomized, Placebo-Controlled Trial

Objective: The purpose of the present study was to investigate the efficacy of combined omega-3 and Korean red ginseng supplementation on ADHD symptoms and cognitive function in children with subthreshold ADHD. Method: 120 children from 6 to 12 years with subthreshold ADHD were enrolled in this 12-week, double-blind, randomized, placebocontrolled study. The primary outcome was measured by Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS). Children Behavior Check List (CBCL), and neuropsychological tests assessing attention, memory, and executive function were included as secondary primary outcome measures. Results: Significant effects on the scores of ADHDRS, as well as several subscales of CBCL including ADHD and attention problem subscales were revealed. Conclusion: The combination of omega-3 and Korean red ginseng may have beneficial effects in children with subthreshold ADHD. Increased clinical awareness of ADHD symptoms even at a subthreshold level is needed.