Safety Of Omega-3 Fatty Acids Research Articles

Efficacy and Safety of Omega-3 Fatty Acids in the Prevention of Cardiovascular Disease: A Systematic Review and Meta-analysis.

It is widely accepted that omega-3 fatty acids are beneficial in the prevention of cardiovascular disease, but many large randomized controlled trial studies and meta-analyses have come to different conclusions. The evidence for omega-3 fatty acids supplementation to prevent cardiovascular disease remains insufficient. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of several types of omega-3 fatty acids supplements. We comprehensively searched the online database and found 15 RCTs. The primary efficacy outcomes included major cardiovascular events, myocardial infarction, heart failure, atrial fibrillation, stroke, cardiovascular death, and all-cause death. The safety endpoints included gastrointestinal problems, bleeding-related disorders, and cancer. Subgroup analysis was conducted according to the main characteristics of the population, and the dose-response relationship of omega-3 fatty acids was evaluated by meta-regression. All results were calculated by the random effect model. Statistical heterogeneity was assessed using chi-square tests and quantified using I-square statistics. The incidence of major cardiovascular events (RR 0.95, 95%CI 0.91 to 0.99, P = 0.026), myocardial infarction (RR 0.90, 95%CI 0.83 to 0.98; P = 0.021), and cardiovascular death (RR 0.94, 95%CI 0.88 to 0.99; P = 0.028) was reduced in the omega-3 fatty acid group compared with the control group. An increased risk of atrial fibrillation (RR 1.25, 95%CI 1.10 to 1.41; P = 0.000) was observed in patients in the omega-3 fatty acid group. No statistical differences were observed between the two groups in heart failure, stroke, and all-cause death. For safety endpoints, there were no statistically significant differences between the two groups in gastrointestinal problems, bleeding-related disorders, and cancer. Subgroup analysis showed that the cardiovascular benefit of omega-3 fatty acids was primarily attributable to the prescription of EPA ethyl ester. Omega-3 fatty acids may reduce the risk of major cardiovascular events in patients with cardiovascular disease or risk factors, and reduce the risk of myocardial infarction in patients without cardiovascular disease; however, they may increase the risk of stroke in patients with myocardial infarction. In addition, prescription omega-3 acid ethyl ester has a good safety profile, and prescription EPA ethyl ester has a high risk of bleeding. Moderate evidence showed that the use of omega-3 fatty acids may reduce the risk of major cardiovascular events, myocardial infarction, and cardiovascular death. Compared to other types of omega-3 fatty acids supplements, we support the use of prescription EPA ethyl ester formulations for the prevention of cardiovascular disease, but the potential risk of atrial fibrillation and bleeding cannot be ignored. It is important to note that omega-3 fatty acids should be applied with caution in patients with previous myocardial infarction, which may increase the risk of stroke. Finally, omega-3 fatty acids are relatively safe and in general do not increase gastrointestinal problems, bleeding-related disorders, or cancer, but attention needs to be paid to the risk of bleeding with prescription EPA ethyl ester formulations.

A Randomized, Prospective Study to Compare the Efficacy and Safety of Omega-3 Fatty Acids as Additional Therapy to Methotrexate versus Methotrexate Monotherapy in the Management of Moderate to Severe Plaque Psoriasis

Psoriasis is a chronic, inflammatory, hyperproliferative, immune-mediated skin disorder, having a prevalence of 0.44-2.8% in India. Methotrexate is a widely used systemic regimen for moderate to severe psoriasis. Supplementation of omega-3 fatty acids has decreased the severity of the disease in some studies. This study aimed to assess the efficacy and safety of omega-3 fatty acids as an add-on to methotrexate versus methotrexate monotherapy in patients with moderate to severe plaque psoriasis. A total of 40 patients with moderate to severe plaque psoriasis were recruited in the study and randomized into two groups of 20 patients each. Group O received omega-3 fatty acids as add-on to methotrexate and Group M received methotrexate monotherapy. Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Physician’s Global Assessment (PGA) were assessed at baseline, 4 weeks, 8 weeks and 12 weeks of treatment. The adverse events were assessed throughout the study period. There was a significant decrease in PASI and DLQI scores from baseline to end of 12 weeks in both groups (p<0.001) but the difference between the two groups was not significant (p>0.05). A higher number of patients had a PGA score of 0 or 1 at the end of 12 weeks in Group O (60%) as compared to Group M (40%) but the difference between the groups was not significant (p=0.34). The treatment was well tolerated in both the groups, with most common adverse events being nausea, diarrhea and epigastric pain. This study showed that the treatment in both the groups was equally effective in decreasing the severity of psoriasis and was well tolerated.

The efficacy and safety of omega-3 fatty acids on depressive symptoms in perinatal women: a meta-analysis of randomized placebo-controlled trials

Omega-3 fatty acids (FA), as a nutrient, has been proven effective in major depressive disorder (MDD), however, the results of monotherapy in perinatal depression (PND) remain unclear. To examine the efficacy and safety of omega-3 fatty acids (FA) monotherapy for perinatal depression (PND) compared with placebo. PubMed, Embase, PsycINFO, MEDLINE, Cochrane Library, and CINAHL were searched from inception up to November 2019. The reference lists of relevant review articles and included studies were also reviewed. Randomized placebo-controlled trials examining the efficacy and safety of omega-3 FA monotherapy in perinatal women with depressive symptoms were included. Pooled standard mean differences (SMD) were calculated and random-effects models were adopted for all analyses. Subgroups analyses and meta-regression were performed to quantify characteristics of the subjects and trials influencing the omega-3 response. In addition, meta-regression was conducted to identify the source of heterogeneity. The study protocol was registered at PROSPERO, CRD42020159542. Eight eligible randomized placebo-controlled trials were included involving 638 participants. There was a significant effect of omega-3 FA on perinatal depression. Omega-3 with higher ratio of EPA/DHA (≥1.5) had significant efficacy both in mild-to-moderate pregnant and postpartum depression with low incidence of side effects. Among the included trials reporting adverse effects, there was no significant difference in incidence of gastrointestinal and neurologic events between the omega-3 and placebo groups. There was no evidence of publication bias. Our findings suggested that omega-3 FA significantly improved depressive symptoms in perinatal women regardless of pregnant or postpartum and well-tolerated. Furthermore, the omega-3 response was linked to higher EPA proportion in omega-3 formula and mild- to-moderate depression.

Efficacy and safety of omega-3 fatty acids on liver-related outcomes in patients with nonalcoholic fatty liver disease: A protocol for a systematic review and meta-analysis.

Background:Non-alcoholic fatty liver disease (NAFLD), especially non-alcoholic steatohepatitis, which is considered as the hepatic manifestation of metabolic syndrome, has a great prevalence all over the world. New drugs are urgently needed for the treatment of NAFLD. This review will be to assess the efficacy and safety of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on liver-related outcomes (liver histology and liver enzymes) in patients with NAFLD.Methods:We will search 5 databases for relative studies: Medline, the Cochrane Library, EMBASE, Web of Science, and ClinicalTrials.gov and identified all reports of randomized controlled trials published prior to July 2020. Two authors will independently scan the articles searched, extract the data from articles included, and assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by discussion among authors. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. Fixed-effects model or random-effects model will be used to calculate pooled estimates of weighted mean difference with 95% confidence intervals.Results:This systematic review aims to examine the effect of n-3 PUFAs on liver histology and liver enzymes in patients with NAFLD.Conclusions:These findings will provide guidance to clinicians and patients on the use of n-3 PUFAs for NAFLD.Ethics and dissemination:This study is a protocol for a systematic review of n-3 PUFAs as a treatment of NAFLD patients. This review will be published in a journal and disseminated in print by peer-review.Systematic review registration:INPLASY202050008.

Omega-3 Fatty Acids as a Treatment for Pediatric Depression. A Phase III, 36 Weeks, Multi-Center, Double-Blind, Placebo-Controlled Randomized Superiority Study.

Background: Depressive disorders in childhood and adolescence are a major health problem and often follow a chronic course with severe consequences in later life. Depressive disorders cause the highest burden of disease in this age group across all medical conditions. Treatment adherence is usually very poor, and the use of antidepressant drugs is heavily debated, as suicidal ideations may increase, in particular in the early phase of treatment. Omega-3 fatty acids rich in eicosapentaenoic acid have shown some promising results in over a dozen small scale randomized controlled trials (RCTs) in adult major depressive disorders, with only very few published RCTs in children and adolescents. High-quality phase III RCTs are missing. Methods and Design: The omega-3-pMDD trial is a carefully designed phase III RCT to assess the efficacy and safety of omega-3 fatty acids in the early course of pediatric major depressive disorder (MDD). The study is designed as a multi-center, double-blinded, placebo-controlled, randomized clinical trial enrolling 220 patients aged 8 to 17 years meeting DSM-IV criteria for major depressive disorder of at least moderate symptom severity. After a single-blinded placebo-lead-in phase (7 to 10 days) patients are randomly assigned to omega-3 fatty acids or placebo over 36 weeks. Primary outcomes are changes in depression severity, as well as remission and recovery rates. Secondary outcome measures include the omega-3 index and inflammatory parameters as predictors of response. Data analysis will be performed in the intention-to-treat sample using a (generalized) linear random intercept regression model. Through sampling of blood, hair, saliva, and urine, further putative biological markers for depression and omega-3 fatty response will be investigated. Discussion: This trial addresses if omega-3 fatty acids play a role in the pathogenesis of pediatric MDDs and have antidepressant properties, in particular in clinically depressed children and adolescents with a pre-existing omega-3 fatty acid deficiency, increased markers of oxidative stress, and/or markers of (low grade) inflammation. Ethics and Dissemination: The study was approved by the local ethics committees. The results will be published in peer-reviewed journals irrespective of specific outcomes. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03167307.

Omega-3 fatty acids for the treatment of depressive disorders in children and adolescents: a meta-analysis of randomized placebo-controlled trials

BackgroundTo investigate the efficacy and safety of omega-3 fatty acids (O3FA) in treating depressive disorders in children and adolescents.MethodWe conducted a comprehensive search in electronic databases and hand-searched articles included for relevant studies. We included randomized controlled trials which studied on O3FA for treatment of children and adolescents with depression. The standard mean differences (SMDs) and the odds ratios (ORs) with 95% confidence intervals (CIs) were estimated by a random-effects model. The primary outcomes were end-point depressive symptoms scores (efficacy) and all-cause discontinuation (safety). The secondary outcome of response rate was also assessed. Subgroup analyses were performed by age, severity of depression and dosage. Risk of bias assessment was performed based on the Jadad score and the Cochrane Collaboration’s risk-of-bias method.ResultsA total of four studies with 153 participants were included. In terms of efficacy, there was no significant difference of end-point depressive symptoms scores between O3FA and placebo (SMD = − 0.12, 95% CI − 0.53 to 0.30, P = 0.58; I2= 30%). In terms of safety, the all-cause discontinuation showed no statistical significance between O3FA and placebo (OR = 1.3, 95% CI 0.58 to 2.93, P = 0.53; I2= 0%). The response rate of O3FA was also not significant better than that of placebo (OR = 1.57, 95% CI 0.26 to 9.39, P = 0.62; I2= 71%). Besides, there were also no significant differences in those subgroup analyses outcomes. The risk of bias of included trials were not high.ConclusionsOnly considering the limited evidence of O3FA in the acute treatment of major depressive disorder, it did not seem to offer a clear advantage for children and adolescents.

Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

BackgroundCardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia.MethodsThis randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment.ResultsAfter 8 weeks of treatment, the percent changes from baseline in TG (−29.8% vs. 3.6%, P<0.001) and non-HDL-C (−10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups.ConclusionThe addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.

Omega 3 Fatty Acid Treatment in Autism

The purpose of this study was to determine the efficacy and safety of omega-3 fatty acids for children with autistic spectrum disorder (ASD). This was an open-label pilot study. Ten children aged 4-7 years old with ASD according to the Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition (DSM-IV), were given 1 gram daily of omega-3 fatty acids for 12 weeks. The main outcome measure used was the Autism Treatment Evaluation Checklist (ATEC). These data were collected between July, 2006, and June, 2007. Of the 9 subjects who completed the study, 8 showed improvement of about 33% on the Autism Treatment Evaluation Checklist (ATEC). None worsened and no side effects were reported. Omega-3 fatty acids appear to be safe and might be helpful for children suffering from ASD. Further study is needed with a larger number of children in a double-blind design and with various doses of omega-3 fatty acids.

Omega-3 fatty acid monotherapy for pediatric bipolar disorder: A prospective open-label trial

Background: To test the effectiveness and safety of omega-3 fatty acids (Omegabrite® brand) in the treatment of pediatric bipolar disorder (BPD). Method: Subjects ( N = 20) were outpatients of both sexes, 6 to 17 years of age, with a DSM-IV diagnosis of BPD and Young Mania Rating Scale (YMRS) score of > 15 treated over an 8-week period in open-label trial with omega-3 fatty acids 1290 mg–4300 mg combined EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). Results: Subjects experienced a statistically significant but modest 8.9 ± 2.9 point reduction in the YMRS scores (baseline YMRS = 28.9 ± 10.1; endpoint YMRS = 19.1 ± 2.6, p < 0.001). Adverse events were few and mild. Red blood cell membrane levels of EPA and DHA increased in treated subjects. Conclusions: As only 35% of these subjects had a response by the usual accepted criteria of > 50% decrease on the YMRS, omega-3 fatty acids treatment was associated with a very modest improvement in manic symptoms in children with BPD.

Omega-3 fatty acids

Maternal depression affects a mother and her baby. However, treatment with antidepressants during pregnancy may pose risks. Optimal care of depression during pregnancy would be efficacious and safe for both mother and baby. Treatments that provide additional health benefits to the mother and baby would be ideal. Currently there are no evidence-based guidelines to inform the use of antidepressant medications in pregnancy and postpartum. Some women may be unwilling to accept standard antidepressant medications in pregnancy because the long-term effects on the child are unknown. Omega-3 fatty acids are natural compounds with many established health benefits. The safety of omega-3 fatty acids in pregnancy has been demonstrated, and specific health benefits during pregnancy have been associated with their use. Epidemiological data, treatment data and biochemical rationale support the research of omega-3 fatty acids for depression during pregnancy.