Safety and tolerability of prescription omega-3 fatty acids: A systematic review and meta-analysis of randomized controlled trials

Chang, Cheng-Ho; Tseng, Ping‐Tao; Chen, Nai-Yu; Lin, Pei‐Chin; Lin, Pao‐Yen; Chang, Jong Sun; Kuo, Feng-Yu; Lin, Jenshinn; Wu, Ming‐Chang; Su, Kuan‐Pin

doi:10.1016/j.plefa.2018.01.001

Cited by 87 publications

(48 citation statements)

References 62 publications

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“…There were no SAEs and no group differences in AEs, with the exception of muscle cramps, which were reported more frequently in the fish oil group. Gastrointestinal AEs, which are commonly reported during fish oil supplementation (Chang et al 2018), were reported at a similar frequency in both treatment groups. Consistent with prior evidence that chronic high-dose fish oil (Harris 2007) or elevated n-3 PUFA blood levels (Salisbury et al 2012) are not associated with clinically significant increases in bleeding time in adult patients with cardiovascular diseases, we did not observe significant group differences in bleeding-related AEs or baseline-endpoint changes in laboratory measures of hemostasis.…”

mentioning

confidence: 54%

Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial

McNamara

Tallman

Welge

et al. 2020

Journal of Child and Adolescent Psychopharmacology

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Objectives: To evaluate the clinical and neurochemical effects of 12-week fish oil, a source of omega-3 polyunsaturated fatty acids (n-3 PUFAs), in depressed adolescents with a family history of bipolar I disorder. Methods: Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ‡40, and at least one biological parent with bipolar I disorder were randomized to double-blind treatment with fish oil (2100 mg/day) or placebo for 12 weeks. The primary outcome measure was change in CDRS-R total score, and secondary outcomes measures were change in manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S] /CGI Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations using proton magnetic resonance spectroscopy at 4 T. Results: Fifty-six patients were randomized, and 42 completed the 12-week trial (placebo: n = 21; fish oil, n = 21). Subjects randomized to fish oil, but not placebo, exhibited a significant baseline to endpoint increase in erythrocyte n-3 PUFAs. Reductions in CDRS-R scores did not differ between treatment groups (p = 0.15), and similar remission (p = 0.58) and response (p = 0.77) rates were observed. Fish oil produced a significantly greater decrease in CGI-S (p = 0.0042) and CGI-I (p = 0.036) scores compared with placebo. Baseline to endpoint change in ACC creatine (p = 0.004) and ACC choline (Cho) (p = 0.024) differed significantly between groups. Baseline ACC Cho levels were inversely correlated with baseline and baseline to endpoint change in CDRS-R scores, and baseline to endpoint change in ACC Cho correlated with baselineendpoint change in CDRS-R scores and n-3 PUFA. There were no group differences in safety and tolerability ratings or laboratory measures. Conclusions: Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement. Associations among ACC Cho levels, depression symptom severity, and n-3 PUFA warrant additional investigation.

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mentioning

confidence: 54%

Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial

McNamara

Tallman

Welge

et al. 2020

Journal of Child and Adolescent Psychopharmacology

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“…The Matsuyama paper studied a nutritional intervention for a chronic disease: it purported to show that a diet rich in omega-3 polyunsaturated fatty acids reduced inflammation and improved exercise capacity in persons with chronic obstructive pulmonary disease (COPD). Omega-3 polyunsaturated fatty acids are of particular interest as an adjunct to conventional pharmacotherapies in people with inflammatory diseases such as hypertriglyceridemia and rheumatoid arthritis, due to the cost-effectiveness and favorable safety profile (Calder and Zurier 2001;Chang et al 2018;Samuel et al 2011). The design used in the Matsuyama study is the strongest established method for showing treatment efficacy: a randomized controlled trial (RCT).…”

Section: Case Studymentioning

confidence: 99%

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

Schneider

Hill

et al. 2020

Scientometrics

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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. 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. 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.

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“…Indeed, in a recent systemic review and meta-analysis dedicated to the safety and tolerability of prescription of omega-3 fatty acids, fishy taste and belching were significantly more frequent in treated subjects than in controls. 44 What Should be the Next Step?…”

Section: Pufas Supplementation For Adhdmentioning

confidence: 99%

Omega-3 Supplementation for Children with Learning Difficulties and Attention Deficit Disorder: Is it Beneficial?

Gadoth

2019

J Pediatr Neurol

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The use of “natural medicines,” food supplements, and in particular long-chain polyunsaturated fatty acids (omega-3/6) for a large variety of ailments including attention deficit hyperactivity disorder (ADHD) and other developmental behavioral disorders has dramatically increased in the past few years. In recent publications, doubts have been raised in regard to the benefits and risks of this form of treatment for ADHD. In this article, a short history of the way this treatment has evolved, its theoretical basis, and evidence-based data on the value of this popular supplementation will be reviewed.

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Safety and tolerability of prescription omega-3 fatty acids: A systematic review and meta-analysis of randomized controlled trials

Abstract: RxOME3FAs are generally safe and well tolerated but not free of adverse effects. Post-marketing surveillance and observational studies are still necessary to identify long-term adverse effects and to confirm the safety and tolerability profiles of RxOME3FAs.

Cited by 87 publications

References 62 publications

Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial

Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial

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

Omega-3 Supplementation for Children with Learning Difficulties and Attention Deficit Disorder: Is it Beneficial?

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