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    Pronova Inc fish-oil concentrate soft gelatin capsules
    Fish Oil Concentrate Soft Gelatin Capsules, supplied by Pronova Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/fish+oil+gelatin+capsules/fish+oil+concentrate+soft+gelatin+capsules/pmc07049091-8611-140-146
    Average 90 stars, based on 1 article reviews
    fish-oil concentrate soft gelatin capsules - by Bioz Stars, 2026-10
    90/100 stars

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    Control:

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. 35% were non-compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months Outcomes Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) Notes Study funding: the study was supported in part by a grant from the NHLBI, NIH (HL62154) Risk of bias table Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Computer-generated randomisation tables for each collaborating site, stratified by site Allocation concealment (selection bias) Low risk Author confirmed allocation was concealed from investigators Blinding of participants and personnel (performance bias) Unclear risk Study referred to as "double blind" and gelatin capsules (verum and placebo) were stated as being of identical appearance but no discussion of taste or smell.

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators N: intervention 200, control 202 Level of risk for CVD: high (patients with implanted cardioverter defibrillators) Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear number of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Intention was to increase omega‐3, difference between arms was 4.8 g/d PUFA, 2.2% E PUFA, > 10% increase from assumed baseline of 6% E PUFA PUFA dose : 2.2% E PUFA Duration of intervention: average 28 months Outcomes Main trial outcome: regression of coronary artery lesions Dropouts: 10 intervention, 11 control Available outcomes: total and CV deaths, fatal and non‐fatal MI, stroke, angioplasty or coronary artery bypass graft, unstable angina, CHD, cancer diagnosis, combined CV events, side effects Response to contact: yes Notes Trial funding: National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Bethesda, Maryland, Warner Lambert‐Parke Davis (pharmaceutical company), East Hanover, New Jersey; and by an Established Investigator Award to Dr. Sacks from the American Heart Association, Dallas, Texas Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk “randomization” stratified by clinical management regime and TC/HDL ratio Allocation concealment (selection bias) Unclear risk No further details Blinding of participants and personnel (performance bias) All outcomes Unclear risk Quote: “patients and personnel responsible for lab measurements, cardiac catheterization, and analysis of angiography films were blinded to the treatment assignment”. .. Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (patients with ICDs). Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega 3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (participants with ICDs). Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. Difference 0.84% E PUFA Baseline PUFA: unclear Compliance by biomarkers: platelet phospholipid EPA + DHA higher in intervention group than control, no data on total PUFA or TC Compliance by dietary intake: not reported Energy intake: not reported Total fat intake: not reported SFA intake: not reported PUFA intake: not reported PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported Trans fat intake: not reported MUFA intake: not reported CHO intake: not reported Sugars intake: not reported Protein intake: not reported Alcohol intake: not reported Compliance, other measures: pill counts suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Inclusion basis: no intention to increase total PUFA. Intention was to increase omega‐3, difference between arms was 0.84% E PUFA, > 10% more than control PUFA dose: 0.84% E Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal VF/VT Dropouts: intervention 13 deaths, unclear number of dropouts; control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Medications:

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. 35% were non-compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months Outcomes Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) Notes Study funding: the study was supported in part by a grant from the NHLBI, NIH (HL62154) Risk of bias table Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Computer-generated randomisation tables for each collaborating site, stratified by site Allocation concealment (selection bias) Low risk Author confirmed allocation was concealed from investigators Blinding of participants and personnel (performance bias) Unclear risk Study referred to as "double blind" and gelatin capsules (verum and placebo) were stated as being of identical appearance but no discussion of taste or smell.

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Intention was to increase omega‐3, difference between arms was 4.8 g/d PUFA, 2.2% E PUFA, > 10% increase from assumed baseline of 6% E PUFA PUFA dose : 2.2% E PUFA Duration of intervention: average 28 months Outcomes Main trial outcome: regression of coronary artery lesions Dropouts: 10 intervention, 11 control Available outcomes: total and CV deaths, fatal and non‐fatal MI, stroke, angioplasty or coronary artery bypass graft, unstable angina, CHD, cancer diagnosis, combined CV events, side effects Response to contact: yes Notes Trial funding: National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Bethesda, Maryland, Warner Lambert‐Parke Davis (pharmaceutical company), East Hanover, New Jersey; and by an Established Investigator Award to Dr. Sacks from the American Heart Association, Dallas, Texas Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk “randomization” stratified by clinical management regime and TC/HDL ratio Allocation concealment (selection bias) Unclear risk No further details Blinding of participants and personnel (performance bias) All outcomes Unclear risk Quote: “patients and personnel responsible for lab measurements, cardiac catheterization, and analysis of angiography films were blinded to the treatment assignment”. .. Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Comparison:

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. 35% were non-compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months Outcomes Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) Notes Study funding: the study was supported in part by a grant from the NHLBI, NIH (HL62154) Risk of bias table Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Computer-generated randomisation tables for each collaborating site, stratified by site Allocation concealment (selection bias) Low risk Author confirmed allocation was concealed from investigators Blinding of participants and personnel (performance bias) Unclear risk Study referred to as "double blind" and gelatin capsules (verum and placebo) were stated as being of identical appearance but no discussion of taste or smell.

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators N: intervention 200, control 202 Level of risk for CVD: high (patients with implanted cardioverter defibrillators) Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear number of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Intention was to increase omega‐3, difference between arms was 4.8 g/d PUFA, 2.2% E PUFA, > 10% increase from assumed baseline of 6% E PUFA PUFA dose : 2.2% E PUFA Duration of intervention: average 28 months Outcomes Main trial outcome: regression of coronary artery lesions Dropouts: 10 intervention, 11 control Available outcomes: total and CV deaths, fatal and non‐fatal MI, stroke, angioplasty or coronary artery bypass graft, unstable angina, CHD, cancer diagnosis, combined CV events, side effects Response to contact: yes Notes Trial funding: National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Bethesda, Maryland, Warner Lambert‐Parke Davis (pharmaceutical company), East Hanover, New Jersey; and by an Established Investigator Award to Dr. Sacks from the American Heart Association, Dallas, Texas Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk “randomization” stratified by clinical management regime and TC/HDL ratio Allocation concealment (selection bias) Unclear risk No further details Blinding of participants and personnel (performance bias) All outcomes Unclear risk Quote: “patients and personnel responsible for lab measurements, cardiac catheterization, and analysis of angiography films were blinded to the treatment assignment”. .. Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (patients with ICDs). Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega 3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (participants with ICDs). Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. Difference 0.84% E PUFA Baseline PUFA: unclear Compliance by biomarkers: platelet phospholipid EPA + DHA higher in intervention group than control, no data on total PUFA or TC Compliance by dietary intake: not reported Energy intake: not reported Total fat intake: not reported SFA intake: not reported PUFA intake: not reported PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported Trans fat intake: not reported MUFA intake: not reported CHO intake: not reported Sugars intake: not reported Protein intake: not reported Alcohol intake: not reported Compliance, other measures: pill counts suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Inclusion basis: no intention to increase total PUFA. Intention was to increase omega‐3, difference between arms was 0.84% E PUFA, > 10% more than control PUFA dose: 0.84% E Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal VF/VT Dropouts: intervention 13 deaths, unclear number of dropouts; control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Capsules:

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. Men: intervention 84.5%, control 81.7% Page 89 of 419 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only Database - Dataset 1, page 67 Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). .. 35% were non-compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months Outcomes Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) Notes Study funding: the study was supported in part by a grant from the NHLBI, NIH (HL62154) Risk of bias table Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Computer-generated randomisation tables for each collaborating site, stratified by site Allocation concealment (selection bias) Low risk Author confirmed allocation was concealed from investigators Blinding of participants and personnel (performance bias) Unclear risk Study referred to as "double blind" and gelatin capsules (verum and placebo) were stated as being of identical appearance but no discussion of taste or smell.

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators N: intervention 200, control 202 Level of risk for CVD: high (patients with implanted cardioverter defibrillators) Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear number of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta-blockers Medications taken by 20% - 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Intention was to increase omega‐3, difference between arms was 4.8 g/d PUFA, 2.2% E PUFA, > 10% increase from assumed baseline of 6% E PUFA PUFA dose : 2.2% E PUFA Duration of intervention: average 28 months Outcomes Main trial outcome: regression of coronary artery lesions Dropouts: 10 intervention, 11 control Available outcomes: total and CV deaths, fatal and non‐fatal MI, stroke, angioplasty or coronary artery bypass graft, unstable angina, CHD, cancer diagnosis, combined CV events, side effects Response to contact: yes Notes Trial funding: National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Bethesda, Maryland, Warner Lambert‐Parke Davis (pharmaceutical company), East Hanover, New Jersey; and by an Established Investigator Award to Dr. Sacks from the American Heart Association, Dallas, Texas Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk “randomization” stratified by clinical management regime and TC/HDL ratio Allocation concealment (selection bias) Unclear risk No further details Blinding of participants and personnel (performance bias) All outcomes Unclear risk Quote: “patients and personnel responsible for lab measurements, cardiac catheterization, and analysis of angiography films were blinded to the treatment assignment”. .. Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: .. Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). ..

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (patients with ICDs). Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20% ‐ 49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear). Dose: 2.6 g/d EPA + DHA Control: 4 ×1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA and < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces Compliance: pill counts and platelet phospholipid data suggested greater omega 3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Duration of intervention: 12 months , . .. Outcomes , Main study outcome: fatal ventricular arrhythmias Dropouts: intervention 13 deaths, unclear no. of dropouts, control 12 deaths, dropouts unclear Available outcomes: deaths, cardiovascular deaths, CVD events, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    Article Title: Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Participants , People with implanted cardioverter defibrillators (ICDs) N: intervention 200, control 202 Level of risk for CVD: high (participants with ICDs). Male: intervention 84.5%, control 81.7% Mean age (SD): intervention 65.7 (11.6), control 65.3 (11.7) years Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by ≥ 50% of those in the control group: ACEi, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: Ca channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white , . .. Interventions , Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 x 1 g/d fish oil gelatin capsules, 2.6 g EPA + DHA/d (Pronova Biocare, quantities of EPA + DHA unclear): EPA + DHA 2.6 g/d Control: 4 x 1 g/d olive oil capsules, 4 g/d (in identical gelatin capsules, < 0.06 g/d EPA + < 0.06 g/d DHA) All were advised to use olive oil rather than the common plant seed oils for cooking, dressings, and sauces PUFA Dose : (intended) Dose aim : intervention 2.6 g/d EPA + DHA, 1.2% E n3, 1.2% E PUFA, control 4 g olive oil, 20% LA, 0.8 g/d PUFA, 0.36% E PUFA. Difference 0.84% E PUFA Baseline PUFA: unclear Compliance by biomarkers: platelet phospholipid EPA + DHA higher in intervention group than control, no data on total PUFA or TC Compliance by dietary intake: not reported Energy intake: not reported Total fat intake: not reported SFA intake: not reported PUFA intake: not reported PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported Trans fat intake: not reported MUFA intake: not reported CHO intake: not reported Sugars intake: not reported Protein intake: not reported Alcohol intake: not reported Compliance, other measures: pill counts suggested greater omega‐3 intake in intervention participants. 35% were non‐compliers (36.5% intervention, 34.2% control) Inclusion basis: no intention to increase total PUFA. Intention was to increase omega‐3, difference between arms was 0.84% E PUFA, > 10% more than control PUFA dose: 0.84% E Duration of intervention: 12 months , . .. Outcomes , Main trial outcome: fatal VF/VT Dropouts: intervention 13 deaths, unclear number of dropouts; control 12 deaths, dropouts unclear Available outcomes: deaths, CV deaths, deaths from heart failure, fatal arrhythmias, MI, angina Response to contact: yes (data provided) , .

    other:

    Article Title: Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
    Article Snippet: Dose: unclear Control: described only as "placebo" Compliance: not reported Length of intervention: 12 months Outcomes Main trial outcome: AF relapse Dropouts: not reported Available outcomes: recurrent AF (reported in Mariani 2013 ), mortality (none) Response to contact: no reply to date Notes Funding source: not reported Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned" Allocation concealment (selection bias) Unclear risk Not described Blinding of participants and personnel (performance bias) All outcomes Unclear risk Described as triple‐blind, but no further details provided (only an abstract with some details in a related trial publication and some in a systematic review by the same author) Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described, but analysis appears to have been carried out blind to intervention/control status Incomplete outcome data (attrition bias) All outcomes Unclear risk Number randomised not described Selective reporting (reporting bias) Unclear risk Unclear, no trial registry entry or protocol found Attention Unclear risk Not described Compliance Unclear risk Not described Other bias Low risk None noted Erdogan 2007 Methods Fatty Acid Antiarrhythmia Trial – FAAT Randomisation: RCT, parallel, 2 arms, (n‐3 EPA + DHA vs MUFA), 12 months Summary risk of bias: moderate or high Participants People with implanted cardioverter defibrillators N: intervention 200, control 202 Level of risk for CVD: high (patients with implanted cardioverter defibrillators) Men: intervention 84.5%, control 81.7% Mean age in years (SD): intervention 65.7 (11.6), control 65.3 (11.7) Age range: unclear Smokers: intervention 15%, control 11.4% Hypertension: unclear Medications taken by at least 50% of those in the control group: ACE inhibitors, beta‐blockers Medications taken by 20%‐49%: diuretics Medications taken by some, but < 20%: calcium channel blockers, amiodarone, sotalol, type 1 antiarrhythmics Location: USA Ethnicity: intervention 95.5% white, control 96.5% white Interventions Type: supplement/capsule Comparison: EPA + DHA vs MUFA Intervention: 4 ×1 g/d fish oil gelatin capsules, 2.6 g/d EPA + DHA (Pronova Biocare, quantities of EPA + DHA unclear).



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