Kumar 2013.
Methods | RCT, parallel, (fish oil vs nil), 12 months Summary risk of bias: moderate or high |
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Participants | Patients > 60 years with sinoatrial node disease and dual chamber pacemakers N: 39 intervention, 39 control randomised (18 intervention vs 39 control at 12 months) Level of risk for CVD: moderate/high Male %: 46% intervention, 56% control Mean age in years (SD): 78 (7) intervention, 77(8) control Age range: not reported Smokers: not reported Hypertension: 72% Medications taken by at least 50% of those in the control group: statin, renin‐angiotensin system inhibitors Medications taken by 20%‐49% of those in the control group: anti‐arrhythmic drugs Medications taken by some, but less than 20% of the control group: not reported Location: Australia Ethnicity: not reported |
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Interventions | Type: omega 3 capsule Comparison: EPA + DHA vs nil Intervention: a triglyceride preparation containing a total of 6 g/day of omega‐3 polyunsaturated fatty acids of which 1.8 g/day were n‐3 (1.02 g EPA and 0.72 g DHA). Dose: 1.8 g/d EPA + DHA Control: no supplements Compliance: measured by weekly dietary history and pill count. Fatty acid status measured at randomisation and between 1‐3 months post randomisation (blood samples). Duration of intervention: median 378 days |
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Outcomes | Main study outcome: atrial fibrillation burden Dropouts: 1 intervention, 0 control Available outcomes: all cause mortality, CV mortality, AF (frequency and duration but not recurrence so not used), adverse events Response to contact: written but no contact yet |
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Notes | Study funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using sequentially numbered, opaque, sealed envelopes. |
Allocation concealment (selection bias) | Low risk | As above |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label design |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "At each visit, stored AT/AF diagnostic data were retrieved in an un‐blinded fashion" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 1 lost, and reason explained. 21 of the 39 randomised to the intervention were crossed over to control at 6 months so 12‐month outcomes are reported for 17/18 intervention while baseline characteristics are reported for the 39 patients. |
Selective reporting (reporting bias) | Low risk | Trial prospectively registered and outcomes stated were reported |
Attention | Unclear risk | As only the intervention group had supplements there was potential for attention differences. Other contact appears the same. |
Compliance | Low risk | EPA was 3‐fold higher and DHA 1.8 fold higher compared with controls. EPA and DHA did not change significantly in controls upon repeat testing |
Other bias | High risk | Odd design – 21 of the 39 randomised to the intervention were crossed over to control at 6 months |