Skip to main content
. 2018 Nov 30;2018(11):CD003177. doi: 10.1002/14651858.CD003177.pub4

Kumar 2013.

Methods RCT, parallel, (fish oil vs nil), 12 months
Summary risk of bias: moderate or high
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
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
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
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
HHS Vulnerability Disclosure