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. 2018 Nov 30;2018(11):CD003177. doi: 10.1002/14651858.CD003177.pub4

Kumar 2012.

Methods RCT, parallel, (fish oil vs nil), 12 months
Summary risk of bias: moderate or high
Participants Patients with persistent atrial fibrillation (AF) on warfarin
N: 92 intervention, 90 control (91 and 87 analysed ITT)
Level of risk for CVD: high
Male %: 82.4 intervention, 72.4 control
Mean age in years (SD): 63 (10) intervention, 61(13) control
Age range: 18‐85 years (inclusion criteria)
Smokers: 22.2% intervention, 11.5% control
Hypertension: 45.6% intervention, 58.6% control
Medications taken by at least 50% of those in the control group: anti‐arrhythmic drugs, renin‐angiotensin system inhibitors
Medications taken by 20%‐49% of those in the control group: statins
Medications taken by some, but less than 20% of the control group: not reported
Location: Australia
Ethnicity: not reported
Interventions Type: fish oil capsule
Comparison: EPA + DHA vs nil
Intervention: 6 capsules/day of a fish oil preparation containing a total dose of 1.02 g of EPA and 0.72 g DHA. Participants in the omega‐3 group were asked to continue fish oils till a maximum of 1 year or till return of persistent AF. Dose: 1.7 g/d EPA + DHA
Control: no supplements. Patients were advised not to take any fish oil supplements.
All patients underwent cardioversion following randomisation.
Compliance: was monitored on a weekly basis via telephone and during follow‐up by using a pill count plus serum EPA and DHA levels which were significantly increased
Duration of intervention: 1 year (or AF recurrence)
Outcomes Main study outcome: atrial fibrillation recurrence
Dropouts: 4 intervention, 0 control
Available outcomes: all‐cause mortality (nil death), AF recurrence, time to AF recurrence, adverse events
Response to contact: contact not yet established
Notes Study funding: the study was funded in part by the National Heart Foundation of Australia and the Pfizer Cardiovascular Lipid Research Grant.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients were randomised to a control or an omega‐3 group in a 1:1 fashion (no details of method)
Allocation concealment (selection bias) Unclear risk No further details
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label with no placebo control
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open label
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT analysis was conducted
Selective reporting (reporting bias) Unclear risk Trial registered 2005 but data collection started 2003
Attention Unclear risk Intervention group had capsules, while control group did not. Potential for greater contact and checking with intervention group on this basis, although otherwise both groups seem to have had the same care.
Compliance Low risk EPA and DHA levels were significantly higher in intervention group
Other bias Low risk None noted
HHS Vulnerability Disclosure