| Methods | RCT, parallel, (EPA + DHA + statins vs statins), 12 months Summary risk of bias: moderate to high |
|
| Participants | Statin treated CAD patients undergoing PCI N: 38 intervention, 36 control Level of risk for CVD: high Men: 63.2% intervention, 72.2% control Mean age in years (SD): 59.6 (9.1) intervention, 60.7 (0.8) [sic] control Age range: unclear Smokers: 36.8% intervention, 58.3% control Hypertension: 50% in both groups Medications taken by at least 50% of those in the control group: aspirin, clopidogrel, ACE inhibitors/ARB, beta‐blockers, atorvastatin Medications taken by 20%‐49% of those in the control group: cilostazol Medications taken by some, but less than 20% of the control group: rosuvastatin, nitrates, calcium antagonists Location: South Korea Ethnicity: not reported |
|
| Interventions | Type: supplement (capsule) Comparison: EPA + DHA vs unclear (nil) Intervention: 3 g of ω‐3 PUFA containing 1395 mg of EPA and 1125 mg of DHA per day. No further details. Dose: +2.52 g/d EPA + DHA Control: unclear whether control group were given placebo or only statins Compliance: unclear how it was measured but reported good compliance with no numbers Length of intervention: 12 months |
|
| Outcomes | Main study outcome: change in atherosclerotic burden Dropouts: none Available outcomes: lipids (TG reported as median, IQR so not used), atheroma volume, neointimal volume index Response to contact: no |
|
| Notes | Study funding: the study was supported by clinical research grant from Pusan National University Hospital | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Simple randomisation was carried out using random number tables to assign each participant to the intervention or control group |
| Allocation concealment (selection bias) | Low risk | Participants were assigned randomisation numbers sequentially on recruitment to the study, and the randomisation codes were retained by the clinical research coordinator. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The personnel responsible for randomisation as well as those performing laboratory measurements were blinded to the randomisation assignments. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial register entry found |
| Attention | Unclear risk | No details |
| Compliance | Unclear risk | No details on how it was measured and no fatty acid levels reported |
| Other bias | High risk | It's unclear whether the study was placebo controlled or the control group had no intervention. Also, some of the SDs appear to be incorrectly reported. |
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