EPIC‐1 2008.
Methods | EPANOVA in Crohn's disease, study 1 (EPIC‐1) RCT, parallel, 2‐arm (omega 3 vs MCT), 52 weeks Summary risk of bias: moderate or high |
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Participants | Adults with quiescent Crohn's disease (CDAI) score < 150 N: 188 intervention, 186 control Level of risk for CVD: low Men: 48.1% intervention, 41.1% control Mean age in years (SD): 40.5 (15.2) intervention, 38.2 (13.1) control Age range: 18‐70 years Smokers: 30.6% intervention, 34.4% control Hypertension: unclear Medications taken by at least 50% of those in the control group: oral 5‐ASA therapy, Systemic corticosteroids – prednisolone, budesonide Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: antibiotic therapy, topical rectal therapy, immune‐modifying agents, immune modifiers/biologics Location: Canada, Europe, Israel, USA Ethnicity: not reported |
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Interventions | Type: supplement (capsule) Comparison: EPA + DHA vs SFA (medium chain triglycerides of short SFAs) Intervention: 2 × 2 1 g gelatin capsules omega‐3 free fatty acids (Epanova‐ 2.2 g EPA, 0.8 g DHA). Dose: 3 g/d EPA + DHA Control: 4 x1 g capsules medium chain triglycerides Compliance: pill counts, 79.2% adhered intervention, 75.6% adhered control Length of intervention: mean 52 weeks |
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Outcomes | Main study outcome: Crohns relapse‐free time
Dropouts: 80 intervention, 91 control Available outcomes: total deaths, non‐fatal arrhythmias, cancer diagnoses, cancer deaths, adverse events Response to contact: yes (data provided) |
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Notes | Study funding: Tillotts Pharma, authors had extensive financial disclosures | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by number generator. Used a centralised randomisation procedure via interactive voice recognition system. |
Allocation concealment (selection bias) | Low risk | Centralised randomisation (see above) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blinding stated, identical capsule (slow‐release capsules). Neither investigator nor participant knew the allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study states double‐blind but does not state that outcome assessors were blinded or provide a mechanism for this |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of dropouts and reasons provided. 171 of 187 in intervention group and 174 of 184 in control group provided data for primary outcome, (7% dropout), though 80 in the intervention group and 91 in the control group terminated early. |
Selective reporting (reporting bias) | High risk | Trials registration (NCT00613197) first received in 2008, but study started in 2003 and was published in 2008 |
Attention | Low risk | As investigators were blinded attention bias was not possible. |
Compliance | Unclear risk | Pill counts, 79.2% adhered intervention, 75.6% adhered control |
Other bias | Low risk | No further bias noted |