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

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
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
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
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)
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
HHS Vulnerability Disclosure