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

Reed 2014.

Methods RCT, parallel, 3 arms (fish oil or borage oil), 18 months
Summary risk of bias: low
Participants Adults with rheumatoid arthritis
N: 53 intervention, 52 control (28 intervention, 24 control analysed)
Level of risk for CVD: low
Men: 13.2% intervention, 23.1% control
Mean age in years (SD): 57.3 (12.3) intervention, 60.3 (9.2) control
Age range: not reported but 18‐85 inclusion criteria
Smokers: not reported
Hypertension: not reported
Medications taken by at least 50% of those in the control group: methotrexate, DMARDs, and TNF blockers
Medications taken by 20%‐49% of those in the control group: corticosteroids and TNF blockers
Medications taken by some, but less than 20% of the control group: not reported
Location: USA
Ethnicity: black/African‐American: intervention (fish oil): 7.8% control (borage oil): 7.8%
Interventions Type: supplement (fish oil vs borage oil)
Comparison: EPA + DHA vs Omega 6
Intervention: 7 fish oil (2.1 gm EPA:1.4 gm DHA) capsules and 6 sunflower seed oil capsules daily = 13 capsules divided doses. Dose: 3.5 g/d EPA + DHA
Control: 6 borage seed oil (1.8 g GLA) capsules plus 7 sunflower seed oil capsules daily
Compliance: assessed by capsule counts and patient report. Patient report, indicates that 45% of patients reported ever missing a dose (borage: 42%, fish 48%). Median total capsules missed (excluding those with 0) were 182 (borage: 164, fish 169)
Duration of intervention: 18 months
Outcomes Main study outcome: RA modified disease activity score
Dropouts: 25 intervention, 28 control
Available outcomes: mortality (nil death), CVD events (nil), DAS score, CDAI score. Authors suggested that LDL and total cholesterol were reduced in the intervention group at 18 months, and HDL was increased in both intervention and control at 18 months, while diastolic BP was reduced in the intervention group at 18 months, but no numbers provided. CRP and ESR data were provided combined for the intervention and control arms in the author response, so not useable
Response to contact: yes, authors supplied details of methodology but no usable outcome data
Notes A third arm (45 participants) were given a combination of both oils but not discussed here.
Study funding: National Institutes of Health Grant RO1‐AT000309 from the National Center for Complementary and Alternative Medicine
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Author stated "stratified random block, stratified by site using random blocks of 3 & 6"
Allocation concealment (selection bias) Low risk No methodology provided in the paper, but the author suggested concealment
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind, all capsules were identical in appearance and colour, they were shipped in opaque plastic bottles to the University of Massachusetts University Hospital pharmacy, from where they were distributed to participating centres. However no information provided as to their smell and taste.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Author confirmed outcome assessors were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Authors mention intention‐to‐treat analysis but shows completers analysis. Numbers of participants are not provided for all outcomes measured. Provide results for the overall group (69 participants table 3a) while the flow diagram states there are 74 completers. 51% dropped out.
Selective reporting (reporting bias) Low risk Study prospectively registered in 2003, estimated study completion November 2008, published in 2014. Both outcomes reported in registry are reported in the publication.
Attention Low risk All patients were evaluated at 3‐month intervals, by the same examiner.
Compliance Unclear risk Assessed by capsule counts and patient report. Patient report, indicates that 45% of patients reported ever missing a dose (borage: 42%, fish 48%). Median total capsules missed (excluding those with 0) were 182 (borage: 164, fish 169)
Other bias Low risk None noted
HHS Vulnerability Disclosure