Reed 2014.
Methods | RCT, parallel, 3 arms (fish oil or borage oil), 18 months Summary risk of bias: low |
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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% |
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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 |
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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 |
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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 |
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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 |