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

Berson 2004.

Methods RCT, parallel, (n‐3 DHA vs n‐6 LA), 48 months
Summary risk of bias: low
Participants People with retinitis pigmentosa aged 18‐55 years
N: 221 randomised overall, analysed 105 intervention, 103 control
Level of risk for CVD: low
Men: 48% intervention, 54% control
Mean age in years (SD): 37.8 (6.5) intervention, 36.0 (7.2) control
Age range: unclear (18‐55 inclusion criterion)
Smokers: not reported
Hypertension: not reported
Medications taken by at least 50% of those in the control group: vitamin A
Medications taken by 20%‐49% of those in the control group: multivitamins
Medications taken by some, but less than 20% of the control group: not reported
Location: USA
Ethnicity: unclear (6% of the study population were minorities)
Interventions Type: supplement (DHA capsules)
Comparison: DHA vs omega 6
Intervention: 6 × 500 mg capsules/d of DHA (1.2 g/d DHA plus 1.8 g vegetable oil) plus < 0.0006 mg/d tocopherols plus 15,000 IU retinyl palmitate (vitamin A). Dose: +1.2 g/d DHA
Control: 6 × 500 mg capsules/d of soy and corn oils (half each) with 120 mg/d ALA, plus < 0.0006 mg/d tocopherols plus 15000 IU retinyl palmitate (vitamin A)
Compliance: 92% of capsules taken by both intervention and control groups (assessed by monthly calendars), Plasma DHA much higher in intervention than control
Length of intervention: 48 months
Outcomes Main study outcome: retinal degeneration
Dropouts: 5 or 6 intervention, 7 or 8 control
Available outcomes: mortality, cancer diagnoses, lipids, eyesight
Response to contact: yes (no data provided)
Notes Study funding: National Eye Institute and Foundation Fighting Blindness
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Random numbers available only to programmer who provided assignments to data manager, all staff in contact with patients were masked to group assignment
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk States that all staff in contact with participants were masked to group assignment, as were participants. However no information was provided regarding the taste, smell and appearance of the active and placebo capsules
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All assessments were performed blind to study allocation. Each ocular examination was performed without review of previous records. All serum samples were analysed without knowledge of treatment group assignment.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Numbers of dropouts and reasons for dropouts not stated. 221 participants randomised, data presented on 208 participants
Selective reporting (reporting bias) Unclear risk No trials registry entry or protocol found.
Attention Low risk Staff in contact with patients were masked, so unable to bias time, etc.
Compliance Low risk 92% of capsules taken by both intervention and control groups (assessed by monthly calendars), Plasma DHA much higher in intervention than control
Other bias Low risk None noted
HHS Vulnerability Disclosure