Bates 1989.
| Methods | RCT, parallel, (n‐3 EPA + DHA vs MUFA), 24 months Summary risk of bias: moderate or high |
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| Participants | People with multiple sclerosis N: 155 intervention, 157 control. (analysed, intervention: 145 control: 147) Level of risk for CVD: low Men: 34.2% intervention, 30.6% control Mean age in years (SD): 34.0 (6.6) intervention, 33.7 (6.3) control Age range: not reported but 16‐45 years inclusion criteria Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49%: not reported Medications taken by some, but < 20%: not reported Location: UK Ethnicity: not reported |
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| Interventions | Type: supplement (fish oil capsule) Comparison: EPA + DHA vs MUFA Intervention: 20 × 0.5 g/d capsules MaxEPA fish body oil (10 g/d fish oil providing 1.71 g/d EPA +1.14 g/d DHA +10 IU/d vitamin E), plus all advised to reduce animal fat and ensure plentiful omega‐6 fats. Dose: +2.85 g/d EPA + DHA Control: 20 × 0.5 g/d capsules olive oil (10 g/d olive oil), plus all advised to reduce animal fat and ensure plentiful omega‐6 fats. All capsules contained 0.5 IU vit E and 100 ppm dodecyl gallate to minimise peroxide formation Compliance: serum EPA and DHA rose in intervention group but fell in controls Duration of intervention: 24 months (5 years mentioned but outcomes not reported) |
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| Outcomes | Main study outcome: multiple sclerosis progress Dropouts: 10 intervention, 10 control Available outcomes: all‐cause mortality, progress of MS, rate of MS relapse Response to contact: yes (no data provided) |
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| Notes | Study funding: Multiple Sclerosis Society of Great Britain and Northern Ireland, but Marfleet Refining provided fish oil and placebo capsules | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | No further details |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Paper states research was "double blind" and control capsules "had the same appearance and flavour as the fish oil capsules and were packed and dispensed in identical fashion" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low risk at reported time points |
| Selective reporting (reporting bias) | High risk | No protocol or trials registration entries found. Study was intended to run for 5 years, but outcomes only appear to be reported for the first 2 years. |
| Attention | Low risk | Unlikely as each had capsules |
| Compliance | Low risk | Serum EPA and DHA rose in intervention group but fell in controls |
| Other bias | Low risk | Not noted |