Weinstock‐Guttman 2005.
| Methods | RCT, parallel, (low fat diet (15% fat) with n‐3 fish oils vs AHA Step I diet (fat ≤ 30%) with olive oil supplements), 12 months Summary risk of bias: moderate or high |
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| Participants | Population: adults with multiple sclerosis N: 15 intervention, 16 control (analysed, intervention: 13, control: 14) Level of risk for CVD: low Men: 15.4% intervention, 14.3% control Mean age in years (SD): 39.9 (10.0) intervention, 45.1 (7.7) control Age range: not reported Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: all patients received 400 units of vitamin E, one multivitamin tablet (not containing any PUFA) and at least 500 mg calcium per day 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: not reported Location: USA Ethnicity: not reported |
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| Interventions | Type: dietary advice plus supplement Comparison: EPA + DHA vs MUFA (low fat diet (15% fat) with n‐3 fish oils vs AHA Step I diet (fat ≤ 30%) with olive oil supplements) Intervention: 1.98 g/d EPA, 1.32 g/d DHA supplements (EPAX 5500 EE, Tishcon Corp) + low fat diet (< 15% total calories). Dose: 3.3 g/d EPA + DHA Control: one 1 g olive oil placebo capsules 6 times daily, moderate fat diet (< 30% total calories) (American Heart Association Step 1 diet) Compliance: assessed by individual food records; intervention 69.2% control 66.7% compliance; also at 12 months there was a significant difference between the fatty acid status of the intervention and control groups in terms of EPA (P = 0.027), as described in table 3 of the main paper Duration of intervention: 12 months |
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| Outcomes | Main study outcome: physical component scale (PCS) Dropouts: 3 intervention, 7 control Available outcomes: Mental Health Inventory, Modified Fatigue Impact Scale, weight change, HDL and LDL cholesterol, adverse events (MS relapse, TNF‐alpha, ICAM‐1, VCAM‐1 and other inflammatory markers, SF‐36 not used) Response to contact: no |
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| Notes | Study funding: National Multiple Sclerosis Society (PP0620T), Mellen Center Foundation and ''The Jog for the Jake'' grant | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | States "randomly assigned", no further details |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Patients knew the percentage of dietary fat but did not know the assignment of capsules oil supplementation." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Discrepancy in numbers of participants discontinued and numbers analysed. Per protocol analysis |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trials register entry found |
| Attention | Low risk | Treated equally |
| Compliance | Low risk | Assessed by individual food records; intervention 69.2% control 66.7% compliance. At 12 months there was a significant difference between the EPA status of the intervention and control groups (P = 0.027). |
| Other bias | Low risk | None noted |