Ramirez‐Ramirez 2013.
| Methods | RCT, parallel, (fish oil vs sunflower oil), 12 months Summary risk of bias: moderate or high |
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| Participants | People with relapsing remitting multiple sclerosis N: 25 intervention, 25 control. (analysed, intervention: 20 control: 19) Level of risk for CVD: low Men: 83% intervention, 82% control (but these appear unlikely) Mean age (SD) years: 35.1 (7.6) intervention, 34.9 (7.8) control Age range: not reported but 18‐55 years were inclusion criteria Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: 100% treated with interferon beta1b for at least 1 year before the trial began 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: Mexico Ethnicity: not reported |
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| Interventions | Type: supplement Comparison: DHA + EPA vs sunflower oil Intervention: 4 g/d omega Rx capsules (Dr Sears zone diet, with excipient of glycerin, water, tocopherol, sunflower oil, titanium dioxide, includes 0.8 g/d EPA plus 1.6 g/d DHA). Dose: 2.4 g/d EPA + DHA Control: excipient only (Perfect Source Natural Products, glycerin, water, tocopherol, sunflower oil, titanium dioxide) Compliance: consumption diary plus pills returned at each visit, adherence calculated (correct formula?? pills consumed × 100/pills returned), optimal adherence was considered to be > 80%, 1 intervention and 3 control were excluded due to compliance < 80%. Blood DHA and EPA were significantly different at 12 months. Duration of intervention: 12 months |
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| Outcomes | Main study outcome: TNF‐alpha Dropouts: 5 of 25 intervention, 6 of 25 control Available outcomes: TNF‐alpha, IL‐6, IL‐1 beta, nitric oxide catabolites, MS relapse, disability EDSS, liver and renal function tests, haemoglobin, leucocytes, platelets, oxidative outcomes (glucose and lipids data collected but not reported, for BMI and BP paper reports "no difference through study") Response to contact: not yet attempted |
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| Notes | Study funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence (blocks of 4) |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "capsules were identical in appearance, packaging and labelling", "physicians and patients were blind to the intervention", and there was a rosemary flavour to mask. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "an independent physician evaluated the EDSS score and collected samples at each clinic visit" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Loss of 11/50 over 1 year, 22% loss |
| Selective reporting (reporting bias) | High risk | Paper reports analysis of glucose and lipids but these are not reported |
| Attention | Low risk | Appeared similar, reviewed every 3 months |
| Compliance | Low risk | Blood DHA and EPA were significantly different at 12 months |
| Other bias | Low risk | None noted |