Houtsmuller 1979.
Methods | RCT, parallel, (increase LA vs usual diet), 72 months maximum Summary risk of bias: moderate or high |
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Participants | Adults with newly diagnosed diabetes N: 51 intervention, 51 control (analysed unclear intervention, unclear control) Level of risk for CVD: moderate Male: 56% overall (not stated by intervention arm) Mean age (SD): not reported Age range: not reported 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% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: statins (probably) Location: Netherlands Ethenicity: not reported |
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Interventions | Type: dietary advice Comparison: omega‐6 vs SFA and CHO Intervention: aims total fat 40% E, 1/3 linoleic acid, CHO 45% E, protein 15% E; methods unclear, surveyed by dietitian. Intervention appears to be delivered by dietitian but no clear details on format or frequency Control: aims SFA 35% E, CHO 50% E, protein 15% E; methods unclear, surveyed by dietitian Dose aims: increase ˜9% E LA (aims imply no LA in control, but paper states LA was 4 × higher in intervention than control, est 3% E control, 12% E intervention, so increase of ˜9% E) Baseline n‐6: unclear Compliance by biomarkers: good, serum total cholesterol significantly reduced in intervention compared to control (−0.47mmol/L, 95% CI −0.76 to −0.18), no significant differences in men, but significant improvements in women from 3 years Compliance by dietary intake: unclear (not reported)
Duration of intervention: 72 months |
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Outcomes | Main study outcome: progression of diabetic retinopathy Dropouts: unclear Available outcomes: CHD events (total MI and angina), total cholesterol, TGs (data read off graph), CHD mortality (fatal MI), progression of retinopathy, GTT and insulin (measured but results are reported in figures for a subgroup) |
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Notes | Study funding: Dutch Heart Foundation Response to contact: attempted but no contact established |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants matched in pairs then randomised |
Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear, though unlikely as dietary advice provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear, deaths, cancer and CV events are drop‐outs, trialists asked for data – unclear if any data missing |
Selective reporting (reporting bias) | Unclear risk | No protocol or trials registry entry found |
Attention Bias | Unclear risk | Unclear as methods unclear |
Compliance | Low risk | Compliance good assessed by biomarkers |
Other bias | High risk | Some concerns around fraud in the first authors later research on diet in cancer. No allegations found regarding his research in diabetes (but much information is in Dutch). Numbers of events are not clear by arm and assumed from adding across various publications |