Muscari 2001.
Methods | Participants did not receive lipid‐lowering drugs for 3 months before randomisation 3‐Month randomised double‐blind placebo‐controlled trial |
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Participants | 60 men aged 55 to 64 years with C3 > 1.19 g/L, TC ≥ 5.56 mmol/L Exclusion criteria: none reported Placebo: Baseline TC: 6.68 mmol/L (258 mg/dL) Baseline HDL‐C: 1.35 mmol/L (52 mg/dL) Atorvastatin: Baseline TC: 6.47 mmol/L (250 mg/dL) Baseline HDL‐C: 1.36 mmol/L (53 mg/dL) |
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Interventions | Placebo for vitamin E low cholesterol Vitamin E low cholesterol Placebo for atorvastatin high cholesterol Atorvastatin 10 mg/d high cholesterol Atorvastatin 10 mg/d + vitamin E high cholesterol |
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Outcomes | % change from baseline of TC and HDL‐C | |
Notes | Placebo for atorvastatin high cholesterol and atorvastatin 10 mg/d high cholesterol were analysed SDs were imputed WDAEs were not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information about sequence generation was provided to permit judgement of 'yes' or 'no' |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment was provided to permit judgement of 'yes' or 'no' |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double‐blindly" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3/30 participants who received atorvastatin only were not analysed (10%); some bias is possible |
Selective reporting (reporting bias) | High risk | LDL‐C and TG data were not reported; WDAEs were not reported |
Other bias | Low risk | The study appears to be free of other sources of bias |