Mullen 2000.
Methods | Participants were not taking cholesterol‐lowering medication; therefore no wash‐out period was required 6‐Week randomised double‐blind placebo‐controlled 2 × 2 factorial trial |
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Participants | 84 men and women aged 18 to 45 years with type 1 diabetes mellitus; LDL‐C < 4.5 mmol/L Exclusion criteria: none reported Baseline TC: 4.92 mmol/L (190 mg/dL) Baseline LDL‐C: 3.08 mmol/L (119 mg/dL) Baseline HDL‐C: 1.47 mmol/L (57 mg/dL) Baseline TG: 0.83 mmol/L (74 mg/dL) |
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Interventions | Placebo + placebo Arginine + placebo Arginine + atorvastatin 40 mg/d Placebo + atorvastatin 40 mg/d |
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Outcomes | Per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | No lipid data provided for the 3 groups titled:
Data were provided for the group titled placebo + atorvastatin 40 mg/d This last group was analysed SDs were imputed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Atorvastatin 40 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of random sequence generation is not applicable |
Allocation concealment (selection bias) | Unclear risk | Atorvastatin 40 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of allocation concealment is not applicable |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Atorvastatin 40 mg/d; intervention was analysed, and as no placebo group was included for comparison, blinding status is not applicable |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on all participants were reported |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | Low risk | The study appears to be free of other sources of bias |