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. 2015 Mar 11;2015(3):CD008226. doi: 10.1002/14651858.CD008226.pub3

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
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)
Interventions Placebo + placebo
Arginine + placebo
Arginine + atorvastatin 40 mg/d
Placebo + atorvastatin 40 mg/d
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:
  • Placebo + placebo

  • Arginine + placebo

  • Arginine + atorvastatin 40 mg/d


Data were provided for the group titled placebo + atorvastatin 40 mg/d
This last group was analysed
SDs were imputed
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