Cubeddu 2006.

Methods	8‐Week wash‐out period 12‐Week double‐blind randomised placebo‐controlled double‐dummy parallel study Randomly assigned by a double‐dummy design to 4 groups
Participants	99 men and women from the USA aged > 20 years; LDL‐C 140 to 190 mg/dL (3.62‐4.91 mg/dL) 25 participants received policosanol, 25 received atorvastatin, 25 received policosanol plus atorvastatin, 24 received placebo Exclusion criteria: individuals with CVD, hepatic dysfunction, renal dysfunction, uncontrolled diabetes mellitus, alcohol or drug abuse, oral hypoglycaemic therapy within 4 weeks of study, cancer, hyperthyroidism, women who might become pregnant, HRT Placebo baseline TC: 6.23 mmol/L (241 mg/dL) Placebo baseline LDL‐C: 4.08 mmol/L (158 mg/dL) Placebo baseline HDL‐C: 1.31 mmol/L (51 mg/dL) Placebo baseline TG: 1.80 mmol/L (159 mg/dL) Atorvastatin baseline TC: 6.54 mmol/L (253 mg/dL) Atorvastatin baseline LDL‐C: 4.34 mmol/L (168 mg/dL) Atorvastatin baseline HDL‐C: 1.38 mmol/L (53 mg/dL) Atorvastatin baseline TG: 1.82 mmol/L (161 mg/dL)
Interventions	Placebo Atorvastatin 10 mg/d Policosanol 20 mg/d Policosanol 20 mg/d + atorvastatin 10 mg/d
Outcomes	Per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C and TG
Notes	Placebo and atorvastatin monotherapy group was analysed SDs were imputed WDAEs were reported
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	"A noninvestigator pharmacist provided to the study coordinator the medications according to the randomization code"
Blinding (performance bias and detection bias) All outcomes	Low risk	"Atorvastatin and dummy atorvastatin were provided in identical bottles" "A randomized, parallel, double‐blind"
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	High risk	PHARMED Group funded the study; PHARMED Group markets policosanol; data may support bias against atorvastatin