Methods |
Randomised, controlled, cross‐over trial. |
Participants |
18 adults (6 males, 12 females) with FH on cholesterol‐lowering drug therapy. Mean (SEM) age of 48 (2) years). |
Interventions |
Low fat plant sterol ester spread or low fat plant stanol ester spread over over and above ongoing drug therapy. |
Outcomes |
Total, VLDL, HDL & LDL cholesterol, triglycerides, Apo‐B and non‐cholesterol sterols. |
Notes |
NB: Only short term outcomes were assessed; No treatment period involved a phase of lipid‐lowering drug given alone. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Stated 'randomised' but method not described. |
Allocation concealment (selection bias) |
Unclear risk |
Unclear. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Described as double‐blind, but not stated who was blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Intention‐to‐treat analysis was considered adequate. |
Selective reporting (reporting bias) |
Low risk |
All the outcomes stated in methods were reported |