| Methods |
Randomised controlled cross‐over trial. |
| Participants |
30 adults with heterozygous FH and 32 with type IIa primary hypercholesterolaemia (26 females), (mean age 51.6 years). |
| Interventions |
A plant sterol‐enriched fat spread (8 weeks) versus a control fat spread not enriched with plant sterols (8 weeks). No washout period. |
| Outcomes |
Serum total, HDL, LDL cholesterol, apolipoprotein A‐1 and B, liver function tests and plant sterol and cholesterol precursor sterol levels. |
| Notes |
Due to evidence of significant carry‐over effect , analysis was restricted to first treatment period only. The authors provided data for only 15 patients with FH. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers were used to assign the participants to either test or the control group with equal probability. |
| Allocation concealment (selection bias) |
Low risk |
Tamper proof block randomisation was used and clinic and lab staff remained unaware of the assigned treatment throughout the trial. |
| 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. No dropouts. |
| Selective reporting (reporting bias) |
Low risk |
All the outcomes stated in methods were reported |
