| Methods |
Radnomised double blind, parallel trial. |
| Participants |
145 participants recruited, 11 excluded, 134 completed trial. 69 participants with FH (57% female, mean age 53 years), 65 unaffected (69% female, mean age 46 years). |
| Interventions |
3 treatment groups: STE: 1.6g + 1 placebo cereal bar daily; LSTA: 1.6g + 1 placebo cereal bar daily; HSTA: 1.6 g+ 1 g stanol ester daily. Each treatment lasted 2 months following a 1 month run‐in on placebo margarine and followed by a 1‐month washout on placebo margarine. |
| Outcomes |
Changes in serum lipids, total and LDL cholesterol, serum apoB and LDL cholesterol: apo B ratios, changes in non‐cholesterol sterols (lathosterol, sitosterol, campesterol), changes in 7 alpha OH‐cholestenone. |
| Notes |
|
| 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 |
All patients were included in the analysis. |
| Selective reporting (reporting bias) |
Low risk |
Reporting bias was not present. |
