Weidner 2008 Parallel To assess the 50 subjects with Subjects consumed Compliance by Dietary intake Significant reduction Power lipid-lowering untreated moderate 200mL soy drink counting empty analysis not in total and LDL calculation for effects of plant each morning, with packets. Dietary reported. cholesterol. No LDL-C sterols in a soy were randomised, or without added intake by food Groups change in HDL performed. 49 completed trial plant sterols (2.6g survey at baseline generally well cholesterol or No difference (38% male, 19-65y). sterol esters, and of intervention matched at triglyceride levels. in adverse equivalent to 1.6g Blood lipid analysis baseline. effects free methods not between 2wk run-in then 8wk reported, LDL-C groups. intervention. Dietary calculated. Intention Funding recommendations to treat analysis source during run-in and used. unclear. trial to avoid plant sterol enriched foods. Abbreviations used: AHA; American Heart Association, ANCOVA; analysis of covariance, ANOVA; analysis of variance, HDL; high density lipoprotein, LDL-C; low-density lipoprotein cholesterol, RMANOVA; repeated measures ANOVA Appendix 3 Risk of bias assessment – Blinding of Blinding of Incomplete Random sequence Allocation participants and Selective outcome outcome data Reference generation concealment personnel reporting Other assessors (attrition bias) (selection bias) (selection bias) (performance (reporting bias) (detection bias) >20% = high bias) Matched on age, total Numbered Investigators Expected cholesterol, codes, Double- blinded until 10% Allen 2008 ? low low low low low outcomes low BMI, but investigators blind after attrition reported method not blinded analysis described Unclear Expected Not Not No Banuls 2010 ? ? high ? low low low method of Not blinded outcomes described described attrition randomisation reported
Weidner 2008 Parallel To assess the lipid-lowering effects of plant sterols in a soy 50 subjects with untreated moderate were randomised, 49 completed trial (38% male, 19-65y). Subjects consumed 200mL soy drink each morning, with or without added plant sterols (2.6g sterol esters, equivalent to 1.6g free 2wk run-in then 8wk intervention. Dietary recommendations during run-in and trial to avoid plant sterol enriched foods. Compliance by counting empty packets. Dietary intake by food survey at baseline and of intervention Blood lipid analysis methods not reported, LDL-C calculated. Intention to treat analysis used. Dietary intake analysis not reported. Groups generally well matched at baseline. Significant reduction in total and LDL cholesterol. No change in HDL cholesterol or triglyceride levels. Power calculation for LDL-C performed. No difference in adverse effects between groups. Funding source unclear. Abbreviations used: AHA; American Heart Association, ANCOVA; analysis of covariance, ANOVA; analysis of variance, HDL; high density lipoprotein, LDL-C; low-density lipoprotein cholesterol, RMANOVA; repeated measures ANOVA Appendix 3 – Risk of bias assessment Reference Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Blinding of outcome assessors (detection bias) Incomplete outcome data (attrition bias) >20% = high Selective reporting (reporting bias) Other Allen 2008 ? Matched on age, total cholesterol, BMI, but method not described low Numbered codes, investigators blinded low Double- blind low Investigators blinded until after analysis low 10% attrition low Expected outcomes reported low Banuls 2010 ? Unclear method of randomisation ? Not described high Not blinded ? Not described low No attrition low Expected outcomes reported low
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