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. 2012 May 16;2012(5):CD002137. doi: 10.1002/14651858.CD002137.pub3

Anderson 1990.

Methods RCT
Participants Moderately hypercholesterolaemic, non‐obese Caucasian men and women aged 30‐50 (USA)
 CVD risk: moderate
 Control: randomised 62, analysed 51
 Intervention: randomised 56, analysed 47
 Mean years in trial: control 0.91, intervention 0.92
 % male: control 61, intervention 66
 Age: mean control 40.3 (sd 5.4), intervention 40.7 (sd 5.2) (all 30‐50)
Interventions Reduced fat diet vs usual diet
Control aims: no diet intervention
 Intervention aims: 25%E from fats, 20%E from protein, 55%E from CHO, <200mg chol /day
(Also an intervention arm with similar aims plus increased fibre intake)
Control methods: no intervention
Intervention methods: seminars and individual eating patterns taught, 10 weeks teaching and 40 weeks maintenance
Total fat intake (at 1 year): low fat 30 (sd 7.5), cont 31 (sd 5.7)%E
Saturated fat intake (at 1 year): low fat 9 (sd 2.7), cont 10 (sd 2.9)%E
Style: diet advice
Setting: community
Outcomes Stated trial outcomes: diet composition, lipids
 Data available on total mortality? yes (none)
 Cardiovascular mortality? yes (none)
 Events available for combined cardiovascular events: cardiovascular deaths, fatal and non‐fatal MI, stroke (none)
Secondary outcomes: total and non‐fatal MI, stroke
Tertiary outcomes: total, LDL and HDL cholesterol
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "matched on age, gender & cholesterol level, randomly assigned to intervention group using systematic random procedure"
Allocation concealment (selection bias) Unclear risk Randomisation method not clearly described
Blinding (performance bias and detection bias) 
 All outcomes High risk Participants were aware of their dietary advice, researchers were not
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Deaths, cancer and CV events are drop‐outs, trialists asked for data
Selective reporting (reporting bias) Low risk Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias Low risk  
Free of systematic difference in care? High risk See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat? Low risk (As the high fibre arm has not been used in the data set). See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies