STARS 1992.

Study characteristics
Methods	RCT St Thomas' Atherosclerosis Regression Study (STARS) Summary risk of bias: moderate to high for CVD outcomes, low for all‐cause mortality
Participants	Men with angina referred for angiography (UK) CVD risk: high Control: unclear how many randomised (30?), analysed 24 Intervention: unclear how many randomised (30?), analysed 26 Mean years in trial: control 2.9, intervention 3.0 % male: 100% Age: mean control 53.9, intervention 48.9 (all < 66) Ethnicity: not stated Statins use allowed? No (1 arm of the trial, not described here, prescribed cholestyramine) % taking statins: 0%
Interventions	Reduced and modified fat diet vs usual diet Control aims: no diet intervention but advised to lose weight if BMI > 25 Intervention aims: total fat 27%E, SFA 8 ‐ 10%E, omega‐3 and omega‐6 PUFA 8%E, increase in plant‐derived soluble fibre, dietary cholesterol 100 mg/1000 kcal, advised to lose weight if BMI > 25 Control methods: usual care but no formal dietetic counselling. They were counselled against smoking if appropriate and advised about daily exercise level. Intervention methods: Usual care plus dietetic individual assessment of diet and advice. Further dietetic counselling and food stuffs were given to participants who did not achieve or maintain certain levels of serum cholesterol reduction Initial intervention was delivered individually face‐to‐face by a dietitian and follow‐up by a clinician. Total fat intake, %E (through study): int 27 (SD 7), cont 37 (SD 5) (mean difference ‐10.00, 95% CI ‐13.35 to ‐6.65) significant reduction Saturated fat intake, %E (through study): int 9 (SD 3), cont 16 (SD 4) (mean difference ‐7.00, 95% CI ‐8.97 to ‐5.03) significant reduction PUFA intake, %E (through study)§: int 7 (SD 2), cont 5 (SD 2) (mean difference 2.00, 95% CI 0.89 to 3.11) significant increase PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported MUFA intake, %E (through study)§: int 10 (SD 4), cont 17 (SD 5) (mean difference ‐7.00, 95% CI ‐9.52 to ‐4.48) significant reduction CHO intake, %E (through study)§: int 49 (SD 7), cont 41 (SD 7) (mean difference 8.00, 95% CI 4.12 to 11.88) significant increase Protein intake, %E (through study)§: int 19 (SD 4), cont 18 (SD 2) (mean difference 1.00, 95% CI ‐0.73 to 2.73) no significant effect Trans fat intake: not reported Replacement for saturated fat: CHO and PUFA (based on aims and achievements) Style: diet advice Setting: community §Blann 1995
Outcomes	Stated trial outcomes: angiography Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: cardiovascular deaths, non‐fatal MI, angina, stroke, CABG, angioplasty, stroke, total MI, CHD events, plus cancer deaths (none) Secondary outcomes: total, HDL, LDL cholesterol, TGs, total/HDL and LDL/HDL ratios, 2‐hour post‐load glucose (weight and BP "remained similar" but were not reported, Lp(a) reported but as geometric means)
Notes	Study duration: 3 years Study aim was to reduce saturated fats (to 8 ‐ 10%E), and saturated fat intake in the intervention group was significantly reduced SFA reduction aimed and achieved Total serum cholesterol, difference between intervention and control, mmol/L: ‐0.76 (95% CI ‐1.19 to ‐0.33), statistically significant reduction Trial dates: Study dates not reported (published in 1992) Funding: Unilever plc, the Chemical Pathology Fund of St Thomas' Hospital, and Bristol‐Meyers Ltd Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"blinded random cards issued centrally by statistician advisor"
Allocation concealment (selection bias)	Low risk	"blinded random cards issued centrally by statistician advisor"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participant blinding: inadequate
Blinding of outcome assessment (detection bias) CVD outcomes	Unclear risk	Physician blinding: unclear
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Blinding is not relevant in assessment of mortality.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear, deaths, cancer and CV events are dropouts ‐ unclear if any data missing
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists were asked for data
Free of systematic difference in care?	High risk	Usual care in both groups, dietetic counselling only in the intervention group. See control and intervention methods in the Interventions section of the table of Characteristics of included studies
Stated aim to reduce SFA	Low risk	Aim to reduce SFA stated
Achieved SFA reduction	Low risk	SFA reduction achieved
Achieved TC reduction	Low risk	Statistically significant TC fall
Other bias	Low risk	None noted