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Study Title and Description

Lack of benefit of dietary advice to men with angina: results of a controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Lack of benefit of dietary advice to men with angina: results of a controlled trial.
Author Burr ML., Ashfield-Watt PA., Dunstan FD., Fehily AM., Breay P., Ashton T., Zotos PC., Haboubi NA., Elwood PC.
Country University of Wales College of Medicine, Cardiff, UK. michael.burr@bro-taf-ha.wales.nhs.uk
Year 2003
Numbers Pubmed ID: 12571649
15296 (internal)

Secondary Publication Information
UI Title Author Country Year
Secondary prevention of CHD in UK men: the Diet and Reinfarction Trial and its sequel. Burr ML. Department of Epidemiology, Statistics and Public Health, Cardiff University, Cardiff CF14 4YS, UK. burrml@cf.ac.uk 2007
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Fish + Fish oil with or without fruit advice
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2 No intervention with or without fruit advice
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3 "Fish oil" (DHA+EPA) subrandomization of fish+fish oil arm in second half of study.
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4 Fish subrandomization of fish+fish oil arm in second half of study.
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) DART-2
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Country in which study conducted (where subjects live) UK
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: men <70 y/o who were being treated for angina. The following subjects were excluded from the trial: men who denied ever having exertional chest pain or discomfort (except for men who never hurried whose pain was brought on by stress); men awaiting coronary artery by-pass surgery; men who already ate oily fish twice a week; men who could not tolerate oily fish or fish oil; men who appeared to be unsuitable on other grounds (eg other serious illness, likelihood of moving out of the area)
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 9 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... Angina
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... dietary fish vs. fish oil; fruit advice vs no fruit advice
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Study start date(s) 1990
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Baseline Characteristics
Question Fish + Fish oil No intervention "Fish oil" (DHA+EPA) Fish Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 12.5 12.3 nd nd
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48.6 47.4
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49.7 50.2
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Baseline characteristics, continuous 61 61 nd nd
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141.9 141.6
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84.8 84.6
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6.4 6.4
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28.2 28.1
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Male, percent 100
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Race nd
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Comments about baseline data No data entered.
Baseline diet description nd
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: Death      Population: 45365
Time Point Measure Fish + Fish oil No intervention "Fish oil" (DHA+EPA) Fish


9 years

N Enrolled 1571 1543 462 1109
Counts 283 242 85 198
Percentage 18.0 15.7
Outcome: Death      Population: 45366
Time Point Measure Fish + Fish oil No intervention "Fish oil" (DHA+EPA) Fish


9 years

N Enrolled 1571 1543 462 1109
Counts 180 139 59 121
Percentage 11.5 9.0
Outcome: arrhythmia      Population: 45369
Time Point Measure Fish + Fish oil No intervention "Fish oil" (DHA+EPA) Fish


9 years

N Enrolled 1571 1543 462 1109
Counts 73 47 24 49
Percentage 4.6 3.0

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? UNCLEAR
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Was ALLOCATION adequately concealed (prior to assignment)? LOW
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Were PARTICIPANTS adequately BLINDED? HIGH unblinded
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Were OUTCOME ASSESSORS adequately BLINDED? LOW
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? UNCLEAR no specific data on compliance; just that it was good based on FFQ from a subset of participants
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Group SIMILARITY AT BASELINE (**OMEGA-3**) LOW
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes LOW
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes LOW
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Quality Rating
Guideline Used Overall Rating