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Study Title and Description

The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction. A controlled clinical trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction. A controlled clinical trial.
Author zz_REJECT_Leren P.
Country -- Not Found --
Year 1966
Numbers Pubmed ID: 5228820

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) fish consumption as part of a diet plan
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2 No intervention
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) Norway
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Funding source No Data on funding or affiliations
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Eligibility Criteria: Previous MI within 1-2 years; age 30-64, male
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 5 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... Previous MI
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... age, cholesterol, weight, bp, smoking, presence of CVD
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Study start date(s) 1956
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 30, 64 30, 64
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nd nd
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nd nd
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nd nd
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296 296
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mg/dL mg/dL
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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Male, percent 100 100
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Race nd nd
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Comments about baseline data blood pressure was slightly higher in the diet group
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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? No
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Results & Comparisons


Results Data
Outcome: cardiac      Population: 52296
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 206 206
Counts 34 54
Outcome: cardiac      Population: 52297
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 206 206
Counts 8 20
Outcome: arrhythmia      Population: 52298
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 206 206
Counts 22 16
Outcome: Death      Population: 52299
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 206 206
Counts 10 23
Outcome: composite      Population: 52300
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 206 206
Counts 64 90

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)? UNCLEAR
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Were PARTICIPANTS adequately BLINDED? LOW no blinding but outcomes unlikely to be affected
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Were OUTCOME ASSESSORS adequately BLINDED? LOW no blinding but outcomes unlikely to be affected
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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)? Yes Subgroups reporting is incomplete and inconsistent.
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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? No 84% good or excellent compliance
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Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR
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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
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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
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Quality Rating
No quality rating data was found.