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Study Title and Description

Absence of prophylactic effect of linolenic acid in patients with coronary heart-disease.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Absence of prophylactic effect of linolenic acid in patients with coronary heart-disease.
Author zz_REJECT_Borchgrevink CF., Skaga E., Berg KJ., Skjaeggestad O.
Country -- Not Found --
Year 1966
Numbers Pubmed ID: 4161161

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 ALA
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2 Placebo
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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: Male patients under 70, discharged from Ulleval Hospital, with a diagnosis of recent or impending myocardial infarction
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Study Population Secondary Prevention (history of CVD event)
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Comment about study design: Patients continued treatment through followup
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Duration of Intervention Unsure
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... a diagnosis of recent or impending 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? No
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Baseline Characteristics
Question ALA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 3 2
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nd nd
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nd nd
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7 10
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nd nd
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22 27
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previous infarction previous infarction
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nd nd
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nd nd
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3 4
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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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Baseline characteristics, continuous 57.3 57.4
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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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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 nd nd
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Race nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: Death      Population: 55979
Time Point Measure ALA Placebo


Mean Obs. Period (0.83 for treatment and 0.78 for control) years

N Enrolled 100 100
Counts 10 12
Outcome: arrhythmia      Population: 55980
Time Point Measure ALA Placebo


Mean Obs. Period (0.83 for treatment and 0.78 for control) years

N Enrolled
Counts
Outcome: cardiac      Population: 55983
Time Point Measure ALA Placebo


Mean Obs. Period (0.83 for treatment and 0.78 for control) years

N Enrolled 100 100
Counts 6 8
Outcome: cardiac      Population: 55984
Time Point Measure ALA Placebo


Mean Obs. Period (0.83 for treatment and 0.78 for control) years

N Enrolled 100 100
Counts 1 0

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

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low
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Was ALLOCATION adequately concealed (prior to assignment)? Low
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Were PARTICIPANTS adequately BLINDED? Low
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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) No
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Group SIMILARITY AT BASELINE (**GENERAL**) Unsure
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Was there incomplete COMPLIANCE with interventions across groups? Unsure
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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. Yes Omega 3 intake dose unclear
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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.