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Study Title and Description

Mediterranean alpha-linolenic acid-rich diet in secondary prevention of 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 Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease.
Author zz_REJECT_de Lorgeril M., Renaud S., Mamelle N., Salen P., Martin JL., Monjaud I., Guidollet J., Touboul P., Delaye J.
Country INSERM (Institut National de la Santé et de la Recherche Médicale), Units 63, Bron, France.
Year 1994
Numbers Pubmed ID: 7911176
16804 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 ALA n=302
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2 No intervention n=303
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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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What is the name of this study? (e.g. DART, Physician's Health Study) Lyon Diet Heart Study
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... France
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Funding source No Data on funding or affiliations
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Eligibility Criteria: Patients of both sexes, less than 70 years old, who survived a myocardial infarction within 6 months.
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Comment about Eligibility Criteria: exclusion include heart failure, hypertension, inability to complete exercise test.
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Study Population Secondary Prevention (history of CVD event)
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Comment about study design: no interaction or subgroup analysis
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Duration of Intervention 5 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Other ... Myocardial infarction
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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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Study start date(s) 1988
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Baseline Characteristics
Question ALA No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous skip 53.5
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53.5 skip
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10 10
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119 120
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skip skip
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1 1
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74 74
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skip skip
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1 1
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nd nd
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skip 6.47
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6.50 mmol/L
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mmol/L 0.07
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0.08 4.54
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4.52 mmol/L
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mmol/L 0.06
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0.07 1.17
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1.16 mmol/L
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mmol/L 0.01
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0.02 2.00
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2.15 mmol/L
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mmol/L 0.07
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0.09 25.8
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25.8 skip
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skip 0.2
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0.2 73.7
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74.2 Kg
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Kg 0.6
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0.7
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Male, percent 89.4 92.1
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Race nd nd 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? No
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Results & Comparisons


Results Data
Outcome: Death      Population: 51909
Time Point Measure ALA No intervention


0 months

N Enrolled
Counts


27 months

N Enrolled 302 303
Counts 8 20
Rate (per 100 pt-yrs) 1.32 3.37
Outcome: Death      Population: 51910
Time Point Measure ALA No intervention


0 months

N Enrolled
Counts


27 months

N Enrolled 302 303
Counts 3 16
Rate (per 100 pt-yrs) 0.50 2.69
Outcome: bp      Population: 51904
Time Point Measure ALA No intervention


0 weeks

N Analyzed 289 295
Mean 74 74
SE 1 1


8 weeks

N Analyzed 278 280
Mean 75 76
SE 1 1


52 weeks

N Analyzed 239 241
Mean 77 78
SE 1 1


104 weeks

N Analyzed 171 168
Mean 78 79
SE 1 1
Outcome: bp      Population: 51905
Time Point Measure ALA No intervention


0 weeks

N Analyzed 289 295
Mean 119 120
SE 1 1


8 weeks

N Analyzed 278 280
Mean 120 122
SE 1 1


52 weeks

N Analyzed 239 241
Mean 124 125
SE 1 1


104 weeks

N Analyzed 171 168
Mean 126 129
SE 1 1
Outcome: lipid      Population: 51906
Time Point Measure ALA No intervention


0 weeks

N Analyzed 289 295
Mean 4.52 4.54
SE 0.07 0.06


8 weeks

N Analyzed 278 280
Mean 4.32 4.31
SE 0.07 0.11


52 weeks

N Analyzed 239 241
Mean 4.20 4.16
SE 0.06 0.07


104 weeks

N Analyzed 171 168
Mean 4.18 4.11
SE 0.08 0.09
Outcome: lipid      Population: 51907
Time Point Measure ALA No intervention


0 weeks

N Analyzed 289 295
Mean 1.16 1.17
SE 0.02 0.01


8 weeks

N Analyzed 278 280
Mean 1.18 1.22
SE 0.02 0.02


52 weeks

N Analyzed 239 241
Mean 1.23 1.28
SE 0.02 0.02


104 weeks

N Analyzed 171 168
Mean 1.28 1.32
SE 0.03 0.03
Outcome: lipid      Population: 51908
Time Point Measure ALA No intervention


0 weeks

N Analyzed 289 295
Mean 2.15 2.00
SE 0.09 0.07


8 weeks

N Analyzed 278 280
Mean 2.14 1.96
SE 1.00 0.07


52 weeks

N Analyzed 239 241
Mean 1.99 1.85
SE 0.09 0.09


104 weeks

N Analyzed 171 168
Mean 1.85 1.92
SE 0.12 0.13

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?
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Was ALLOCATION adequately concealed (prior to assignment)? low prospective randomised single-blinded trial
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Were PARTICIPANTS adequately BLINDED? high diet trial
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Were OUTCOME ASSESSORS adequately BLINDED? high bp is one outcome.
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data low claim missing at random
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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? low withdrawal rate low-nothing directly said about compliance
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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. No
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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 high mortality vs bp for example
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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