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Study Title and Description

The effect of dietary omega-3 fatty acids on coronary atherosclerosis. A randomized, double-blind, placebo-controlled 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 dietary omega-3 fatty acids on coronary atherosclerosis. A randomized, double-blind, placebo-controlled trial.
Author von Schacky C., Angerer P., Kothny W., Theisen K., Mudra H.
Country University of Munich, Germany. vonschacky@medinn.med.uni-muenchen.de
Year 1999
Numbers Pubmed ID: 10189324
16767 (internal)

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) 112 patients
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2 No intervention 111 patients
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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) Canada
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: 1) stenosis > 20% in at least one vessel 2) revascularization, PTCA or coronary bypass performed in previous 6 months in no more than one vessel
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Study Population Secondary Prevention (history of CVD event)
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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) 1992
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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 57.8 58.9
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skip skip
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9.7 8.1
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132.0 129.6
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18.9 skip
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80.7 17.8
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skip 79.8
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10.5 skip
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nd 9.6
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6.30 nd
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mmol/L 6.10
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1.12 mmol/L
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4.10 1.13
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mmol/L 4.00
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1.06 mmol/L
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1.32 0.91
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mmol/L 1.30
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0.34 mmol/L
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2.20 0.36
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mmol/L 2.16
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1.33 mmol/L
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nd 1.10
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78.7 nd
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Kg 78.3
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12.6 Kg
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11.1
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Male, percent 82.0 78.6
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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? No No No
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Results & Comparisons


Results Data
Outcome: bp      Population: 51427
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed
Mean
SD


1 months

N Analyzed 101 104
Mean 138.4 138.2
SD 18.3 16.8


6 months

N Analyzed 101 101
Mean 139.7 137.0
SD 16.2 18.0


12 months

N Analyzed 95 88
Mean 140.8 138.5
SD 15.9 17.1
Outcome: bp      Population: 51428
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed
Mean
SD


1 months

N Analyzed 101 104
Mean 82.9 82.6
SD 9.3 10.6


6 months

N Analyzed 101 101
Mean 84.7 82.9
SD 10.7 11.6


12 months

N Analyzed 95 88
Mean 84.7 83.6
SD 10.4 11.7
Outcome: lipid      Population: 51429
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed
Mean
SD


1 months

N Analyzed 101 104
Mean 4.05 3.95
SD 0.98 1.08


6 months

N Analyzed 101 101
Mean 4.30 3.85
SD 1.21 1.09


12 months

N Analyzed 95 88
Mean 4.20 3.95
SD 1.09 1.13
Outcome: lipid      Population: 51432
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed
Mean
SD


1 months

N Analyzed 101 104
Mean 1.35 1.30
SD 0.37 0.44


6 months

N Analyzed 101 101
Mean 1.30 1.35
SD 0.42 0.35


12 months

N Analyzed 95 88
Mean 1.40 1.30
SD 0.36 0.43
Outcome: lipid      Population: 51433
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed
Mean
SD


1 months

N Analyzed 101 104
Mean 1.74 2.44
SD 1.06 1.25


6 months

N Analyzed 101 101
Mean 1.98 2.52
SD 1.38 1.93


12 months

N Analyzed 95 88
Mean 1.94 2.46
SD 1.33 1.34

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse Event 1 gastrointestinal discomfort 4 112 1 yr
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No intervention 3 111 1 yr
"Fish oil" (DHA+EPA) Adverse Event 1 dermatosis 1 112 1 yr
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No intervention 0 111 1 yr

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 double-blinded
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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? low
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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 bp
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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