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Study Title and Description

Controlled trial of fish oil for regression of human coronary atherosclerosis. HARP Research Group.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Controlled trial of fish oil for regression of human coronary atherosclerosis. HARP Research Group.
Author Sacks FM., Stone PH., Gibson CM., Silverman DI., Rosner B., Pasternak RC.
Country Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Year 1995
Numbers Pubmed ID: 7759696
16796 (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)
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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) US
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Eligible patients had narrowing of =>30% lumen diameter of a major coronary artery, as shown by diagnostic coronary angiography at either Brigham and Women's or Beth Israel Hospitals, a total cholesterol concentration <250 mg/dl (6.43 mmol/liter) and triglyceride level <350 mg/dl (4.0 mmol/liter) and were between the ages of 30 and 75 years. Patients with congestive heart failure; liver, renal or serious gastrointestinal disease; insulin dependent diabetes mellitus; current cigarette smoking or alcohol intake >14 drinks/week were excluded.
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 2.4 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... total cholesterol concentration <250 mg/dl (6.43 mmol/liter) and triglyceride level <350 mg/dl (4.0 mmol/liter)
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Cardiac disease ... narrowing of =>30% lumen diameter of a major coronary artery
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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 baseline lipid levels, change in lipid levels, baseline coronary lesion diameter, and adipose tissue n-3 fatty acid levels
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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) 1993 (approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 16 11
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55 57
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52 43
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Baseline characteristics, continuous 62 62
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7 7
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126 133
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29 19
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76 77
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16 7.6
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nd nd
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189 184
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33 28
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122 117
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29 27
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41 40
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9 12
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128 137
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67 73
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nd nd
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80 79
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Kg Kg
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14 15
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mg/dL mg/dL
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mg/dL mg/dL
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mg/dL mg/dL
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mg/dL mg/dL
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Male, percent 93.5 92.9
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Race nd
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Comments about baseline data During the initial hospital stay for coronary catheterization, dietary instruction was provided to every patient according to the guidelines of the National Cholesterol Education Program Step I
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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 No No
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Results & Comparisons


Results Data
Outcome: cardiac      Population: 51645
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 1 2
Outcome: cerebro      Population: 51646
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 1 0
Outcome: cardiac      Population: 51647
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 3 4
Outcome: cv      Population: 51648
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 3 3
Note All angioplasty (no CABG) All angioplasty (no CABG)
Outcome: cardiac      Population: 51649
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 0 1
Outcome: death      Population: 51650
Time Point Measure "Fish oil" (DHA+EPA) Placebo


2.4 years

N Enrolled 31 28
Counts 0 1
Outcome: bp      Population: 51640
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 31 28
Mean 76 77
SD 16 7.6


2.4 years

N Analyzed 31 28
Mean 77 77
SD 7 7
Outcome: bp      Population: 51641
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 31 28
Mean 126 133
SD 29 19


2.4 years

N Analyzed 31 28
Mean 129 137
SD 16 29
Outcome: lipid      Population: 51642
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 31 28
Mean 41 40
SD 9 12


2.4 years

N Analyzed 31 28
Mean 42 42
SD 11 13
Outcome: lipid      Population: 51643
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 31 28
Mean 122 117
SD 29 27


2.4 years

N Analyzed 31 28
Mean 132 122
SD 30 24
Outcome: lipid      Population: 51644
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 31 28
Mean 128 137
SD 67 73


2.4 years

N Analyzed 31 28
Mean 101 143
SD 50 67

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? 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 HIGH dropouts = 25%
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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.
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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.