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Study Title and Description

Effects of highly purified eicosapentaenoic acid and docosahexaenoic acid on hemodynamics in humans.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of highly purified eicosapentaenoic acid and docosahexaenoic acid on hemodynamics in humans.
Author Grimsgaard S., Bønaa KH., Hansen JB., Myhre ES.
Country Institute of Community Medicine, University of Tromsø, Norway. Sameline.Grimsgaard@ism.uit.no
Year 1998
Numbers Pubmed ID: 9665096
16792 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 DHA
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2 EPA
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3 Placebo corn oil
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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: they reported being healthy nonsmokers, did not use nonprescribed or prescribed drugs, and consumed less than four fish dishes per week in their usual diet. They also had serum cholesterol concentrations < 8.0 mmollL, diastolic blood pressure < 95 mm Hg, and systolic blood pressure < 160 mm Hg.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 2 months
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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? ... Which predictors/variables? Yes ... SBP, DBP, MAP, heart rate, creatinine, sodium, potassium, plasma active renin
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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
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Baseline Characteristics
Question DHA EPA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 43.2 44.3 45.1
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5.1 5.2 5.6
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121.3 123.2 122.2
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9.3 9.8 5.7
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76.1 78.1 76.9
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6.9 7.3 8.0
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90.6 92.9 91.8
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skip skip skip
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7.3 8.0 9.1
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6.00 5.98 6.02
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mmol/L mmol/L mmol/L
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0.95 0.94 1.08
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4.06 4.06 4.04
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mmol/L mmol/L mmol/L
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0.86 0.83 0.98
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1.36 1.33 1.41
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mmol/L mmol/L mmol/L
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0.30 0.31 0.28
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1.24 1.23 1.22
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mmol/L mmol/L mmol/L
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0.58 0.57 0.55
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24.9 25.6 24.6
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skip skip skip
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2.6 2.9 2.7
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nd nd nd
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Male, percent nd nd nd
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description 0.18 +/- 0.20 g (EPA), 0.34 +/- 0.32 g (DHA) 0.19 +/- 0.18 g (EPA), 0.35 +/- 0.28 g (DHA) 0.19 +/- 0.21 g (EPA), 0.36 +/- 0.32 g (DHA)
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Baseline omega-3 intake nd 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: bp      Population: 55923
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
Mean 121.3 123.2 122.2
SD 9.3 9.8 10.8


2 months

N Analyzed 72 75 77
SD 5.4 5.7 4.8
Change in Mean 0.5 -0.5 0.7
Outcome: bp      Population: 55924
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
Mean 76.1 78.1 76.9
SD 6.9 7.3 8.0


2 months

N Analyzed 72 75 77
SD 4.6 4.2 3.9
Change in Mean 0.7 0.5 1.1
Outcome: bp      Population: 55925
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
SD 7.3 8.0 9.1
Mean 90.6 92.9 91.8


2 months

N Analyzed 72 75 77
SD 5.9 4.8 4.3
Change in Mean 1.2 0.4 0.8
Outcome: lipid      Population: 55926
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
SD 0.30 0.31 0.28
Mean 1.36 1.33 1.41


2 months

N Analyzed 72 75 77
SD 0.13 0.12 0.11
Change in Mean 0.06 0.01 -0.01
Outcome: lipid      Population: 55927
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
SD 0.86 0.83 0.98
Mean 4.06 4.06 4.04


2 months

N Analyzed 72 75 77
SD 0.46 0.48 0.48
Change in Mean 0.07 -0.08 0.06
Outcome: lipid      Population: 55928
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
SD 0.58 0.57 0.55
Mean 1.24 1.23 1.22


2 months

N Analyzed 72 75 77
SD 0.31 0.40 0.34
Change in Mean -0.22 -0.15 0.11
Outcome: lipid      Population: 55929
Time Point Measure DHA EPA Placebo


0 months

N Analyzed 72 75 77
SD 1.19 1.24 1.19
Mean 4.62 4.70 4.43


2 months

N Analyzed 72 75 77
SD 0.52 0.47 0.62
Change in Mean -0.19 -0.13 0.11

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

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW computer-generated random numbers were used for assignment
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Was ALLOCATION adequately concealed (prior to assignment)? LOW double blinded
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Were PARTICIPANTS adequately BLINDED? LOW double blinded
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Were OUTCOME ASSESSORS adequately BLINDED? LOW double blinded
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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**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) No Data
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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 LOW double blinded
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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
No quality rating data was found.