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Study Title and Description

Omega-3 fatty acid therapy dose-dependently and significantly decreased triglycerides and improved flow-mediated dilation, however, did not significantly improve insulin sensitivity in patients with hypertriglyceridemia.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Omega-3 fatty acid therapy dose-dependently and significantly decreased triglycerides and improved flow-mediated dilation, however, did not significantly improve insulin sensitivity in patients with hypertriglyceridemia.
Author Oh PC., Koh KK., Sakuma I., Lim S., Lee Y., Lee S., Lee K., Han SH., Shin EK.
Country Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea; Gachon Cardiovascular Research Institute, Incheon, Republic of Korea.
Year 2014
Numbers Pubmed ID: 25147070

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo
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2 "Fish oil" (DHA+EPA) 1g
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3 "Fish oil" (DHA+EPA) 2g
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4 "Fish oil" (DHA+EPA) 4g
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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) ... Specify Other(s) [Separate countries with commas]: ... Korea
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: We recruited patients from a primary care setting in the Vascular Medicine and Atherosclerosis Unit, Cardiology, Gil Medical Center, Gachon University. We excluded patients with moderate or severe hypertension, uncontrolled diabetes (HbA1c N 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease. No patient had taken any cholesterol-lowering agent, hormone replacement therapy, or antioxidant vitamin supplements during the 2 months preceding study enrollment.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 2 months
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... hypertriglyceridemia
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Hypertriglyecridemia + Metabolic Syndrome/DM Type 2
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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 Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 5 7 33 36
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36 36 7 5
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100 100 100 100
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Baseline characteristics, continuous 54 55 54 55
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9 9 9 8
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201 197 195 198
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mg/dL mg/dL mg/dL mg/dL
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29 29 31 30
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111 109 109 110
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mg/dL mg/dL mg/dL mg/dL
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34 32 33 33
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42 41 43 40
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mg/dL mg/dL mg/dL mg/dL
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8 8 7 7
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281 286 267 287
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mg/dL mg/dL mg/dL mg/dL
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63 73 118 73
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Male, percent 54.8 50.0 53.5 52.3
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Race 100 100 100 100 100
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Not explicitly stated. Study conducted in Korea Not explicitly stated. Study conducted in Korea Not explicitly stated. Study conducted in Korea Not explicitly stated. Study conducted in Korea Not explicitly stated. Study conducted in Korea
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Comments about baseline data No data entered.
Baseline diet description nd nd nd nd
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Baseline omega-3 intake nd nd nd nd
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Does this study report baseline omega-3 biomarker data? No No No No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 52273
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 42 44 43 44
Mean 42 41 43 40
SD 8 8 7 7
SE


2 months

N Analyzed 42 44 43 44
Mean 43 43 42 40
SD 7 9 8 8
SE
Outcome: lipid      Population: 52273
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 17 19 17 18
Mean 42 42 43 40
SD 7 9 8 9
SE


2 months

N Analyzed 17 19 17 18
Mean 43 44 42 40
SD 8 10 8 8
SE
Outcome: lipid      Population: 52274
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 42 44 43 44
Mean 111 109 109 110
SD 34 32 33 33
SE


2 months

N Analyzed 42 44 43 44
Mean 109 110 113 109
SD 34 33 32 33
SE
Outcome: lipid      Population: 52274
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 17 19 17 18
Mean 110 105 111 112
SD 42 30 39 33
SE


2 months

N Analyzed 17 19 17 18
Mean 107 108 114 113
SD 42 35 39 31
SE
Outcome: lipid      Population: 52275
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 42 44 43 44
Mean 281 286 267 287
SD 63 73 118 73
SE


2 months

N Analyzed 42 44 43 44
Mean 247 229 203 191
SD 102 99 106 117
SE
Outcome: lipid      Population: 52275
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 months

N Analyzed 17 19 17 18
Mean 268 274 231 276
SD 66 70 119 56
SE


2 months

N Analyzed 17 19 17 18
Mean 243 227 182 175
SD 104 82 135 80
SE

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

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)? Low
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INTENTION-TO-TREAT analysis? (Yes/No) No 3 out of 176 lost to follow up (moved away), no comment re ITT
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Group SIMILARITY AT BASELINE (**GENERAL**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Unsure
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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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.