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Study Title and Description

N-3 polyunsaturated fatty acids in the treatment of atherogenic dyslipidemia.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title N-3 polyunsaturated fatty acids in the treatment of atherogenic dyslipidemia.
Author Vecka M., Dušejovská M., Stankova B., Zeman M., Vavrova L., Kodydkova J., Slaby A., Zak A.
Country 4th Department of Internal Medicine, 1st Faculty of Medicine of Charles University, Prague, Czech Republic. marvec@volny.cz
Year 2012
Numbers Pubmed ID: 23183517
15266 (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 ... Describe: Other ... Non-randomized cross-over study
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Czech Republic
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Funding source No Data on funding or affiliations
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Eligibility Criteria: The inclusion criteria were: met the IDF criteria for the metabolic syndrome, and fasting plasma triacylglycerols exceeded 1.7 mmol/l. The exclusion criteria were as follows: insulin dependent diabetes mellitus, age > 75 years, myocardial infarction or stroke in previous six months, chronic heart failure, renal or hepatic failure, obesity grade 2+ (BMI > 35 kg/m2), serious endocrinopathies, pregnancy and breastfeeding.
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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 crossover trial (phase 1: 6 weeks; phase 2: 6 weeks)
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If crossover trial, duration of washout period not reported
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... statin vs. no statin (non-random)
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Study start date(s) 2010 (approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 52.4
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ND
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ND
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ND
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ND
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3.23
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mmol/L
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89.6
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Kg
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3.22
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mmol/L
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1.19
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mmol/L
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Male, percent 65%
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Race nd
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Comments about baseline data No data entered.
Baseline diet description NCEP step II dietary recommendations
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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: lipid      Population: 45660
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed
Mean
SD
SE


6 weeks

N Analyzed 60 60
Mean 2.29 3.22
SD 1.99 3.97
SE
Outcome: lipid      Population: 45661
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed
Mean
SD
SE


6 weeks

N Analyzed 60 60
Mean 1.23 1.18
SD 0.26 0.25
SE
Outcome: lipid      Population: 45662
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed
Mean
SD
SE


6 weeks

N Analyzed 60 60
Mean 3.33 3.06
SD 0.89 0.86
SE

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? High No mention of randomization
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Was ALLOCATION adequately concealed (prior to assignment)? High No mention of randomization
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Were PARTICIPANTS adequately BLINDED? Low
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Were OUTCOME ASSESSORS adequately BLINDED? Unsure blinding of outcome assessors not mentioned in report
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Unsure missing outcome data not mentioned in report
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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? Unsure
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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 Unsure
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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 Unsure missing outcome data not mentioned in report
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Quality Rating
Guideline Used Overall Rating