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Study Title and Description

Short report: the effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Short report: the effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention.
Author Sacks FM., Hebert P., Appel LJ., Borhani NO., Applegate WB., Cohen JD., Cutler JA., Kirchner KA., Kuller LH., Roth KJ.
Country Channing Laboratory, Boston, MA.
Year 1994
Numbers Pubmed ID: 8021472
18365 (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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What is the name of this study? (e.g. DART, Physician's Health Study) TOHP
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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: age 30-54 years, mean diastolic blood pressure <95 mmHg, serum cholesterol <26o mg/dl and non-fasting serum glucose <200 mg/dl.
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Study Population Primary Prevention, Healthy
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Comment about study design: Since the placebo group served as a control not only in the fish oil trial but also for a trial of potassium supplementation, approximately half of the subjects in the placebo group (n = 86, 49o/o) were given olive oil capsules, and half (n = 89, 51 o/o) were given placebo potassium tablets.
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Duration of Intervention 6 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? 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) 1987
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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 122.9 122.6 43
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8.8 8.3 6.7
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81.0 81.1
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5.1 4.9
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nd nd
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190 189
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mg/dL mg/dL
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29 32
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nd nd
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46 45
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mg/dL mg/dL
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13 12
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nd nd
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nd nd
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nd nd
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Male, percent 70%
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Race 84-88%
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Comments about baseline data Baseline data wasn't collected for all subjects
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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
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Results & Comparisons


Results Data
Outcome: bp      Population: 52227
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 175 175
Mean 81.0 81.1
SD 5.1 4.9


3 months

N Analyzed 165 168
Change in Mean (SD) 5.6 5.5
Change in Mean -0.9 0.2


6 months

N Analyzed 161 157
Change in Mean (SD) 4.9 4.5
Change in Mean -0.5 0.0
Outcome: bp      Population: 52227
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6 months

Change in Mean 3
P value 0.01 compared with lowest quartiles
Outcome: bp      Population: 52227
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6 months

Change in Mean nd
Outcome: bp      Population: 52228
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

Mean 122.9 122.6
SD 8.8 8.3
N Analyzed 175 175


3 months

N Analyzed 165 168
Change in Mean (SD) 7.3 7.3
Change in Mean -1.4 -0.1


6 months

N Analyzed 161 157
Change in Mean (SD) 6.9 5.7
Change in Mean -1.1 -1.0
Outcome: lipid      Population: 52229
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 84 84
Mean 46 45
SD 13 12


3 months

N Analyzed 67 75
Change in Mean (SD) 6.6 7.1
Change in Mean -1.4 -1.6


6 months

N Analyzed 60 66
Change in Mean (SD) 8.1 7.4
Change in Mean 0.1 -1.7

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? Unsure Says "randomly assigned" but not how
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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
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? High Only total and HDL, not LDL
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INTENTION-TO-TREAT analysis? (Yes/No) No
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Group SIMILARITY AT BASELINE (**GENERAL**) Unsure
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Was there incomplete COMPLIANCE with interventions across groups? High Compliance was 69-74% in fish oil group
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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
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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.