This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Reduction of blood pressure and plasma triglycerides by omega-3 fatty acids in treated hypertensives.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Reduction of blood pressure and plasma triglycerides by omega-3 fatty acids in treated hypertensives.
Author Lungershausen YK., Abbey M., Nestel PJ., Howe PR.
Country CSIRO Division of Human Nutrition, Adelaide, South Australia.
Year 1994
Numbers Pubmed ID: 7852747
15611 (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)
  • Comments Comments (
    0
    ) |
2 Placebo Corn oil
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Australia
  • Comments Comments (
    0
    ) |
Funding source Industry only donated materials (eg, supplements)
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Volunteers with uncomplicated essential hypertension controlled by monotherapy with a beta-blocker or diuretic, or a combination of the two. Excluded if with history of unstable heart, renal, or liver disease, or with DBP >105mmHg, consumed more than 20 cigs or 40g EtOH per day, or exercised erratically. ANY VARIATION IN ANTIHYPERTENSIVE DRUG THERAPY WOULD NECESSITATE WITHDRAWAL OF THE INDIVIDUAL FROM THE STUDY.
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Duration of Intervention 6 weeks
  • Comments Comments (
    0
    ) |
If crossover trial, duration of washout period 4-6 weeks
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Hypertension ... Treated for hypertension, on medication
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Study start date(s) 1992 (approx)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100
  • Comments Comments (
    0
    ) |
Baseline characteristics, continuous 61
  • Comments Comments (
    0
    ) |
11.34
  • Comments Comments (
    0
    ) |
132.57
  • Comments Comments (
    0
    ) |
11.43
  • Comments Comments (
    0
    ) |
76.52
  • Comments Comments (
    0
    ) |
7.23
  • Comments Comments (
    0
    ) |
5.74
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
0.21
  • Comments Comments (
    0
    ) |
4.04
  • Comments Comments (
    0
    ) |
0.19
  • Comments Comments (
    0
    ) |
1.03
  • Comments Comments (
    0
    ) |
0.04
  • Comments Comments (
    0
    ) |
27.33
  • Comments Comments (
    0
    ) |
3.93
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
Male, percent 30.95
  • Comments Comments (
    0
    ) |
Race nd
  • Comments Comments (
    0
    ) |
Comments about baseline data Age, SBP, DBP, and BMI were presented separately for group given corn oil initially (n=22) and fish oil initially (n=20); sd derived from se, and combined mean and sd calculated per Cochrane Handbook.
  • Comments Comments (
    0
    ) |
Baseline diet description nd
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake nd
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? No
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: bp      Population: 46167
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 42 42
Mean 132 132
SD
SE 2 2


6 weeks

N Analyzed 42 42
Mean 128 131.1
SD
SE 2 2
Outcome: bp      Population: 46168
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 42 42
Mean 76.2 76.2
SD
SE 1.1 1.1


6 weeks

N Analyzed 42 42
Mean 73.6 75.4
SD
SE
Outcome: lipid      Population: 46169
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 42 42
Mean 1.6 1.6
SD
SE 0.12 0.12


6 weeks

N Analyzed 42 42
Mean 1.24 1.56
SD
SE 0.07 0.1
Outcome: lipid      Population: 46170
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 42 42
Mean 1.03 1.03
SD
SE 0.04 0.04


6 weeks

N Analyzed 42 42
Mean 1.06 1.04
SD
SE 0.05 0.04
Outcome: lipid      Population: 46171
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 42 42
Mean 4.04 4.04
SD
SE 0.19 0.19


6 weeks

N Analyzed 42 42
Mean 4.21 4.04
SD
SE 0.19 0.18

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) nd
  • Comments Comments (
    0
    ) |
Placebo

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low Cross-over study. Initial randomization (no further details) -- but everyone got the intervention.
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? Unsure
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? Low
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? Unsure
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Low Only one subject was withdrawn out of 43; not included in analysis. Reason: unstable HTN.
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) Yes
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) Low
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? Low
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table. No
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.