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. 2016 Aug 18;2016(8):CD005282. doi: 10.1002/14651858.CD005282.pub3

Bennett (low) 1995.

Methods

  • Study design: double blind RCT

  • Time frame: 6 months

  • Follow‐up period: 6 months
Participants

  • Country: USA

  • Setting: multicentre (3 kidney transplant centres)

  • 18 to 70 years, clinically stable kidney transplants (16 week open‐label baseline evaluation period)

  • Number: treatment group (22); control group (25)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: myocardial infarct/arrhythmia < 6 months; liver disease; malignancy < 2 years; investigational drug use < 3 months; severe gastrointestinal malabsorption; severe COPD; pregnancy; lactation; active infection; acute rejection < 2 weeks prior to period 2
Interventions Treatment group

  • 9 g MaxEPA (EPA 180 mg/g, DHA 120 mg/g) daily


Control group

  • Corn oil 9 g


Co‐interventions: not reported
Outcomes

  • Patient survival

  • Graft survival

  • Acute rejection

  • Kidney function (GFR and CrCl)

  • HDL/LDL cholesterol
Notes

  • Bennett (high) 1995 is the same study as Bennett (low) 1995

  • The high dose arm is analysed compared to half of the control group for continuous outcomes. Dichotomous outcomes analysed together

  • Results for low and high dose corn oil were combined (n = 50) in the published report

  • Exclusions post randomisation but pre intervention: none

  • Unpublished data provided by triallists

    • Stroke and myocardial infarction: no events

  • Completeness of follow‐up: 90/133 patients evaluated (similar number of patients in both groups)

  • Rate of non‐compliant drop‐outs not reported (although mentioned)

  • Results for low and high dose corn oil were combined (n = 50) in the published report.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Intention‐to‐treat analysis High risk No
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: 43 (32%)
Selective reporting (reporting bias) Low risk Outcomes relevant to our review were reported