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Type: Journal article
Title: Pitfalls in the use of randomised controlled trials for fish oil studies with cardiac patients
Author: James, M.
Sullivan, T.
Metcalf, R.
Cleland, L.
Citation: The British Journal of Nutrition, 2014; 112(5):812-820
Publisher: Cambridge University Press
Issue Date: 2014
ISSN: 0007-1145
Statement of
Michael J. James, Thomas R. Sullivan, Robert G. Metcalf and Leslie G. Cleland
Abstract: Randomised controlled trials (RCT) examining the effects of fish oil supplementation on cardiac outcomes have yielded varying results over time. Although RCT are placed at the top of the evidence hierarchy, this methodology arose in the framework of pharmaceutical development. RCT with pharmaceuticals differ in important ways from RCT involving fish oil interventions. In particular, in pharmaceutical RCT, the test agent is present only in the intervention group and not in the control group, whereas in fish oil RCT, n-3 fats are present in the diet and in the tissues of both groups. Also, early phase studies with pharmaceuticals determine pharmacokinetics and pharmacodynamics to design the dose of the RCT intervention so that it is in a predicted linear dose-response range. None of this happens in fish oil RCT, and there is evidence that both baseline n-3 intake and tissue levels may be sufficiently high in the dose-response range that it is not possible to demonstrate a clinical effect with a RCT. When these issues are considered, it is possible that the changing pattern of fish consumption and fish oil use over time, especially in cardiac patients, can explain the disparity where benefit was observed in the early fish oil trials but not in the more recent trials.
Keywords: Randomised controlled trials; Fish oil; Cardiac patients
Rights: © The Authors 2014
RMID: 0030013581
DOI: 10.1017/S0007114514001408
Appears in Collections:Public Health publications

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