Control of bias in dietary trial to prevent coronary recurrences: The Lyon Diet Heart Study.

BACKGROUND AND OBJECTIVES

A major limitation of dietary trials is that double blind design is not feasible. These trials are therefore prone to biases. The Lyon diet heart study is a single-blind secondary prevention trial to test the hypothesis that a Mediterranean-type of diet may prevent recurrences after a first myocardial infarction. A surprising 73% reduction of the risk of new major cardiac events was observed in the experimental group. For this reason, it is important to describe the methods used in the trial. We now report our techniques to randomize the patients, to change their diet and to control for possible bias, in particular any investigator or attending physician bias.

DESIGN

In this dietary trial, a specific design was used to recruit and randomize the patients without informing them and their physicians that they were participating in a comparative trial. The attending physician bias was evaluated by studying drug usage and the investigator bias by constructing a questionnaire from which specific scores were used to evaluate (1) how the patients appreciated their participation in the study and (2) whether this participation resulted in significant changes in their way of living.

SUBJECTS

605 survivors of a first myocardial infarction were randomized into either a control or a Mediterranean group.

RESULTS

The two randomized groups were similar for all the variables of prognosis. Drug usage was not significantly different between groups, suggesting that there was no major attending physician bias. Analyses of the appreciation scores and of the change score did not detect any significant investigator bias.

CONCLUSIONS

Although the study cannot be completely shielded from minor biases, the data presented here provide evidence that the dietary modifications per se were protective, not other (including psychosocial) changes resulting from the participation to the trial.