University of Minnesota

Bierenbaum St. Vincent’s Hospital Study

Type Diet/Drug (Stage): Diet (2º)
Study Category: The Prevention Trials (1946-1973)
Year Begun: 1959
Principal Investigator(s): Bierenbaum, M.L.

An early trial with design problems was carried out among 100 younger coronary patients: Marvin Bierenbaum’s 1959 study at St. Vincent’s Hospital in New York City. It originally avoided design issues similar to those of the Morrison and the New York Anti-coronary Club efforts by randomization of patients to treatments. But when the lower-fat, greater-polyunsaturates-diet failed to produce different blood-cholesterol levels between the groupa after six months, Bierenbaum and colleagues simply threw in the towel for the randomized design and recruited a group defined as matched-controls having “similar characteristics” to the original patients (Bierenbaum et al. 1967).

            After five years they found 16 coronary events in the diet group versus 19 in the so-called “controls” and claimed “significance,” a finding also not accepted by the scientific community. Bierenbaum continued to carry out similar types of projects and to claim benefit for hypertension with a calcium supplement and for coronary disease with vitamin E. Later he extolled both phytochemical and nutriceutical dietary supplements.

            Despite their basic misadventure, these early trial efforts served to arouse the medical community’s awareness of the opportunities for and the feasibility of intervening on diet in free-living populations. But they primarily demonstrated the overriding need to improve the design and conduct of preventive trials if the work were to be credible.

Bierenbaum, M. Modified-fat Dietary Management of the Young Male with Coronary Disease.  A five-year report.

(1967) JAMA. 202(13): 1119-1123.