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Efficacy of the National Cholesterol Education Program Step I Diet: A Randomized Trial Incorporating Quick-Service Foods

Ira S. Ockene, MD
Arch Intern Med. 1996;156(19):2262. doi:10.1001/archinte.1996.00440180126016.
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The article on the efficacy of the National Cholesterol Education Program Step I diet by Davidson et al,1 which appeared in the February 12, 1996, issue of the Archives, has a number of flaws that seriously compromise the results; in addition, the data were presented in a way that came across as quite misleading in the national press. The article emphasizes the value of a Step I diet that incorporates quick-service foods, but, in fact, it would have been more appropriate to have titled the article "Relative Inefficacy of a Step I Diet Incorporating Quick-Service Foods as Compared With a Usual Step I Diet." In Davidson and colleagues' study, the traditional Step I diet lowered total serum cholesterol levels by 8%, as opposed to only 3% in the fast-food diet group; likewise, low-density lipoprotein cholesterol levels were lowered 10% vs 4%.

The absence of a true control group seriously


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