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July 14, 1999

Effect of Lifestyle Changes on Coronary Heart Disease

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999

JAMA. 1999;282(2):130-132. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-2-jbk0714

To the Editor: Dr Ornish and colleagues1 report that intensive lifestyle changes without lipid-lowering drugs may induce reversal of coronary heart disease. This study is described as a randomized controlled trial, but the characteristics of the control group are uncertain.

The trial was conducted between 1986 and 1992 and all subjects at entry were not taking lipid-lowering drugs.2 The findings reported at 1 year indeed showed no meaningful changes in lipid levels in the control group. Ornish has stated, however, that he "went over their [control group] results with them after a year and invited them to attend a retreat to learn our program. Surprisingly, only a third of them did. Two have made changes comparable to those of the experimental group, about seven are making moderate changes, and the rest are doing pretty much what they were doing before."3 This statement directly contradicts the JAMA article,1 which states, "control group patients were asked to follow the advice of their personal physicians regarding lifestyle changes." Moreover, the report demonstrates that the control group at 5 years had lower lipid levels. Were these changes related to crossover between the experimental and control groups, use of lipid-lowering agents, or a combination of these factors? In any event, it appears that the "controls" were neither "usual care" nor "controls," for their status was changed at 1 year. Data concerning their care between years 2 through 5 would be helpful in interpreting the outcomes reported.