Copyright 1999 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.1999
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.
Herbert PN. Effect of Lifestyle Changes on Coronary Heart Disease. JAMA. 1999;282(2):130–132. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-2-jbk0714
Customize your JAMA Network experience by selecting one or more topics from the list below.